Organogenesis Announces Initiation of Biologics License Application for ReNu®
Organogenesis Holdings Inc., a leader in regenerative medicine, has started a rolling submission for FDA approval of ReNu. This biologic therapy aims to treat knee osteoarthritis (OA), a condition affecting over 31 million Americans. If approved, it would become the first non-surgical option for all patients, including those with severe symptoms.
ReNu is a cryopreserved, amniotic suspension allograft designed to manage symptomatic knee arthritis. The therapy was previously available under Section 361 of the Public Health Service Act and sold commercially for around six years. Now, Organogenesis is seeking full approval through a Biologics License Application (BLA), with completion expected in the first half of 2026.
The treatment has already undergone three large randomised controlled trials involving over 1,300 patients. In 2021, it received the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation for knee OA. Beyond the US, the European Medicines Agency (EMA) will review ReNu for potential approval in Europe. Knee osteoarthritis remains a widespread issue, with cases projected to rise to 34.4 million Americans by 2027. Organogenesis specialises in regenerative solutions for wound care, surgery, and sports medicine, offering a range of products to support patient recovery.
The BLA submission marks a key step toward making ReNu the first non-surgical biologic therapy for knee OA. If approved, it could provide a new treatment option for millions suffering from the condition. The EMA’s decision will determine its availability in Europe.
