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.
Knee osteoarthritis currently affects an estimated 31.1 million Americans, a figure projected to rise to 34.4 million by 2027.
For many of these patients, total knee replacement is the only remaining option once conservative treatments fail.
Organogenesis is positioning ReNu as a critical non-surgical intervention to manage pain and delay the need for invasive surgery.
The rolling BLA process allows the FDA to review completed sections of a biological license application as they are submitted, rather than waiting until every part of the application is finished, potentially accelerating the overall approval timeline.