Organogenesis provides update on second Phase 3 ReNu study

Organogenesis (ORGO) announced that the second Phase 3 randomized controlled trial of ReNu, a cryopreserved amniotic suspension allograft for the management of symptoms associated with knee osteoarthritis, did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial. Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study. Additionally, the ReNu results continued to demonstrate a favorable safety profile. The study demonstrated a numerical improvement of -0.51 favoring ReNu. The first Phase 3 trial achieved improvement of -0.72 favoring ReNu, which was statistically significant. Organogenesis believe these results support the potential approval of ReNu for pain symptoms associated with knee OA. As a next step, the company will request a pre-BLA meeting with the FDA by the end of October to discuss the submission pathway. Additionally, the FDA granted ReNu Regenerative Medicine Advanced Therapy designation based on ReNu demonstrating the potential to treat an unmet medical need related to a serious condition.