Regenity Biosciences received FDA 510(k) clearance for its RejuvaKnee implant for soft tissue injuries of the meniscus. The minimally invasive, collagen-meniscal implant aids in the reinforcement and repair of soft tissue injuries of the meniscus. RejuvaKnee delivers a more complete recovery by facilitating the regeneration of the native meniscal tissue instead of cutting or replacing it.
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In a 12-month animal study, RejuvaKnee demonstrated that, in three months, its regenerated meniscus can withstand full weight bearing. Additionally, the knee returns to the normal range of motion. The company says its results prove superior to those of meniscectomy and allograft transplantation.
Neovascularization and tissue histology also demonstrated healthy tissue regeneration with RejuvaKnee, Regenity said. It achieved nearly five times more growth than the standard of care.
Regenity estimates a total potential market for the device at more than $900 million. It now plans to explore opportunities through a strategic partner to commercialize the device in the U.S.
“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.”
