Organogenesis Holdings Inc. Confirms FDA Type-B Meeting Outcome, Plans Rolling BLA Submission For ReNu Before December 2026

Organogenesis Holdings Inc. Organogenesis Holdings Inc., a leading regenerative medicine company focused on developing, manufacturing, and commercializing product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, announced the successful completion of a planned Type-B meeting with the U.S. Food and Drug Administration U.S. Food and Drug Administration. The meeting resulted in confirmation that Organogenesis can proceed with a rolling Biologics License Application (BLA) submission for ReNu, expected to begin before the end of December 2026.

Patrick Bilbo Patrick Bilbo, Chief Operating Officer of Organogenesis, stated that the outcome of the FDA meeting represents an important milestone for the ReNu program. He highlighted that the program—which includes two large Phase 3 randomized controlled trials, a robust commercial history, and a Regenerative Medicine Advanced Therapy (RMAT) designation—is well-positioned for BLA submission. He added that if approved, ReNu has the potential to address a significant medical need for a large and growing patient population suffering from knee osteoarthritis (OA).

Knee osteoarthritis is a degenerative joint disease affecting an estimated 31.1 million Americans, a number projected to rise to 34.4 million by 2027. It is one of the most common causes of disability and diminished quality of life, often characterized by chronic pain and reduced mobility. For patients with end-stage knee OA, total knee replacement surgery is generally considered the last resort after other treatment options have been exhausted. Organogenesis aims for ReNu to provide an alternative therapy that can address this unmet medical need and improve patient outcomes.

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