“We are very pleased that the FDA recognizes the unique potential benefits of MeniscoFix for patients suffering from pain and loss of mobility associated with a meniscus injury and previous meniscectomy,” remarked NovoPedics co-founder Dr. Michael Dunn. “The Breakthrough Device Designation will enable us to interact with the FDA more rapidly and effectively to accelerate preclinical studies and subsequent clinical trials for MeniscoFix.”
NovoPedics co-founder Dr. Charles Gatt added, “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.”
Recently, the U.S. Department of Defense (DoD), through the Joint Warfighters Medical Research Program, awarded a $4.42 million grant to the research and development teams at Rutgers University and NovoPedics (Dr. Dunn, principal investigator) to support further pre-clinical development of MeniscoFix.
“The FDA Breakthrough Device Designation, coupled with the new DoD funding, will synergistically accelerate our research and development efforts for MeniscoFix, the first mechanically functional total meniscus replacement device designed to be gradually resorbed by the body and replaced by new tissue. We look forward to making this new technology available to orthopedic surgeons to address a significant unmet need in the treatment of patients with meniscus injuries,” added Dunn.