Organogenesis received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for ReNu®, a cryopreserved amniotic suspension allograft to treat symptoms associated with knee osteoarthritis (OA).
ReNu comprises amniotic fluid cells and micronized amniotic membrane, and contains cellular, growth factor and extracellular matrix components.
FDA granted RMAT designation for ReNu based on clinical evidence from a 200-patient multicenter single-blinded randomized controlled trial demonstrating, at six months, that patients with knee OA treated with ReNu experienced a statistically significant reduction in pain and improvement in function vs. hyaluronic acid and saline.
FDA's RMAT designation program is designed to expedite development and review of regenerative medicine therapies intended to treat, modify, reverse or cure a serious or life-threatening disease or condition. To qualify, the therapy must be supported by preliminary clinical evidence indicating the potential to address unmet medical needs related to the serious condition.
RMAT designation includes all of the benefits of the Fast Track and Breakthrough Therapy designation programs. It provides early interactions and intensive guidance from the FDA on development of the therapy, including potential priority review of the biologics license application (BLA) and potential ways to support accelerated approval and satisfy post-approval requirements.
“Securing RMAT designation is a significant milestone for ReNu that underscores the potential impact of this therapy for knee osteoarthritis,” said Gary S. Gilheeney, Sr., President and CEO of Organogenesis. “We are very pleased that the FDA has provided us with these key regulatory advantages and a pathway for expedited approval of ReNu for this degenerative and life-altering disease.”