Regenity Wins FDA Nod for Regenerative Meniscus Implant

Regenity Biosciences, a regenerative medicine and Linden Capital Partners portfolio company, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for RejuvaKnee, a minimally invasive, collagen-based meniscal implant to reinforce and repair soft tissue injuries of the meniscus.
 
RejuvaKnee facilitates regeneration of the native meniscal tissue instead of cutting or replacing it. A 12-month animal study that examined biochemical and biomechanical attributes and histology for tissue growth showed that in three months, the regenerated meniscus can withstand full weight bearing and the knee returns to normal range of motion.
 
The natural bovine-derived collage RejuvaKnee implant facilitates host tissue ingrowth and repair of damaged or injured meniscal tissue. Regenity, partnering with a panel of sports medicine opinion leaders, showed application and ease of use for arthroscopic implantation in human cadaver studies using a range of instruments available on the market.
 
Regenity estimates the market potential for its device at over $900 million based on the volume of eligible meniscectomies performed in the U.S. each year. The company is exploring opportunities via a strategic partner to sell 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.”

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“Many complex meniscus tears are currently treated with a partial resection for symptomatic relief, but with the significant risk of increased contact pressures and more rapid progression of arthritis. RejuvaKnee provides a scaffold for the patient to regenerate their own meniscal tissue for these defects. Favorable incorporation of the scaffold can not only offer symptomatic relief, but also has the potential to reduce osteoarthritis and quality of life over time for patients. I am very encouraged by the results of these animal and cadaveric studies for what could be a transformative treatment and alternative to meniscectomy,” added Dr. Asheesh Bedi, MD, Clinical Professor at the University of Chicago, Chief Medical Officer for the NBPA, and Vice Chair of Research and Innovation at NorthShore/Endeavor Health System.