Organogenesis Completes FDA BLA Submission for ReNu Knee OA Allograft
Organogenesis completed submission of its rolling Biologics License Application for ReNu®, including clinical and CMC modules, to the FDA. If approved, the cryopreserved amniotic suspension allograft could treat symptomatic knee osteoarthritis in over 31.1 million Americans and broaden the company’s regenerative therapy portfolio.
1. Completion of Rolling BLA Submission
On April 28, Organogenesis finalized its rolling Biologics License Application to the FDA for ReNu®, having initially submitted non-clinical modules in December 2025 and now adding clinical and chemistry, manufacturing, and controls modules to complete the application.
2. ReNu Product and Clinical Data
ReNu is a cryopreserved amniotic suspension allograft composed of amniotic fluid cells and micronized membrane, studied in three randomized trials involving over 1,300 patients and granted FDA RMAT designation in 2021 for knee osteoarthritis.
3. Market Opportunity and Next Steps
Knee osteoarthritis affects an estimated 31.1 million Americans, rising to 34.4 million by 2027; Organogenesis will engage with FDA reviewers on safety and efficacy data before potential approval and commercial launch.