The FDA has granted Pre-Market Approval (PMA) to OrthogenRx, Inc.’s GenVisc 850 hyaluronic acid (HA) as a knee replacement fluid to treat osteoarthritis.
GenVisc had been approved in 60 countries outside the U.S. The product was developed in collaboration with Meiji Seika Pharma Co., Ltd. of Japan and subsidiary, Tedec-Meiji Farma S.A. in Spain.
18 Month Approval
But here’s the most interesting part, it only took company CEO and President Mike Daley, Ph.D., around 18 months from receiving funding and a lot less than the usual $100 million required to gain FDA approval. And he did it with only two employees.
OrthogenRx announced the approval on October 8, 2015. The product is commonly injected 3-5 times weekly into the knee and, according to the company, can provide patients up to 6 months pain relief.
The product is the first 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 company focuses on the commercialization of generic Class III orthopedic medical devices. Its business model utilizes exclusive supply and license agreements for products presently on the market outside the U.S. and seeks generic product approval in the U.S. potentially saving the healthcare system billions in cost. The strategy utilizes existing regulations for an abbreviated regulatory approval for generic devices, analogous to generic drugs.
The company estimates the U.S. HA market at almost $1 billion and through lower costs and more efficient distribution channels believes its products may save $300 million in healthcare costs and $50 million in patient co-pays over five years. There are other products in the company pipeline.
Funding came from angel equity investments and the Ben Franklin Technology Partners of Southeast Pennsylvania.
Hyaluronic Acid
The use of hyaluronic acid (HA) to treat osteoarthritis was originally proposed 70 years ago by Hungarian scientist Endre A. Balasz. By 1987, hyaluronic acid treatments were being used overseas, though the first viscosupplement available in the U.S., Hyalgan, wasn’t approved by the FDA until 10 years later. There are now various hyaluronic acid treatments for knee osteoarthritis in use in the U.S., including: Hyalgan, Orthovisc, Supartz, Synvisc, Euflexxa and now, GenVisc 850.
The company, now with three employees, is located in Doylestown, Pennsylvania.
