Organogenesis achieves primary endpoint in Phase 3 trial of ReNu

Organogenesis Holdings announced that its Phase 3 randomized control trial evaluating the safety and efficacy of ReNu, a cryopreserved amniotic suspension allograft, ASA, for the management of symptoms associated with knee osteoarthritis achieved its primary endpoint upon the analysis of positive top line data. The study demonstrated a statistically significant reduction in knee OA pain at six months as assessed by the Western Ontario and McMaster Universities Arthritis Index pain scale compared with subjects treated with saline control. ReNu showed a favorable safety profile consistent with prior studies. “These top line results are a milestone achievement for Organogenesis,” said Gary Gillheeney, Sr., President and Chief Executive Officer of Organogenesis. “We look forward to sharing this compelling new evidence in our ongoing discussions with the FDA as we believe ReNu can provide clinically meaningful benefits where few non-surgical options exist. If approved, introducing Renu as an innovative pain management solution for the millions of patients suffering from knee OA represents a significant new addressable market opportunity for Organogenesis.”