Tentative Date for FDA Advisory Panel Review of Cartiva SCI

FDA has tentatively scheduled a meeting of the Orthopaedic and Rehabilitation Devices Panel on April 20, 2016 to review Cartiva’s Premarket Approval Application (PMA) for the Cartiva Synthetic Cartilage Implant (SCI), for the treatment of great toe osteoarthritis.

FDA recently completed a 5-day inspection of Cartiva’s manufacturing operations and quality systems in Georgia, with no observations noted and no Form 483 issued.

Source: Cartiva, Inc.

Cartiva submitted the final module of its PMA application to FDA in mid-2Q15. Shortly thereafter, the company secured US $8.5MM in an oversubscribed Series D financing to fund the PMA, as well as post-510(k)-clearance clinical evaluations of the ProxiFuse Hammertoe Correction System and GRIP Study evaluating SCI to treat thumb base OA.