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news.Biomaterial products developer Ortec International has filed the final safety and efficacy data required by the Food and Drug Administration to evaluate its pre-market approval application for the use of OrCel in the treatment of venous leg ulcers.
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Ortec had filed the chemistry, manufacturing and control (CMC) section of the current pre-market approval (PMA) earlier in the year. Ortec also previously developed a statistical plan with FDA for combining the data from its original PMA filing with the additional data from this confirmatory trial in order to effectively double the number of patients evaluated. The combined data show a significant improvement in wound healing in the OrCel-treated patients.
Costa Papastephanou, Ortec’s CEO, said: “We are delighted that the results met our expectations for the trial. We are confident that the combined results of the confirmatory trial and the earlier trial support the approval of OrCel, and we will be working with FDA to secure such approval as soon as possible.”