Press release
Organogenesis Announces Initiation of Biologics License Application for ReNu®
Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026 CANTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) --
About this update from Organogenesis Holdings Inc.
[{"type":"text","content":"Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026\nCANTON, Mass., Dec. 23, 2025 (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 initiation of a rolling submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for ReNu,® a cryopreserved, amniotic suspension allograft developed for the management of symptomatic knee arthritis. Organogenesis plans to complete the BLA submission with the final modules submitted in the first half of 2026. “This is another significant achievement for the ReNu clinical development program and a pivotal moment for Organogenesis,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “If approved, ReNu would be the first non-surgical biologic therapy to address knee osteoarthritis pain for all patients, especially for those classified as most severe.” 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 on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis ...