Organogenesis Holdings Inc. announced a favorable outcome from the interim analysis of its second Phase 3 randomized control trial for ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis. The analysis was conducted on 50% of the planned 474 patients with moderate to severe knee OA.
The independent Data Monitoring Committee (DMC) recommended that the trial proceed without modification and without an increase to the sample size. This recommendation indicates that the study is progressing as expected and is consistent with the statistical plan and efficacy assumptions.
Additionally, the DMC confirmed that the safety data observed in the trial is consistent with the known safety profile for ReNu. This positive interim analysis marks a critical milestone in the ReNu development program, which targets a significant unmet medical need affecting over 30 million Americans.
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