Organogenesis Reports Positive Phase 3 Clinical Trial Data for ReNu

DENVER, Colo., May 02, 2024 ( Organogenesis Holdings Inc. (Nasdaq:ORGO) reported that its Phase 3 randomized control trial evaluating the safety and efficacy of ReNu, for the management of symptoms associated with knee osteoarthritis (OA) achieved its primary endpoint upon the analysis of positive top line data, by demonstrating 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, while showing a favorable safety profile consistent with prior studies.

“These top line results are a milestone achievement for Organogenesis,” commented Gary S. 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.”

“To date, non-surgical treatment options for severe OA patients (KL 4) are limited—which represented approximately 30% of the enrolled patient population for this study,” stated Adam B. Yanke, MD, PhD, Associate Professor of Orthopedics at Rush University Medical Center, a sports medicine and orthopedic surgeon and Co-Principal Investigator. “These topline results provide statistically significant evidence that the use of ReNu is a safe, effective treatment option for knee OA patients, if approved.”

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