Organogenesis Announces Successful FDA Meeting and Plan to File BLA for ReNu® for Knee Osteoarthritis Pain

Core Insights - Organogenesis Holdings Inc. has successfully completed a Type-B meeting with the FDA, confirming the initiation of a rolling Biologics License Application (BLA) for its product ReNu, expected to be submitted by the end of December 2025 [2][3] Company Overview - Organogenesis Holdings Inc. is a leading regenerative medicine company focused on developing, manufacturing, and commercializing solutions for advanced wound care and surgical and sports medicine markets [5] - The company offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care [5] Product Details - ReNu is a cryopreserved amniotic suspension allograft designed for managing symptomatic knee osteoarthritis, consisting of amniotic fluid cells and micronized amniotic membrane [4] - The product has been studied in three large randomized controlled trials (RCTs) involving over 1,300 patients and received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis in 2021 [4] Market Context - Knee osteoarthritis (OA) affects an estimated 31.1 million Americans, projected to increase to 34.4 million by 2027, making it one of the most common causes of disability and poor quality of life [3]