Organogenesis Completes Rolling BLA Submission for ReNu® Cell Therapy Targeting Symptomatic Knee Osteoarthritis

Recently, the leading regenerative medicine company Organogenesis announced that it has completed the rolling Biologics License Application (BLA) for its cell therapy ReNu to the FDA.（BLA）Submitted for the treatment of symptomatic knee osteoarthritis. The application, initiated in December 2025, has now completed all submissions for the clinical and CMC modules.

ReNu is a cryopreserved amniotic membrane suspension allograft composed of amniotic fluid cells and micronized amnion.Rich in cells, growth factors, and extracellular matrix components. The product had previously been commercially sold for about six years under FDA 361 and received Regenerative Medicine Advanced Therapy (RMAT) designation in 2021.（RMAT）Recognition.

Knee osteoarthritis is one of the most common causes of disability and decreased quality of life, characterized by pain and functional impairment. End-stage patients often can only undergo total knee arthroplasty, indicating a significant unmet medical need.

ReNu has been involved in three large randomized controlled trials(Involving Over 1,300 Patients)Conduct research in China. Among them, the first Phase III trial was conducted inSignificant reduction in knee pain and significant maintenance of function were achieved at six monthsThe primary endpoint; rescue medication for breakthrough pain in the saline control group(Acetaminophen)Significantly more. Subgroup analysis of the second Phase III trial showed, the response in pain relief between the most severe patients (KL4 grade) and moderate patients (KL3 grade)Similarly, further supporting the overall results.

Organogenesis Expresses Confidence in Regulatory Communication Progress, Looks Forward to Continued Discussions with FDA During Review Process; If Approved, ReNu Will Offer Millions of Knee Osteoarthritis Patients a New Non-Surgical Regenerative Treatment Option.

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