Regenerative medicine company Regenity Biosciences has received 510(k) clearance from the US Food and Drug Administration (FDA) for its RejuvaKnee meniscus implant.
This device is designed to reinforce and repair soft tissue injuries of the meniscus through a minimally invasive, collagen-based approach.
RejuvaKnee promotes a more comprehensive recovery by supporting the regeneration of the meniscus rather than removing or replacing it.
A 12-month animal study that assessed biomechanical, biochemical and histological parameters showed that within three months the regenerated meniscus could bear full weight, and knee function returned to normal.
These outcomes surpass those of meniscectomy and allograft transplantation.
The study also revealed that RejuvaKnee facilitated nearly five-times more tissue growth compared with the current standard of care.
Unlike meniscectomy, which may lead to further surgeries or a predisposition for osteoarthritis, RejuvaKnee aims to extend the longevity of knees affected by meniscal injuries.
Regenity Biosciences CEO Shawn McCarthy said: “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 US.
“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."
The RejuvaKnee implant, derived from natural bovine collagen, encourages the ingrowth and repair of damaged meniscal tissue.
Regenity, in collaboration with experts in sports medicine, has also demonstrated the ease of arthroscopic implantation use in human cadaver studies using a variety of standard instruments.
With the vast number of meniscectomies performed annually in the US, the market potential for RejuvaKnee is estimated to exceed $900m.
Regenity is actively seeking a strategic partner to commercialise the device in the US market.
