US-based bioresorbable technologies provider Regenity Biosciences has received the US Food and Drug Administration (FDA) 510(k) approval for its RejuvaKnee implant device.
RejuvaKnee is a minimally invasive collagen-based implant indicated for reinforcing and repairing soft tissue injuries of the meniscus.
Derived from natural bovine collagen, the device promotes host tissue ingrowth and facilitates the repair of damaged meniscal tissue.
It promotes a more complete recovery by supporting the regeneration of native meniscal tissue, providing an alternative to cutting or replacing the damaged tissue.
In human cadaver studies, RejuvaKnee showed effectiveness and ease in arthroscopic implantation using widely available surgical instruments.
Regenity conducted the studies in collaboration with sports medicine experts.
RejuvaKnee implant also showed positive results in a 12-month animal study that assessed biochemical and biomechanical attributes and histology for tissue growth.
Within three months, the device resulted in a regenerated meniscus that can withstand full weight bearing and the knee returned to normal range of motion.
Regenity said the results are superior to meniscectomy and allograft transplantation, and its RejuvaKnee achieved nearly five times more tissue growth compared to the standard of care.
Regenity Biosciences CEO Shawn McCarthy said: “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.
“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.”
According to Regenity, meniscectomy can provide short-term success, but often leads to repeat procedures or increases the risk of osteoarthritis.
Its RejuvaKnee device is designed to extend the functional lifespan of a knee affected by meniscal injury, said the company.
Regenity estimates the market potential for its implant at more than $900m, based on the volume of eligible meniscectomies performed in the US each year.
The bioresorbable technology company is currently exploring opportunities for strategic partnerships to commercialise the device in the US.
University of Chicago clinical professor, NBPA chief medical officer, and Endeavor Health System research and innovation vice chair Asheesh Bedi said: “RejuvaKnee provides a scaffold for the patient to regenerate their own meniscal tissue for these defects.
“Favourable 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.”
