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 John Higuchi the co-founder and CEO, for Aciont Inc., a Salt Lake City, UT-based biopharmaceutical company supported by the National Eye Institute’s (NEI) NIH’s SBIR program and Francis Tsow the VP of R&D of TF Health Co. in Tempe, AZ also supported by the NIH’s SBIR program.
What is your company’s lead product or technology?
John Higuchi, Aciont Inc: Aciont’s lead technology is the Visulex passive diffusion-based, non-invasive ocular drug delivery technology that delivers small molecules to the anterior and posterior sections of the eye. For the target indications, our treatment intends to eliminate the need for frequent eye drop applications for anterior eye diseases and replace the need for localized injections/implants or systemic therapy for posterior eye disease indications.
Visulex is a self-adhering ocular drug delivery applicator that fits on the eye similar to a scleral contact lens and it has a five minute treatment duration. This topical application delivers drug transsclerally or through the white part of the eye. DSP-Visulex is our first product for the treatment of uveitis which utilizes this technology with our customized steroid formulations; this novel combination is being tested in a multi-center clinical trial in the United States.
Francis Tsow, TF Health Co: Our company has two products that are ready for sale or in the final stage of development. The first product is a total volatile organic compound monitor. It is designed to have the ability to monitor the personal environmental of the user. The second product is a metabolic tracker. The device provides a personal metabolic rate tracker to the general public who is interesting in measuring their metabolic rate to help manage their weight or other metabolic related diseases.
How has the NIH SBIR program helped your company grow?
John Higuchi, Aciont Inc: We would not exist today without our NEI/NIH support. The NIH funding helped us to advance our technology from a preclinical, GLP, proof of concept stage in animals to a more validated human tested product in a phase 1/2 clinical stage environment. Also, the NIH reviewer comments throughout the funding cycles were very informative and helpful. Specifically, a reviewer adamantly encouraged us to pursue first an indication deemed to be a low hanging fruit commercialization opportunity in which after further analysis, we felt made a lot of sense.
Francis Tsow, TF Health Co: The program has helped us move from the research lab to the marketplace. First, it provides the necessary funding to further develop the technology and get it robust, reliable, and reproducible for every day real-world application. Second, it affords us a window to meet other SBIR grantees, investors, industrial alliances, and most importantly, the end-consumer. These experiences are just as important as the financial supports as they help us identify keys that can make a successful translational research.
What are the upcoming milestones and long-term priorities for your company?
John Higuchi, Aciont Inc:We are completing long term stability studies for both our manufactured preservative free steroid formulations and prepackaged Visulex ocular drug delivery applicator. Besides posterior uveitis, we anticipate treating other back of the eye diseases such as diabetic macular edema with DSP-Visulex. We may advance other product options using other generic drugs with our formulation specific to the Visulex system or in-license molecules or partner our technology as a joint venture to treat other ocular diseases such as glaucoma, dry eye, diabetic retinopathy and age related macular degeneration.
Francis Tsow, TF Health Co: We have multiple parallel milestones for every project that we have. In short, we can summarize as follows: to develop the next generation sensors that can make an impact in their respective fields. Our long-term priorities are driven by our vision and how to accomplish them. Specifically, we need to develop a sustainable business model to drive innovations firstly based on current market needs, and if opportunities present themselves, to fulfill underdeveloped market needs.
What do you hope to gain out of your participation at the 2015 BIO International Convention?
John Higuchi, Aciont Inc: The ever growing BIO International Conference is ginormous and overwhelming. This permits many potential highly diverse interactions toward a variety of product development, collaborative and financing opportunities. Based on the meetings we have been able to schedule so far with the sophisticated one-on-one partnering system, it appears this enables efficient speed dating interactions we may not otherwise get through conventional networking opportunities.
Francis Tsow, TF Health Co: First of all, we are honored to be invited to the Convention. We would like to 1) meet other innovative companies, interact, and explore opportunities with them; 2) to take this opportunity in showcasing our technologies to an educated audience; 3) to learn from the speakers and experts in the field; 4) and to experience the Convention as an exhibitor.
Tell us something about your company that investors might not know.
John Higuchi, Aciont Inc: Visulex may end up with many potential applications and be used by many practitioners, health care providers and possibly patients themselves at home or with the assistance of a friend, relative or caregiver. This all can lead our approach to a path toward improving treatment access in underserved regions and blockbuster sales.
Our lead Visulex technology is based on passive diffusion; however, the NIH SBIR program also funded an extension to this technology relating to a process known as iontophoresis which employs a mild electrical current to facilitate the enhanced flux of drugs through the pores of human tissue. During iontophoresis, electroosmosis occurs which induces the convective flow of water through pores. We have found that this action greatly accelerates the movement of macromolecules such as bevacizumab (MW-150KD) noninvasively through human scleral tissue.
Both our passive diffusion and iontophoresis-based renditions of our Visulex technology platform are able to target drugs to the posterior pole of the eye, transsclerally, almost readily through the suprachoroidal space between the deep scleral and choroid tissues of the eye. We are also working on formulations for poorly water soluble agents and methods to increase the residence time of the drug in the eye’s tissues following treatment.
Francis Tsow, TF Health Co: We are a special group of passionate researchers who want to make an impact beyond the typical academia and reach out to the society. Our vision is to provide personal medical and environmental innovations to meet urgent and unmet needs.