Organogenesis Holdings Completes Type-B Meeting With FDA Resulting In Confirmation To Initiate Rolling BLA For ReNu Planned Before December End

Clinical Development Program Appropriate for Rolling BLA 

Submission Expected by the End of 2025

CANTON, Mass., Dec. 15, 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 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.

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.