PARAMUS, N.J., Oct. 8, 2024 /PRNewswire/ — Regenity Biosciences, a global leader in regenerative medicine and Linden Capital Partners portfolio company, today announced that it has received FDA 510(k) clearance to market RejuvaKnee™, a minimally invasive collagen-based meniscal implant indicated for use in the reinforcement and repair of soft tissue injuries of the meniscus.
RejuvaKnee™ allows for a more complete recovery by facilitating the regeneration of the native meniscal tissue instead of cutting or replacing it. In a 12-month animal study that examined biochemical and biomechanical attributes and histology for tissue growth, RejuvaKnee™ demonstrated that in three months, the regenerated meniscus is able to withstand full weight bearing, and the knee returns to normal range of motion1. These results are superior to that of meniscectomy and allograft transplantation. Neovascularization and tissue histology also demonstrated healthy tissue regeneration with RejuvaKnee™ achieving nearly five times more tissue growth than the standard of care. Meniscectomy can offer high short-term clinical success rates but can frequently lead to follow-on meniscectomy or predisposition for osteoarthritis2,3, as opposed to RejuvaKnee™, which is designed to elongate the life of a knee that has been impacted by meniscal injury.
“The FDA clearance of RejuvaKnee™ represents a turning point in the meniscal repair market and marks an exciting innovation milestone for Regenity as a global leader in regenerative medicine solutions,” said Shawn McCarthy, CEO of Regenity Biosciences. “The pre-clinical animal study data supports our confidence that RejuvaKnee™ will deliver results by facilitating significant tissue regeneration and balanced implant resorption. As the only FDA-cleared regenerative implant device for meniscal repair on the market, this is a game changer for the industry given it will be indicated for a significant portion of the more than one million meniscectomies that are performed each year in the United States. With this innovation, our 60th 510(k) approval, we are further expanding the Regenity product portfolio that we bring to our commercial partners to improve patient outcomes.”
View full details in PRNewswire