Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®
Organogenesis completed the rolling submission of a Biologics License Application (BLA) to the FDA for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis. The submission began in December 2025 and has now been finalized with the clinical and CMC modules, marking a transition from the product's previous 361 regulatory pathway. ReNu, which received RMAT designation in 2021, is supported by three large RCTs involving over 1,300 patients and targets a U.S.
Key figures
- Drug Name
- ReNu(®)
- Oa prevalence us
- 31.1 million
- Rct patient count
- more than 1,300
- Oa projection 2027
- 34.4 million
- Rmat designation year
- 2021
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