This week in Philadelphia at the BIO International Convention, BIO is partnering with the National Institutes of Health (NIH) and the National Science Foundation (NSF) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone, which opens tomorrow, will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.
The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.
Today, we spoke with Robert Bowser, the President and CEO of Iron Horse Diagnostics based in Scottsdale, AZ, Sean Self the President of Nimbic Systems in Stafford, TX. These two biotechnology companies have been supported by the NIH’s SBIR program.
What is your company’s lead product or technology?
Robert Bowser, Iron Horse Diagnostics: Iron Horse is commercializing diagnostic tests for amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease) and traumatic brain injury. Our ALS diagnostic test will be released to the market later this calendar year.
Sean Self, Nimbic Systems: The atmospheric environment in operating rooms is extremely dynamic and is a major source of bacteria that cause surgical site infections, particularly after prosthesis implantation procedures. Nimbic Systems' lead product is the Air Barrier System (ABS) which prevents potentially infection-causing bacteria present in operating room air from entering incision sites during surgery. The ABS accomplishes this by creating a non-turbulent, clean air field surrounding an incision that repels native airborne contaminants. The ABS is currently cleared by the FDA for use in hip and posterior spine surgical procedures.
The ABS consists of two components: a reusable Filter unit that provides a source of ultra-clean air, and a sterile Nozzle with a hose that connects to the Filter air source and is applied to the surgical drape near the incision area. Clean air flows from the Filter unit through the Nozzle to create a protective "cocoon" of air surrounding the incision site that greatly reduces the presence of bacteria at the incision.
How has the NIH SBIR program helped your company grow?
Robert Bowser, Iron Horse Diagnostics: The NIH SBIR program has been instrumental in providing the early funding necessary to validate our diagnostic test for ALS and perform a multi-site validation study. NIH funding has been leveraged to successfully obtain state and pharma funding to Iron Horse Diagnostics. We continue to add employees and this has only been possible from the initial NIH funding through the SBIR program.
Sean Self, Nimbic Systems: SBIR support has played a crucial role in refining the ABS device and building evidence during clinical trials to support its efficacy. In recent years it has become increasingly difficult to navigate hospital purchasing channels, and this process is especially challenging for novel technologies that may not be well known by product reviewers. Therefore, it has been very important for our company to build a portfolio of clinical evidence.
The results of our SBIR Phase I pilot trial, demonstrated that the ABS greatly reduces the presence of airborne bacteria at surgical incisions and the study results were published in Journal of Arthroplasty. This study helped us achieve FDA 510(k) clearance and begin obtaining early-adoption sales. Our SBIR Phase II clinical trial of 300 patients was completed recently, and we expect to report and publish favorable evidence that the ABS can reduce the clinical incidence of infection after prosthesis implantation procedures. Through the support of a NIH SBIR Phase IIB grant, we have recently begun a multi-center trial of the ABS with a planned enrollment of over 800 patients.
The NIH SBIR program has played an invaluable role in enabling our company to conduct these expensive and time-consuming studies that are needed to commercialize novel, therapeutic medical devices in today's industry environment.
What are the upcoming milestones and long-term priorities for your company?
Robert Bowser, Iron Horse Diagnostics: Short-term milestones include introduction of our ALS diagnostic test to the market, addition of private investor and/or Angel funding, and submission of additional NIH SBIR grant applications. Long-term priorities include completing clinical validation studies of our tests for traumatic brain injury, and obtaining Series A VC related funding for the continued growth of the company.
Sean Self, Nimbic Systems: Based on prior studies supported by the NIH SBIR program, Nimbic has been successful in obtaining ABS use by key opinion leaders and early adopters. We believe that successful publication of the recently-completed Phase II clinical trial will greatly enhance the ability to expand the ABS user base. Success in the multi-center Phase IIB trial, which will conclude in 2017, will enable Nimbic to establish the ABS as a standard of care. Our company is seeking strategic partners that will be able to expand market coverage for the ABS over the long-term.
What do you hope to gain out of your participation at the 2015 BIO International Convention?
Robert Bowser, Iron Horse Diagnostics: Increased company PR, introductions to new potential investors, generation of new leads for collaborations with other companies, and potential CRO opportunities for Iron Horse.
Sean Self, Nimbic Systems: We hope for the opportunity to showcase and publicize the infection prevention solution that the ABS technology now offers to the healthcare community and to raise awareness of the importance of controlling the airborne environment in the operating room. We would like to build strategic relationships with BIO attendees who may be able to assist with the successful commercialization of the ABS technology.
Tell us something about your company that investors might not know.
Robert Bowser, Iron Horse Diagnostics: Our company name, Iron Horse Diagnostics, honors Lou Gehrig, who was known as the Iron Horse.
Sean Self, Nimbic Systems: Nimbic's management team has worked together in the medical device industry for over twenty years and founded Nimbic after the successful sale of its prior medical device firm.