Regenity Biosciences said it has received FDA clearance to begin marketing RejuvaKnee, what it's calling a minimally invasive collagen-based meniscal implant designed to help with the reinforcement and repair of soft tissue injuries of the meniscus.
It could signal a major change in how meniscus injuries are treated, since it involves the regeneration of the native meniscal tissue instead of cutting or replacing it.
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"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."
RejuvaKnee is a natural bovine-derived collagen implant that facilitates host tissue ingrowth and repair of damaged or injured meniscal tissue. In human cadaver studies, Regenity, in partnership with a panel of key opinion leaders in sports medicine, demonstrated the application and ease of use for arthroscopic implantation using a wide range of instrumentation currently available on the market.
"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," said 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.
