"The SBIR program democratizes funding for emerging companies, providing critical financial resources to regions of the country that may not have access to the venture capital of the major metropolitan areas."
– Eric Buckland, CEO and President, Bioptigen
Macular degeneration is a disease that afflicts 11 million patients in the United States and is estimated to cost the global economy more than $300B annually. The first generation of Optical Coherence Tomography (OCT) was introduced to visualize retinal pathology and was finding a role in the monitoring treatments for age-related macular degeneration (AMD). This first-generation imaging technology suffered from low resolution and low speed. Joseph Izatt, Bioptigen’s scientific co-founder, recognized the value in a new implementation of OCT—Spectral Domain OCT—that operated up to 1000 times faster and had the potential for visualizing structures of the eye at a much finer resolution. Bioptigen was formed to bring this new class of imaging to researchers and clinicians, with the goal of observing defect and changes to ocular physiology at its very earliest phases, promoting the advancement of research into therapies and cures, and improving the clinical efficacy of imaging in the treatment and monitoring of eye disease.
Image of the human retina acquired with Bioptigen Spectral Domain Ophthalmic Imaging System, inset showing layer detail and capillary bed in the inner retina and capillaries.
Addressing the Challenge
Bioptigen targeted the development of volumetric imaging systems with the highest image quality and finest resolution designed to help researchers and clinicians understand physiology and monitor pathology with a degree of clarity not previously available. The OCT system was initially targeted to vision science researchers, who contemporaneously had transgenic mice as a model for the study of eye disease. Bioptigen developed high resolution, high-speed OCT imaging systems supported by custom imaging optics tuned to the rodent eye, changing the paradigm of small animal research by providing a non-invasive image modality for longitudinal studies.
The introduction of Bioptigen small animal OCT (Envisu R) was adopted by academic researchers, government and non-profit research institutions, pharma and biotech companies, and CROs as murine and rabbit OCT images were adopted as valid endpoints in pre-clinical research and drug development processes. Bioptigen also developed the first handheld OCT targeted at the newborn population, and as of today the Envisu C remains the only instrument of its kind, sold in 30 countries and used in clinical evaluation of newborns, research, and clinical trials for drugs that directly and indirectly impact the health of the pediatric eye.
Live, non-contact, mouse retinal imaging with the Bioptigen Envisu R2200 Ultra-High Resolution OCT system and the patented Rodent Alignment Stage
Fueled by SBIR Funding + Accelerators
Bioptigen applied for and won three Phase I SBIR grants that provided critical seed funding under the umbrella of business accelerator, Southeast TechInventures, Inc. This funding provided immediate validation of the technology and commercial objectives; and provided runway to prototype the early product and explore hypotheses with the market. These awards were also instrumental in securing initial investor financing from local angels, and credibility in recruiting initial hires to the team. With our first Phase II grant, the Bioptigen team participated in the NIH Commercialization Assistance Program (CAP), where the go-to-market strategy was developed, as well as strong relationships with advisors.
When it comes to funding challenges, Mr. Buckland says, “Not every new technology or product is an appropriate candidate for venture capital, and SBIRs fund projects that would otherwise not meet the investment criteria of venture capital. In a risk averse economy, SBIR provides a vital source of early stage funding to validate technology and markets, and to prepare companies for outside investment.” He also credits the NIH institute program officers for providing valuable insight to awardees, helping companies address the problems of greatest importance, and offering critical feedback to strengthen their proposals and enhance their value proposition.
Each product that Bioptigen successfully commercialized were at least in part funded through the use of Phase I awards to test technology concepts; Phase II awards fleshed out the product, evaluated clinical utility and reduced regulatory risk. Some Phase I awards did not progress to Phase II projects, due to additional technology hurdles, or due to finding an insufficient market driver for continued development. Over the pre-acquisition history of Bioptigen, the company executed nine Phase I awards, four Phase II awards, and one Fast-Track award. Out of the Phase II awards, Bioptigen commercialized four product lines in research, clinical, and surgical ophthalmology.
First intrasurgical OCT imaging of the surgical placement of a Second Sight Argus Retinal Prosthesis. Left: Kirsten Locke, photographer, with the Envisu C2300 OCT system. Right: Dr. Mark Humayan viewing the OCT image of Argus on the retina.
Measuring Industry Success
Bioptigen successfully translated two products to the clinic with FDA 510(k) clearance. The first was for a tabletop ophthalmic OCT suited for both retina and cornea imaging; the second was for the first handheld ophthalmic OCT system, that was also the first OCT system explicitly cleared for pediatric use, including for premature newborns.
At its height, this small business employed approximately 30 people, manufactured its product locally, and sold product in 30 countries. In 2015, Bioptigen was acquired by Leica Microsystems, a Danaher operating company. Leica Microsystems continues to operate Bioptigen from its Morrisville, NC facility, where the Envisu and EnFocus product lines are developed and manufactured. The Leica Microsystems organization now markets and sells the product lines globally under the Leica brand. Under Leica Microsystems, two sequential 510(k) clearances were awarded for intrasurgical OCT in 2015 and 2016.
Bioptigen now ranks among the top 5 company patent holders in the optical coherence tomography technology space, with over 60 US patents granted and 18 in-licensed. Bioptigen was twice recognized for technology leadership by Frost and Sullivan, with an Excellence in Research Award in 2007 and Technology Leadership Award in 2016.
Bioptigen team before 2015 acquisition. L to R: Denise Armiger, Thomas Thorne, Eva Kielczewski, Ann Poorboy, Hafeez Dhalla, Tammy Carrea, Mark Bowers, Elizabeth Hummel, Joe Vance, Bob Hart, George Wildeman, Eric Buckland, Phil Coveney, Sheila Snyder, Teri Mejia, Genine Grant, Ron Ghofrani, Chis Saxer).
Location: Morrisville, NC
Information for this success story was gathered through an interview with Eric Buckland, Ph.D., conducted by Patricia Swayne, the NIH SBIR/STTR Communications Specialist.