NovoPedics’ MeniscoFix Granted Breakthrough Device Designation

By Julie A. Vetalice

NovoPedics’ MeniscoFix Granted Breakthrough Device Designation

FDA has granted NovoPedics a Breakthrough Device Designation, which will expedite development and prioritize review of the MeniscoFix™ device.

Further, the U.S. Department of Defense awarded a $4.42 million grant to research and development teams at Rutgers University and NovoPedics to support further pre-clinical development of MeniscoFix.

MeniscoFix is a polymer fiber-reinforced scaffold for total meniscus replacement that is designed to be gradually resorbed by the body and be replaced by new tissue. Its patented fiber-reinforced design is similar to the native meniscus. The device is attached to both soft tissue and bone, potentially enabling its use in total meniscus replacement.

NovoPedics Co-Founder Dr. Charles Gatt said, “In contrast to partial meniscus replacement devices, MeniscoFix is uniquely designed to be securely fixed within bone tunnels and to support mechanical loads along the entire implant periphery, making it potentially useful even in patients with a compromised meniscal rim.”

Product Labels: Traditional Soft Tissue Repair

Tags: Funding, Regulatory