Building Companies, Changing Lives
Issue 54– May 2017
The Institute has finalized a first-round funding agreement with Amend Surgical, a medical device company with technology developed at the University of Florida. Amend Surgical is focused on enhancing the healing and regenerative capacity of bone grafts, including allograft, xenograft tissues and synthetic materials. The company’s pipeline includes novel, osteoinductive bone extracts, and will expand in the future to include disruptive products based on discovery and development of novel therapeutic additives with tissue-specific regenerative characteristics.
MYOLYN, a medical technology company dedicated to improving health and human performance, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for two of its cutting-edge technologies, the MyoCycle Home and the MyoCycle Pro. Both devices are stationary cycling systems that use MYOLYN’s patent-pending functional electrical stimulation (FES) technology to empower anyone who has difficulty activating their own muscles. Such systems are also known as FES bikes. Clearance from the FDA marks a major milestone, allowing the company to enter both the professional rehabilitation and the homecare medical device markets. MYOLYN received initial funding from the Institute in 2015.
Vigilant Biosciences, Inc., a leading innovator and developer of solutions that aid in the early detection and intervention of oral/oropharyngeal cancer, announced the launch and first patient enrollment for clinical studies of its OncAlert® point-of-care qualitative assay in support of its registration submission to the Food and Drug Administration (FDA). The study is designed to validate performance and evaluate implementation of the OncAlert RAPID point-of-care qualitative assay into the standard of care paradigm for patients presenting with increased clinical risk for oral/oropharyngeal cancer, and will enroll up to 1,000 patients with sites located in the United States as well as internationally.
Biscayne Neurotherapeutics, Inc., a clinical-stage company developing novel treatments for neurological disorders, announced that lead compound BIS-001 has received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of Dravet syndrome, a severe form of childhood epilepsy that has no approved therapies. Additionally the company has been cleared to begin a Phase 1b trial of BIS-001 at the Royal Melbourne Hospital in Australia, with enrollment expected to commence in the coming weeks. BIS-001 is in clinical development as a novel treatment for adults with refractory complex partial seizures.
The Florida Venture Forum and Space Florida announced the winners of the 10th Annual 2017 Florida Early Stage Capital Conference and Space Florida’s Accelerating Innovation prize at the Omni ChampionsGate in Orlando. Two Institute-funded companies took home second and third prizes respectively: Auxadayne, based in Keystone Heights, and Admiral, based in Gainesville. Twenty-two companies were selected to present from a statewide pool of more than 130 applicants, and cash prizes, provided by Space Florida, were awarded to the top three companies.
KynderMed Winner of Innovation Park's 2017 TechGrant Program
Save the Date for 2017 BioFlorida Annual Conference
Innovation and Entrepreneurship