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

Clinical Development Program Appropriate for Rolling BLA 

Submission Expected by the End of 2025

CANTON, Mass., April 06, 2026 -- 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 successful completion of a planned Type-B meeting with the Food and Drug Administration (FDA) resulting in confirmation to initiate a rolling Biologics Licenses Application (BLA) for ReNu planned before the end of December.

“We are excited about the outcome of our FDA meeting and reaching this important milestone in the ReNu program,” said Patrick Bilbo, Chief Operating Officer of Organogenesis. “We are pleased the ReNu clinical development program consisting of two large Phase 3 randomized controlled trials (RCT), extensive commercial history and Regenerative Medicine Advanced Therapy (RMAT)-designation is appropriate for BLA submission. If approved, we believe that ReNu will address a significant medical need for a large and growing patient population.”

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 offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care.