Organogenesis Announces Initiation of Biologics License Application for ReNu®

Core Insights - Organogenesis Holdings Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft aimed at managing symptomatic knee arthritis, with final modules expected in the first half of 2026 [1][2] 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 [4] Product Details - ReNu is designed for the management of symptomatic knee osteoarthritis and consists of amniotic fluid cells and micronized amniotic membrane, containing cellular, growth factor, and extracellular matrix components [3] - The product has been studied in three large randomized controlled trials (RCTs) involving over 1,300 patients and received FDA RMAT designation for Knee OA in 2021 [3] Market Context - Knee osteoarthritis (OA) affects an estimated 31.1 million Americans, projected to increase to 34.4 million by 2027, and is a leading cause of disability and poor quality of life [2]