ALPHARETTA, Ga.--(BUSINESS WIRE)--Cartiva, Inc., (Company) a developer of innovative products for the treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a meeting of the Orthopaedic and Rehabilitation Devices Panel on April 20, 2016 to review the Company’s Premarket Approval Application (PMA) for its Cartiva Synthetic Cartilage Implant (SCI) for the treatment of osteoarthritis at the base of the great toe.
The Company also announced that FDA has recently completed a five day inspection of its Alpharetta, Georgia facility, manufacturing operations and quality systems. No observations were noted and no Form 483 was issued.
“We are looking forward to the opportunity to present the safety and clinically relevant efficacy data from our pivotal clinical study, the largest ever conducted for this painful condition,” said Timothy J. Patrick, president and CEO of the Company. “This panel meeting is the culmination of many years of hard work by our employees and clinical researchers and marks one of the final steps on the path to commercialization of Cartiva in the United States. I am also particularly pleased with the outcome of the recent FDA inspection of our facility, which is a testament to our robust quality system.”
About Cartiva, Inc.
Based in Alpharetta, Ga., Cartiva, Inc. develops and markets innovative solutions for patients with osteoarthritis, cartilage damage and other musculoskeletal conditions. Cartiva’s venture investors include New Enterprise Associates, Windham Venture Partners and Domain Associates. Additional information is available on the company’s website at www.cartiva.net.
