Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis

About this update from Organogenesis Holdings Inc.

CANTON, Mass., July 06, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing determination and accepted for review the Company's Biologics License Application (BLA) for ReNu®, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027. "We are pleased to reach this important milestone and look forward to working with the FDA as they complete their review,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are now one step closer to our goal of bringing the first non-surgical biologic therapy to the millions of Americans whose lives are impacted by knee OA pain.” Knee OA is a degenerative joint disease that is estimated to affect nearly 31 million Americans and projected to grow to more than 34 million Americans by 2027. It is ranked among the most common causes of disability and poor quality of life, generally characterized by pain and functional deficits. End stage management of the disease in these patients is typically a total knee replacement when all other treatment options have been exhausted.About ReNu®ReNu® is a cryopreserved, amniotic suspension allograft developed for the treatment of pain in 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. The FDA has conditionally accepted Amnuvx (azimplacel) as the proprietary name, pending review and approval by the FDA.About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit&nbs...

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