Small Business Innovation Research (SBIR) Small Business Technology Transfer (STTR)
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Maureen L. Mulvihill, PhD, President and CEO of Actuated Medical

“It’s the mission of improving patient outcomes that keeps us going. Nurses tell us how TubeClear® makes it easier for them to do their jobs, and we learn about the patients that we help – these stories demonstrate that we’re improving patient’s lives.”

– Maureen L. Mulvihill, PhD, President and CEO of Actuated Medical

For Maureen L. Mulvihill, a Materials scientist, the desire to start Actuated Medicalexit disclaimer icon began with a trip to a doctor’s office, where she realized the direct clinical need of using motion technologies to improve medical devices and solve patients problems. She decided to leave her current job and founded Actuated Medical in 2006.

For almost a decade, Actuated Medical has been creating a new generation of minimally invasive instruments and devices for clearing occlusions, penetrating bone and tissue, and enabling the emerging MRI–guided surgical procedure industry. Based in Bellefonte, Pennsylvania, Actuated Medical also performs research and development work for clients including design, prototyping, and manufacturing. All work is completed in their FDA compliant and ISO–certified facility. The company currently has 25 employees, and is continuing to expand.

Leveraging SBIR to Expand the Product Pipeline

“SBIR helped us get to a post-revenue inflection point,” says Mulvihill. “Right now we have two products on the market, so we’re not only conducting R&D, we’re actually selling products. SBIR has also been instrumental in helping us expand our pipeline of offerings so we’re creating products we want to develop, instead of only doing contract research for other companies.” So far their SBIR projects have yielded 10 patents, 5 in tissue penetration and 5 in the occlusion clearing space, which have significantly increased the valuation of the company.

TubeClear®exit disclaimer icon was the first product Actuated Medical launched after receiving Phase II and IIB SBIR grants from the National Science Foundation (NSF), with Phase II follow-on funding from the National Institute of Child Health & Human Development for pediatric indications.

Using proprietary mechanical motion technology, TubeClear® helps clear clogged feeding and decompression tubes while the tube remains in–patient, thus helping prevent the expense and risk of tube replacement. If tubes remain clogged, patients can go without food or medication for hours or even days. “The first patient we helped was a 27 year old soldier, which was a rewarding and emotionally powerful experience,” says Mulvihill.

TubeClear® is FDA cleared and CE Marked specific to nasoenteral (NE), nasogastric (NG), gastrostomy (G), and jejunostomy (J) feeding and decompression tubes. CORPAK MedSystemsexit disclaimer icon, located in Buffalo Grove, Illinois, is a worldwide distributor of TubeClear® and Actuated Medical has had a partnership with them since March 2014. TubeClear® is used by nurses in ICUs and ERs and is in place at the VA hospital in Omaha, Nebraska and Salt Lake City, Utah. CORPAK and Actuated Medical are focusing on expanding sales in homecare, which is quickly increasing in market share in the United States.

 

GentleSharp™exit disclaimer icon, Actuated Medical’s other product available on the market, provides a more humane blood sampling tool for animal research that received SBIR funding from the National Institute of Aging. It uses low–frequency micro–vibrations to help needles glide more smoothly into tissue, which requires less force and thereby reducing stress during blood sampling procedures. Other benefits of this device include allowing researchers to sample more than one site in animals, do larger collections, and permitting easier insertions for less experienced clinicians.

GentleSharp™ is currently being directly sold to major pharmaceutical companies and university research laboratories, as well as directly to the MRI lab at NIH. Actuated Medical has signed an exclusive distribution deal with The Gramercy Company who is based in Connecticut and covers the region between Boston, New York, and Philadelphia.

GentleSharp

TubeClear

Actuated Medical Products on the Horizon

Building on their proprietary tissue penetration technologyexit disclaimer icon, Actuated Medical has received NIH SBIR funding to continue research on numerous products, including a Smooth Insertion Spinal Needle device and a Low Insertion Force Epidural device, both funded by the National Institute of General Medical Sciences, and a Biopsy Force Reduction device to ease bone biopsy needle entries, funded by the National Cancer Institute. Actuated Medical has also received SBIR funding from the National Institute of Allergy and Infectious Diseases to develop a needle free drug delivery patch for HIV patients.

In addition, Actuated Medical has partnered with the Children’s Hospital of Philadelphia setting up a pending IRB clinical study due to begin in March 2015 to test a child’s reaction to a pediatric version of TubeClear®. These results will help them continue to pursue a 510k FDA clearance for this pediatric device.

As true of all pediatric applications, a large unmet need exists, but pediatrics research is very expensive and requires extensive regulatory oversight. “This is where the SBIR program can really assist,” explains Mulvihill. “SBIR helps remove some of the financial and technical risk for companies to develop products for children.” As Actuated Medical continues to expand, Mulvihill quickly realized they were outgrowing their 9,000 square foot facility, and have plans to build a new 18,000 square foot facility in Bellefonte, Pennsylvania. “This new building will help us advance our three year strategy to increase sales and take three additional products to FDA,” explains Mulvihill. “We’ll also strive to retain a strong corporate culture with high employee engagement. Right now, if you ask people what the company’s mission is, they’ll say to improve patient outcomes. We want to keep it that way.”

Actuated Medical is continually seeking strategic partners to engage and help move products forward through FDA. “With our ISO–certifications, Actuated Medical can help faculty or entrepreneurs move a product through the FDA regulatory process, at which point someone else can help sell, market or distribute them,” says Mulvihill.

Notable Achievements and Awards

Actuated Medical has taken advantage of the technical assistance programs that NIH offers SBIR/STTR awardees, including the Niche Assessment Program and the Commercialization Assistance Program (CAP). “CAP advisers moved us toward a greater understanding of strategic partnership engagement, and specifically helped us review the terms of the distribution deal during negotiations with CORPAK MedSystems. The Niche program provided us with a great overview of the market and helped us identify a contact that is currently on our medical advisory board.”

Actuated Medical also received the prestigious 2014 Tibbetts Award from the Small Business Administration, and was a finalist for the T2013 Pennsylvania BIO Patient Impact awardexit disclaimer icon. Additionally, Actuated Medical received an NIH scholarship to attend Advamed in 2014 and the 2014 BIO Innovation Zone. With many new products in the pipeline, we look forward to seeing how Actuated Medical’s innovations continue to produce positive outcomes in patients throughout the country and world.

 

Location: Bellefonte, Pennsylvania

Company Website: http://www.actuatedmedical.com/exit disclaimer icon

Contact (for questions): info@actuatedmedical.comexit disclaimer icon; (814) 355-0003 x117

 

Information for this success story was gathered through an interview that was conducted by Dr. Lenka Fedorkova, the NIH SBIR/STTR Program Manager and Betty Royster, the NIH SBIR/STTR Communications Coordinator.