Cartiva Submits First Module Of PMA Application For Cartiva SCI
6/10/2014 10:12:13 AM
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.
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