USFDAApr 28, 2026, 04:31 PM
ORGO Completes BLA Submission to FDA for ReNu® for Knee OA
AI Summary
Organogenesis Holdings Inc. announced the completion of its rolling Biologics License Application (BLA) submission to the FDA for ReNu®, a cryopreserved, amniotic suspension allograft for symptomatic knee osteoarthritis (OA). The submission included clinical and chemistry, manufacturing, and controls (CMC) modules, following the initiation of non-clinical modules in December 2025. This milestone represents a significant step in bringing a new regenerative therapy to patients suffering from knee OA, a condition affecting millions of Americans.
Key Highlights
- ORGO completed rolling BLA submission to FDA for ReNu
- ReNu is a cryopreserved, amniotic suspension allograft for symptomatic knee osteoarthritis (OA)
- Submission included clinical and chemistry, manufacturing, and controls (CMC) modules
- Knee OA affects an estimated 31.1 million Americans, projected to grow to 34.4 million by 2027
- ReNu previously received FDA RMAT designation for Knee OA in 2021
- ReNu was commercially available for approximately six years under Section 361 of the Public Health Service Act
Price Impact
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