Company Successfully Completes Pre Approval Manufacturing Inspection with No Observations
Cartiva, Inc., (Company) a developer of innovative solutions for the treatment of cartilage injuries, osteoarthritis and other musculoskeletal conditions, announced today that the U.S. Drug and Food 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 Implant (SCI) for the treatment of osteoarthritis at the base of the big toe.
The Company also announced that the 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 commercializtion 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."
Peter Pizzo, 770-754-3855
Chief Financial Officer