FDA Clears Regenerative Meniscus Implant

Image credit: u_if8o5n0ioo via Pixabay

Regenerative medicine medtech, Regenity Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its minimally-invasive, collagen-based implant used to help treat soft tissue injuries within the knee’s meniscus cartilage.

Known as the RejuvaKnee, the device promotes better recovery by supporting the regeneration of the patient’s own meniscal tissue, as opposed to current techniques which involve slicing or replacing it.

A 12-month animal study showed that within three months, the regenerated meniscus utilising the RejuvaKnee could tolerate full weight bearing, with the knee restored to a typical range of motion.

The study also revealed robust tissue regeneration, with RejuvaKnee achieving nearly five times the tissue growth as compared with conventional treatments.

“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 Regenity Biosciences’ Chief Executive Officer, Shawn McCarthy in a statement.

“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.”

For further information, refer to the press statement issued by Regenity Biosciences.