Cartiva, Inc., (Company) a developer of innovative solutions for the treatment of cartilage damage, osteoarthritis and other musculoskeletal conditions, announced today that it has submitted the final module of the pre-market approval (PMA) application for its Cartiva® Synthetic Cartilage Implant (SCI) to the U.S. Food and Drug Administration (FDA). The final module, which covers the clinical results from the MOTION trial evaluating the safety and effectiveness of Cartiva SCI for the treatment of osteoarthritis at the base of the great toe, completes the Company’s PMA application for the product. Results from the MOTION study have been accepted for presentation at the July Annual Meeting of the American Orthopaedic Foot and Ankle Society (AOFAS).
“The completion of our PMA submission is the most significant milestone in the Company’s history and is the culmination of many years of dedicated research,” said Tim Patrick, President and Chief Executive Officer of Cartiva, Inc. “This is the largest and most rigorous FDA trial ever completed for this clinical condition. We look forward to working with FDA to bring the first synthetic cartilage product to market.” Mr. Patrick concluded, “We are also very excited about the upcoming presentation of our clinical results at the AOFAS meeting, and the opportunity to educate this preeminent group of surgeons on the clinical benefits of Cartiva SCI.”
The MOTION study involved enrollment of 236 patients at 12 centers in Canada and the United Kingdom. The trial was designed to determine the safety and efficacy of Cartiva SCI in comparison to arthrodesis (fusion) for reducing the debilitating pain associated with osteoarthritis in the great toe. Patients were randomized 2:1 to either Cartiva SCI or arthrodesis. The primary endpoint for the trial is a composite evaluation of pain, function and safety.
About Cartiva SCI
Cartiva SCI is comprised of a proprietary polyvinyl alcohol (PVA) hydrogel designed to mimic natural cartilage. PVA is a synthetic polymer prepared by the hydrolysis of polyvinyl acetate and has been used in medical device applications for over 20 years. A patented manufacturing process enables Cartiva, Inc. to customize the PVA hydrogel to meet defined functional requirements. The physical properties of Cartiva SCI, including the water content, compressive properties and low coefficient of friction, are similar to natural cartilage. Along with its ability to withstand physiologic loading, the Cartiva implant’s properties make it an ideal design for the replacement of damaged articular surfaces. Additionally, relative to other alternatives, Cartiva SCI minimizes the amount of bone that needs to be removed from the patient.
Peter Pizzo, 770-754-3855
Chief Financial Officer