ALPHARETTA, Ga.--(BUSINESS WIRE)--Marking a major milestone in the advancement of new treatments for osteoarthritis, Cartiva, Inc. (Company) today announced that it has submitted the first module of the pre-market approval (PMA) application for its Cartiva® Synthetic Cartilage Implant (SCI) to the U.S. Food and Drug Administration (FDA). Cartiva SCI is a proprietary biomaterial designed to mimic the key attributes of natural cartilage: low-friction, compressibility and durability. The device is currently under clinical investigation in a randomized pivotal study (the MOTION Study) to determine its safety and effectiveness compared to fusion for the treatment of osteoarthritis of the first metatarsophalangeal (MTP) joint. The fifth and final module, including the clinical data from the MOTION Study, is scheduled for submission in the second quarter of 2015, putting the Company on track for possible FDA approval as early as the second half of 2015.
More than two million people in the United States suffer from osteoarthritis of the MTP joint, which serves the function of pushing the foot away from the ground when walking. When the MTP joint is affected by arthritis, it can become painful and stiff, leading patients to make adjustments to their movement that can have an adverse impact on other joints and lead to a sedentary lifestyle. The current standard of care for moderate to severe osteoarthritis of the first MTP joint is fusion, a surgical procedure requiring removal of cartilage and bone followed by permanent fusion of the joint using plates and screws. While usually quite successful in eliminating pain, the loss of natural joint motion and a lengthy rehabilitation period are downsides of a joint fusion procedure. Cartiva SCI is comprised of a proprietary biomaterial with physical properties similar to natural cartilage. In a Cartiva procedure, the damaged cartilage is replaced with a new, synthetic bearing surface, restoring a more natural range-of-motion and avoiding a fused joint.
"Cartiva SCI has the potential to fill a large unmet need for a less invasive treatment that preserves motion and minimizes bone loss," said Timothy J. Patrick, president and chief executive officer. "The submission of the first module of our PMA application is a significant milestone for the Company. The MOTION study is the largest randomized study ever undertaken for great toe arthritis. As such, it will provide the highest level of clinical evidence ever published. We look forward to interfacing with FDA throughout the review process as we work to bring the first synthetic cartilage device to the U.S. market."
About the MOTION Trial
A Prospective, Randomized, Non-Inferiority Study to Evaluate the Effectiveness of Cartiva Synthetic Cartilage Implant in the Treatment of First Metatarsophalangeal Joint Osteoarthritis as Compared to a Control, or the MOTION trial, is an international, multi-center study of Cartiva SCI. The results of the MOTION trial, which enrolled 236 patients at 12 sites in Canada and the United Kingdom, are intended to establish the basis for a Premarket Approval Application to the U.S. Food and Drug Administration. The MOTION trial, the largest prospective randomized clinical trial for osteoarthritis of the first MTP joint, was designed to determine the safety and efficacy of Cartiva SCI in comparison to arthrodesis (joint fusion), the current standard of care, for reducing the debilitating pain associated with osteoarthritis of the MTP joint in the great toe. The primary endpoint for the trial is a composite evaluation of pain, function and safety. The last patient was enrolled in June 2012 and follow-up is expected to be completed in the fourth quarter of 2014.
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.
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis or cartilage damage. Additional information is available on the Company’s website at www.cartiva.net.