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rtec International, Inc. announced that a preliminary review of the first thirteen patients completing its pivotal venous leg ulcer trial using its frozen (cryopreserved) form of OrCel™ indicated that 69.2 percent (9/13) patients achieved 100-percent wound closure in 12 weeks.
       Moreover, all of the four patients who had not achieved 100-percent wound closure within 12 weeks achieved at least 90-percent wound closure. The data also showed that no clinically relevant immune responses were evident in any of the patients treated with the frozen product.
       The primary purpose of treating these initial patients was to assess whether there would be any negative reactions to treatment with a cryopreserved version of OrCel. Accordingly, these patients were not compared to control group. The patients were treated at 5 of the 35 clinical centers that are expected to be involved in the venous leg ulcer trial. The median wound size of these patients treated was 3.54cm2. All patients were screened to have hard-to-heal wounds. Patients were treated with a single application of OrCel per week, for up to four weeks.
       For more information, visit www.ortecinternational.com.