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Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®
If approved, ReNu® will revolutionize treatment options for millions of patients with knee OA pain CANTON, Mass., April 28, 2026 (GLOBE NEWSWIRE) --
About this update from Organogenesis Holdings Inc.
[{"type":"text","content":"If approved, ReNu® will revolutionize treatment options for millions of patients with knee OA pain\nCANTON, Mass., April 28, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the completion of a rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for ReNu®, a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis (OA). “We are pleased to complete the BLA submission for ReNu®, which represents a significant milestone in our drive to bring a new regenerative therapy to knee OA patients,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are confident in the progress of our regulatory engagement and look forward to continuing our productive discussions with the FDA during the review process.” Organogenesis initiated the rolling BLA submission in December 2025 with non-clinical modules and has now completed the application with the submission of the clinical and chemistry, manufacturing, and controls (CMC) modules. Knee OA is a degenerative joint disease that is estimated to affect nearly 31.1 million Americans and projected to grow to 34.4 million Americans by 2027. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functionality deficits. End stage management of the disease in these patients is typically a total knee replacement when all other treatment options are exhausted. About ReNu®ReNu is a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee osteoarthritis. ReNu consists of amniotic fluid cells and micronized amniotic membrane and contains cellular, growth factor, and extracellular matrix components. ReNu has been studied in three large RCTs consisting of more than 1,300 patients and received FDA RMAT designation for Knee OA in 2021. ReNu was previously marketed under Section 361 of the Public Health Service Act and was commercially available for approximately six years. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine company focused...