Self-reported Success Stories

Related Award(s):

1R43NR003474

Technology Developed:

The purpose of the early SBIR grant work was to validate and automate a standardized assessment instrument (the Pressure Sore Status Tool, originally authored by Dr. McNees' colleague, Dr. Barbara Bates-Jensen) for use in field settings for describing and tracking status changes in chronic wounds (e.g. pressure ulcers). The WSIS (Wound and Skin Intelligence System (tm) or WSIS(tm)) provides clinicians with the ability to assess risk and request a "case specific" prevention plan for reducing the probabilities that a wound will develop. The system tracks the realities of prevention and treatment outcomes over time and relates these outcomes to individual risk and wound profiles and interventions employed. Thus, the system has the capacity to "learn" from its own experience. All users of the WSIS submit periodic data to Applied Health Science in Seattle. Dr. McNees reports that currently the data comes in from Australia, New Zealand, Canada and the United States. The company's relationship (described subsequently) with Bristol-Myers Squibb and ConvaTec will likely result in dissemination and data accumulation from approximately 75 countries. Through this strategic world-wide approach to standardized assessment, intervention specification, data integration and analysis, Dr. McNees anticipates much faster determination of "better" practice and incremental improvements over time. A two-year controlled evaluation in a health region in British Columbia, Canada has been completed. The results reflect marked decreases in pressure ulcer prevalence and significant decreases in time to healing for chronic wounds.

Key Words:

Chronic wound, Pressure ulcer, Risk assessment, Pressure Sore Status Tool, WSIS

Uses of Technology/Products/Service:

Fundamental Assumption of Utility: The work was premised on the assumption that appropriate chronic wound management and treatment, as well as general improvements in practice could best be accomplished through: (a) objective descriptions of the status of the wound and (b) subsequent reliable reflections of change in that status. No such methodology or technology existed. Joining forces with Dr. Nancy Bergstrom (NINR has funded her prior R01 research; Chair of the AHCPR panels for Pressure Ulcer Prevention and Treatment) and Dr. Barbara Braden (namesake of the Braden Scale, the most widely used pressure ulcer risk assessment instrument) the system was elaborated to include not only wound assessment, but also risk assessment and tracking of changes in status across time. Through review of literature, guidelines and Dr. McNees' own data which was accumulated from beta testing, Dr. McNees has devised and automated a clinical decision support component for the system. Dr. McNees' publications support these statements.

Benefit to Company:

Dr. McNees states that his company has generated almost $2.25 million in addition to SBIR for product finalization and commercialization. Dr. McNees states that the current projections reflect $30 million annually in revenue from the United States market. ConvaTec is in the process of forming a new business unit. Applied Health Science anticipates adding about one employee for each 75 users of the system. Together with ConvaTec, Dr. McNees' company is forming strategic partnerships and alliances with other small businesses who provide technologies and services which add function and value to the existing system (e.g. a tele-medicine home health company in Chicago and a long term care claims processing company in Nashville).

How Product Was Commercialized:

ConvaTec is a wholly owned business unit of Bristol Myers-Squibb and is the largest wound products company in the world. After being approached by many of the major wound and skin products companies, Dr. McNees' company developed a strategic alliance with ConvaTec wherein they would provide continuation funding for follow-along and bridge work leading to the commercialization. In exchange, Dr. McNees granted a right-of-first-refusal for licensing the system. ConvaTec subsequently executed that right, thus merging Dr. McNees' technology and research capabilities with ConvaTec's marketing power; a presence in about 80 countries world-wide. ConvaTec subsequently bought all rights to the software. However, Applied Health Science (AHS) retained the world-wide data "pipelines", warehouse and analytical functions. AHS also has a right-to-first-review for any elaborations of or changes in the system.

Related Award(s):

5R43CA081835

Technology Developed:

Plate based assays for non-radioactive determination of PI(3,4,5)P₃ levels and PI 3-K activity in vitro and in biological samples.

Key Words:

Phosphoinositide 3-Kinase, PI 3-K, PI(3,4,5)P3, PI 3-Kinase, PI3K, Echelon

Uses of Technology/Products/Service:

Echelon has developed a non-radioactive way to measure and detect Phosphoinositide 3-Kinase activity in vitro and in biological samples. This technology has applications in cancer research focused on the PI 3-K cell signaling pathway. This pathway is suspected to play a major role in certain types of cancer.

Benefit to Company:

The benefit to our company from the PI 3-Kinase assay kit is: 1. Development of PI 3-K assay has lead to other ground-breaking research which has lead to more grants and more products. 2. New products have lead to increased sales revenue.

How Product Was Commercialized:

The PI 3-Kinase assay kit was commercialized through direct mail, tradeshow promotion, an email campaign, new product releases in content relevant publications and through research publication in peer reviewed journals.

Related Award(s):

N44CM097025

Technology Developed:

Humanitas, Inc., developed a suite of cancer informatics applications to assist health professionals in managing cancer clinical trials. This suite is distributed at no charge to users at a dedicated WebTIE website, http://www.webtie.org. The technology developed includes software for grading toxicity using a handheld computer, distance learning applications featuring searchable transcripts and audiovisual slide presentations, and an online document/proposal management system (http://www.epanel.cc).

Key Words:

cancer clinical trials, handheld computers, distance learning, website, document management, proposal management, online meetings

Uses of Technology/Products/Service:

Handheld CTC applications for the Palm PC and the Palm Pilot assist with recording and reporting accurate toxicity grading information with high integrity in a portable format. The State of the Science distance learning application provides searchable transcripts and audio-visual slide presentations about leading-edge basic and clinical cancer research issues presented at invitation-only meetings. The ePanel application is an online conferencing and document review management application that facilitates proposal evaluation in real time by participants in remote locations; provides a virtual conference room where users can create and share written evaluations, score, vote, and collaborate to produce an evaluation summary; and offers users the ability to manage a proposal or document evaluation process, including panel coordination, conference calls, customized voting and scoring, archived record storage, document sharing, and management reports. All applications have been independently evaluated and found to produce both usefulness and usability benefits to intended audiences. Humanitas has adapted the underlying technology for these products to serve the needs of the project's original sponsors and other federal and nonprofit health organizations. http://www.webtie.org http://www.epanel.cc http://www.humanitas.com

Benefit to Company:

The SBIR/STTR program has enabled Humanitas to broaden its expertise in developing innovative informatics technologies to meet the needs of health organizations. Products and services developed under the SBIR program were commercialized even before the end of Phase II, enhancing our firm's reputation for timely and excellent technical performance. These products and services have produced a steady stream of revenue and generated new corporate capabilities and growth.

How Product Was Commercialized:

Related Award(s):

1R43AA10181-01A1

Technology Developed:

An interactive CD-ROM offering information and treatment interventions to health professionals working across the perinatal/pediatric continuum.

Key Words:

FAS, Prenatal Alcohol Exposure, Obstetrician education, Pediatrician education, Birth Defects, Alcohol-Related defects, FAS Diagnosis, FAS Treatment

Uses of Technology/Products/Service:

This CD-ROM offers physicians, nurses, and other health professionals a concise and comprehensive course on FAS and other alcohol-related birth defects. Presenting the most recent research from the Institute of Medicine and featuring a cross-collaborative approach, this interactive CD-ROM: - Provides an overview of FAS including historical perspectives and diagnostic signs. - Details the prevalence and etiology of FAS. - Demonstrates methods for identifying women and children at risk, prenatally through adolescence. - Offers criteria to use in making a diagnosis of FAS. - Suggests strategies for making treatment plans and referrals for mothers and children afflicted by FAS. - Presents the most current and complete list of FAS resources.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

1R43DE010455,5R44DE008879,1R43DE011639

Technology Developed:

The technology developed from the NIH sponsored research was the SONICARE Power Toothbrush.

Key Words:

SONICARE, SONIC, Power Toothbrush, Cleans Beyond the Bristle

Uses of Technology/Products/Service:

Sonicare is highly valued by dental professionals as a consumer home care oral hygiene device.Sonicare cleans and whitens teeth;reverses gingivitis and reduces periodontal pockets;it also gently removes coffee,tea and tobacco stains while cleaning between the teeth.

Benefit to Company:

The NIH funding allowed Optiva to create a $300MM business and over 500 jobs.Sonicare has a 26% share of the USA power toothbrush business and, is now distributed worldwide. Optiva was sold to Philips Electronics in 2000.

How Product Was Commercialized:

The basis of Sonicares commercial success is strong professional endorsement. Awareness, trial and recommendation by dentists and hygienists is the primary area of focus.The product is broadly distributed in retail channels and supported by over $25MM in annual advertising spending.

Related Award(s):

1R43RR014937,5R44RR014937

Technology Developed:

Stellar Biotechnologies has successfully developed, optimized and demonstrated the first dedicated aquaculture technologies and non-lethal hemocyanin extraction methods for commercial scale production of keyhole limpet hemocyanin (KLH) from Megathura crenulata (the giant keyhole limpet) for biomedical applications. As part of our Phase 1 SBIR grant from the National Center for Research Resources, we successfully demonstrated that it is feasible to apply controlled-environment aquaculture technology to spawn and grow Megathura in captivity, and furthermore that these proprietary aquaculture technologies could support the sustained production of KLH for biopharmaceutical applications. In Phase II, we developed commercial-scale aquaculture systems and methods which were used to produce a controlled, sustainable, and highly reproducible supply of high quality crude KLH from animals grown in aquaculture.

Key Words:

KLH, hemocyanin, Megathura, Limpet, cancer, vaccine, aquaculture, immunostimulatory

Uses of Technology/Products/Service:

KLH has a long history of biomedical use as an immune potentiating molecule and carrier protein to which haptens and other poorly immunogenic molecules are conjugated to increase immunogenicity via recruitment of T helper cells. The current applications for KLH include a wide variety of promising experimental vaccines, including vaccines for the treatment of cancers, chemical dependencies and infectious diseases, and for immunological control of reproductive hormones. Among the most promising current applications for KLH are anti-idiotype and other tumor-associated antigen vaccines for the treatment of lymphomas and solid tumors. The technology developed through this SBIR grant will enable the controlled and sustained production of commercial quantities of this medically valuable immunostimulatory protein from a renewable aquaculture source. KLH, which is a high molecular weight marine natural product protein, has previously only been obtainable by lethal ex-sanguination of the marine mollusc Megathura crenulata. Prior to the successful completion of this SBIR project, the potential for commercialization of KLH-based therapeutic products was greatly constrained due to dependence upon the variable, limited and potentially threatened wild population of animals. Additionally, the lack of control and potential for adventitious contamination of zoonotic products derived from wild sources has made the regulatory approval of KLH-based products from wild animals increasingly more difficult. With the success of this SBIR project, KLH is now available in commercial quantities from a fully controlled aquaculture source. Our proprietary, non-lethal methods are harmless to the source animals and proven to maintain the highest possible quality and reproducibility of the finished product. These innovations will assure a reliable supply of safe, medical-grade KLH for better vaccine discovery, development, and commercialization to the benefit of cancer patients, researchers, and clinicians worldwide.

Benefit to Company:

The financial support from the NCRR’s SBIR program has provided a critical financial bridge between the initial development and subsequent commercial demonstration of our aquaculture technology for KLH production. Despite a clear need for our technology and product by several biopharmaceutical companies, the technology was thought to be too specialized and costly to justify direct capitalization by strategic partners. The continuity of support provided by the SBIR program allowed our company to negotiate future supply agreements with prospective customers during the demonstration of the commercial feasibility of the technology, thus facilitating both development and future commercialization of the needed technology. The SBIR support also allowed the company to acquire and train technical staff and dedicate specialized facilities required for KLH production operations.

How Product Was Commercialized:

Early commercialization of the KLH product resulting from the successful completion of this project has been accomplished through the formation of strategic alliances and/or supply agreements with biopharmaceutical companies currently developing KLH-based vaccine products. Stellar identified a least six companies with KLH-based cancer vaccine products in late-stage clinical trials and has already negotiated KLH supply agreements with two of these companies. The commercialization strategy embodied in these supply agreements, offers our commercial partners: 1. A guaranteed minimum supply of KLH to meet the partner’s requirements during clinical trials and Biologics License Application (BLA) approval. 2. Guaranteed production capacity to meet the commercial demand at the level forecasted after BLA approval. 3. An established price structure acceptable to both parties based on product specifications and demand estimates for the post-BLA approval period. 4. Guaranteed minimum purchase quantities sufficient to meet Stellar’s operating costs and overhead, as required, to support the guaranteed capacity. 5. Acceptable provisions for early termination in the event of the failure to obtain BLA approval. Through this formula Stellar expects to continue to provide a supply of crude KLH sufficient to support the current demand of researchers and clinicians, both in the private sector as well as within the multi-categorical institutes of the NIH, with scalability to meet demand during commercialization

Related Award(s):

5R44MH057614-03

Technology Developed:

The project was successful and additional enhanced versions of the SmartQuest software package continue to be released and paid for entirely through sales of this self-sustaining project. SmartQuest was developed as a computerized system that admininisters dynamic questionnaires (i.e., computerized adaptive tests, CAT), collects and manages patient-reported outcomes (PRO) data, and creates reports of health-related quality of life status for clinical researchers, patients, and health care providers (NIH RFA-RM-04-011).

Key Words:

Patient-Reported Outcomes, IVR, CAT, Mental Health, Substance Abuse, Interactive Voice, Computerized Adaptive, IRT

Uses of Technology/Products/Service:

SmartQuest is designed to administer surveys to anyone who has access to a telephone. SmartQuest software can run up to 99 surveys simultaneously, in any language. The system has the ability to branch to different questions, surveys, or telephone numbers based on callers' responses and complex algorithms. It automatically scores surveys as they are completed and stores all results in a Microsoft Access or other standard database. Patients can call directly into a survey or be transferred to a survey by a staff member. Either way, SmartQuest provides the potential for real-time outcomes tracking 24 hours a day, 365 days a year. Each SmartQuest CD installs easily on a PC, and with the help of a standard telephone, customers can create and record their own surveys or interviews for callers. These surveys can gather numeric or spoken information and can relay information tailored to the individual client. With the new DialQuest feature, customers can import calling lists, admininister fully-automated surveys, or deliver recorded information to their screened client list. No special training is required to operate SmartQuest Interactive Voice Response (IVR) software.

Benefit to Company:

The project was successful and additional enhanced versions of the SmartQuest software package continue to be released and paid for entirely through sales of this self-sustaining product. With the new DialQuest feature, customers can import calling lists, administer fully-automated surveys, or deliver recorded information to research subjects.

How Product Was Commercialized:

SmartQuest had many users outside of Mental Health and Healthcare more broadly. These additional users have the capacity to drive further technological innovations of SmartQuest. Telesage had benefited greatly from NIH grant awards and SmartQuest has achieved financial self-sufficiency. A sample of TeleSage customers who have purchased SmartQuest is provided below: Grant-based Healthcare Research: Case Western Reserve University, Cincinnati Children’s Hospital Medical Center, Cook County Hospital, The Johns Hopkins School of Medicine, McLean Hospital, University of California-Los Angeles, University of California-San Diego Medical Center, University of Central Florida-Orlando, University of Connecticut, University of Michigan, The University of North Carolina, University of Pennsylvania Health System, University of Vermont, and University of Washington School of Medicine. Private Healthcare Research: BehaviorTech Solutions, Blue Cross/Blue Shield, Camino Medical Group, Florida Department of Children and Families, Friends Hospital, Idaho Department of Health and Welfare, KidsPeace, Mid Valley Behavioral Care Network, 18 counties in the Ohio Public Mental Health System, Ohio University, Providence Hospital, Psagot Institute, Public Health Institute, United Behavioral Health, and ValueOptions. Other Purchasers: ALCOA, Area Market Research, Arlex Technology, ASDE Survey Sampler, Audiomakers, Casey Industrial, Certified Audit of Circulations, Coastline Community College, Consumer Aptitudes, Cummins Inc., DISC Information Services, Daimler Chrysler Services, Delfax Solutions, ESPN, Facts Research, Fastline Publications, Fireman’s Fund Insurance Company, Founders Bank, GE Capital Bank of Sweden, Global Marketing, Hammer & Williams, Interviewing Services of America, Jostens, Market Probe, Markinetics, Microfour, Muskingum Valley ESC, National Research Corp, National Support Center, PSP HR Consulting, Panel Opinions, Pitney Bowes, Predictive Concepts, PriceWaterhouseCoopers, RAND, RTNielson, Research International, Sawtooth, Score Sports Network, Shop ‘n Chek, Silicon Smarts, Smith Research, Statistics Canada, Trend Integration, VGM Technologies, and Westat.

Related Award(s):

1R41HD039020-01,1R41HD039020-02

Technology Developed:

The SmartWheel examines the biomechanics of wheelchair propulsion by precisely measuring parameters including stroke frequency, propulsion angle, acceleration, forces applied to the handrim, velocity, and distance traveled. The SmartWheel is the only commercial product in the world that measures propulsion biomechanics in the natural environment of the wheelchair user. The SmartWheel's high-speed wireless technology, sophisticated on-board computer, and user-friendly interface allow for the collection of wheelchair propulsion data in nearly any lab, clinical or field setting. The unique capabilities that the SmartWheels offers have the potential to revolutionize wheelchair-related rehabilitation research and clinical practice.

Key Words:

wheelchairs, wheelchair propulsion, wheelchair biomechanics, measurement, wheelchair positioning, wheelchair selection, wheelchair seating, insurance justification

Uses of Technology/Products/Service:

The SmartWheel is a research tool and is being developed as a clinical tool. As a research tool, the SmartWheel has been used for over a decade to measure the biomechanics of wheelchair propulsion and, in turn, enhance understanding of the causes of pain and injury among wheelchair users. Dr. Rory A. Cooper and his colleagues built the original hard-wired SmartWheel and published the first paper (Asato, Cooper, Robertson, & Steer, 1993) validating its use as a propulsion biomechanics measurement tool. Since then, research has continued to accumulate on the antecedents and consequences of manual wheelchair propulsion biomechanics. The SmartWheel has also been used to study how wheelchair equipment decisions affect propulsion and to demonstrate the efficacy of interventions intended to improve an individual’s ability to propel a wheelchair. Today, wireless SmartWheels produced by Three Rivers reside at leading research institutions across the US and Canada including the Rehabilitation Institute of Chicago, the University of Michigan, the Rehabilitation Institute of Montreal, the University of Washington, the Kessler Medical Rehabilitation Research and Education Corporation, the University of Pittsburgh, and the University of Alberta. The SmartWheel is also being developed as a leading edge clinical tool that can assist clinicians with: 1) Justification of Equipment Decisions for Insurance Reimbursement: The data generated by the SmartWheel provides a quantified, concrete, and easily understood justification for wheelchair-related equipment decisions. For example, because the SmartWheel measures the amount of force a person is able to apply to the wheelchair handrim, it can be used to determine (and justify) whether an individual may be best suited for a manual, power-assist, or power wheelchair. 2) Selection of the Appropriate Manual Wheelchair: The SmartWheel allows for comparisons of force and power output profiles as the user propels in different manual wheelchairs. So, for example, a user's performance (e.g., propulsion efficiency) can be compared when propelling in a lightweight chair vs. an ultra-lightweight chair. 3) Training Wheelchair Users to Improve Propulsion Efficiency: Training can be employed to assist wheelchair users to reduce the stress on their arms by using a longer stroke, reducing their stroke frequency, and minimizing wasted forces (e.g., pushing directly down on the handrim). Because the SmartWheel provides biofeedback information including real-time values for parameters such as stroke length and peak force, this real-time feedback can assist wheelchair users to maximize their propulsion efficiency. 4) Creation of a Patient Data Base: Data collection with the SmartWheel is fully automated. Each time a client propels a wheelchair on which a SmartWheel has been mounted, a complete report is automatically generated. These reports can then be easily imported into a database. This database can be used to further support equipment decisions (by allowing referral to similar cases in the past) and can be used to compare a client's propulsion efficiency from one clinic visit to the next, providing the clinician with the ability to track the progress of physical therapy on propulsion ability. Taken together, these applications of the SmartWheel will play an important role in helping clinicians quantify the process of wheelchair selection and training, and will help to reduce the risk of pain and injury (e.g., repetive strain injuries) that are so common among manual wheelchair users.

Benefit to Company:

The SBIR/STTR Program has provided a tremendous benefit to our company. The Phase I and Phase II grants expedited the product development and testing of the SmartWheel – and in particular facilitated its transformation from a hard-wired non-commercial research tool to a wireless, user-friendly commercial clinical and research tool. The grants also allowed us to partner (via subcontracts) with leading experts (Dr. Rory A. Cooper and Dr. Michael Boninger at the University of Pittsburgh) insuring a high quality R & D effort. Finally, by expediting R & D, the SBIR/STTR program also accelerated the timeline of market entry, so the SmartWheel could get to the clinicians and researchers who need it most. The SmartWheel was also Three Rivers’ first commercial product, introduced in the first half of 2002. Revenue from SmartWheel sales grew by 20% from 2002 to 2003 and will very likely double from 2003 to 2004. By 2006, we expect that cumulative SmartWheel sales will exceed $1 million.

How Product Was Commercialized:

The primary strategy used in the commercialization of the SmartWheel has been to direct initial sales efforts at “centers of influence” in both the clinical and research community. Direct sales efforts (e.g., in-services, demonstrations at professional conferences, and face-to-face educational efforts) have successfully penetrated these leading clinics and research institutions, and they, in turn, have provided and will continue to provide the most rigorous test of the SmartWheel. In addition, successful incorporation of the SmartWheel into the central mission of these “centers of influence” has helped and will help pave the way for sales throughout the research and clinical communities.

Related Award(s):

5R44CA081948

Technology Developed:

A computerized tailored intervention was developed using expert system technology, aimed at increasing effective stress management. The program provided individualized, tailored feedback based on the Transtheoretical Model of Behavior Change on a population basis through the mail and telephone. Individuals completed assessments either on the telephone or through the mail, and received tailored print communications in addition to a stage-of-change-based manual. The expert system and stage-based manual have since been adapted for interactive use on the Internet.

Key Words:

stress management, Transtheoretical Model, Stage of Change, Population Intervention, Tailored Communications

Uses of Technology/Products/Service:

The stress management health behavior change intervention is based on the Transtheoretical Model of Change and consists of stage-matched, normative feedback reports (compared to peers) at 0, 3, and 6 months, with an addition of ipsative feedback (compared to self) at 3 and 6 months. Feedback reports are tailored to the individual at each time point based on the theoretical model, scientific databases, and their survey responses to specific constructs including stage of change for stress management, use of processes or strategies of change, self-efficacy or confidence, and decisional balance (pros and cons). These tailored print communications are provided to participants through the mail. In addition, participants receive a stage-based self-help manual for stress management to which feedback reports refer the participants for more guidance. This stress management intervention has been licensed for use by: --Schering Plough for HUMANA employees online in the form of an interactive workbook --Blue Cross Blue Shield of RI for a pilot incentive health behavior change program for their employees through online and paper versions --Haelan Group for their subscribers who take the program online after being recognized through a health risk assessment.

Benefit to Company:

The Pro-Change Stress Management Program is a computerized tailored intervention based on the Transtheoretical Model of Behavior Change (TTM). It consists of a series of assessments and tailored feedback that provides both normative (compared to peers) and ipsative (compared to self) guidance to individuals on how they can more effectively manage their stress. Interactions take place either through the mail and telephone, or can be interactive over the Internet. Communications are tailored to the individual during each interaction based on the TTM, scientific databases, and survey responses to specific constructs including stage of change for stress management, use of processes (strategies of change), self-efficacy (confidence), and decisional balance (pros and cons). In addition, participants have access to a stage-based, self-help manual for stress management to which tailored communications refer participants for more guidance. These manuals are available in a print form, or in an interactive online workbook. Results of a clinical trial of the effectiveness of the program can be found in: Evers, K.E., Prochaska, J.O., Johnson, J.L., Mauriello, L.M., Padula, J.A., & Prochaska, J.M. (2006). A Randomized Clinical Trial of a Population and Transtheoretical-Based Stress Management Intervention. Health Psychology, 25 (4), 521-529. For a short demo of the online program, go to: http://www.prochange.com\stressdemo The Pro-Change Stress Management Program has been licensed for use either individually or as a module in the larger LifeStyle Management Program by: —Healthways, Inc., who in turn distributes the program to employers and insurance providers. —Schering Plough, for employees to use online in the form of an interactive workbook. —Blue Cross Blue Shield of RI, for a pilot incentive health behavior change program for their employees through online and paper versions. —Quality Health Solutions, who in turn distributes the programs to employers and universities. —MediFit, who in turn distributes the program to large employers.

How Product Was Commercialized:

Pro-Change commercialized the Stress Management Program through in-house resources.

Related Award(s):

5R44MH052484-03S1

Technology Developed:

Journey into the Brain is CD-ROM adventure game for children ages 7-11. It is marketed as both as a consumer product for 11-14 year olds and as a supplemental learning program for middle schools.

Key Words:

CD-ROM, Neuroscience, Education, Multimedia, Computer Game

Uses of Technology/Products/Service:

Journey into the Brain • Generates increased interest and knowledge in neuroscience among children, ages 7-11, by making this complex science exciting and accessible to them through the use of multimedia. • Communicates complex concepts so young children can follow their interests in a way that allows for differences in modes of learning. Key concepts of brain structure and function are woven into the game play. • Increase the level of safety awareness among this age group of children regarding issues such as the im-portance of wearing bike helmets. * Gives children a sense of awe for their own rapidly developing brains while helping them develop a stronger, more powerful brain.

Benefit to Company:

Morphonix, a developer of new technology (CD-ROMs and web sites) was founded to bring together professionals to design and create programs that educate and support children. The SBIR program has helped Morphonix to develop technology-based computer games and instructional materials that make learning challenging, engaging and fun. New technology is helping educators face the challenge of preparing youth for higher education, work and citizenship in a changing world. Morphonix supports this process by creating material that fit into diverse settings. Journey into the Brain has won many awards including: Best of Show, 1999 Best of the Northbay Awards; the 2000 National Parenting Publications Gold Award; All-Star Rating from Children’s Software Review; Finalist, 1999 Educational Title of the Year (The Academy of Interactive Arts and Sciences); Finalist, Independent Games Festival at the 1999 Computer Game Developers Conference. Many software games spur adolescents to use their brains, but Journey into the Brain is the first to teach children the science of their brains at the same time.

How Product Was Commercialized:

Journey into the Brain was released in 1999 and has sold over 36,000 copies. Morphonix sells its products though distributors and its web site.

Related Award(s):

5R44HG002003

Technology Developed:

The project contributed to the development of BeadLab, a high-throughput system for single nucleotide polymorphism (SNP) genotyping.

Key Words:

polymorphism, SNP, genotyping, genetics, oligonucleotide, fiberoptic, array, multiplex

Uses of Technology/Products/Service:

The BeadLab technology is used for large-scale genotyping projects for the analysis of genetic variation, such as the International HapMap Project (http://www.hapmap.org). A primary use of the technology is to help identify the genetic causes of disease, with the aim of improving diagnosis, management, treatment and prevention of common diseases, and to assist in drug discovery and development. The system is designed not only for generating many genotypes per sample, but also to process many samples accurately, with automated sample tracking and data analysis. The system has been demonstrated to be accurate, robust, high-throughput and cost-effective, and is used by a number of major genomics centers throughout the world. It is also used by Illumina, Inc. as part of its genotyping services operation.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

R21HG001911

Technology Developed:

The project demonstrated the feasibility of decoding randomly assembled arrays of beads in wells. The decoding process is a crucial aspect of Illumina’s BeadArrayTM technology.

Key Words:

decoding, bead, random, oligonucleotide, fluorescence, microarray, snp genotyping, gene expression

Uses of Technology/Products/Service:

The project enabled the manufacture of a novel type of microarray based on random assembly of beads in wells. This is called the BeadArrayTM technology. The arrays are highly miniaturized, robust and cost-effective. As a result, the project has enabled the development of a wide variety of applications based on BeadArray technology, including single nucleotide polymorphism (SNP) genotyping and gene expression profiling. Illumina sells genotyping and gene expression profiling systems that are based on decoded arrays, and also supplies the arrays and reagents as consumables for these high-throughput systems.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

5R42MH059501

Technology Developed:

INSL developed radio frequency coils integrated into animal holders for high field magnetic resonance imaging in conscious mice, rats, and monkeys.

Key Words:

imaging conscious animals, functional MRI, radiofrequency electronic, mental illness, drug discovery, drug addiction, epilepsy

Uses of Technology/Products/Service:

Insight currently has over 150 products in use and partnerships with several OEM Companies. Our customers include numerous pharmaceutical companies, and major research universities throughout the world. I Insight technology has been used in over 40 peer reviewed articles and over 90 conference proceedings.

Benefit to Company:

Work in this field has lead to the successful marketing of a line of preclinical/research imaging products. The capabilities developed at our company over the last 10 years has lead to the development of 2 commercial clinical products, with future products under development.

How Product Was Commercialized:

Related Award(s):

N44CO33073

Technology Developed:

Under Phase I and Phase II SBIR contracts from the NCI, ISG developed a complete patient record in electronic form on a very compact medium that could be carried by a typical oncology patient and used at various health care provider organizations in the course of treatment for that patient. In conjunction with Sony North America, who had developed a suitable medium and inexpensive platform-independent player, ISG developed and demonstrated a RDBMS-based system for the exchange of medical record information among computerized patient record systems. Textual and image longitudinal patient data and patient specific information retrieved from knowledge bases such as PDQ and Cancerlit were stored on a Minidisk magneto-optical storage disk. Patient and provider authorization cards were used for security control. Standards from ACM, HL-7, ACR and others were used for representation of various types of medical information.

Key Words:

patient record, medical information, electronic storage, portable

Uses of Technology/Products/Service:

The patient record in electronic form on a very compact medium can be carried by a typical oncology patient and used at various health care provider organizations in the course of treatment for that patient.

Benefit to Company:

How Product Was Commercialized:

This program is currently in the Phase III commercialization stage awaiting the legislative impetus that will move health care facilities toward adoption of fully electronic patient information systems. When the infrastructure becomes available for widespread implementations of computerized patient record systems, the Portable Patient Record concept is in place for the exchange of data.

Related Award(s):

1R43GM061511-01

Technology Developed:

The project developed ultra high throughput synthesizer of oligonucleotides which enabled Illumina’s technology of randomly assembled arrays. Centrifugation synthetic technology was applied to the challenging area of extremely moisture sensitive DNA synthetic chemistry.

Key Words:

DNA synthesis, automated synthesizer, SNP analysis, genotyping

Uses of Technology/Products/Service:

An array of automated synthesizers was built and the specialized laboratory (Oligator Farm® facility) was created. This dedicated facility has now a capacity of over 400 million bases in one year (more than 20 million DNA of an average length 20). Output of this laboratory is used for internal consumption in the genotyping and gene expression products and services provided by Illumina, Inc, and serves the needs of external customers. Orders of custom oligonucleotides in the range of hundreds to tens of thousands are fulfilled promptly at industry leading prices. The quality of the production is carefully monitored not only at the end of the synthesis by classical analytical techniques (capillary electrophoresis and mass spectrometry), but also every step during the synthetic process is evaluated in the real time by an application of noninvasive optical (proprietary) process.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

5R44AI043789-04,5RR44AI043789-6

Technology Developed:

LigoCyte has developed a monoclonal antibody capable of inhibiting inflammatory disease in the lung.

Key Words:

chronic inflammation, antibody, adhesion, pulmonary

Uses of Technology/Products/Service:

This technology is a therapeutic drug to treat chronic inflammatory disease.

Benefit to Company:

The SBIR program has had a profound impact on the ability of the company to develop this technology. Using data generated through research performed under the grant, LigoCyte was able to secure a pharmaceutical partner for the technology who is supporting further development, human clinical testing, manufacturing and product sales.

How Product Was Commercialized:

In continuing partner discussions.

Related Award(s):

1R43MH058964,1R44MH058964,1R43DA014889,5R44DA014889

Technology Developed:

Automated digital video analysis of lab animal behaviors, especially rodents' behaviors. These behaviors include home cage activity, open field locomotion, object recogntion, various mazes, fear conditioning, depression tests, etc.

Key Words:

digital video, lab animal, behaviors, automated analysis

Uses of Technology/Products/Service:

(1) Developing advanced digital video technologies in behavior analysis that can be applied for behavior analysis for both human and lab animals (2) Automatic analysis of lab animal behaviors (3) Using animal's full body information and identify their body parts to determine their behaviors (4) First time making it possible to exactly measure many novel behaviors and novel parameters that have never been possible before (5) Achieving real time operation and high throughput to meet the demands in scientific research

Benefit to Company:

(1) Company grows from 2 people to 6 persons (2) Establish technology platform (3) One patent issued from USPTO, 2 pending (4) 25 high profile customers in 14 months, including MIT Whitehead, Salk Institute, The Jackson Lab, Johns Hopkins University, University of Cincinnati, University of Florida, Eli Lilly, Merck Sharp and Dhome, Astra Zenica, J&J, Amgen, etc (5) $300K commercial revenue and $35K non-NIH grant (6) Technologies that can be extended to many other fields including homeland security (7) Increasingly large market share and $500K to $1M annual revenue expected.

How Product Was Commercialized:

We have been successfully self-bootstrapping in commercializing our products. We invest our own money and all SBIR fees to attend conferences like SFN. We started to get customers from those tradshows. We use the sales of first few products to attend more tradeshows and visit potential customers for demos. These activities attracted more customers. We also use email, websites, and publications to gain more customers.

Related Award(s):

5R44AA011703

Technology Developed:

1. A Windows-based brief motivational intervention for problem drinkers, the Drinker's Check-up (DCU). 2. A follow-up Windows program that automates collection of follow-up data and provides outcome report functions, the Follow-up Drinker's Check-up (FDCU). 3. A web application for the general public that parallels the Windows version of the DCU.

Key Words:

alcohol problems, brief intervention, computer intervention, program evaluation

Uses of Technology/Products/Service:

The DCU web application for the general public is for heavy drinkers who have experienced alcohol-related problems or are at risk for developing alcohol problems. It helps them resolve their ambivalence about changing and enhances their internal motivation to change their drinking. The Windows programs are designed for use in healthcare clinics and treatment programs. The DCU does the same thing as the web application but the Windows program has an Administrator's module in which therapists can manage the database. The FDCU allows providers to collect follow-up data at up to 3 follow-up points. It also has extensive outcome report features that can be used both clinically and in program evaluation.

Benefit to Company:

How Product Was Commercialized:

Both products were ready for release to the public by the end of the research grant. The web application is marketed through ads on Google and addiction related web sites.

Related Award(s):

2R44HL059715,1R43CA077098-01,1R41CA081842-01,1R41RR013233-01,1R43AI052504-01,1R43DE015923-0,5R44HL070411-03

Technology Developed:

We developed a highly sensitive test to detect low concentrations of volatile organic compounds in breath. Clinical studies have shown that this breath test provides a sensitive and specific marker of heart transplant rejection, lung cancer, breast cancer and pulmonary tuberculosis. The Food & Drug Administration has approved the breath test for heart transplant rejection (Heartsbreath) for clinical use.

Key Words:

breath, volatile, heart transplant, lung cancer, breast cancer, tuberculosis

Uses of Technology/Products/Service:

Breath testing could provide a new way to detect diseases such as lung cancer and breast cancer in their earliest stages, when treatment is most effective. Breath tests are completely safe and painless, as well as less expensive than competing technologies. Potentially, these new breath tests could save lives and reduce the cost of health care.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

5R44AI034805-03

Technology Developed:

Calanolide A is a non-nucleoside reverse transcriptase inhibitor (NNRTI) of HIV-1 and, as such, belongs to a highly favored drug class among practicing physicians who treat HIV patients, primarily because NNRTIs have longer-term therapeutic benefits over other drug classes.

Key Words:

HIV, Clinical Trials, NNRTI, resistance, in vitro, in vivo, calanolide, natural product

Uses of Technology/Products/Service:

Calanolide A has a resistance profile that positions it well for rapid entry into the salvage treatment market for treatment-experienced patients, and also first- and second-line treatment strategies. In vitro studies show that Calanolide A remains active against many drug-resistant forms of HIV, while also interacting synergistically with other anti-HIV drugs, thereby positioning the drug well for future therapeutic combination treatments.

Benefit to Company:

Calanolide A is the Company's lead product. If It can become our Company's first commercialized product it will both help seriously ill patients improve their lives and will help the Company prosper.

How Product Was Commercialized:

Sarawak MediChem Pharmaceuticals has assembled a network of contract providers to assist in the preclinical and clinical development of calanolide A. This network has conducted the numerious preclinical laboratory and animal studies as well as the phase I human clinical trials necessary to test the safety of Calanolide A in humans. Our joint venture with the Malaysian Government has helped fund the development process.

Related Award(s):

1R43CA086767-01,2R44CA086767-02,1R43CA094628-01

Technology Developed:

MarkPap(r) technology (formerly CAP-PAP test) is a specific biomarker-based in vitro diagnostic investigational medical device for detection of abnormal cells in cervico-vaginal specimens. The biomarker is the cervical acid phosphatase (CAP), which is visualized as a red intracellular deposit on a bluish Papanicolaou background (PAP). It clearly highlights abnormal cells and serves as a "stop light" for sceeners to prevent overlooking abnormal cells. The test increases accuracy (better sensitivity, equivalent specificity) of cervical cancer screening.

Key Words:

MarkPap test, Cervical cancer, Acid phosphatase, Pap test, Cancer biomarkers, Pap smear, Liquid-based Pap, Cancer screening

Uses of Technology/Products/Service:

Cervical cancer is a preventable disease if detected on time. In spite of efforts and improvements, the rate of false-negatives is still high. Using MarkPap technology in two clinical laboratory trials on 2,000 subjects/specimens, we have seen 50% increase in detection of abnormal specimens and 50% decrease of false-negatives in comparison with the standard. The MarkPap Research Kit (manufactured by Ricca Chemical Company, Arlington, TX) and the MarkPap Solution are available for research purposes only in the US. The test is made very simple, customer-friendly and inexpensive that could be easily implemented in every laboratory performing Pap test.

Benefit to Company:

The financial support from NIH/NCI SBIR program was crucial for the development of MarkPap technology from an original idea to commercial products (test, kit and solution). SBIR phase-1 grants helped to prove the feasibility of the new concept on both slides and liquid-based specimens, and the phase-2 SBIR grant helped to prove the safety and efficacy of the new technology in comparison with the standard clinical practices. A Continuation phase-2 SBIR grant application, intented to acquire data required for FDA Pre-Marketing Approval, is pending review in July 2004.

How Product Was Commercialized:

BioSciCon is looking for partners to commercialize the technology for intended application.

Related Award(s):

5R44EY014739

Technology Developed:

This initial grant was the first of several successful SBIR grants the culmination of which is SurModics’ PhotoLink® surface modification technology platform. This photochemical process improves medical device surface characteristics such as lubricity, hemocompatibility, infection resistance, biomolecule immobilization, and tissue integration. Coatings modify surface characteristics by either passivation to prevent undesirable biological responses, or by activation to incorporate a specific functionality or functionalities into the device/environment interface. PhotoLink technology allows device manufacturers to design products with the biocompatibility and functionality they require without sacrificing desired physical or dimensional properties. The proven success of the PhotoLink technology and process lies in its inherent simplicity, versatility, and consistently high performance.

Key Words:

Surface modification, Immobilization chemistry, Medical device coatings, Hemocompatibility, Cell encapsulation, Drug-eluting coatings, DNA immobilization, Photoactivation

Uses of Technology/Products/Service:

The PhotoLink technology platform is widely commercialized for use on medical devices such as catheters, guidewires, pacemaker leads, coronary stents, etc. and also led to the successful development and commercialization of an activated slide for DNA immobilization. Additionally, the technology has been adapted for use in delivering drugs from the surface of a device as well as cell encapsulation and other tissue engineering applications.

Benefit to Company:

The initial project was successful, and along with several additional SBIR-sponsored projects, enabled SurModics to develop a surface modification technology platform which it now licenses to medical device manufacturers around the world. SurModics had its first profitable year in 1997 and became a public company in March 1998.

How Product Was Commercialized:

SurModics' strategy is to license its surface modification technology to medical device manufacturers who apply the coatings to products in their own facilities. By partnering with the world's leading medical device and biotechnology companies, SurModics has leveraged and expanded its core lubricious coating technology, and now offers a diverse portfolio of product-enhancing capabilities.

Related Award(s):

1R43HD039036-01,2R44HD039036-02

Technology Developed:

The StepWatch Activity Monitor (SAM) is a highly adjustable, computer-programmable instrument that is worn on the ankle and records the number of steps taken every minute for up to 2 months between downloads. It is unobtrusive, waterproof, maintenance-free, and extremely durable. Accuracy typically exceeds 98% regardless of walking style, from completely functional to highly impaired. It is equally accurate for persons who are obese as for those who are not and is capable of monitoring low weight-bearing activities such as water aerobics. The data are transferred to a personal computer for display, filtering and analysis. Because the step counts are recorded every minute, patterns and intensity profiles of activity can be examined as well as overall activity level. A standard report can be printed for inclusion in medical records. The raw data and analysis results can easily be exported to spreadsheets. A built-in database can be used to track individuals over time or compare study groups.

Key Words:

walk, physical activity, ambulatory monitoring, pedometer, StepWatch, SAM, step, instrument

Uses of Technology/Products/Service:

The StepWatch is in use by researchers and/or clinicians on four continents to evaluate status, function, outcome or behavior for many purposes. Topics have included lower limb prosthetics, total hip replacement, total knee replacement, hip fracture rehabilitation, stroke rehabilitation, bio-materials development, surgical efficacy, diabetes, peripheral vascular disease, brain injury, spinal cord injury, Parkinson’s disease, dementia, cerebral palsy, muscular dystrophy, spina bifida, obesity, physical therapy, exercise interventions, health maintenance, population description, and many others.

Benefit to Company:

The Phase I and II SBIR grants allowed us to effectively start up the company; attract talented, experienced employees; re-design hardware for manufacturability; significantly reduce manufacturing costs; create powerful, user-friendly software (PC and Mac); collect normative data; complete demonstration projects; and obtain FDA clearance for the StepWatch.

How Product Was Commercialized:

The product was initially commercialized solely through scientific presentations/ publications, word of mouth, and information available on a website. Recently added approaches are trade show and scientific conference exhibitions, advertisements in trade magazines, direct mailings, targeted emails, press releases, and newspaper articles.

Related Award(s):

1R43DK054559,2R44DK055909,1R43DK061815

Technology Developed:

People with diabetes are highly susceptible to ulceration and amputation of their lower extremities due to the development over time of peripheral neuropathy. The lack of feeling in the feet, our body’s early warning system, combined with any type of mechanical stress can lead to inflammation which places the patient at a high risk for amputation. Xilas has developed a family of products that assist the diabetic patient and their doctors in the prevention of these devastating and costly events.

Key Words:

diabetes, diabetic foot ulcer, amputations, friction, dermal thermometer, early warning tool, GlideSoft, TempTouch

Uses of Technology/Products/Service:

Xilas developed two products that prevent ulcers and amputations – the GlideSoft (TM) insole which can eliminate mechanical stress on the diabetic foot and the TempTouch (TM) home use foot thermometer, which can provide the patient with an early warning of developing ulcers. Both devices are tools that assist the patient in compensating for the lack of feeling in their feet, a complication common in people with diabetes. The GlideSoft(TM) insole is an innovative device that provides the patient with the benefit of reducing shear or rubbing (friction) on the bottom of the foot. It has been designed to be worn in off-the-shelf extra depth shoes normally recommended for high-risk diabetics and has been proven in clinical trials to be effective in preventing foot ulcers. The TempTouch(TM) dermal thermometer provides the diabetic patient with an objective means whereby they can take the temperature of key sites on the feet to call attention to the presence of inflammation that they would otherwise not be aware of. The device is used in the home environment by the patient on a daily basis as an early warning tool and is designed to accommodate people with advanced levels of obesity or osteoarthritis. Experts estimated that each year in the U.S. people with diabetes experience in excess of 1.2 million foot ulcers and 100,000 amputations that cost the healthcare system over $20 billion per year to manage. Based on its clinical trials funded by the National Institutes of Health, Xilas has shown that the GlideSoft(TM) insole and the TempTouch(TM) dermal thermometer can effectively prevent over 80% of these ulcers and amputations.

Benefit to Company:

Xilas Medical has diligently applied for, and been privileged to receive, $2.7 million from the National Institutes of Health (NIH) via the Small Business Innovation Research (SBIR) program. As a consequence, Xilas has utilized these funds to evaluate, refine and validate four separate products, each in it own right important to improving outcomes and lowering healthcare costs in the area of diabetic foot complications. As a result of its clinical trials, Xilas has moved to bring two products into the commercial market in 2004, the GlideSoft insole and the TempTouch dermal thermometer. Revenues from product sales are estimated to be $1.2 million in 2004, $6.6 million in 2005, and $19.0 million in 2006 with most sales planned to occur in the U.S. Of significant importance, is the fact that Xilas has signed a Vendor/Partner Alliance with XLHealth of Baltimore, Maryland to provide over $1.2 million of GlideSoft and the TempTouch devices in support of the Center for Medicare and Medicaid Services (CMS) Disease Management Demonstration project designed to dramatically improve health care outcomes for seriously ill Medicare participants residing in the state of Texas. It is Xilas’ belief that the outcomes demonstrated through the SBIR grants will be replicated in the CMS demonstration project resulting in a significant reduction in the occurrence of ulcers and amputations in these high-risk patients with diabetes. Furthermore, XL Health has already indicated their intention to become our first customer of the TempTouch RM™ temperature device once further development has been completed. Without the opportunity provided by the SBIR program, it is not likely that Xilas would be in the position it is in today to bring these clinically proven devices into the market at a time when prevention of complications associated with diabetes is at such a high level of importance due to the epidemic-like condition that currently exists. Xilas believes that this work will benefit both the U.S. citizens with diabetes and the existing burden on the health care system, as well as allow the Company to build a profitable business. After pursuing our products’ adoption in the U.S., Xilas will pursue European market introduction of these devices.

How Product Was Commercialized:

Related Award(s):

2R44CA075881-02A1,2R44DE012989-02A1,2R44CA078114-02A2

Technology Developed:

The NIH SBIR/STTR program has significantly contributed to the overall technology development of IOS’s portfolio of sensing, imaging, and toxin detection products. This in turn has helped the Company maintain a strong image, and has established IOS’s reputation for leadership in advanced optical sensing and analytical technology development that continues to grow worldwide. The fully distributed DICAST® sensing methodology bridges the gap between point detection and standoff detection, and is based on fiber optic cables in which the sensor material is the cladding component of the fiber optic itself, hence the entire length of the cable is agent sensitive. making it ideal for the protection of fixed assets.

Key Words:

Fiber, Sensors, Distributed, Specific, Biofilms, Real-time, Adaptive, Network

Uses of Technology/Products/Service:

The field of optics has been revolutionized in the past 25 years. Rapid advances in optoelectronics and materials science, stimulated by the spread of fiber optic communication technology, are creating opportunities to develop entirely new classes of products. Simultaneously, the need for protection against chemical threats has never been greater. The DICAST product line is a group of multipoint distributed sensors; that fills the vulnerability gap, left by existing CWA, and other toxin sensors. Point detectors only cover a particular location. Standoff detectors cover a wide path, but require “line of sight” capabilities, and are also very expensive. In contrast, IOS’s DICAST® is based on long specially created fibers that detect at all areas along their length, and that can be “snaked” around corners, or perimeters. IOS also has developed many complementary sensors snd sensor systems, that provide sensitive real-time multianalyte simultaneous detection and reporting.

Benefit to Company:

The entire SBIR process, and training sessions, and meetings that bring entrepreneurs together, is in and of itself a creative process, and is energizing, and helps us to grow, both as a company, and as employees. As a result of SBIR-supported research, and of its total commitment to commercialization, IOS has focused on subsidiary development -- a commercial activity that has received private investments totaling over $20 million. This has allowed the rapid transition to commercially viable products. Since its inception, IOS has established a reputation for leadership in advanced optical sensing and analytical technology development that continues to grow worldwide. This focused approach, combining vision, expertise, and dedication, has enabled the IOS team to make rapid progress in the commercialization of advanced optical technologies. Since January 2000, IOS has formed two joint ventures, has spun out five companies to commercialize various IOS proprietary technologies, and has put in place licensing/technology transfer agreements with several major industries. The company occupies a modern and spacious facility in southern Los Angeles County. Various state-of-the-art research laboratories include those dedicated to optical fiber sensor development, integrated optics, chemical sensing, physical sensing, spectroscopy, biomedical and biochemical research, image analysis, and instrument control. The Company currently employs 40 highly trained Scientists, and Business Staff. Its current sales mix is almost 80% non-SBIR business.

How Product Was Commercialized:

IOS’s proven commercialization model proceeds in one of three ways: 1) Spin offs 2) Technology Licensing 3) Joint ventures and partnerships IOS does not undertake production in our Research & Development facility, however space is available for staff and pre-production prototyping activities to reduce start-up costs. As production grows, operations move to a new bigger facility. In the 4 1/2 years since our incorporation, we have successfully spun off four companies and raised close to $30 million dollars in total funding for commercialization of the IOS technologies they have licensed from us. In the case of the present technology, it is our belief that a Licensing strategy will be most effective for IOS/Optech. IOS and Optech will aggressively pursue licensing opportunities as well as partnering opportunities. IOS is in touch with the largest players in the field. Once the licensing deal is completed, manufacturing and sales will be their responsibility , and they will have the full technicalsupport of IOS. We focus on transforming innovative proof-of-concept research into technological innovations, which are exploited to set up successful business ventures or are licensed to commercial partners. To date, IOS has attracted $23 M via private and investment funding to support commercialization efforts. Much of this investment was put into our spin-off companies. Optinetrics manufactures and markets active and passive integrated optic components based on IOS-developed technology for the telecommunication industry. Maven Technologies was formed to enhance and market the Biomapper technologies developed by IOS. Optisense manufactures and distributes gas sensors for the automotive, aerospace, and industrial safety markets, and will be providing H2 and O2 optical sensor suites designed to enhance the safety of NASA launch operations. OSS, which is IOS’s newest spin-off company, was formed to commercialize chemical sensors for security and industrial applications. Within the last 2 years, IOS has spun off two commercial technologies and has raised $4 M

Related Award(s):

2R44CA071271

Technology Developed:

Interactive multimedia CD-ROM entitled “Kidz with Leukemia: A Space Adventure” for 4-11 year-olds with leukemia (PC compatible), their friends and families. With the help of games, voiceover, videos, animation, graphics, and music, children learn about their illness, diagnosis, treatment, as well as some helpful coping skills. There are 3 pathways in this CD-ROM (4-6 year-olds, for which no reading is required; 7-11 year-olds, and adult).

Key Words:

leukemia, child, cancer, education, interactive, multimedia, CD-ROM, pediatric

Uses of Technology/Products/Service:

With the help of games, voiceover, videos, animation, graphics, and music, this interactive multimedia CD-ROM helps children with leukemia learn about their illness, diagnosis, and treatment, as well as offers some helpful coping skills during their cancer treatment. Various cancer clinics, children’s hospitals, cancer organizations and camps, and many families with a cancer patient have copies of our CD-ROM, which helps children with leukemia and their families learn about the illness in a non-threatening and fun way. The CD-ROM also helps kids pass their time and get distracted while getting chemotherapy. There are 3 pathways in this CD-ROM: for 4-6 year-olds (for which no reading is required); for 7-11 year-olds; for adults.

Benefit to Company:

- The CD-ROM has won 4 awards to date: “All Star Software Award” – Children’s Software Revue, 2002; “Roland Tibbetts Award” from SBA for “Model of Excellence”, 2001; “Cool for Kids Award – Technology Games, 2000; and “Outstanding Achievement Award” – Commonwealth of Virginia, 1999. - This project led to successful publications in each of the following journals – Patient Education and Counseling (46; 2002), and The Patient’s Network (Winter 2000). The CD-ROM received favorable reviews in the following journals – American Journal of Health-System Pharmacy (May 15, 2001), Library Journal (April 1, 2001), as well as in various newsletters by childhood cancer organizations and children’s interactive technology groups. - This CD-ROM, along with the awards, reviews, and publications, helped us become a known entity in the pediatric oncology world. We were approached by some senior pediatric oncology researchers to help them develop a web site for survivors of childhood cancer, which we successfully completed in early 2006. - The success of this project & product helped us think about future childhood cancer products, and we successfully developed another excellent resource for adolescents with solid tumors in 2006 – “Conquering Cancer Network: Empowering Teens with Tools, Info, and Inspiring Stories” (aka CCN). Developed with SBIR funding from NCI, this interactive multimedia CD-ROM educates teens with solid tumors about their diagnosis, treatment, side effects, coping skills, and potential effects. CCN includes voiceovers, videos, graphics, games, and animations. Comprehensive information is presented in a teen-friendly format, and this is an excellent teaching tool for healthcare providers. For more information including product reviews, excerpts, and testimonials please visit www.conqueringcancer.net. - Through August 2007, 516 copies of the CD-ROM have been sold in 15 countries (including 37 states in the United States of America), thereby adding to the company's revenues. We also have one licensing agreement with a children’s hospital and are working on others. - Talks are on with pharmaceutical companies re: sponsorship, so a certain number of this CD-ROM may be available free of cost to families in the near future.

How Product Was Commercialized:

Internet, mailings, exhibiting at conferences, reviews and publications in magazines/newsletters.

Related Award(s):

2R44MH061277

Technology Developed:

We developed the Wirm Application Server and the Vivalog Knowledge Management Framework, a platform for building web-based multimedia clinical applications. We used this technology to develop MyPACS.net, a system for collaborative authoring of case-based medical image repositories.

Key Words:

content management, radiology teaching files, medical image repository, PACS, enterprise software

Uses of Technology/Products/Service:

MyPACS.net is being used by thousands of radiologists at over 400 institutions to create a growing repository of teaching file cases. Currently, over 5000 cases have been submitted containing 20,000 images. We also offer a premium enterprise version, which hospitals purchase and deploy behind their firewall, enabling radiologists, pathologists, and other image workers to easily create, search, and manage cases. The system supports role-based policies for importing images from medical systems such as PACS, editing, certifying, and publishing cases.

Benefit to Company:

The SBIR program has lead to the development of a commercially successful software product, the MyPACS Enterprise System. Sales of the product have doubled every year for the past three years, and it has been purchased by a growing number of institutions, including the Mayo Foundation, the University of Washington, Boston Childrens Hospital, the University of Texas, and Cincinnati Childrens Hospital. Prices range from $20,000 to $100,000.

How Product Was Commercialized:

Related Award(s):

5R44MH043075,5R44NS027392,N44MH30023,5R44NS032241,N44MH60027

Technology Developed:

MANSCAN® is a comprehensive, integrated hardware and software system for data acquisition and exploratory analysis of human neurophysiological (EEG) & neuroanatomical (MRI) data. Hardware includes 22-bit, 152-channel MICROAMPS™ neurophysiological signal amplifiers and XCALIPER™ rapid digital electrode position measurement device. Software comprises ~500,000 lines of C++ code running under Windows XP operating system. MANSCAN® embodies many patented signal processing algorithms for EEG analysis and EEG/MRI co-registration and localization analysis, including DEBLURRING™ to estimate electrical potentials at the cortical surface from recordings at the scalp, and Event-Related Covariance to characterize rapidly shifting, sub-second distributed functional cortical networks. Please see http://www.manscaneeg.com/ for product details.

Key Words:

human brain function, EEG, evoked potential, MRI, digital signal processing, pattern recognition, bioamplifiers, 3D visualization

Uses of Technology/Products/Service:

MANSCAN® is used in research on human brain function. It was the first system to integrate the high time resolution of EEG with the high anatomical resolution of MRI, and the first to allow sub-second measurement of rapidly shifting functional cortical networks. MANSCAN® enabled a new generation of research and a number of significant advances in understanding attention, memory and other basic cognitive brain functions have been made with it. A number of competing products worldwide were modeled on MANSCAN®.

Benefit to Company:

MANSCAN®’s unique functionality evolved from the results of prior NIH R01s. The SBIR program has allowed us to turn these basic research results into robust algorithms embodied in a convenient, integrated system to enable research on human brain function that would not otherwise be commercially available. In addition to its use in research at customers’ and collaborators’ labs, we have used MANSCAN® in the development of our next-generation medical neurological devices that will test vital cognitive brain functions.

How Product Was Commercialized:

MANSCAN® is sold to qualified scientists at US universities, medical schools and government labs. ~30 MANSCAN® systems are currently in use.

Related Award(s):

2R44NS028623,2R44NS032241,N44MH30023

Technology Developed:

IMAGE VUE™ is a wizard-driven software system, running under Windows XP, for co-registering EEGs with MRIs, performing patented DEBLURRING™ spatial enhancement and several types of source localization analysis, and interactive 3-D graphics visualization. The patented XCALIPER™ hardware and associated software facilitates rapid measurement of EEG electrode positions needed for co-registration with MRIs.

Key Words:

medical imaging, human brain, epilepsy, seizure localization, EEG, MRI, 3-D graphics

Uses of Technology/Products/Service:

IMAGE VUE™ is used primarily to visualize and localize the origin and spread of epileptic seizures in the human brain in planning neurosurgical treatment of complex partial seizure disorders that are refractory to treatment with antiepileptic drugs.

Benefit to Company:

The SBIR program allowed us to develop a first-of-its-kind, turn-key software package for an important medical neurological niche market for which the economics did not justify private sector investment. In the course of developing IMAGE VUE™, we gained experience in making an easy-to-use specialized system, in developing software in accordance with FDA Good Manufacturing Practices, in registering a medical device with the FDA, and in negotiating an equitable distributor agreement with a company 100 times larger than ours. A number of competing products worldwide were modeled on IMAGE VUE™ .

How Product Was Commercialized:

IMAGE VUE™ is marketed to neurologists by Nicolet Biomedical, Inc., a subsidiary of VIASYS Healthcare (NYSE: VAS), and the world’s largest supplier to the clinical neurology market. See http://www.nicoletbiomedical.com/imagevue.shtml. To date, Nicolet has purchased ~100 systems from us.

Related Award(s):

1R43DK055445,5R44DK055445

Technology Developed:

Interactive computer program entitled dbaza Diabetes Education for Kids for children with type 1 diabetes. This multimedia educational tool helps children and their families understand the basic principles of self-care and learn about the skills necessary for self-management.

Key Words:

diabetes education, interactive learning, children with diabetes, pediatric diabetes care, diabetes self-management, CD-ROM

Uses of Technology/Products/Service:

dbaza Diabetes Education for Kids is an educational tool that covers the four basic areas of diabetes self-management, including blood glucose monitoring, insulin injections, dietary management, and physical activity. The CD-ROM presents an age-appropriate story line, using animated characters (created by the child or caregiver) to engage the child in the learning process. It offers opportunities to apply the information in an interactive format; and provides feedback and positive reinforcement for correct choices. The learning experience encompasses interactive exercises, pop quizzes, and guided and unguided practices of diabetes-related skills. The interactive program keeps track of all activities throughout the CD-ROM, recording the number of correct and incorrect answers, which can be printed out for a later review. As part of learning process, the child creates pages of a book based on what was learned. The book then can be printed out providing a personalized diabetes reference. dbaza Diabetes Education for Kids is available for both home and clinical use. The detailed product information is available on line at http://www.dbaza.com/dek/

Benefit to Company:

Since the launch of a new version in 2003, over 4000 copies of the CD-ROM were distributed to children and their families. The educational program has received “Favorably Reviewed” status from the American Association of Diabetes Educators. More than one hundred children’s hospitals and clinics have been using the CD-ROM as an adjunct to their traditional diabetes education.

How Product Was Commercialized:

The primary commercialization strategy evolved publicity among health care professionals (pediatric endocrinologists and diabetes educators) and professional member organizations (American Association of Diabetes Educators and American Diabetes Association).

Related Award(s):

1R43HL066829,1R43HL068463

Technology Developed:

The patented Apnea Risk Evaluation System (ARES) is an easy-to-apply, in-home system for diagnosing obstructive sleep apnea (OSA). The ARES combines a miniaturized, battery-powered device to measure blood oxygen levels, pulse rate, snoring sounds, nasal pressure and head position/movement with a questionnaire to assess known risk factors.

Key Words:

sleep apnea, in-home monitoring, pulse-oximetry, sleep disorders, apnea risk questionnaire

Uses of Technology/Products/Service:

Obstructive Sleep Apnea (OSA) is one of the world’s most prevalent, underdiagnosed disorders, responsible for more mortality and morbidity than any other sleep disorder and recognized as a major public health concern. OSA is characterized by recurrent failures to breathe during sleep resulting from obstruction of the upper airway. OSA can cause daytime drowsiness and memory impairment, and has been associated with hypertension, increased risk of cardiovascular disease, diabetes and stroke. Untreated OSA patients are 3-7 times more likely to be involved in industrial and motor vehicle accidents due to slower reaction times and impaired vigilance. Despite this growing evidence that OSA threatens public health, safety and productivity, current estimates reveal that 93% of women and 82% of men with moderate to severe OSA remain undiagnosed. One reason for this is that the current gold standard for diagnosing OSA, the laboratory sleep study, is cumbersome, uncomfortable, time-consuming and expensive. ARES offers a convenient, affordable alternative to lab studies. A large, multi-site clinical trial with 280 patients compared ARES to lab sleep studies. In-home studies were also conducted either prior to, or following in-lab. In-lab comparisons resulted in a 0.96 correlation between the ARES results and those obtained in the laboratory sleep study (0.96 correlation), proving ARES to be a viable alternative to lab testing.

Benefit to Company:

With funding from the SBIR program, Advanced Brain Monitoring, Inc. is addressing sleep apnea, memory dysfunction, and alertness monitoring with instrument systems that combine laboratory level accuracy with the portability, ease of use and low cost of consumer electronics. SBIR funds have allowed ABM to complete comprehensive multi-site clinical trials to establish the validity of the technologies. These studies would be difficult to fund with private sector financing.

How Product Was Commercialized:

ABM now holds six patents on these technologies and the ARES was recently cleared by the FDA. ABM systems will be sold to medical, industrial, research and consumer markets. The systems enable widespread use by physicians, dentists, industrial/transportation companies, and consumers possible.

Related Award(s):

4R44DA013325-02, 5R44DA013325-03

Technology Developed:

Enterprise training and assessment application to affect attitudes, behavior and school performance of adolescents. The program addresses a wide range of personal, social and structural factors that affect adolescents' likelihood to engage in unhealthy behaviors, including the use of drugs and alcohol. It uses evidence-based cognitive, behavioral, social skill and affective strategies to change behavior. It is designed for culturally competent adaptation to site-specific situations and intended for individualized, self-directed use in facilitated settings. 172 inter-linking, reading independent, culturally sensitive, media rich tutorials each have ten or more modes of interactive learning. Students and/or their adult facilitators can choose the tutorials that most meet their individual needs and/or group goals. Program tracks student progress automatically, implementers can delete any topics they consider inappropriate. In 2003-04 a series of six simultaneous studies, funded by SBIR, demonstrated the effectiveness of the software with diverse populations with special risks. Overall effects of self-directed use at sites where implementation was high and dosage-correlated effects at sites where implementation was low both showed a positive effect on risk and protective factors. Students in the intervention groups had significantly higher grade point averages, less fatalistic thinking, fewer absences, less tardiness, and fewer disciplinary referrals than students in the comparison group. An unexpected finding from one site was that perception of harm of marijuana was lower than the control group, but actual referrals for drug use were also significantly lower than in the control group.

Key Words:

violence prevention, behavior training, software, substance abuse, truancy, adolescent risk factors, school failure, social-emotional skills

Uses of Technology/Products/Service:

Besides health settings, such as school nurses offices, Ripple Effects software is being used in special education resource rooms, counselor's offices, advisory periods, regular classrooms, after-school programs, and discipline settings, especially in-school suspension. It has become an effective supplement for a wide range of violence, drug and alcohol prevention programs in diverse cultural settings across the country. It is also increasingly being used as a tool for addressing disproportionate discipline rates.

Benefit to Company:

Phase I SBIR funding from NIH enabled Ripple Effects to get expert panel review of a forerunner product and usable specifications for revisions to align it more closely with evidence-based practices. Phase II NIH funding enabled the company to incorporate those suggestions into a new product and do a set of small RCTs to test the effects of the new product. These studies focused on 500 high risk students under real world conditions. The 4 RCTs and 2 quasi-experimental small studies showed the program enhances protective factors and reduces risk factors, associated with the interlocking issues of school failure, adverse health outcomes and problematic social behavior. Summary findings from the research were presented at the Society for Prevention Research 2007 conference. Based on the results of this project, we not only ended up with a specific drug abuse prevention curriculum, we were able to begin the process of being listed on the National Registry of Effective Programs, and we successfully repackaged and repositioned our whole line of educational materials.

How Product Was Commercialized:

As of 2007, child, teen and staff versions of this software have been purchased by more than 550 school districts across the country to prevent youth injury and illness, and promote school and life success Showing important school-related distal effects (truancy, grades, discipline referrals) with a tool that does not require cutting into academic instruction time has enabled us to more easily get schools to commit to prevention, and early intervention on mental health issues, fulfilling our social as well as economic mission.

Related Award(s):

1R43AG013515-01,5R44AG013515-03,1R43DC004481-01

Technology Developed:

Hybrid Adaptive Beamformer, or HAB, is a directional listening technology that can be used to determine the direction of origin of sounds, isolate particular sounds in a cluttered environment, or improve performance of audio applications by removing unwanted background noise. HAB combines the output of multiple microphones to form one or more “listening beams” which focus on sounds from a preferred direction, while reducing or eliminating background noise or unwanted sounds from other directions. Applications include automatic speech recognition, hearing enhancement, consumer or military headsets, and communications devices.

Key Words:

array, speech intelligibility, microphone, speech in noise, microphone, beamformer

Uses of Technology/Products/Service:

HAB was originally developed to improve speech intelligibility in noise for hearing aid wearers. In our research, using the Hearing in Noise Test, we found that while using a single HAB-enabled device, hearing aid and cochlear implant users could understand speech in noise as well as unaided normal hearing individuals could understand the same material, listening binaurally. HAB has many additional applications, and can be used to improve the performance of the multitude of audio-input applications that are focused on picking up sounds from a particular direction. For example, HAB can support accurate speech recognition without the need for a headset. The technology can also be used to support high-resolution direction finding. PSI has applied the technology to a variety of low-power small form-factor devices for military and commercial applications including hearing aids, cochlear implants, voice-control and voice-input for PDAs, covert listening, acoustic gunshot detection and location, and streaming audio for a micro-unmanned aerial vehicle.

Benefit to Company:

We have successfully transitioned HAB as originally developed for NIH to a variety of public and private sector applications, and we have licensed the technology for a commercial product to be released shortly. The US Army supported development of a speech-enabled PDA for battlefield medicine, using HAB to provide robust automatic speech recognition, with contracts in 2002 and 2003 totaling $2,400,000. Support is current and follow-on is expected. The US Army supported development of a specialized listening device in 2002 with contracts totaling approximately $330,000. The US Air Force supported development of a micro-miniature audio sensor for the BATCAM Unmanned Aerial Vehicle with a contract totaling $20,000. The US Army supported development of a sniper detection device in 2004 with a contract for $64,000. At least $500K follow-on for this application is expected to develop a fieldable device. These projects have provided revenue for the company, increased our SBIR commercialization score, and provided funding to further improve and adapt the technology to new application areas.

How Product Was Commercialized:

HAB was commercialized by seeking new and innovative applications of the core technology to new fields of use. We leveraged our existing network of Department of Defense customers, as well as identifying potential commercial sector partners who could benefit from the technology.

Related Award(s):

1R43DK53114-01,1R44DK53114-02

Technology Developed:

CFD Research Corporation has developed and patented a novel and significantly improved hemodialysis catheter (Patent # US 6,409,700 B1). This fixed tip catheter combines ease of insertion with high flow and very low recirculation, delivering the ultimate high efficiency dialysis. The catheter has been designed and optimized with extensive use of advanced computer simulations (computational fluid dynamics (CFD) and coupled fluid-structural interactions) and a complimentary series of experimental investigations.

Key Words:

Catheter, hemodialysis, access recirculation, suction pressure, hemolysis

Uses of Technology/Products/Service:

The developed catheter has been specifically designed and tested for hemodialysis applications. Its uniquely engineered tip provides outstanding performance with the following characteristics: - Improved functionality by reductions in occlusion potential, recirculation, and arterial suction pressure. - Maximum arterial blood flow when the catheter tip contacts the vessel sidewall. - Reduced red blood cell damage. - Reduced blood clotting and potential side effects. - Improved ease of insertion. Benefits to dialysis patients will include increased safety and comfort level, and possibly a short therapeutic time.

Benefit to Company:

This SBIR program and other NIH funding have enabled CFDRC to broaden its expertise in developing biomedical devices using coupled virtual prototyping and experimental approach. This expertise has been applied to develop other devices and obtain more patents, leading to increased revenues and profitability of the company.

How Product Was Commercialized:

CFDRC patented the new design and, after investigation of several biomedical companies, selected Spire Biomedical Inc. as a commercialization partner for this product. CFDRC granted an exclusive license to Spire, with provisions for: (a) milestone payments, e.g. with FDA approval and launch of product, and (b) royalties based on net sales.

Related Award(s):

5R44HL057739,1R43HL057739-01,2R44HL057739-02,1R41HL060468-01,2R42HL060468-02,4R44HL064434-02

Technology Developed:

NIH SBIR/STTR funding enabled EKOS Corporation to develop and commercialize ultrasonic infusion systems intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS MicrolysUS® infusion system is a 510K cleared device to treat peripheral arterial occlusion. In addition, this microcatheter has IND approval to participate in Phase II Interventional Management of Stroke (IMS) clinical study to treat ischemic stroke using a combined IV/IA rtPa infusion approach. The EKOS LysUS® infusion system is also a 510K cleared device to treat peripheral arterial occlusion. This 5 Fr catheter system is available in treatment zone ranging from 6 to 50 cm to match a variety of clot lengths and ensure uniform drug/ultrasound energy distribution into the large arterial and venous clots found in the peripheral vasculature. Besides the therapeutic application, EKOS devices have a diagnostic feature to monitor blood flow in occluded lesions during the treatment. The flow sensor feature is based on the catheter ultrasonic element’s temperature that will be monitored and displayed on the EKOS control unit, which additionally provides power to drive catheter ultrasonic elements. The temperature variations directly correspond to the local flow rate of the blood in the occluded lesion and inform the doctors of the treatment status. We believe EKOS infusion catheters provide unique benefit to the patient with vascular thrombotic occlusions in the cerebral and peripheral vasculature. In ischemic stroke, accelerated thrombolysis leads to faster restoration of nutrient blood flow to the ischemic tissue and greatly improves the patient’s chances of survival with minimum brain damage and reduced burden of neurologic deficits. Potential benefits specific to the infusion of thrombolytics with EKOS LysUS® infusion system to treat peripheral arterial occlusion may include a decreased thrombolysis time (e.g., decreased time from the start of the procedure to recanalization) due to the improved dispersion and availability of the thrombolytic within the clot. This in turn may reduce the amount of thrombolytic agent used.

Key Words:

Ischemic Stroke, PAO, Infusion catheters, flow sensor, therapeutic ultrasound, manufacturing

Uses of Technology/Products/Service:

Peripheral arterial occlusion (PAO) of the lower extremity can cause limb-threatening ischemia and, if left untreated, is associated with a high rate of amputation. The standard of treatment for many years has included open surgical intervention, but this carries a significant risk to life and limb. Attempts to treat PAO by intravenous infusion of thrombolytics have met with low success, and unacceptably high rates of morbidity resulting from serious hemorrhagic events (Kandarpa, 2000; Kessel et al; 2004, Berridge et al, 1991). In 1974 Dotter et al (Dotter et al, 1974) introduced the concept of infusion of thrombolytic agents directly near, or into, the site of occlusion. Efficacy was attained with greatly decreased dosage levels; mortality and morbidity were decreased. The EKOS Peripheral Infusion System is intended for controlled and selective infusion of physician-specified fluids into the peripheral vasculature. Infusion of thrombolytic agents is included in the intended use of the EKOS infusion system. Potential benefits specific to the infusion of thrombolytics with this system may include a decreased thrombolysis time (e.g., decreased time from the start of the procedure to recanalization) due to the improved dispersion and availability of the thrombolytic within the clot. This in turn may reduce the amount of thrombolytic agent used. This result in reduced patient discomfort, reduced risk of hemorrhage as a potential side effect of thrombolytics and better patient health, and cost savings to health care providers. The diagnostic flow sensor feature of EKOS Infusion systems could provide doctors with real-time insight into the recanalization status of the occluded lesion and could be used as an indicator for the end of treatment.

Benefit to Company:

NIH SBIR/STTR funding provided development of critical testing and contributed to the development and commercialization of devices which we believe will improve the health of 150,000 American patients with Peripheral arterial occlusions and up to 500,000 patients who suffer from ischemic strokes each year.

How Product Was Commercialized:

While currently cleared by the FDA for sale in the US, EKOS is electing to introduce these products in a controlled release while collecting user feedback and experience. Full market release for the peripheral products is expected in Q4-05 and for the microcatheter in Q1-06.

Related Award(s):

N43CB56000

Technology Developed:

This highly-successful software project substantially advanced Celadon’s flagship software product, ProbeITy, which is a sophisticated expert system for the design of oligonucleotide assays. The project advanced the science of oligonucleotide design, and implemented automated assay design for a number of the most widely-used genomic methods, including: PCR; PCR-Sequencing; Mass Extend SNPs; and Amplicon Walking.

Key Words:

oligonucleotide, assay design, PCR, SNPs, primers, probes, genomics, bioinformatics

Uses of Technology/Products/Service:

The use of ProbeITy results in better, less-costly, assay design for a variety of oligonucleotide methods. These methods apply to fundamental and widely-used genomic applications, including: amplification, sequencing, gene expression, SNP genotyping, gene expression analysis, and Quantitative PCR. These methods help scientists to identify genes that are involved in disease, to identify new drugs, and to describe the effects of drug candidates. In addition to the methods listed above, a number of other methods are available, including: TaqMan qPCR; Amplifluor SNPs; Amplifluor Gene Expression; and siRNA for RNA Interference.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

1R43HL062079-01A2

Technology Developed:

SBIR Phase funding enabled Transonic Systems, Inc. to develop, validate, and commercialize (a) compact and low-power transit-time flowmeter electronics suitable for chronic implantation, (b) a new backpack telemetry flowmeter for animal studies, (c) integrated circuit flowmeter chips that will spawn a new generation of fully implantable flowmetry systems. The telemetry technology is essential for chronic studies of cardiovascular diseases and their genetic causes and treatments, without the impairment of tethering to electronic devices. A first backpack telemetry device was introduced into the market during this grant’s Phase II, and a fully implantable telemetry unit for use in small species is in preparation. The compact, low power flowmeter technology developed under this grant is now also in use in a host of human clinical applications requiring compact and accurate blood and fluid flow monitoring.

Key Words:

Wireless, Transit-Time, Flow, Ultrasound, Bluetooth, Telemetry, Flowmeter, Manufacturing

Uses of Technology/Products/Service:

Many physiological studies involve animals, and researchers often must measure arterial blood flow to properly evaluate a drug or device's safety and effectiveness. For example, drugs used to prevent heart disease are tested in pigs while many ventricular assist and artificial heart prototypes are tested in sheep and cows. However, traditional measurement technology requires that researchers hard-wire the implanted flow sensors to a bench-top flowmeter. This experimental setting can put stress on the animal to alter the behavior and physiological condition of the subject such as increasing blood pressure or cardiac output and thereby confound the experimental results. These preparations also require close supervision to assure humane conditions, avoid infections, and prevent loss or damage to the instrumentation. With NIH/NHLBI SBIR research support and corporate internal development funds, Transonic Systems developed in Phase I a miniaturized low-power flowmeter board. This first step - the feasibility demonstration of a new transit-time ultrasound flow detection approach - produced a flowmeter that is small enough to be carried by laboratory animals, and that maintains the accuracy of benchtop flowmeters. During Phase II, this first discrete-component flowmeter unit was converted into large-scale integrated chips. The Phase II chipset is the first step towards the ultimate SBIR project goal of a fully implantable telemetered flowmeter, first for animal studies, later for chronic human implant in applications such as Ventricular Assist Devices and post-op monitoring after bypass surgery. The advent of accurate, chronically implantable flowmeter technology as pioneered by Transonic has revolutionized academic biomedical research and patient monitoring and enhanced the measuring/monitoring capabilities for medical devices. The new Transonic technologies developed under this grant open the door to a wider array of such innovation-enabling advances. On the animal studies front, the Transonic hardware will allow studies to proceed faster and with fewer animals, since the investigator can now monitor blood flow in animals during the full course of a disease/treatment study under less stressful conditions. For product information and pictures of the commercialized hardware, see the following URL: http://www.transonic.com/physiogear.shtml.

Benefit to Company:

SBIR Phase I & II funding enabled Transonic Systems, Inc. to develop, validate, and commercialize a new telemetered blood flow monitoring systems for free-roaming animal studies. This technology is essential to medical studies of diseases, their genetic causes, and treatments. This new product is the fourth Transonic product developed and commercialized under NIH SBIR program. Previous commercialized products include the HD01 Hemodialysis Monitor; the 0.5PSB and 0.7PSB Mouse blood flowprobes and TS420-series flowmeter; and the AngioFlow angioplasty flow monitoring catheter. Around 25% of our product sales include SBIR-developed technologies.

How Product Was Commercialized:

During Phase II, Transonic incorporated the Phase I-developed miniature flowmeter system into a backpack-telemetry flowmeter system: “PhysioGearTM I”. The system employs a battery subsystem and Bluetooth wireless communications, and has expansion capacity for additional physiological signal monitoring. After beta testing with three university sites in 2004, product sales began July 1st, 2005. Sample applications of current PhysioGear customers are: · Several pharmaceutical companies - drug efficacy studies; · Naval Medical Research study - new vascular grafts and wound care that may be applied to post trauma treatment and saving limbs; · A University Hospital in Belgium - translational research studies in pigs to improve clinical outcomes in liver transplant cases · A Veterinary College in England - fetal & pregnancy blood flow studies in sheep. The same miniature flowmeter board is also used to improve human health. A number of biomedical product companies have incorporated OEM (Original Equipment Manufacturer) versions of this technology into their products, which include: * Organ Preservation Machines * Eye Surgery * Heart Lung Machines * Circulatory Support Devices * Hemodialysis Machines * Oxygenators * Extracorporeal Patient Monitoring Machines

Related Award(s):

1R43MH065796

Technology Developed:

The Interactive Computer Interview (ICI) was developed by CRS for the administration of clinical rating scales. (A provisional patent was also issued in 2003). The ICI is computerized interview that simulates a clinician’s administration of a rating scale and uses program logic to select a sequence of probes and follow-up queries necessary to assign symptom severity ratings.

Key Words:

CNS outcomes, Rater Reliability, Clinical Trials, Site Monitoring, Computerized Adaptive Tes, Mental Health, Bipolar Disorder

Uses of Technology/Products/Service:

The ICI was found to be a well accepted, reliable, and valid method for eliciting and assessing manic and depressive symptoms. There are 3 current uses for the technology: 1. Remote site monitoring in multi center trials to improve rater reliability. The ICI computer assessment is paired with live rater assessments on standardized rating scales (YMRS, MADRS, HAMD, HAMA). 2. A stand alone Rater Station ™ system that assesses subjects and generates a score for standardized rating scales. 3. A prompted clinical interview, where a human rater uses the ICI to administer a standardized rating scale either live or over the telephone. The fact that the system can be easily translated makes it an inexpensive, valid option for CNS research in foreign countries and bi-lingual communities in the US.

Benefit to Company:

The SBIR funding was critical in allowing CRS to conduct an initial validity study. The data generated strongly indicated that the product was a reliable and valid method to assess manic and depression patients. The CNS drug and reseach industry were and continue to be very concerned with the issue of rater reliability in multi center trials. The SBIR data provided evidence of a validated approach to reducing rater reliability. Additionally, the SBIR funded a modified CSQ, along with minority and patient focus groups to evaluate the product. These provided valuable feedback and led to further enhancements to the product.

How Product Was Commercialized:

The remote site monitoring system that includes the ICI is now in use in major multi-center CNS pharmaceutical studies. The Rater Station ™ system is now in use in various investigator initiated studies and proposed for use in multi-center trials.

Related Award(s):

1R43DK055444

Technology Developed:

NIH SBIR Phase I funding enabled Transonic Systems, Inc. to develop, validate, and commercialize a new catheter-based blood flow measurement device for measuring flow changes cause by angioplasty of hemodialysis PTFE grafts and native fistulae. Doctors can now measure the volumetric (milliliters/minute) flow changes caused by each angioplasty balloon expansion & therefore can repeat the angioplasty until the desired graft access flow is restored. This is of great benefit to the hemodialysis patient, since an effective flow restoration procedure extends access life; reduces patient morbidity; and forestalls hospitalization. This will also reduce healthcare costs because an outpatient flow restoration procedure replaces the full hospitalization required to install a new graft.

Key Words:

Blood, Dilution, Hemodialysis, Angioplasty, Access Flow, Stenosis, PTFE Graft, Fistulae

Uses of Technology/Products/Service:

Patients suffering from kidney failure – formally known as End-Stage Renal Disease (“ESRD”) – must have their blood filtered by machines. This filtration - called “hemodialysis”- is done three times per week to remove toxins and liquids normally removed by the kidneys. Prior to starting hemodialysis the patient typically has a Teflon tube – called a “shunt” or "PTFE graft" - implanted into their forearm. The shunt is the critical connection to the hemodialysis machine, since the patient’s blood is withdrawn and returned via needles inserted into the shunt. Shunts suffer from a progressive disease called stenosis, meaning that the shunt gradually blocks up. When the stenosis progresses to the point where the shunt flow is less than the flow drawn by the dialysis machine, then patient will become under-dialyzed and become sick, since the dialyzer will recirculate freshly dialyzed blood rather than process the patient’s entire blood supply. Stenosis can be treated by angioplasty, a procedure where doctors insert a special balloon catheter into the graft and expand the balloon to restore flow. However, until Transonic developed the flow-measurement catheters, doctors had no way to intraoperatively measure the flow improvements caused by angioplasty, and it was common to have to have multiple angioplasty sessions before flow was truly restored. The new Transonic technology lets doctors measure flow changes before & after angioplasty by simply inserting a catheter into the graft and making an injection of room-temperature saline. Doctors can release patients from the radiology suite confident that they’ve eliminated the graft stenosis and that they will not have to repeat the angioplasty session days later. This results in reduced patient discomfort, better patient health, and cost savings to health care providers. Transonic and AngioDynamics, Inc. have commercialized the devices developed under Phase-I research, with sales starting in April 2004 (see links below). Press Release announcing start of sales: http://www.transonic.com/Hemodialysis_Home/News/Press_Releases/AngioDynamics/angiodynamics.html AngioDynamics web page for AngioFlowTM meter and catheters: http://www.angiodynamics.com/pages/products/angioFlow.asp. Product brochure for AngioFlowTM meter and catheters: http://www.angiodynamics.com/pages/pdf/AngioFlow3.25.pdf

Benefit to Company:

NIH SBIR Phase-I funding allowed Transonic to develop and commercialize a device that will measurably improve the health of 300,000 American kidney failure patients.

How Product Was Commercialized:

The Phase-I research was commercialized via an OEM (Original Equipment Manufacturer) agreement with AngioDynamics, Inc. – a leading supplier of dialysis and angioplasty catheters. Under this agreement, AngioDynamics will distribute Transonic-manufactured meters and catheters under the AngioDynamics brand name, and AngioDynamics will handle marketing, sales, and support. The Commercialization timeline is given below : • June, 2001 – Phase-I SBIR Research Completed • March, 2002 – Transonic Systems receives FDA Approval for First-Generation catheter and meter • September, 2002 – NIDDK Awards Transonic Phase-II SBIR to develop Second-Generation devices & evaluate them at three clinical study sites. • December, 2002 – AngioDynamics and Transonic Systems sign OEM agreement • April, 2004 – AngioDynamics begins sales of First-Generation catheter and flowmeter under the AngioDynamics brand name The AngioDynamics-branded Transonic hardware is manufactured in Ithaca, NY.

Related Award(s):

5R44CA092976-03

Technology Developed:

A disposable test strip and hand-held reader combination that can measure white blood cell count in biological fluids quantitatively and with high accuracy.

Key Words:

white blood cell, chemotherapy, mastitis, diagnostic, point-of-care, portable

Uses of Technology/Products/Service:

This portable and simple-to-use test system has many uses. It allows first time cancer patients to monitor their white blood cell counts at home, dairy farmers to screen their cows for mastitis, and veterinarians to check companion animals for infection.

Benefit to Company:

This unique point-of-care technology platform has found many applications besides its original application for cancer patients undergoing chemotherapy. The firm has commercialized the product in the dairy market and entered into a licensing agreement for the companion animals market. Within the past 3 years, PortaScience has been transformed from an R&D boutique into a product company, with an expected growth rate of over 50% in the next 5 years.

How Product Was Commercialized:

A new division, PortaCheck, was formed to manufacture and market the product to the dairy industry. With only one competitor who sells a product for 10 times the price, PortaCheck was able to make significant inroads into a $20 million dollar market in a short period of time. The licensing agreement for the companion animals application, with an expected launch date in 4th quarter 2006, adds an additional potential market of $15M per year.

Related Award(s):

1U44DK066724-03

Technology Developed:

Computer games "Escape from Diab" and "Nanoswarm: Invasion from Inner Space" are designed to modify children's behavior regarding diet and exercise. The goal is preventing childhood obesity and, ultimately, type 2 diabetes. In both games, players must set and achieve diet and exercise goals to win.

Key Words:

serious games, video games, diabetes, obesity, prevention, physical activity, nutrition, children

Uses of Technology/Products/Service:

Videogames challenge players to effectively use learned information, thus providing an important education and training modality. This has given rise to the emerging genre of “serious” videogames that employ the medium’s rich, role-playing, story-based environments to teach, train and change knowledge, attitudes, and even behaviors. "Diab" and "Nanoswarm" employ traditional video games’ rich immersive capabilities to deliver positive messages through compelling situations. Players participate as characters in a story to learn through actual experience. Game design uses evidenced-based behavior modification algorithms based on tailoring, self-efficacy and intrinsic motivation. Decision-making, goal setting, and problem-solving activities occur within interactive computer environments thematically themed to storylines.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

1R41DC005110,2R42DC005110,1R41DC006509,5R42DC006509,1R41DC007773

Technology Developed:

An automated pure-tone hearing test was developed with embedded quality indicators that assess the accuracy of the test. An automated test of speech understanding and an improved earphone for hearing testing are in development.

Key Words:

hearing test, pure-tone audiometry, speech recognition, speech audiometry, earphone, audiology

Uses of Technology/Products/Service:

Clinical and industrial hearing testing.

Benefit to Company:

SBIR/STTR funding was essential in developing these products. The funding provided the capability to partner with research institutions and other companies to assemble a team with expertise in many areas. Two license agreements have been executed which will provide the mechanism for marketing, distributing, and supporting the products. STTR grant funding with its peer-review process provides a level of credibility that is attractive to industry and helpful in establishing licensing agreements. STTR funding eliminated the need to obtain venture capital, positioning the company for competitive pricing.

How Product Was Commercialized:

The products will be commercialized through license agreements with established manufacturers of hearing test equipment.

Related Award(s):

1R43DC003613-01A1,2R44DC003613-03

Technology Developed:

Drs. Daniel S. Arick and Shlomo Silman of ARISIL, Inc. developed and patented (Patent # US 5,419,672 and 5,885,242) the EarPopper, which has FDA 510(k) approval for marketing as a prescriptive medical device. The EarPopper is a hand-held, battery-operated modified Politzer autoinsufflation device that emits controlled air pressure and flow that can be adjusted according to the patient's age and magnitude of hearing loss. It is used for non-surgical and non-pharmaceutical treatment of otitis media with effusion with associated hearing loss and Eustachian-tube dysfunction.

Key Words:

EarPopper, otitis media, middle-ear effusion, eustachian tube, autoinsufflation, Politzer method, manufacturing

Uses of Technology/Products/Service:

Middle ear fluid is one of the most common reasons that U.S. children visit the doctor, second only to the common cold, resulting in more than 30 million doctor visits each year and adding $4 billion in medical costs to the health care system. Although increasing concerns about the risks of resistance to antibiotics recently led doctors to recommend "watchful waiting" as the first line of treatment, more than 10 million antibiotic prescriptions are written annually to treat middle ear fluid or otitis media with effusion (OME). Persistent OME often is treated with ear surgery. More than 700,000 children undergo this procedure each year. In many cases, both antibiotics and surgery have proven problematic and often unsuccessful. The Ear Popper directs a steady, controlled stream of air into the nose, and swallowing diverts the air into the Eustachian tube, opening the Eustachian tube and relieving pressure imbalance in the middle ear. The EarPopper can be used in the physician’s office or parents can use the EarPopper at home on their children for a period of approximately 7 weeks. The results of the feasibility study and clinical trials conducted by ARISIL, Inc. revealed that the EarPopper was easy to use and well tolerated by children (4 or more years of age) as well as adults. The results also revealed that treatment with the EarPopper brought 73.9% of the treated ears were within normal limits as compared with only 26.7% of the control ears that did not receive the EarPopper. When the treatment period was extended for those who did not recover within 7 weeks, the recovery rate for the EarPopper increased to 84%. In these children, use of the EarPopper meant that they did not have to undergo ear surgery and they did not suffer the possible sequelae of ear surgery such as permanent hearing loss or permanent damage to the middle ear.

Benefit to Company:

ARISIL, Inc. was privileged to receive two grants totaling $1,024,123 from the National Institutes of Health (NIH) National Institute on Deafness and Other Communication Disorders (NIDCD) via the Small Business Innovation Research (SBIR) Program. With this NIH NIDCD funding, ARISIL was able to construct the prototype EarPopper and to conduct the feasibility study and clinical trials with the device at Brooklyn College, CUNY, which kindly, under the aegis of President Christoph M. Kimmich, also provided ARISIL, Inc. with support. ARISIL also benefited from the advice and consultation provided by Lynn E. Luethke, Ph.D., Program Director, Hearing Program, NIDCD/NIH. The feasibility and clinical trials results were extremely successful and two articles based on the clinical trials were published in Ear, Nose & Throat Journal in 2005.

How Product Was Commercialized:

In early 2005, ARISIL, Inc. enabled the technology for the intended application to be commercialized when it leased the EarPopper to Micromedics, Inc., an innovative surgical products company located in St. Paul, MN. Micromedics, Inc. was one of several companies to approach ARISIL, Inc. for a leasing agreement for the EarPopper. Micromedics, Inc. had conducted its own successful feasibility study on the EarPopper before the leasing agreement between ARISIL, Inc., and Micromedics, Inc. was finalized. Micromedics, Inc. made the EarPopper commercially available beginning October, 2005. The company widely promotes the EarPopper in the U.S. and abroad. The website for Micromedics, Inc. is http://www.micromedics-usa.com and it maintains a site for the EarPopper at http://www.earpopper.com.

Related Award(s):

1R44DE015912-03

Technology Developed:

Xoran developed small, low radiation CT scanners for dental and medical specialists to diagnose their patients at their point-of-care. Xoran’s first product was a dental CT scanner (now called i-CAT). Before i-CAT, most dental specialists needing diagnostic images of their patients either used in-house 2D x-ray devices or sent their patients to hospitals and imaging centers for CT scans. Both options posed problems: 2D x-ray often failed to show details important to full and accurate diagnosis and operative planning, and outsourcing CT scans led to delays in patient diagnosis and treatment. Using i-CAT, dental specialists have instant access to exceptional quality, 3D images, expediting accurate diagnosis, and improving operative outcomes. Xoran next launched its MiniCAT™ sinus and ear CT scanner used by physicians to diagnose patients during office exams. Before MiniCAT™, these doctors had to send their patients off-site to hospitals or imaging centers for CT scans, requiring patients to make several trips between their doctors’ office and the imaging center and to make multiple health insurance co-pays. With MiniCAT™, doctors scan their patients during their exam and get instant access to high-quality CT scans, expediting diagnosis and treatment. In addition, MiniCAT™ scans are quick and safe: adult scans take 40 seconds, pediatric scans take only 20 seconds, and MiniCAT™ sinus scans have ten times of a lower radiation dose than sinus scans taken on a full-body CT scanner.

Key Words:

MiniCAT, i-CAT, 3D x-ray, Computed Tomography (CT), CT scanner, Temporal Bone CT, Skull-Base CT

Uses of Technology/Products/Service:

MiniCAT™ meets the current and evolving needs of ENT and Allergy Physicians and their practices and patients, and i-CAT meets the specific imaging needs of dental specialists. Xoran’s scanners create high resolution CT slices as thin as 0.2 mm, and display instant digital views in all three of the axial, coronal, and sagittal planes. This is considerably better spatial resolution than scans taken with a full-body CT scanner. The dental specialist or physician controls the timing and quality of scans. The scan takes only 40 seconds for adults and 20 seconds for children, and the radiation dose to the patient is 10X lower than scans taken on a full-body scanner. Xoran’s MiniCAT™ scanners are compatible with most image-guided surgery systems and provide more flexibility for surgical planning and post-operative evaluations and care. MiniCAT™ features industry standard DICOM network capabilities, making it simple to transmit images for teleradiology services. With the MiniPACS web-enabled system, doctors can view images anywhere with internet access.

Benefit to Company:

Thanks to NIH SBIR grants from the National Institute of Dental and Craniofacial Research (NIDCR), Xoran Technologies, Inc. (www.xorantech.com) brought its specialized point-of-care computed tomography (CT) scanners from the research lab to the commercial market in less than 3 years. Xoran has sold more than 600 of its dental i-CAT scanners worldwide through a licensed distributor, and more than 100 MiniCAT™ sinus and ear scanners nationwide. Xoran’s initial NIH SBIR NIDCR grants totaling $850K, along with about $200K in non-NIH support, directly lead to about $15M in sales revenue from a new technology that improves patient care, and has created 36 jobs to date for Xoran, about the same amount for Xoran’s dental distributor, and generated substantial business for U.S. vendors and component suppliers. The NIH SBIR program made it possible for Xoran to grow from a two man start up to a profitable commercial enterprise with significant sales revenue with two of its initial product lines now sold throughout the world.

How Product Was Commercialized:

The NIH SBIR program made it possible for Xoran to fund early development of its technology. When Xoran obtained FDA approval for its CT technology, it licensed the right to distribute its specialized dental scanners (i-CAT) to a dental imaging company. In its first year of sales, Xoran’s dental distributor sold more than 80 dental scanners in the U.S., Brazil, Korea, and Japan. Today, more than 600 i-CAT scanners have been sold worldwide. Then Xoran launched direct sales of MiniCAT™ and has sold more than 100 scanners throughout the U.S.

Related Award(s):

5R44HL083553,1R43IP000005

Technology Developed:

Through the generous support of the SBIR Program among other prestigious sources, Hawaii Biotech has developed a protein production platform for the development of vaccines targeting numerous infectious diseases with the aim of meeting requirements such as safety, production yield, rapid response, and efficacy. The Company’s vaccine technology is based on the production of high quality recombinant proteins. The high quality of the proteins produced in this system result in immune responses equivalent to or better than traditional live or inactivated virus approaches. Furthermore, the purified recombinant proteins provide for a significantly improved safety profile. This platform technology is applicable to a wide variety of diseases including West Nile, influenza, dengue fever, hepatitis C, malaria, Japanese encephalitis, Eastern equine encephalitis, and others.

Key Words:

vaccine, recombinant, West Nile, malaria, influenza, dengue

Uses of Technology/Products/Service:

The Company’s lead development projects using the protein production platform are a West Nile vaccine, seasonal influenza vaccine and dengue vaccine. Proof-of-concept animal studies show that a number of HBI prototype vaccine formulations against West Nile are efficacious in the well-validated golden hamster model; similarly, positive immune response data have been obtained in mouse models with a prototype vaccine against influenza virus. The Company intends to file an Investigational New Drug application (IND) with the US Food and Drug Administration (FDA) to begin human clinical trials with its West Nile vaccine in 2007. Hawaii’s ethnically-diverse population makes it an ideal location to conduct such Phase I studies, and the local clinical research infrastructure is well-developed. Hawaii Biotech enjoys exceptional community and regional support, as Hawaii’s legislators work to diversify the State’s economy that currently, is heavily reliant on service-oriented industries. Also in 2007, the Company has embarked on the development of its recombinant Influenza vaccine, designed to be safer than the current generation of Influenza vaccines manufactured in eggs. Once established, this technology could be applied to the development of a pandemic influenza vaccine as well. Finally, HBI’s dengue vaccine formulations have been tested in both mouse and primate studies for ability to induce protective immune responses. These studies have demonstrated that high titer virus neutralizing antibodies (PRNT) are induced by several candidate formulations and that these formulations protect against viremia following challenge with live dengue virus.

Benefit to Company:

Since 2001, Hawaii Biotech has successfully competed for more than $30 million in Federal and State grants, including those available through the SBIR mechanism. In turn, this validation of our scientific programs by the nation’s top researchers, and the exceptional commercial potential of the Company’s SBIR-funded product candidates, has been leveraged to attract additional millions in private investment and Hawaii State matching funds. Together, this investment has enabled the Company to grow during the past two decades from 15 to 50 highly-trained biotechnology employees; outfit 20,000 square feet of state-of-the-art molecular biology, cell culture and protein biochemistry laboratories; complete the preclinical development program and design the clinical development program for two product candidates (West Nile and dengue fever vaccines); obtain robust proof-of-concept data supporting vaccine development for other diseases such as tick-borne encephalitis and malaria and funding positive preliminary data for influenza. In addition this support has provided scientific assistance to biodefense researchers in the U.S. Department of Defense as well as to pathogen detection researchers in the U.S. Department of Agriculture. Other collaborators that have benefited from scientific and commercial collaboration with Hawaii Biotech include the University of Texas Medical Branch, Harvard Medical School, University of Hawaii and Walter Reed Army Institute of Research. Hawaii Biotech has also generated $2 million in licensing royalties and product sales; spun-off a Federally-funded Drug Discovery division which acquired research projects involving Anthrax, Ebola and Botulism; now known as PanThera Biopharma, LLC; in addition to forming a separate privately-held biotechnology company, Cardax Pharmaceuticals, Inc. that is completing the preclinical development of a cardiovascular product candidate.

How Product Was Commercialized:

The recombinant vaccine products will be commercialized following safety and efficacy clinical trials in appropriate populations. HBI will focus on licensing its pipeline of vaccine candidates in order to achieve a stream of revenues from licensing fees, milestone payments and royalties.

Related Award(s):

1R43AG010659

Technology Developed:

Decision Systems developed a map-based computer system, called “TeleMinder”, which automatically telephones people and gives them emergency instructions, provides important information, or asks questions. The systems are designed to provide health care information, management information and crime notification and prevention.

Key Words:

teleminder, communications, disaster relief, computer system

Uses of Technology/Products/Service:

In times of disaster, older people suffer more death, injury, financial loss, and stress than younger people. This pattern of neglect can be reduced by improving communications between community elders and agencies providing emergency and disaster relief services. Teleminder can assist in providing a) notifications and instructions to residents in times of imminent danger, b) identification and evacuation of older residents prior to disasters, c) rapid damage and injury assessment after disasters, and d) effective communication and outreach for relief agencies during disaster recovery. During non-emergency periods, it can provide community wide services such as daily check-up calls for elders and a telephone bulletin board of community events and services. Vertical markets for TeleMinder include a) police and fire departments, b) local, county, state, and federal offices of emergency services, c) state and federal disaster relief agencies, and d) business using or producing toxic materials.

Benefit to Company:

Dr. Von O. Leirer, president of the company, estimates that the company has paid over $300,000 in federal income tax from the sale of these systems as a result of the NIH/National Institute of Aging’s initial investment of $50,000.

How Product Was Commercialized:

Several newspaper articles (National Fire and Rescue, 1997; The Sun Bulletin, March 1998; Los Angeles Times, June 1999), testimonial letters (Anna G. Eshoo, Member of Congress) and brochures for the TeleMinder systems have been resulted from the development

Related Award(s):

1R43AG012080

Technology Developed:

Evening Star Productions was awarded a Phase I SBIR grant to develop a video and print series for older adults and caregivers to improve their life skills. That grant resulted in the development of a commercialized video and print series, Living Well, hosted by Nick Clooney. This five part video series deals with nutrition and diet, exercise and fitness, Medicare and Medicaid, legal and financial issues, and how to improve your health care. A 52 page referral and resource booklet is included with the video series. The product is sold on QVC, through national aging and disease organizations, PBS, and through retail outlets including Borders. After the series was produced, a 26-week television series based on the grant findings was produced. This series received a Bronze Award in the National Mature Media Awards and was the first Phase III funding through the Department of Health and Human Services (HCFA) which sponsored the series. Additional support for the series was provided by the Jewish HealthCare Foundation.

Key Words:

health care, life skills, nutrition and diet, exercise and fitness, legal and financial, video series

Uses of Technology/Products/Service:

The technology resulted in a 26 week 30 minute program series on PBS, five 30 minute videos, and a 52 page resource and referral booklet.

Benefit to Company:

Cumulative sales revenues to date from SBIR-developed technology: The revenue generated from this project has been in excess of $1,000,000.

How Product Was Commercialized:

The 26-week series is airing on all the major PBS stations and reaches over 25 million viewers. It is also distributed to major colleges and universities through the Adult Learning Service of PBS. Beginning in January 2000, the series will also air on the new FOX Health Network with an additional 27 million viewers. Living Well is one of three SBIR grants that Evening Star Productions has successfully commercialized.

Related Award(s):

N44CO33071

Technology Developed:

Developed an interface that integrates isolated-word speech for entering a search query and continuous speech for accessing retrieved information. Gained an understanding of conversational interaction between humans and machines and implementing a dialog that incorporates conversational features. Recognized the need for a speech interface to adapt to the user’s level of expertise — whether a new or experienced user — and implementing voice prompts that make this adaptation.

Key Words:

speech interface, voice prompts, dialog, conversational features

Uses of Technology/Products/Service:

Results of this SBIR contract were presented by project participants to the following organizations and audiences: American Medical Informatics Association (AMIA) symposium (Washington, D.C.); Symposium on Computer Applications in Medical Care (SCAMC); ANSI Healthcare Informatics Standards Planning Panel (Crystal City, Virginia); ARPA Domain Specific Software Architecture Healthcare Meeting (John Silva, M.D., chairman); American College of Physicians (ACP); Lippincott & Co. (medical publisher); NIH Clinical Center; Illustra; Medical Library Association (annual meeting); International Medical Informatics Association (IMIA) Working Group (Geneva, Switzerland); Healthcare Information and Management Systems (HIMSS) conferences (Phoenix, Arizona, and San Antonio, Texas); Medinfo’95 conference (Vancouver, Canada); National Cancer Institute (NCI); and the Artificial Intelligence in Medicine (AIM) spring symposium. Participants in this SBIR contract authored or co-authored fifteen publications related to SBIR activities. These appeared in journals such as Methods of Information in Medicine and in the proceedings of the Annual Symposium on Computer Applications in Medical Care (SCAMC) and of the annual American Medical Informatics Association (AMIA) and Healthcare Information and Management Systems Society (HIMSS) meetings.

Benefit to Company:

How Product Was Commercialized:

No direct commercialization resulted from the voice-recognition part of the SBIR. However, the work resulted in receiving another grant from the NAPBC program for our Stanford collaborators.

Related Award(s):

N44CO40550

Technology Developed:

Although considerable effort has been put into creating extensive on-line reference resources for oncology, this compiled knowledge has been underutilized in clinical situations. This SBIR project was designed as a step to remedying this deficiency, basically by combining Lexical’s Oncology Knowledge Authority (OKA), a component for retrieving relevant information from machine-readable knowledge sources, with Stanford’s Mobile Access to Oncology Knowledge (MATOK), a pen-based interface.

Key Words:

oncology, machine-readable, pen-based interface, on-line reference

Uses of Technology/Products/Service:

Two deployments of MATOK were carried out during Phase II, at the NIH Clinical Center’s Pediatric Oncology Clinic (in April 1996) and at the Stanford Oncology Day Care Clinic (in July 1996). The OKA and MATOK were installed and placed into use at the NIH Clinical Center at the end of March 1996, using wireless interfaces. The MATOK client was tested and revised extensively, the OKA Access Protocol was modified and extended to handle the scaled-up database and needs of the clinical environment, and the AllTel TDS 7000 system was integrated with MATOK. The server system was installed in the Clinical Center’s machine room, and wireless access points were installed in the Pediatric Oncology Clinic and in the in-patient unit. The four tablet computers were assigned and the initial groups of users were trained on the system. Regular joint meetings between Lexical and Stanford project team members were held to conduct further tests on and to streamline the evaluation of the pen system. Nightly reports testing the OKA showed that both the OKA machine and its Illustra database were stable and continued to work unattended. Very few bugs were reported by users. During 1994-1996, results of this SBIR were disseminated by project participants to the following organizations and audiences: American Medical Informatics Association (AMIA) symposium (Washington, D.C.); Symposium on Computer Applications in Medical Care (SCAMC); ANSI Healthcare Informatics Standards Planning Panel (Crystal City, Virginia); ARPA Domain Specific Software Architecture Healthcare Meeting (John Silva, M.D., Chairman); American College of Physicians; Lippincott & Co. (medical publisher); NIH Clinical Center; Illustra; Medical Library Association (annual meeting); International Medical Informatics Association Working Group (Geneva, Switzerland); Healthcare Information and Management Systems (HIMSS) conferences (Phoenix, Arizona, and San Antonio, Texas); Medinfo’95 conference (Vancouver, Canada); National Cancer Institute; and the Artificial Intelligence in Medicine spring symposium. Fourteen publications resulted from this work.

Benefit to Company:

How Product Was Commercialized:

No direct commercialization has yet occurred.

Related Award(s):

1R43HG002193,2R44HG002193

Technology Developed:

This grant supported the development of a DNA microarray manufacturing instrument that uses DLP technology from Texas Instruments to pattern the light direct DNA synthesis chemistry used to manufacture the microarrays.

Key Words:

microarray, MAS, ChIP chip, CGH, Expression, Manufacture

Uses of Technology/Products/Service:

Our technology manufactures microarrays used for research in a wide variety of fields. Some of these fields are: cancer research, stem cell research, antibiotic resistance, crop improvement, autism research, mental health research and diabeties research.

Benefit to Company:

The SBIR grants (the Phase 1 and Phase 2) came at a pivotal time for the company. They served dual purposes. First, they provided funds for development and second they provided scientific validation of the technology in the eyes of venture capitalists. The peer review process of the grants acted as a form of due diligence for investors which allowed us to bring in additional funding. Ironically, this venture capital then disqualified us from receiving additional SBIR grants because of the ownership restrictions on eligibility for SBIR grants. As a result of the funding from this grant and the additional venture capital that we raised we were able to successfully develop our array manufacturing technology which has formed the basis of our commercial business.

How Product Was Commercialized:

Our initial business model was as a service company that accepted samples from customers and then delivered data. This model has been very successful and has led to rapid growth resulting in the company preparing for an IPO in early 2007. We also recently signed a broad licensing agreement with the current market leader, Affymetrix, that allows us to develop an additional business model that sells arrays directly to customers. We expect this new business model to increase our growth rate and market share even further.

Related Award(s):

1R43HD040743,5R44HD040743

Technology Developed:

Simbex developed a method and algorithm for widespread, cost-effective measurement of head acceleration due to impact. Our long-term goal is to validate a quantitative model of head impact acceleration that enables translational research and development of new clinical and therapeutic techniques to increase detection, reduce the incidence, and improve treatment of concussions or Mild Traumatic Brain Injury (MTBI).

Key Words:

Brain injury, Concussion, Helmet, HIT System, Head impact, Biomechanics, Telemetry, MTBI

Uses of Technology/Products/Service:

HIT System technology measures head acceleration by placing multiple miniature single-axis accelerometers in a helmet (eg. sports, military). Data are transmitted via a telemetry link in real time to a sideline computer. A patented algorithm processes the data and computes the acceleration of the center of gravity of the head. A paging system is implemented to alert medical personnel of a potentially injurious head impact for review. HIT System technology developed under this SBIR has been leveraged in the following public and private applications: - More than 250,000 head impacts in collegiate and high school football have been collected with instrumented helmets under the product name Sideline Response System by industry leader Riddell (commercial) - HIT System technology has been implemented in multiple research programs studying concussion injury, including: soccer (Wayne State University), hockey (Dartmouth College, University of North Carolina), equestrian (University College of Dublin), boxing (Wayne State University, USA Boxing, US Army), and skiing/snowboarding (Dartmouth Hitchcock Medical Center), among others

Benefit to Company:

The SBIR program has been instrumental in providing the research and development funding to develop, validate, and prepare for market this technology.

How Product Was Commercialized:

Simbex first developed and launched prototype HIT System product with several major Division I NCAA colleges (Virginia Tech, University of North Carolina, University of Oklahoma). Simbex then formed a partnership with Riddell, Inc. to commercialize HIT System technology for helmeted team sports applications, while maintaining rights to develop and exploit the technology for other applications including the military. Additional commercial and military applications are in development and on track for commercialization

Related Award(s):

1R44HL072635

Technology Developed:

Talisman has developed a US Food & Drug Administration 510(k) cleared production line automated health interviewing system using audio-visual touch-screen computer assisted self interviewing (AVT-CASI) technology and trade marked it as the Quality Donor System (QDS) (tm). It utilizes a questionnaire standardized by the AABB (formerly the American Association of Blood Banks). QDS was initially installed in a Midwest blood center in 2001. Since then it has been installed and is operational at four additional centers and has assisted in screening over 400,000 blood donations as required by the FDA.

Key Words:

CASI, AVT-CASI, automated interviewing, blood donors, error reduction, honesty, staff satisfaction, donor satisfaction

Uses of Technology/Products/Service:

As noted above, the Quality Donor System (QDS)(tm) is installed at five US blood centers and has been used to screen over 400,000 blood donations. It is the only such interviewing system in large scale use. QDS has been shown in referred scientific publications to vastly increase both donor and staff satisfaction with this highly personal process, reduce US FDA reportable errors by over 60%, increase donor reporting of transmissible disease risky behaviors by a factor of 9 and reduce staff interviewing time by 5 minutes per donation. Organizations currently utilizing QDS are the Mississippi Valley Regional Blood Center, Davenport, IA; the West Tennessee RBC, Jackson, TN; Lifeblood - Mid-South RBC, Memphis, TN; LifeShare Blood Centers, Shreveport, LA; and the Dartmouth-Hitchcock Medical Center, Lebanon, NH. Collectively they have over 50 fixed sites and 100 mobile operations using QDS daily to screen 100% of donations. QDS has recently been expanded to record mini-physical and phlebotomy data, present informed consent statements to donors, and capture donor and staff signatures. These changes are expected to increase FDA reportable error reductions to over 90%.

Benefit to Company:

The SBIR program has allowed Talisman to expand from a staff of two people to seven highly skilled professionals and to develop the Quality Donor System (QDS) (tm) to the point it could obtain US Food & Drug Administration 510(k) clearance to be marketed and operated in blood centers. Without SBIR funding it is very unlikely that this innovative cost-effective error reduction and safety enhancing technology would have ever been marketed thus there could not have been scientific proof of the superiority of the technology over paper and face-to-face health interviewing. Talisman's market share is currently over 90% and licensing revenues are about $200,000/yr. Revenues are expected to reach $1 M in two or three years.

How Product Was Commercialized:

The product was commercialized by obtaining research partners to install and operate the system, and produce related performance statistics, in exchange for very low cost licenses. As noted above, commercialization required US Food & Drug Administration 510(k) authorization to market. Obtaining this clearance is a long and technically complex process the mastering of which would not have been possible without SBIR funding. Talisman's strategy is to be first with the best forever and that requires ever more FDA clearances. A new FDA 510(k) clearance for an Internet Donor version of QDS (iQDS) is currently in process. It will permit prospective blood donors to conduct the screening interview from any place with a broadband connection and complete it at the drawing location. This product is highly sought by employers who view it as saving about five minutes of time away from work stations. Tests have shown that donors prefer iQDS even more than QDS. Earlier this year Talisman hired a full time staff member to launch a promotional campaign to acquire new blood center customers. The program is beginning to bear fruit in the form of new QDS contracts.

Related Award(s):

1R43EY014768-01

Technology Developed:

Prior to the introduction of this product, the benefits of cryopreserved amniotic membrane for the protection, healing and reconstruction of the eye surface required surgery. PROKERA™ was developed so that the same sight saving benefits realized in the operating room could be delivered in the outpatient clinic, hospital bed, emergency room or physician’s office without the need for sutures. PROKERA™ is a sutureless graft that provides the same therapeutic biologic actions of cryopreserved amniotic membrane in an ambulatory setting.

Key Words:

amniotic membrane, ocular surface, wound repair, wound healing, eye surgery, corneal defects, chemical burns, Stevens-Johnson Syndrome

Uses of Technology/Products/Service:

PROKERA™ consists of a dual polycarbonate ring system used to securely clip a circular piece of cryopreserved (frozen) human amniotic membrane (AMNIOGRAFT®) in between. This ring set sits on the eye surface like a contact lens. Amniotic membrane, sometimes referred to as the miraculous tissue of Mother Nature, is the innermost layer of the placenta. The cryopreserved amniotic membrane provides natural healing actions including reduction of scarring, prevention of blood vessel formation, and reduction of inflammation while promoting the healing of the eye surface and reducing pain in the patient eye. Cryopreserved amniotic membrane to restore a healthy eye surface is a scientifically well-accepted application for treating various eye surface diseases that threaten the sight of millions of patients. The polycarbonate ring set also helps maintain space in the eye socket and to prevent the eye from closing or fusing. PROKERA™ acts as a biologic bandage as it delivers the therapeutic benefits mentioned above while providing a physical bandage for the eye surface. When used in the office setting, PROKERA™ provides crucial sight-saving acute treatment that can possibly prevent or delay a surgical procedure or save a graft failure due to high risk corneal transplant. PROKERA™ often eliminates the need for surgery and provides sight saving benefits and the most common indications for use are: • Eye surface defects, erosion, or ulceration • Chemical/thermal burns (acute stage) • Following the removal of corneal lesions, e.g., band keratopathy • Persistent unmanageable inflammation from herpes, or inflammation due to allergies • Stevens-Johnson syndrome (acute stage) • In conjunction with socket or fornix reconstruction (to prevent lid/lash rubbing)

Benefit to Company:

The grant awarded by NIH enabled TissueTech, Inc. to complete the design and commercialize PROKERA™, diversifying their line of cryopreserved amniotic membrane products.

How Product Was Commercialized:

PROKERA™ was approved by the FDA in December of 2003 as a Class II medical device (510(K) Clearance) and was launched in April 2005. Medicare provided a reimbursement supply code for PROKERA™ in October 2006 which has significantly aided in product acceptance.

Related Award(s):

5R44HL061075-03

Technology Developed:

CardioMend developed disposable surgical instruments for sizing, cutting a proprietary tissue pattern, and holding the tissue in anatomical orientation for heart valve reconstruction. CardioMend also developed instruments and methodology for intraoperative testing of the biomechanical properties of the tissue used for the reconstruction.

Key Words:

heart valve, autologous tissue, pericardium, semilunar, tissue testing

Uses of Technology/Products/Service:

With CardioMend disposable surgical instruments, a cardiac surgeon can precisely measure the geometry of a diseased heart valve that needs to be reconstructed. Knowing the required size, he can open a size-specific cardiac valve reconstruction (CVR) kit that contains a cutting die and impact tool to cut a piece of lightly tanned autologous pericardium (LTAP), the trefoil. The trefoil is a seamless flat pattern that when sutured into the aortic or pulmonic root will deform to the shape of a normal native aortic or pulmonic valve. The CVR kit also contains a Tissue Holder that holds the tissue atraumatically in anatomical orientation during placement of six critical sutures that determine the final geometry of the reconstructed valve. The CardioMend Tissue Tester is a reusable instrument that can be used to measure the biomechanical properties of the tissue used for the reconstruction.

Benefit to Company:

SBIR Phase I and II grants were the starting point of CardioMend. During tenure of the grants the Company completed product development, secured 6 U.S. patents, full market approval by the FDA and the CE mark for Europe in preparation for clinical use of its products.

How Product Was Commercialized:

Related Award(s):

1R43DK051466-01

Technology Developed:

Novel technology for high throughput screening assays for drug discovery, Transfection reagents for human stem cells, human endothelial cells, hepatocytes and many hard-to transfect primary cell types, reagents for efficient intracellular delivery of functionally active proteins and peptides, and novel luciferase technology including vector systems and luciferase assay reagents for applications in functional genomics. One of these novel luciferases, Gaussia luciferase, is a secreted luciferase over 1000-times brighter than firefly and renilla luciferase, Reagents and kits for gene silencing and siRNA screening. Technology for non-invasive imaging and tracking of implanted human stem cells using bioluminescent imaging techniques, quantitative assessment of stem cell survival and expansion in vivo.

Key Words:

High throughput screening, Transfection, Protein delivery, siRNA delivery/screening, Luciferase assays/vectors, Lentiviral vectors, Stem cell tracking, Stem cell transfections

Uses of Technology/Products/Service:

The Targefect reagents (for gene transfer and siRNA delivery) have been widely used and are now cited in approximately 100 citations in reputable journals. The Profect reagents (for protein delivery) have also been commercialized and are cited in 8 citations. Modifications of the Targefect and Profect reagents have proven useful for efficient gene and protein delivery into human stem cells. Gaussia luciferase based lentiviral vectors have proved extremely useful for tracking stem cells and monitoring stem cell survival and expansion in vivo. This technology has now been transferred to our recent spin-off Pluristem Innovations. The novel luciferase technology developed at Targeting Systems is now being used for studying reporter gene expression and for HTS (high throughput screening) in drug discovery applications.

Benefit to Company:

Targeting Systems started as a one-person operation entirely with the help of an NIH SBIR Phase I grant. The company commercialized its first line of products, the Targefect reagents and became profitable within 1 year of inception. Revenues from the Targefect reagents in subsequent years helped us to develop new technologies for protein delivery, gene silencing and chemiluminescence-based applications in functional genomics and drug discovery. In addition we were able to spin off a new company "Pluristem Innovations" which offers novel technology for genetically engineering and tracking stem cells in January 2007.

How Product Was Commercialized:

The products were commercialized mostly by word of mouth and press releases in the New Products section of Bitoech publications -Biotechniques, Genetic Engineering News, and Science and by Google based advertising.

Related Award(s):

5R44AI046038-03

Technology Developed:

Increased speed of identification of bacteria by 3x and sensitivity by 2.5x. Marketed successfully for two years. Subsequent modification increases speed of sample preparation by 20x and sensitivity by 10x.

Key Words:

Fatty acid analysis, Bacterial identification, Gas chromatography, Sample preparation, Sensitivity, Speed of identification

Uses of Technology/Products/Service:

Identification of bacteria by gas chromatographic analysis of fatty acid profiles has been improved in terms of sensitivity (20x) in speed of analysis by 3x. Sample preparation time has been reduced from 60 minutes to about 2 minutes. Time for bacterial identification from plate culture is now less than 15 minutes. The next step of the process is to separate the bacteria from the blood in the culture bottle, enabling identification direct-from-blood-culture in less than 30 minutes vs. the normal time of ca. 48 hours.

Benefit to Company:

MIDI was not able to complete all aspects of the research necessary to create the final product during the SBIR Phase II research period. However, marketing of two intermediate products has provided income to help complete the final product development, FDA clearance and marketing. The time frame and expense for such products would not have been feasible without SBIR funding from the National Institute for Allergy and Infectious Diseases.

How Product Was Commercialized:

MIDI commercialized the products through advertising in trade journals and presence at trade shows such as the annual meeting of the American Society for Microbiology.

Related Award(s):

2R44DK056539

Technology Developed:

High-resolution manometry system that utilizes hundreds of points of measurement to generate pressure images of motor function within the GI tract. Developed technology includes a high-resolution solid-state catheter, high-speed data processing electronics, data visualization and analysis software, and an integrated cart workstation.

Key Words:

Manometry, Motility, High-resolution, Gastroenterology, Esophagus, Stomach, Duodenum, Anorectum

Uses of Technology/Products/Service:

The ManoScan 360 (tm), is used both in research and clinical settings for motility studies of the esophagus, small bowel, and anorectum. Because of the many closely spaced sensors, the clinical technician may simply place the catheter in the region of interest, ask the patient to perform certain maneuvers, and all relevant data are collected automatically. For example, in esophageal motility studies, the entire motor physiology from the pharynx to the stomach is imaged as the patient swallows small amounts of water. In contrast, prior conventional manometry systems, with typically three to six pressure sensors, require complex procedures and are subject to artifact due to axial movement of anatomical landmarks and variability in operator technique. In analysis of the acquired data, high-resolution pressure images provide an unprecedented clear view of physiology and disease related pathophysiology. Automated data analysis methods have been developed and shown to yield significantly more reliable and effective diagnostic metrics than are possible with conventional systems.

Benefit to Company:

The Phase I and Phase II SBIR grants provided the seed and primary development funding for the ManoScan system. Simply put, these grants enabled the development of this technology and the formation of our company.

How Product Was Commercialized:

Grant funding provided the main financial resource during the R&D and early product commercialization phases. Modest private funding was then secured to enable building a regulatory compliant production capability and launching the product. Additional key members with experience in sales and marketing within this marketplace joined the team – largely as a result of enthusiasm for the technology. In its first year of sales, Sierra Scientific Instruments reached break-even profitability – based largely on the ManoScan product - and has steadily grown via sales revenues since that time.

Related Award(s):

1R44MH072063,1R43MH062840,1R43MH076188

Technology Developed:

MBF Bioscience has pioneered computerized microscopy tools for morphometric and quantitative analysis in neuroscience. The systems produced by MBF have made important contributions to scientific research worldwide. With its first NIH SBIR grant in 1989 MBF created the Neurolucida system. Today, Neurolucida is in use in over 1000 laboratories around the world and has become the gold standard tool for neuron tracing and brain mapping. In 1995 MBF received an SBIR award to create Stereo Investigator, which has become the most widely used system for stereology. MBF has also created other products funded by the NIH to enhance collaboration among researchers with Neuroinformatica, a tool for virtual slide image collaborative, archive and analysis. In 2004 we received a FastTrack award to create automated 3D and 2D neuron tracing software, called AutoNeuron.

Key Words:

stereology, morphometry, automated analysis, digital image archive, neuron reconstruction

Uses of Technology/Products/Service:

Computerized microscopy tools are used in basic research, drug development and pharmaceutical fields to aid the quantification of objects viewed through the microscope.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

5R44HD037714-03

Technology Developed:

Conception, development, regulatory approval and marketing of first lightweight, durable, folding manual wheelchair from synthetic engineering resins. The colorful, stylish product offers the mobility-limited the opportunity to shed the spectre of disability and offers a fashionable appearance promoting self esteem. Additionally the Company now offers a chair designed and approved for safe use in the MRI suite where the ferromagnetic mass of a metal chair might well be drawn suddenly into the bore of the magnet.

Key Words:

wheelchair, MRI wheelchair, mobility for seniors, plastic wheelchair

Uses of Technology/Products/Service:

There are 12 million Americans who cannot walk one-quarter mile and nevertheless do not use any assistive mobility device. These individuals do not participate in the life of the nation; in our parks and venues, our museums and malls and the excitement of the modern American cityscape. For many the barrier is psychological - they do not want to be seen as disabled. For others it is cost. Turbo Wheelchair's Merlexi Craft series of FDA approved manual wheelchairs offer an inexpensive and stylish approach to the problem of providing mobility for those who need it while meeting the needs of the caregivers who will likely accompany the mobility limited. The products are lightweight, coloorful and durable. The solid, ergonomically designed contoured seat offers client support yet is part of an easily foldable chair construction. Care givers benefit from the unique handles that provide comfort and control to a far greater extent than the standard horizontal rods. In summary the product line is a departure form the chair as a symbol of disease and disability and a model of what mobility should be for those who retain the curiousity and passion for a viogorous mobile life.

Benefit to Company:

Turbo Wheelchair was formed to develop this technology and as an outgrowth of successful adult chair development, the Company has gone on to begin a program of chair design focused on the needs of children, particularly those limited by the presence of high-tone; spasmatic episodes marking certain conditions such as cerebral palsy.

How Product Was Commercialized:

Our Merlexi Craft Liberty series of wheelchairs were commercialized after successful FDA 510k submittal. With approval for marketing the Company markets through web advertising and direct sales contact.

Related Award(s):

1R43AI056409-01,2R44AI056409-02,2R44AI056409-06

Technology Developed:

The Phase I SBIR supported development of a validated virus-specific high throughput screening assay to identify specific inhibitors of variola virus. This assay was used to screen a proprietary chemically diverse library of over 400,000 small molecule compounds for inhibitors of orthopoxvirus-induced cytopathic effects. Inhibitor compounds were evaluated for chemical tractability, antiviral potency and spectrum and selectivity as well as activity against authentic variola virus in cell culture (performed through collaborating laboratories). Lead compounds were optimized and mechanism of antiviral action was determined. The Phase II SBIR supported lead optimization, animal efficacy evaluations, and preclinical development of ST-246 the lead compound identified from the initial screen. This work resulted in a submission of an investigational new drug application (IND) with the FDA to support human clinical development of ST-246 for the treatment of pathogenic orthopoxvirus infections.

Key Words:

antiviral, smallpox, ST-246, egress inhibitor, biodefense, high throughput screen

Uses of Technology/Products/Service:

The primary use of ST-246 is to treat and prevent diseases caused by pathogenic orthopoxvirus infections including smallpox and to prevent side-effects associated with the current smallpox vaccine. While smallpox is no longer endemic it is considered a formidable biowarfare threat. ST-246 works by preventing egress of extracellular forms of virus thereby, blocking the ability of the virus to spread to other cells. This compound is well-tolerated and has been demonstrated to protect mice, rabbits, ground squirrels, and non-humam primates from lethal orthopoxvirus challenge. The compound is safe and well tolerated in humans with plasma drug exposure levels comparable to those that provide efficacy in animal models of orthopoxvirus disease. The FDA has designated ST-246 for “fast-track” status, creating a path for expedited FDA review and eventual regulatory approval. ST-246 can be used for the following indications: • prophylaxis: preventing the orthopoxvirus disease in non-vaccinated individuals • post-exposure therapeutic: treating disease in non-symptomatic people exposed to smallpox virus • therapeutic: treating those with smallpox symptoms • adjunct to vaccination: combining with smallpox vaccines to prevent disease and reduce vaccine-related complications.

Benefit to Company:

Prior to initiation of the biodefense-specific RFA, there was little financial incentive to develop therapeutics for biodefense applications. The SBIR program provided the impetus for establishing screening programs to identify inhibitors of category A biodefense pathogens. The success of these screening programs have lead to potential products that have created value through grants, contracts, and partnering opportunities with the ultimate goal of procurement to the Strategic National Stockpile for biodefense products. SBIR funding provided SIGA with the opportunity to utilize in-house expertise to develop a smallpox antiviral to fulfill this critical unmet need.

How Product Was Commercialized:

The primary customer for biodefense antiviral products will be U.S. government, and specifically the Strategic National Stockpile (SNS). In addition, many category A biowarfare agents are endemic and governments investing in public health will also serve as potential markets. Continued collaboration with the NIH and other government agencies involved in the development and procurement of biodefense products is the primary means to commercialize SIGA products.

Related Award(s):

1R43DK078457-01

Technology Developed:

Food BEAMS is an electronic or web-based data collection tool that enables the user to accurately catalogue competitive foods and beverages sold on school, work site, and health care campuses, and to assess their adherence to food and beverage standards.

Key Words:

Competitive foods, Nutrition, Policy Adherence, Data Collection, Policy Monitoring, Schools, Health

Uses of Technology/Products/Service:

The Food BEAMS electronic data collection system and nutrient database enables users to assess adherence to the state and local nutrition policies, and to identify which foods and beverages need to be changed to increase adherence and create a healthy nutrition environment. Food BEAMS uses an observational data collection methodology to catalogue the foods and beverages sold, links these items to a database containing the entered items' nutrient information, and then produces simple analysis of the adherence of the foods and beverages to state and local standards. Applications: - Use by school administrators, nutritionists, and food service personnel, to monitor adherence to competitive food standards such as California's SB 12 and SB 965 - Use by private or public sector institutions such as work sites and health care institutions to monitor adherence to their own institutional nutrition policies. - Use by advocates, parents, and other key stakeholders to assess the nutritional quality of various environments such as the foods and beverages being sold in schools and public places such as parks, etc.

Benefit to Company:

SBIR Phase I has greatly supported our ability to develop the technical application (functionality, user-friendliness, scalability) of Food BEAMS. We have also benefited from a Technology Niche Analysis provided to us through the SBIR program. As a result Food BEAMS has been used in projects throughout California, and is also being used in other states such as Washington. We are looking forward to applying for Phase II funding and launching our system nationally.

How Product Was Commercialized:

Related Award(s):

1R44AG023407

Technology Developed:

A treadmill-based rehabilitation simulator system, ActiveStep, that imposes dynamic postural perturbations to human subjects. ActiveStep provides the enabling technology for large-scale application of clinically relevant falls assessment and fall prevention training.

Key Words:

Fall prevention, Fall-risk assessment, Falls in the elderly, Task specific training, Neuromuscular programming, Dynamic gait training, Fall recovery

Uses of Technology/Products/Service:

Falls are a leading cause of injury and mortality in the elderly. Ongoing research using the ActiveStep simulator has demonstrated that a training program for tripping and slipping reduces the number of falls in older adults subject to laboratory induced trip and slip disturbances. Use of ActiveStep is hypothesized to reduce the incidence of falls, the leading cause of injury deaths among people over 65 years old, thereby reducing health care costs associated with the treatment and rehabilitation of injuries sustained during a fall. ActiveStep provides repeated exposures to a slip or trip distance to retrain neuromuscular reflexes that affect the biomechanical response to a postural disturbance that results in a recovery rather than in a fall. ActiveStep is intended to reduce the incidence of falls and injuries related to falls,. The product is currently being offered to acute care hospitals, rehabilitation hospitals, Veterans Administration service providers, skilled nursing facilities , assisted living facilities, and other service providers for the elderly by a dedicated sales staff.

Benefit to Company:

The Principal Objective of this NIH SBIR program was to complete product development efforts for and clinical validation of ActiveStep. Current design goals include reducing the cost of goods for manufacturing and meeting electrical and mechanical safety requirements and life-cycle testing that are included in national and international standards for commercial exercise equipment. ActiveStep launches the rehabilitation division of Simbex. The ActiveStep SBIR program and subsequent commercial product(s) provide local jobs for employees in both research and development and light manufacturing.

How Product Was Commercialized:

Simbex commercialized ActiveStep technology in-house using internal funding. Simbex currently manufacturers and distributes the product from its Lebanon, New Hampshire location, with a dedicated sales staff. Financing and operational decisions for ongoing scale-up are under evaluation.

Related Award(s):

1R43EY013896,2R44EY013896

Technology Developed:

LLT has developed a broad and versatile, FDA approved and proprietary technology platform for inkjet printing a digitized iris image or therapeutic coatings for hydrogel and silicone hydrogel contact lenses.

Key Words:

Digitized Iris Image, Inkjet printing, Prosthetic lens, Antimicrobial, Contact lens, Silicone Hydrogel, Lens dryness, Friction reduction

Uses of Technology/Products/Service:

Inkjet printing is an enabling technology with ever expanding applications in everyday life. With inkjet printing, a mirror image of a patient's good eye can be reproduced on a contact lens as a prosthetic lens for the damaged eye at low cost. Further extension of its application would provide a most natural looking cosmetic lens to change or enhance the color of the eye. In additionally, in near future our technology would provide a thin uniform coating on the contact lens surface to provide the following properties for enhancing the health of the eye: * Antimicrobial, to minimize eye infection, recall of lens solutions. * Keeping the lens surface moist to minimize the effect of lens dryness * Friction reduction / comfort enhancement for highly oxygen permeable silicone hydrogel lenses. Use of this technology for drug release to improve efficiency for eye drugs or creating a bionic contact lens is not far off.

Benefit to Company:

In addition to providing seed money to prove feasibility and product safety SBIR enabled LLT to develop a broad based technology platform for contact lenses. While our employee base grew three times we were also able to derive benefits from expertise and resources available at various US universities and small businesses. As a result we have developed proprietary and niche expertise to use advanced inkjet printing equipment and technology to provide health enhancing features to contact lenses. Also we were able to sign co-development and licensing agreement with a strategic partner. The potential annual revenue generated from the sales of products developed with our technology is estimated to be $100s of million in five years.

How Product Was Commercialized:

We plan to commercialize our globally patented and FDA approved technology with a strategic partner.

Related Award(s):

N01ES55545

Technology Developed:

A fluorescent Multiplex ARray for Indoor Allergens (MARIA) has been developed which accurately measures exposure to eight common home allergens in a single test. This technology has greater sensitivity, accuracy and reproducibility than previous methods for allergen exposure assessment and is designed for epidemiologic studies of asthma and allergic diseases, and for monitoring indoor air quality. MARIA measures dust mite, cat, dog, rat, mouse and cockroach allergens.

Key Words:

allergen, microarray, exposure assessment, asthma, indoor allergens

Uses of Technology/Products/Service:

Asthma and allergies strike one out of every four Americans and elevated allergen levels in the home are associated with asthma symptoms in allergic individuals. Asthmatics that have allergies may alleviate symptoms by reducing allergen exposure inside their homes. Indoor Biotechnologies’ scientists have developed breakthrough technology for measuring eight (or more) allergens in a single test using fluorescent multiplex laser array technology . The newly developed Multiplex Array for Indoor Allergens (MARIA) simultaneously measures the most common indoor allergens in a single dust sample with greater sensitivity, accuracy and reproducibility than previous methods. MARIA can analyze 200 individual dust samples for the presence of the eight most common indoor allergens in a day. This technology will enable allergen exposure to be monitored in homes, schools and the workplace and will be used in CDC and NIH studies of the causes of allergic asthma. MARIA technology will help to improve indoor air quality and will enable new procedures and devices for reducing allergen exposure to be developed.

Benefit to Company:

MARIA™ represents the next generation of allergen detection technology and was brought to market in February 2008. MARIA™ was developed in part using a $1.7M Small Business Innovation Research (SBIR) contract from the National Institutes of Environmental Health Sciences. The concept was brought from proof-of-principal to commercialization in under three years and truly represents a quantum leap in allergen monitoring. Indoor Biotechnologies has developed a State-of-the Art laboratory facility in Charlottesville as a result of the SBIR award and has hired four new employees. MARIATM will dramatically improve the ability to measure asthma causing allergens in homes and businesses, and will be the cornerstone of Indoor Biotechnologies growth over the next five years.

How Product Was Commercialized:

Indoor Biotechnologies is the world leader in allergen detection systems and many of our products are unique. MARIA was launched in our on-line newsletter and at the recent annual meeting of the American Academy of Allergy Asthma and Immunology (Philadelphia, March 2008).

Related Award(s):

2R44EY014481-02

Technology Developed:

ViewPlus embossing technology was enhanced by adding color ink jet printing to create the Emprint color embosser and black ink jet printing to create the Pro Ink add-on for the existing Pro embosser. The IVEO SVG Viewer software was developed to permit audio/touch access to graphical information by people who are blind or have other severe print disabilities.

Key Words:

tactile graphics, braille, blindness, dyslexia, accessibility, ink and braille, audio/touch, graphical information

Uses of Technology/Products/Service:

These new products promote better access to information by people who are blind or severely dyslexic. Ink and braille improves communication between blind people and sighted teachers, peers, parents, and others. Color images on embossed graphics improve access to graphical information by people with low vision or dyslexia. Audio/touch accessibility using color tactile graphics and the IVEO SVG Viewer provides tri-modal (seeing, feeling, hearing) access to information. Easy printing of tactile graphics and braille from standard Windows applications and easy creation of SVG graphics reduces cost of making information accessible.

Benefit to Company:

ViewPlus sales revenues have increased steadily as these products have become popular. Its worldwide distribution network is continually becoming stronger because of the popularity of these products. Emprint has become a ViewPlus major revenue source, and the Pro Ink attachment continues to stimulate sales of the Pro embosser as well as contribute directly to ViewPlus revenue stream. ViewPlus estimates that its market share in the braille embosser field has increased from zero in 2000 to 50% in the US and more than 25% outside the US. These products have contributed considerably to that increase. Direct revenues from the Emprint and Pro Ink have exceeded $1M and are growing rapidly. ViewPlus estimates that Emprint sales will be in excess of $1M/year for the next few years.

How Product Was Commercialized:

These products were introduced in trade shows and have been sold largely through ViewPlus' established channels. Many of the top dealers and distributors have joined that network since introduction of the Pro Ink and Emprint.

Related Award(s):

1R43CE00111-01A1,2R44CE00111-02A1,1R43AG018675-01A1,5R44AG018675-03

Technology Developed:

Low Cost PC based driving simulator developed to train novice drivers and assess older drivers. Driving scenarios and performance measures are designed to deal with common driving hazards in urban and rural environments including road profiles, intersections, traffic control devices (signs, signals and markings), traffic and pedestrians. The software and driving controls can be set up on a graphics oriented PC or laptop in a desktop configuration, or with higher end driving controls.

Key Words:

Driving Simulator, Driver Assessment, Driver Training, Driver Rehabilitation, Drug Testing

Uses of Technology/Products/Service:

The simulator technology can be used for the training and assessment of drivers. Longitudinal results for a novice driver training project have shown a reduction in accident rates during the first two years of driving. Results from an older driver project have shown sensitivity to age related deficits. Phase 3 and Phase 4 pharmaceutical testing have shown the simulator to be sensitive to drug effectiveness and side effects. The technology is generally useful for training, assessment and rehabilitation of drivers where low cost and transportability are important. Driving scenarios and performance measurement can be easily specified to meet a range of requirements. The software can also be easily configured for a range of display options (monitors, projectors, narrow and wide angle field of view) and various driving controls options (desktop, consoles, cabs).

Benefit to Company:

SBIR/STTR support has allowed development of simulator capability and testing to demonstrate effectiveness in various applications. Sales have grown substantially and new markets in training, assessment and rehabilitation have opened up. Reporting on the SBIR/STTR supported research has also given more exposure to potential markets. Developments are continuing to meet the demands of new markets. We are currently looking for licensing partners to pursue new market areas in assessment, training and rehabilitation.

How Product Was Commercialized:

Through technical reporting at conferences and Website development. These efforts are continuing.

Related Award(s):

9R44MH076541-02A1

Technology Developed:

Software that incorporates cell recognition algorithms from missile balistics systems research into Verified Computerized Stereoanalysis for automatic analysis of biological features of interest.

Key Words:

stereology, VCS, automatic, cell counting

Uses of Technology/Products/Service:

This software for automatic detection and analysis of cells could be used in a broad range of projects in biomedical research projects in academia, government agencies, and private industry research where scientists are required to quantify changes in cell populations -- for example, pathology or toxicology research.

Benefit to Company:

How Product Was Commercialized:

Related Award(s):

2R44CA097627

Technology Developed:

The BioSEAL consists of a delivery system and a dessicated hydrogel plug that is placed through a coaxial needle following a CT guided lung biopsy. Once deployed the plug absorbs water, swells, anchors and seals the biopsy tract to reduce pneumothorax complications.

Key Words:

BioSEAL, CT guided lung biopsy, hydrogel, pneumothorax, FNA

Uses of Technology/Products/Service:

CT guided lung biopsy using biopsy needles is an extremely sensitive and specific method for the evaluation of indeterminate densities detected on CT and PET/CT imaging. Once the needle is removed, air can leak out of the lung into the surrounding pleural space resulting in a lung collapse. This creates stress for the patient, increased use of hospital, nursing and physician time to monitor the patient and requires chest tube placement and a hospital admission in 10-15% of patients at an average cost of $7000.00. Results from a randomized clinical trial of 300 patients in 17 sites in the U.S. demonstrated a statistically significant reduction in pneumothorax and chest tube rates in patients in the BioSEAL arm as compared to controls. The BioSEAL is commercially available in Europe and is awaiting final clearance from the FDA to be sold commercially in the U.S. A spinoff product, HydroMARK is a novel breast biopsy site marker with a water content of 90% rendering it highly visible under ultrasound imaging for 6 weeks or more. The HydroMARK has FDA clearance and will be released in the U.S. in the 4th quarter of 2008.

Benefit to Company:

With funding from the SBIR program, Biopsy Sciences was available to complete the initial development, proof of concept of the BioSEAL device and to secure a licensing agreement in which we received payments that allowed the company to conduct a clinical trial in order pursue FDA clearance. The BioSEAL was purchased by Angiotech Pharmaceuticals in 2008. Proceeds from that transaction have allowed Biopsy Sciences to hire clinical specialists and launch the HydroMARK in the U.S.

How Product Was Commercialized:

Biopsy Sciences’ large portfolio of patents covering the BioSEAL were acquired by Angiotech. The product is commercially available in Europe and once available in the U.S. will be sold by the Angiotech sales force in the U.S. and abroad. The HydroMARK is sold through a large network of distributors in the U.S. and Europe.

Related Award(s):

2R44HD052329

Technology Developed:

Image-based telehealth technology solutions that connect providers and victims of child abuse in rural and underserved community clinics with experts in tertiary care centers across the United States. The technology (TeleCAM™) supported by SBIR funding, has improved efficiencies in diagnostic evaluation and treatment of victims of child abuse by 32% and is currently in the market place as a commercial product.

Key Words:

child abuse, child maltreatment, Image collaboration, quality review, peer review, telehealth, diagnosis, TeleCAM™

Uses of Technology/Products/Service:

TeleCAM™ is a web-based telehealth technology for physicians and providers associated with child abuse medical evaluation that require a solution for diagnostic services to providers in rural and underserved communities. TeleCAM™ provides access to medical providers located in rural communities that typically do not have the means to link up to a traditional or dedicated telemedicine infrastructure that could be used for clinical peer review and diagnosis. TeleCAM™ tracks the incremental accumulation of case material—images (photo-documentation) and text—from initial creation at a remote clinic through to the final evaluation by a consulting physician, typically located at a hospital or tertiary care center. Accurate and timely diagnosis is supported between two or more providers that share information or evidence consisting of case images (photo-documentation) while maintaining a consultation record for reimbursement and reporting. The innovative core technology that provides and supports text image-based communication for TeleCAM™ has been used in other areas of clinical telehealth. For example, the core technology for child abuse is now used to provide routine screenings for adults with diabetic retinopathy and premature newborn infants with retinopathy of prematurity (ROP). Diabetes is increasing and the use of retinal imaging is the first non-invasive step in diagnosing diabetes in adults. ROP in infants is a condition that if not caught early, can lead to blindness. VisualShare’s telehealth technology is critical and cost effective and allows for early detection by reducing the time to diagnosis and treatment. Additional applications: -teledermatology -telepathology -mobile cardiology -preclinical imaging -late phase clinical trial adjudication

Benefit to Company:

VisualShare has been very fortunate to receive SBIR funding and was able to accomplish the goal of developing core technology to increase efficiencies in diagnosis and treatment in child abuse and other clinical specialties that involve images and providers that are geographically distant from one another. SBIR funded research and development created interest from child abuse early adopters and generated program income from other clinical imaging specialties including pathology, cardiology and ophthalmology. In addition, in late 2008, VisualShare was able to attract investment capital to support additional research and development, support and sales and marketing into pathology, ophthalmology and preclinical imaging in clinical trials.

How Product Was Commercialized:

Commercialization efforts are focused around presentations and displays at professional conferences (e.g., Child Maltreatment, American Telemedicine Association, BioIT Life Sciences), developing partnerships with tertiary care centers that provide services to in/out network providers and word of mouth from early adopters. Future commercialization endeavors will involve hiring sales and marketing to penetrate clinical imaging markets outside of child abuse.

Related Award(s):

2R44EY014723

Technology Developed:

High power prisms were incorporated into prescription eyeglasses for hemianopic patients. An array of inexpensive devices for fitting these lenses and screening hemianopic patients was also developed for use in the clinical trials incorporated into this SBIR.

Key Words:

hemianopia, hemianopsia, quadranopia, quadranopsia, visual field loss, peripheral field loss, Peli Lens, Peli Prism

Uses of Technology/Products/Service:

Hemianopia, or the loss of peripheral vision on the same side of both eyes is a common side effect of stroke or traumatic brain injury and results in difficulty navigating the environment without injury or embarrassment to the individual. This condition affects about 1 million people in the US and prior to this research, no viable help has been available. The prism eyeglasses increase the individuals' visual field 20 degrees into the blind area by creating artificial peripheral vision which has proven helpful for mobility and obstacle avoidance. A set of temporary prisms and a fitting guide was also developed to help eye care professionals determine proper fitting placement for trial and to screen patients to see if they adapted to the prisms. The use of these prisms by hemianopic patients has (anecdotally) decreased their fall and accident rate and increased their quality of life. Many report that they have regained their driving privileges.

Benefit to Company:

Chadwick Optical provides custom eyeglasses for the visually impaired and we have little competition, although, as a company with less than $1mill sales, our marketing budget is limited to word of mouth and trade shows. This SBIR and the clinical trials incorporated in this Grant resulted in the publication of a peer-reviewed article in the Archives of Ophthalmology, May 2008 where we reported a 74% patient acceptance rate. This article and the mention of this research in professional courses and presentations has increased Chadwick Optical's visibility throughout the low vision community. Sales on the peripheral prism glasses and auxiliary products were negligable from April 2005 when the glasses were released through May 2008 when the Archives article was published. The Article has generated increased attention and from May 2008 thru April 2009 these products grew to 3% of our business. We anticipate this percentage to increase steadily as information is disseminated through the optical community via word of mouth, lectures, workshops and seminars. A license agreement has been signed with Schepens Eye Research Institute to manufacture and sell the patented Oblique version of the product. The SBIR program and Chadwick's participation in it has resulted in the recognition of Chadwick as force in the low vision field and has added to it's stature and 20% overall growth rate for the last 5 years.

How Product Was Commercialized:

The product, since its availability in April 2005, has been presented to low vision practitioners via word of mouth and trade shows. This resulted in limited success until the Archives of Ophthalmology article was published in May 2008 reporting a 74% patient adaptation rate. This gave the product credibility because professionals needed the clinical evidence to justify prescribing it. This product is an optical device that helps a neurological problem. Information regarding its use requires that it be brought to the attention of professionals in the field of neurology who deal with stroke and brain trauma. We have been exploring cost effective ways of spreading the word and have not been successful. In May, 2009 we are attacking this problem from a grass roots level via our www.hemianopia.org web site aimed at educating hemianopic patients and their caregivers about the product and directing them to eye care professionals who can fit them with the prisms. That strategy coupled with more seminars and lectures in the optical and low vision field should generate a steady growth in the use of these prism glasses.

Related Award(s):

1R44EY015085

Technology Developed:

Avedro, Inc. has developed Keraflex™, an incision-less vision correction procedure enabled by advanced proprietary technology. Keraflex, which uses focused microwave energy to gently reshape the front surface of the cornea, will represent a unique offering in vision correction as it does not require the creation of a flap in the cornea nor does it involve the removal of any corneal tissue. This well differentiated procedure profile is likely to be particularly appealing to low-to-moderate myopes seeking an alternative to glasses and contact lenses.

Key Words:

Eye, Vision, Ophthalmology, Refractive, Cornea, Myopia, Microwave, Keratoplasty

Uses of Technology/Products/Service:

About 30% of the U.S. population requires correction for myopia (nearsightedness). Keraflex shrinks the superficial layer of the cornea in a ring pattern around the pupil in response to elevation of temperature by absorption of microwave energy. The central region of the cornea flattens as a result, thus correcting for myopia. The novel method offers numerous advantages over the most common surgical treatment for myopia, LASIK (laser assisted in-situ keratomileusis): • No surgical intervention • Minimal discomfort • Minimal period of healing • Involves only a single, 5 minute procedure • No loss of the cornea’s biomechanical integrity • Avoids dry eye complication

Benefit to Company:

The SBIR program funded development of the Vedera KXS, the system for delivering Keraflex treatment. The Vedera KXS includes a computer controlled microwave power source, housed in a control console, and coupled to the patient interface pod (PIP). The user interface includes a keyboard and display. A handheld Keraflex Targeting Stage and Applicator plug into the PIP. The Applicator precisely delivers microwave energy to the cornea, while cooling the surface of the cornea to minimize damage to the endothelium. The system was thoroughly characterized through ex vivo studies, allowing optimization of the device configuration and treatment parameters. The Vedera KXS is now being tested on humans with promising initial results in clinical studies outside the U.S.

How Product Was Commercialized:

Related Award(s):

1R43AI052525,2R44AI052525

Technology Developed:

A new approach to proteomics has been developed by AmberGen, Inc. under this project based on a suite of new technologies including: a) a novel method of printing protein arrays based on photocleavage-transfer of the proteins directly from beads onto surfaces (termed PC-PRINT), b) methods for production of very large scale proteomic bead libraries (termed BS-LIVE-PRO) and c) a proprietary new solid-phase “two-tag” ELISA immunoassay (termed T2-ELISA). The overall approach reflects advances made during the project in cell-free protein synthesis, photocleavage mediated protein purification and multiplexing on beads to facilitate the production of various forms of human protein “arrays”. In initial work based in part on this new technology, we have successfully identified two novel autoantigen biomarkers for the autoimmune liver disease primary biliary cirrhosis (PBC).

Key Words:

Autoimmune, Autoantibody, Autoantigen, Diagnostics, Proteomics, Protein Expression, Microarray, Biomarker

Uses of Technology/Products/Service:

The technology developed under this project will accelerate the pace of research in a variety of fields involving proteomics (the global study of gene products; i.e. proteins) as well as leading to the discovery of new disease-associated markers (biomarkers), especially for the diagnosis of autoimmune diseases. BS-LIVE-PRO provides the means to inexpensively and quickly produce a “proteome-in-a-bottle”, a liquid suspension consisting of millions of individual microscopic beads, each bead having attached one of the tens to hundreds of thousands of proteins that make up the human proteome (the total complement of gene products; i.e. proteins). Importantly, this proteome-in-a-bottle can be randomly arrayed in one quick step onto a microscope slide or the proteins from each bead printed (PC-PRINT) as individual microscopic spots for subsequent characterization. Since proteins are the primary functional components of cells, the proteome-in-a-bottle is immensely useful for scientists to study how each protein functions and interacts with other cellular components in normal and malfunctioning (diseased) cells. One promising use is the discovery of biomarkers which if present in blood signal the presence of specific diseases. In the case of autoimmune diseases, the biomarkers are often freely circulating antibodies which are produced in response to a particular protein(s) that functions as an autoantigen(s). T2-ELISA, which also is based on creating proteins in a bottle, offers significant improvements in the rapid and robust clinical validation of these newly discovered biomarkers. Using T2-ELISA, two new biomarkers discovered by AmberGen for the autoimmune liver disease primary biliary cirrhosis (PBC), a significant cause of liver transplantation, were rapidly validated. We expect that these biomarkers will be diagnostically useful for the early detection and treatment of this debilitating disease. Another application of this new technology is to study how a specific drug which is designed to target a specific protein in the cell also interacts with all of the other proteins making up the human proteome and which often lead to serious side-effects of the drug.

Benefit to Company:

This project is leading to a suite of products and services that AmberGen will commercialize. The development of the “proteome-in-a-bottle” concept will provide researchers powerful tools to use in their biomedical research. One example is kits and reagents including libraries of proteins on beads that allows researchers to rapidly discover new autoantigens associated with specific autoimmune diseases. A second example is to enable researchers to rapidly measure protein-protein or protein-drug interactions. Efforts are currently underway to commercialize some of the technologies and diagnostic biomarkers developed/discovered under this project. Furthermore, this work has benefited AmberGen by leading to the recent publication of some of the foundation work for the developed technologies [Lim and Rothschild (2008) Analytical Biochemistry 383: 103–115 “Photocleavage-based affinity purification and printing of cell-free expressed proteins: Application to proteome microarrays”]. Finally, the work has catalyzed strong collaborations between AmberGen and world-renowned research groups and hospitals in the Boston area.

How Product Was Commercialized:

Related Award(s):

2R44CA110298-04,2R44EY018020-02,1R43CA132395-01A2

Technology Developed:

San Diego-based Lpath is the category leader in lipidomics-based therapeutics, an emerging field of medicine that targets bioactive signaling lipids for treating a wide range of human disease. Lpath’s ImmuneY2™ drug-discovery engine has the unique ability to generate therapeutic antibodies that bind to and inhibit dyregulated bioactive lipids that contribute to diseases. Lpath's is in clinical trials with a humanized mAb directed against Sphingosine-1-Phosphate (S1P), a bioactive lipid that is dysregulated in age-related macular degeneration (AMD) and cancer.

Key Words:

antibodies as drugs, cancer, AMD, bioactive lipid targets, sphingosine-1-phosphate, LPA, Immune-Y2 process, ASONEP

Uses of Technology/Products/Service:

ASONEP is the systemic formulation of Lpath's anti-S1P mAb (sonepcizumab) has recently completed Phase I safety trials in cancer. We believe that this antibody can be effective in reducing tumor cell proliferation and protection from apoptosis, tumor-associated angiogenesis, metastatic potential and resistance to chemotherapeutic agents. iSONEP is the ocular forumation of the same drug substance and has recently completed Phase I clinical trials in age-related macular degeneration.

Benefit to Company:

The SBIR grant process has been critical to the development of ASONEP and iSONEP and has resulted in a world-wide strategic partnership with Merck-Serono.

How Product Was Commercialized:

In October, 2008, Lpath entered into a world-wide exclussive partnership with the pharmaceutical company, Merck-Serono, who may take over full clincial development and the eventual marketing of ASONEP in the cancer disease arena. The ocular product, iSONEP and Lpath's Lpathomab and other programs have not yet been partnered.

Related Award(s):

1R43DK083141-01A1

Technology Developed:

Valencell developed a new method for accurately measuring real-time caloric expenditure using an audio earbud.

Key Words:

energy, balance, calories, fitness, obesity, caloric, metabolism, sensor

Uses of Technology/Products/Service:

Valencell’s patent-pending Healthset® technology monitors vital signs and physical activity through a miniaturized sensor module embedded within an audio earbud. Users simply put on the Healthset wireless audio headset, go about their daily routine, enjoy music, or exercise, while Healthset technology tracks heart rate, distance traveled, calories burned, and aerobic fitness level. This data is sent wirelessly from the headset to mobile phones and digital media players for engaging real-time performance and fitness assessments. Users can meet their fitness goals with feedback tuned to their own bodies. Long-term assessments can be enjoyed through mobile web applications. Applications: 1) Consumer sports & fitness 2) Mobile health management (hypertension, diabetes, obesity) 3) Telehealth (home health monitoring, outpatient health monitoring) 4) Personal protection equipment (PPE) markets (first responder & military vital status monitoring) 5) Clinical Research (monitoring the effects of drugs on the body during real-life activities)

Benefit to Company:

Valencell has just raised Series-A venture funding and is now integrating Healthset® technology into multiple earbuds.

How Product Was Commercialized:

A technology licensing company, Valencell develops new technologies, validates these technologies via clinical testing, and licenses these technologies to multiple companies in multiple markets: consumer fitness, mobile device manufacturers, telehealth, and PPE.

Related Award(s):

1R43GM069026,2R44GM069026

Technology Developed:

The availability of SBIR funding greatly accelerated our efforts to develop and commercialize the Oris™ Cell Migration Assay. The Oris assays use optically clear, 96-well microplates in which wells are populated with silicone stoppers to occlude cell seeding from a 2 mm central zone. Removal of the stoppers reveals the detection zones into which cell migration can occur thereby providing unobstructed viewing of cell motility and decreased assay variability that other cell migration assays do not afford.

Key Words:

cell migration, cell invasion, motility, drug screening, metastasis, wound healing, tissue repair

Uses of Technology/Products/Service:

The Oris Cell Migration Assay is used by academic and pharmaceutical researchers to screen compounds for their ability to modulate cell motility whether for promotion of wound healing or inhibition of cancer metastases. The Oris Assays allow endpoint and kinetic analyses, and are compatible with a variety of readout instruments including plate readers, microscopes and high content imaging systems. Compared to other cell migration assays (i.e., Boyden chamber, transmembrane and scratch assays) the Oris Assays yield more reproducible results.

Benefit to Company:

We have realized many benefits from participation in the SBIR program. • Platypus was able to hire and retain technical personnel. • Since the launch of our first Oris product in Fall 2007 we have expanded the product line to include other surface coatings for migration studies as well as an invasion assay. • We have recently received additional SBIR funding that is allowing us to develop product line extensions. • Finally, funding from this program was instrumental for development of our commercialization infrastructure.

How Product Was Commercialized:

We have been successful in selling our Oris™ products through direct marketing channels (web, targeted e-mail, direct mail, trade show, technical seminars) and distributors to the life science research market. We are actively seeking distributors and OEM resale partners that can help us expand into new markets.

Related Award(s):

5R44NS042451-3,2R44HL075983,5R44NS042451

Technology Developed:

Portable telemetry-based sleep monitors that can be easily deployed in many settings including sleep labs, hospital rooms, patients’ homes, nursing homes, and others. The technology includes miniaturized battery powered hardware with onboard wireless data transmission capabilities. Sophisticated software for data acquisition, review, reporting and analysis was also developed

Key Words:

Home sleep testing, Sleep disorders, Ambulatory monitoring, Wireless, Polysomnography

Uses of Technology/Products/Service:

The technology can be used to facilitate the diagnosis of many sleep disorders including sleep apnea, insomnia, and parasomnia in environments that are more convenient and cost effective to the patients and providers. Instead of in-laboratory testing, which is expensive, presents an unfamiliar surrounding and is often too far from the patient’s home, CleveMed’s wireless monitoring technologies allow the testing to occur directly from the patient’s home. Other important uses of CleveMed sleep technologies include testing surgical patients in their hospital room. Sleep apnea complicates post-operative care in most surgeries; yet, a significant number of patients who are admitted to the operating room are not tested for sleep apnea due to the complexity of current technologies. CleveMed’s equipment, which can fit in the technologist’s coat pocket, can be deployed quickly on the ward. Another use is patient follow-up care. Like any other chronic disease, sleep apnea can be influenced by long-term health changes like weight gain and emerging co-existing diseases (diabetes, asthma, heart diseases). Therefore, it is important to routinely monitor sleep therapy in order to confirm its benefit. The size and wireless capabilities of CleveMed’s equipment allow it to communicate with sleep therapy devices seamlessly; thus, permitting easier follow-up studies in the home.

Benefit to Company:

The SBIR program has played a critical role in CleveMed’s success. CleveMed is now an ISO / CE company with over 10 FDA approved products that are sold nationally and internationally. CleveMed has increased the number of employees by 30% over the past 5 years. Our company-wide product sales have witnessed double digit growth every year for 5 years in a row. We have entered into a licensing agreement with a major hospital, a co-marketing and development agreement with a large corporation, spun off one company and is in a licensing negotiation with another spinoff company. Finally, we continue to expand the number of Key Opinion Leaders that endorse our technologies.

How Product Was Commercialized:

Our products are sold through our own direct sales force and national and international independent representatives and distributors. Our products are sold in over 10 countries including Columbia, Malaysia, Australia, Philippines, Thailand, India, Dubai, Vietnam, and Singapore.

Related Award(s):

5R44EY014768

Technology Developed:

The use of cryopreserved amniotic membrane (AMNIOGRAFT®) to restore a healthy eye surface is a scientifically well-accepted application for treating various eye surface diseases that threaten the sight of millions of patients. Prior to the introduction of PROKERA®, the benefits of cryopreserved amniotic membrane for the protection, healing and reconstruction of the eye surface required surgery. The PROKERA® Sutureless Amniotic Membrane (AM) Graft (a Class II, FDA-cleared, ophthalmic conformer device) was developed so that the same sight saving benefits of AM transplantation could be delivered rapidly in the outpatient clinic, hospital bed, emergency room or physician’s office, and without suture-related complications.

Key Words:

Amniotic Membrane, Ocular Surface Reconstruc, Wound Repair, Wound Healing, Eye Surgery, Corneal Defects, Chemical Burns, SJS-TEN

Uses of Technology/Products/Service:

PROKERA® consists of cryopreserved, human AM (AMNIOGRAFT®) securely clipped into a dual, polycarbonate (PC) ring system and rests on the eye surface like a contact lens, combining the spacing and anti-adhesion properties of a symblepharon ring with the corneal healing, pain reducing, anti-scarring, anti-inflammatory, and blood vessel-prevention properties of human amniotic membrane. Recent peer-reviewed literature has documented many beneficial outcomes following the use of PROKERA® in cases ranging from corneal neovascularization (with or without limbal stem cell deficiency) and pterygium/pseudopterygium to anophthalmic orbital contraction, corneal ulceration, and severe bacterial keratitis, resulting in positive visual outcomes, ocular surface healing, reduced inflammation, and reduced haze, with minimal side effects and good patient tolerance. There has even been a case of necrotizing scleritis in ulcerative colitis, previously unresponsive to oral or topical steroids, but successfully treated with the combined use of processed pericardium and PROKERA® to reduce inflammation and stabilize visual acuity, while avoiding the possible complications of a sutured application of AM. PROKERA® has also been shown to provide rapid delivery of AM's inherent therapeutic properties in the early stages of such devastating and sight-threatening conditions as Stevens - Johnson syndrome and Toxic Epidermal Necrolysis (SJS/TEN) and acute alkaline burns to the ocular surface. Prompt application of the PROKERA® ring set in these conditions often results in dramatic resolution of corneal defects, preservation/restoration of visual acuity, reduction of pain & inflammation, and prevention of limbal stem cell deficiency. While the current size of the PROKERA® ring set may, in some patients, limit the reach and benefits of AM, the success of the SBIR program at TissueTech has allowed us to continue research into the development of the next generation of PROKERA®, in the hopes of further extending the promise and potential of AM’s many therapeutic benefits. Indications & Usage: PROKERA® is intended for use in eyes in which ocular surface cells have been damaged, or underlying stroma is inflamed or scarred. PROKERA® is used in the eye to reduce inflammation, promote healing, prevent scarring, minimize pain, and diminish the formation of abnormal blood vessels on the ocular surface. PROKERA® is for single use and prescription use only. Note: PROKERA® should be used cautiously with patients with irregular elevations of the ocular surface (e.g. glaucoma drainage devices).

Benefit to Company:

Through the support of SBIR and other grants from the NIH, TissueTech, Inc. has been able to broaden and extend the therapeutic reach and market potential of its existing Amniotic Membrane (AM) product platform by contributing to the diversification of our business from a solely tissue-based strategy to one that also includes medical devices (PROKERA®) and other groundbreaking, AM-based therapeutics currently in development. In particular, PROKERA®’s position as a niche, AM-based, medical device has given TissueTech, Inc. a strong competitive edge in the life sciences industry. In addition to the direct commercial success and expanded TissueTech R&D pipeline, the SBIR awards have also contributed to the growth of the Company itself, despite severe nationwide employment contraction and a stagnant economy. Our expanded scientific, product development and compliance capabilities have allowed the Company to both further examine the basic and clinical properties of human amniotic membrane and to explore new markets for their application.

How Product Was Commercialized:

Launched in April of 2005, the PROKERA® sutureless AM graft is promoted through our nationwide network of direct and indirect sales representatives, and distributed to ophthalmic surgeons across the country for the treatment of patients with difficult ocular surface diseases. In addition, our company has attained reimbursement approval by Medicare and other third-party payers.

Related Award(s):

1R43EY016953-01,2R44EY016953-0

Technology Developed:

LookTel is a mobile application for Smartphones that provides a full suite of accessibility and assistance solutions for visually impaired users. LookTel combines real-time object recognition that lets users identify specific objects such as packaged goods, CDs, and money with text-reader capabilities using Optical Character Recognition (OCR). If additional help is desired, the user can immediately connect with a friend or family member using live video or audio chat directly from their mobile phone.

Key Words:

blind, visually impaired, mobile app, phone accessibility, object recognition, OCR, text reader, video conferencing

Uses of Technology/Products/Service:

According to the World Health Organization (WHO), there are over 345 million visually impaired people worldwide, with more than 11 million in the U.S. alone. Until now, these users have not had access to an all-in-one mobile device providing a variety of assistance solutions. Rather, to gain access to tools such as digital magnifiers and optical character recognition (OCR) to turn text into speech, they are forced to buy dedicated devices and applications that can end up costing thousands and are extremely cumbersome to carry around. LookTel solves this problem by providing a full suite of advanced assistance solutions on an off-the-shelf mobile phone that is fully accessible and can be used every day. LookTel also integrates advanced assistance solutions that up until now have never been available such as mobile object recognition. Over the past few years, close to 40 users have been testing the system and have provided convincing feedback that LookTel dramatically increases their functional independence. LookTel was recently awarded first place at the 2010 CTIA E-Tech Awards for Mobile Applications in the Healthcare category.

Benefit to Company:

With funding from the SBIR program, iVisit, LLC is impacting the lives of visually impaired, blind and elderly users by increasing functional independence and providing an affordable all-in-one solution that can be used as both a fully-featured accessibility solution and an everyday cell phone. SBIR funds have allowed iVisit to develop the underlying technology powering the solution and conduct end-user trials in partnership with the US Dept. of Veterans Affairs’ Atlanta Research & Education Foundation (AREF) and Blind Wisdom to prove the technology as a valuable tool for visually impaired users and improve usability and accessibility.

How Product Was Commercialized:

iVisit, LLC formed IPPLEX, LLC to commercialize LookTel and sell directly to consumers and specialty distributors. IPPLEX has also partnered with LinkMeMobile, a leader in mobile object recognition technology with 8 issued US patents and 27 pending globally. IPPLEX has signed up over 30 international specialty distributors for LookTel in the U.S., U.K. Canada and Australia and will soon expand to other regions after completing language localization tasks.

Related Award(s):

2R44CA114995

Technology Developed:

The "gold standard" in kinase assays is the P33 radioisotope based assay. Using SBIR grant funding, RBC created a miniaturized version of this assay called Kinase HotSpot, which uses far less enzyme, compound, and radioactive material.

Key Words:

kinase, assay, P33, kinome, radiolabeled, radioisotope, hotspot

Uses of Technology/Products/Service:

There are over 500 kinases enzymes in the human body that control various aspects of our metabolism. Malfunctions in kinase enzyme functioning can lead to various diseases, including cancer, autoimmune, cardiovascular, and neurological conditions. Using the Kinase HotSpot platform, researchers can economically look for chemicals that inhibit the activity of over 350 different kinases, and possibly become drugs to treat these conditions.

Benefit to Company:

RBC has successfully launched its Kinase HotSpot assay service as a contract research organization. To date, RBC has over 150 customers from around the world including large pharmas, biotechs, non-profit institutions and universities. Revenues from Kinase HotSpot are in the millions per year. RBC has developed a leading position among contract research labs offering kinase assays.

How Product Was Commercialized:

Due to the intense need for economic kinase screening resources, RBC was able to commercialize the product with Google advertising, conference attendance and email marketing. That plus word of mouth and repeat business have led to a customer list of over 150, and a multimillion dollar revenue base.

Related Award(s):

1R43CA139621

Technology Developed:

The "gold standard" in methyltransferase assays is the tritium radioisotope based assay. Using SBIR grant funding, RBC created a miniaturized version of this assay called Methyltransferase HotSpot, which uses far less enzyme, compound, and radioactive material.

Key Words:

tritium, 3h, assay, methyltransferase, epigenetic, drug discovery

Uses of Technology/Products/Service:

A new frontier in drug discovery research is epigenetics, whereby various human enzymes act to turn gene functions on and off. A key group of enzymes with epigenetic effects are methyltransferases. By finding chemicals that inhibit these enzymes, drugs for a wide array of human diseases could possibly be found. Up until now, the main way to discover compounds that would inhibit methyltransferases was a very cumbersome tritium assay, using an isotope of hydrogen. RBC has made the assay much faster and less expensive, making the early stage of drug discovery in this area much more efficient.

Benefit to Company:

RBC is the only contract research company offering a methyltransferase assay service. RBC has successfully launched its Methyltransferase HotSpot assay service to the industry, and in spite of the very early stage in this area, has begun serving large pharmas, biotechs, non-profit institutions and universities. RBC expects to be the leader in early stage epigenetic research services to the drug discovery industry.

How Product Was Commercialized:

Due to the lack of availability of methyltransferase screening resources, RBC was able to commercialize the product with Google advertising, conference attendance and email marketing. That plus word of mouth and repeat business have led to a customer list of over 150 for RBC's other services that can be marketed for Methyltransferase HotSpot.

Related Award(s):

1R43EY017464-01,1R43EY016617-01A1,2R44EY016617-02A1

Technology Developed:

We have developed a new type of artificial cornea, called the KeraKlear, which can be used to treat cornea blindness without the need for donor corneal tissue. This artificial cornea can be implanted through a micro-incision of 3.5 mm using an automated robotic device developed by our company or with a femtosecond laser.

Key Words:

artificial cornea, cornea surgery, cornea blindness, robotic surgery

Uses of Technology/Products/Service:

Our artificial cornea allows treatment of all kinds of cornea blindness without the need for donor tissue. This is an extremely important advantage because there is only enough donor tissue to treat 1% of the 10 million bilaterally cornea blind patients each year. Moreover, the combination of our artificial cornea and our automated robotic device allows the treatment of cornea blindness in the third world because the procedure is simple enough for even non-corneal specialist eye surgeons to perform the implantation. The first two patients who received the implants had remarkably quick recoveries as compared to standard transplantation which typically requires about 12 months before good vision is obtained. The first patient was a 93 year old woman who had been blind for 30 years from an alkali injury and glaucoma. Before her surgery she could only see light, but after the surgery she was able to read the large letters on the eye chart and see the faces of her family. The second patient was even more remarkable. His vision improved from only being able to see hand motions before surgery to being able to read large print (20/80 vision) in one day.

Benefit to Company:

We will be eternally grateful to the SBIR program for giving us the seed funding to begin our artificial cornea project. Without SBIR funding we would never have been able to develop the prototypes that proved the feasibility of our technology.

How Product Was Commercialized:

The KeraKlear has received European CE Mark approval. We are currently organizing a U.S. FDA 510k clinical study to enable use of the product in the U.S.