Organogenesis starts rolling submission for ReNu allograft for knee arthritis

Organogenesis (Nasdaq: ORGO) has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee arthritis.

Initial modules were submitted under rolling review with final modules expected in the first half of 2026. Company executives said ReNu, if approved, would be the first non-surgical biologic therapy for knee osteoarthritis across all patients, including the most severe. Knee osteoarthritis is estimated to affect 31.1 million Americans, rising to 34.4 million by 2027, with end-stage management typically a total knee replacement.

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