Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today reported the favorable outcome of the interim analysis of its Phase 3 clinical trial for the management of symptoms associated with knee osteoarthritis.
The pre-specified interim analysis on 50% of the 474 required patients with moderate to severe knee osteoarthritis (Kellgren-Lawrence [KL] severity grade 2 to grade 4) focused on the 6-month primary endpoint for potential sample size re-estimation. The Independent Data Monitoring Committee (DMC) for the trial provided directional guidance on the results of the interim analysis, while rigorously maintaining all aspects of study blinding. The DMC recommended that the trial proceed without modification and without increase to sample size. Additionally, the DMC found the safety data to be consistent with the known safety profile for ReNu.
https://finance.yahoo.com/news/organogenesis-reports-positive-interim-analysis-210100687.html
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