Organogenesis Holdings (NASDAQ:ORGO), a leader in regenerative medicine, announced today that it has successfully completed a Type-B meeting with the U.S. Food and Drug Administration (FDA).
The meeting resulted in formal confirmation for the company to initiate a rolling Biologics License Application (BLA) for ReNu, its amniotic suspension allograft, with the first parts of the submission planned before the end of December 2025.
The FDA’s confirmation validates the company’s comprehensive clinical development program as appropriate for a BLA submission.
The data package includes results from two large Phase 3 randomized controlled trials (RCTs) and a separate 200-patient RCT, totaling more than 1,300 patients studied.
ReNu is a cryopreserved allograft consisting of amniotic fluid cells and micronized amniotic membrane.
It is designed for the management of symptomatic knee osteoarthritis (OA), a degenerative joint disease characterized by chronic pain and loss of function.
The product previously received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, which allows for increased agency interaction and eligibility for priority review.
The market opportunity for ReNu is substantial.