Next week in Philadelphia at the BIO International Convention, BIO will be 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 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 Gianluca De Luca, V.P. of Product Development at Delsys Inc/Altec Inc. based in Natick, Massachusetts, Andrew Levin, Founder, President and Chief Scientific Officer of Immunetics in Boston, Massachusetts, and Kim Witenberg, President and CEO of Advanced Plasma Products, Inc. in Lenoir City, Tennessee. These three biotechnology companies have been supported by the NIH’s SBIR program.
What is your company’s lead product or technology?
Gianluca De Luca, Delsys: Delsys Inc. and its research subsidiary Altec Inc. are located in Natick, Massachusetts; approximately 20 miles from Boston. We are world leaders in the design, manufacture, and marketing of a broad portfolio of high performance physiological and biomotion sensors used in human movement research, education, and clinical sciences. Since our inception in 1993 we have focused on solving the engineering challenges associated with wearable physiologic sensors while retaining ease-of-use. Our technology provides a wireless capability for measuring human muscle activity and movement that is employed in over 85 countries and thousands of laboratories. Our systems have been integrated with software to solve a broad spectrum of applications from basic kinesiological studies and sports applications, to precision decomposition for studying the control properties of individual motor unit firings. Delsys has been assisting the biomedical community worldwide to unleash their ideas into reality by delivering advanced sEMG, dEMG technologies and software solutions that are based on the conclusive results of extensive research experience and R&D leadership.
Andrew Levin, Immunetics: We specialize in infectious disease diagnostics and pathogen detection. Our C6 ELISA for Lyme disease is well recognized in the infectious disease testing market as one of the most accurate tests available. We have several products in early stages of commercialization, including the BacTx® test for bacterial contamination in platelets that received FDA approval recently, and a screening test for Babesia – a blood safety problem – that is currently in a clinical trial. We are also developing multiplexed molecular assays for fungal and bacterial pathogens.
Kim Witenberg, Advanced Plasma Products, Inc.: Advanced Plasma Products, Inc. is developing its patented technology into an Atmospheric Plasma Wound Applicator for chronic wound treatment and disinfection. Annually in the United States, chronic wounds, such as diabetic foot ulcers, affect seven million patients and cost $25 billion to treat. Recent data has shown that biofilm plays a significant role in the physiology of the majority of chronic wounds since the nature biofilm in the wound bed makes it resistant to systemic and topical antibiotics. Despite numerous advances, chronic wounds continue to be a treatment challenge and new technologies such as the Atmospheric Plasma Wound Applicator which annihilates biofilms is needed. Treatment of wound infection models showed APP’s atmospheric plasma was very effective at killing Pseudomonas aeruginosa, Acinetobacter baumannii Staphylococcus strains including MRSA biofilm on the wounded skin of mice. Importantly, the application of atmospheric plasma did not cause any tissue damage to the skin or underlying tissue.
How has the NIH SBIR program helped your company grow?
Gianluca De Luca, Delsys: Delsys and Altec have been a strong supporter and benefactor of the SBIR program since the inception of our company as a start-up from Boston University’s NeuroMuscular Research Center more than 20 years ago. Our success in working with the SBIR program has been recognized by NASA in choosing us as one of the top 40 SBIR success stories in their publication NASA Spinoff 2000. In 2006 Delsys received the Tibbets Award from the Small Business Technology Council. The Tibbetts Award is presented to those small businesses and individuals judged to exemplify the best in the SBIR program.
We have an established ability to bring technology developed with SBIR support to the marketplace. Our portfolio of SBIR awards have results in six commercial products, with a seventh in progress and on track to be released in two years. Stated simply, the SBIR program has provided us with a bridge to effectively advance new ideas and technologies to the marketplace through a peer-review process that values innovation, impact and strategic planning.
Andrew Levin, Immunetics: The SBIR program has supported the vast majority of the company’s research and development activities, from initial concept through final product and clinical trials for FDA approval. The company’s principal products have all been developed under SBIR grants and contracts. As a small business, we would not have had the resources to support these R&D programs otherwise. The risks inherent in early stage research and product development tend to spook many outside investors, and so the SBIR program fills an ecological niche which can mean the difference between life and death for a small, emerging company.
Kim Witenberg, Advanced Plasma Products, Inc.: NIH’s SBIR program has funded our company, and more specifically has supported our product idea from paper to prototype. The funds have allowed us to bring in expertise in specific technical areas to assist in development of our device that would otherwise be cost prohibitive for a small R&D company.
What are the upcoming milestones and long-term priorities for your company?
Gianluca De Luca, Delsys: Our commitment to innovation and research has enabled us to play a fundamental role in helping solve real-world problems associated with human movement disorders.
We are supported by the NIH SBIR program to develop the most advanced wearable technology for evaluating the efficacy of movement disorder medication in Parkinson’s disease and other neurological disorders based on automated tracking of motor disorder severity. Our Tracker technology delivers enhanced functionality compared to other wearable tracking devices due to our proprietary hybrid sensor designs that combine EMG and biomotion data. The system allows complete freedom to the patient while providing outcome measurements that are sensitive to both temporal and limb-specific changes in movement disorder severity. This technology achieved the highest accuracy for tracking tremor, dyskinesia and freezing of gait in Parkinson’s disease during normal daily activity (no interruptions, no stopping to perform tests, no other burdensome constraints) – and it does so at a resolution that uniquely captures temporal and limb-specific motor fluctuations that are difficult to capture by other means, such as standardized tests. We are planning to expand the capabilities of this technology to other neurological conditions such as essential tremor, restless leg syndrome, Tourette’s, ataxia, and chorea. Our vision is to offer the most in-depth measurement capability for the pharmaceutical industry to transition new therapeutics through all phases of clinical trials, and provide a personalized digital health platform to optimally regulate the delivery of these therapeutics once they reach the patient.
Another upcoming milestone under the SBIR program is the development of new technology for studying the electrical signals that the brain uses to regulate muscle force. These neural control signals (also known as motor unit potentials) are present within the electromyographic (EMG) signal that is recorded when a muscle contracts. Scientists interested in studying the inner workings of the neuromuscular system rely on technologies that can accurately identify and extract these control signals from the larger EMG signal.
The current state of the art, embodied by our recently released dEMG system, has revolutionized the industry by providing a non-invasive and fully automated means of extracting neural signals from the surface EMG signal. The resulting technology provides a ten-fold increase in neural signal yield from only minutes of processing time for isometric contractions. Further improvements are underway: expanding current dEMG technology to applications that involve cyclic dynamic contractions, such as ambulation or repeated exercises. Our goal is to provide a technology that will enable researchers to study elemental aspects of human movement and muscle force production during a variety of activities. As a result, brain and behavior researchers, clinicians, biomechanists, and exercise physiologists will be able to explore the inner workings of the normal and dysfunctional neuromuscular system more effectively.
Andrew Levin, Immunetics: We are currently focused on launching the BacTx® test for bacterial contamination, and completing clinical validations for our Babesia blood screening test. Launching these products is part of our longer term strategy to build a portfolio of unique products based on our immunological and molecular technologies, aimed at the clinical diagnostic and pathogen detection markets, and specifically at emerging pathogens and infectious diseases that are typically underserved by larger market players.
Kim Witenberg, Advanced Plasma Products, Inc.: In June 2015, we are completing our alpha prototype of the Atmospheric Plasma Wound Applicator, and in July we are delivering it to our collaborator to perform a series of tests using wounded diabetic mice as the animal model. These tests will determine the extent our atmospheric plasma device destroys wound bed biofilm and stimulates wound healing.
Our long term goal is to develop a pipeline of devices based on our patented technology. Our primary areas of focus are healthcare and agriculture.
What do you hope to gain out of your participation at the 2015 BIO International Convention?
Gianluca De Luca, Delsys: We are seeking a BIO partnership for Phase III development and introduction of our technology into the commercial marketplace with a form factor tailored for Pharma and clinical use. We are seeking a partner strongly rooted in the pharmaceutical industry with a shared vision for advancing drug development and personalized care using the most advanced and innovative wearable sensor technology.
Andrew Levin, Immunetics: We are hoping to engage with potential corporate, strategic and development partners that are interested in our space in the infectious disease and pathogen testing market. Ideally, initial meetings at BIO could lead to deals for financing, distribution, technology licensing, or other strategic areas that would help the company’s growth.
Kim Witenberg, Advanced Plasma Products, Inc.: We are looking for partnership opportunities to bring our Atmospheric Plasma Wound Applicator to market. Our company physiology is “focus on what you do best” and we are an excellent R&D company with top notch researchers and engineers. We are looking for partners with expertise in the medical device area who are familiar with bringing product to market.
Tell us something about your company that investors might not know.
Gianluca De Luca, Delsys: This past week we received Notification of Intent for Phase I SBIR funding for a new project to develop a non-invasive interface able to extract nerve-mediated signals (referred to as motor unit signals) from residual muscles, and use this information as a control source to drive upper-limb prostheses for amputees. Motor unit signals provide high levels of incremental control for intact limbs and therefore have the potential of providing a more natural and seamless way of restoring motor function for amputees. Our goal is to provide a relatively low cost non-invasive solution to improving myoelectrically driven prostheses without resorting to surgically-implanted interfaces.
Andrew Levin, Immunetics: Immunetics was the first biotech company to move into Boston’s “Innovation District” ten years ago, when the area was known mainly for ship repair and fish processing. It was terra incognita for biotech – and attracted me partly for that reason. With financial help from the city and the state, we were able to build out a custom office and laboratory facility with picture windows overlooking all of Boston Harbor – quite a view, which among other things makes it a pleasure to come to work every day, and keeps me there many evenings to watch the sunset [facing an active drydock on the South Boston waterfront].
Kim Witenberg, Advanced Plasma Products, Inc.: We have developed and commercialized two other products based upon our atmospheric plasma technology.