DOYLESTOWN, Pa.--(BUSINESS WIRE)--OrthogenRx Inc. has announced the US Food and Drug Administration (FDA) approval of GenVisc 850® (sodium hyaluronate) for the treatment of patients with osteoarthritis (OA) knee pain. GenVisc 850® is a solution of purified hyaluronic acid (sodium hyaluronate; HA), similar to the normal knee fluid. HAs replace the fluid in the knee that has degraded with the development of OA. Commonly injected 3-5 times weekly into the knee, in clinical studies HAs have been shown to provide patients up to 6 months pain relief.
GenVisc 850® is the first Pre-Market Approval (PMA) to be approved based upon indistinguishable characteristics of composition, and non-inferior clinical performance compared to an approved product, much analogous to approvals of generic drugs and biosimilars. The FDA regulates HAs as Class III medical devices, the most stringent level of review for devices. GenVisc 850® was developed in collaboration with Meiji Seika Pharma Co., Ltd. (Japan) and subsidiary, Tedec-Meiji Farma S.A (Spain). GenVisc 850® has been approved in 60 countries (outside US) under the Adant® brand and distributed by Meiji Seika Pharma Group and partners.
The 2014 US HA market was $924MM. OrthogenRx’s business model is to license/develop ex-US products for FDA approval. Through lower costs and more efficient distribution channels, OrthogenRx’s products may save $300MM in healthcare costs and $50MM in patient co-pays over 5 years. OrthogenRx has multiple products in various stages of development using this strategy.
The OrthogenRx team obtained the GenVisc 850® PMA approval within 18 months of funding while the industry standard is 6-8 years and $100MM for development. OrthogenRx has a rich pipeline of products and is headquartered in Doylestown, PA. OrthogenRx was supported by Angel equity investments and the Ben Franklin Technology Partners of Southeast Pennsylvania.
OrthogenRx Inc. is a late stage development company headquartered in Doylestown, PA. It licenses, develops, and sells equivalent orthopedic medical devices at competitive pricing and efficient operating processes, thereby maintaining favorable margins. This reduced cost to the healthcare system maintains affordable access to quality healthcare. The management team has decades of industry experience in product development, commercialization, sales/marketing, and reimbursement of medical device products.