Organogenesis Reports Positive Interim Analysis of Second Phase 3 Clinical Trial of ReNu for Knee Osteoarthritis [Yahoo! Finance]
Organogenesis Holdings Inc. - Class A (ORGO)
Last organogenesis holdings inc. - class a earnings: 3/9 04:05 pm
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Source: Yahoo! Finance
development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the favorable outcome of the interim analysis of its second Phase 3 randomized control trial of ReNu, a cryopreserved amniotic suspension allograft (ASA), for the management of symptoms associated with knee osteoarthritis (OA). The pre-specified interim analysis on 50% of the planned 474 patients with moderate to severe knee OA (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 pr
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ORGO
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- 11/12/24 - Beat
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- 12/19/24 - Form S-3
- 12/16/24 - Form 4
- 12/12/24 - Form 4
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