Organogenesis Holdings Inc. (ORGO) announced that the U.S. Food and Drug Administration has accepted its Biologics License Application (BLA) for ReNu, a cryopreserved amniotic suspension allograft intended to alleviate pain in patients with symptomatic knee osteoarthritis.
Knee osteoarthritis, a degenerative disease, currently affects nearly 31 million Americans and is projected to rise to more than 34 million by 2027. It is a leading cause of disability, often resulting in total knee replacement when other treatments fail.
ReNu combines amniotic fluid cells with a micronized amniotic membrane, delivering cellular, growth‑factor, and extracellular matrix components. The therapy has been evaluated in three large randomized controlled trials involving over 1,300 patients and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in 2021.
The FDA has set a PDUFA decision date of April 24, 2027. Organogenesis noted that this milestone brings the company closer to offering what could become the first non‑surgical biologic therapy for the millions of Americans living with knee osteoarthritis pain.
The FDA has conditionally approved the proprietary name “Amnuvx” (azimplacel) for ReNu, pending final review and approval.
