Clinical Trials

Ortec announces positive results in confirmatory venous leg ulcer trial

Published in Medical Letter on the CDC and FDA, October 15th, 2006

Ortec International, Inc. (OTCI) announced that a preliminary review of the un-audited data of all the patients treated in its recently completed confirmatory trial indicates OrCel healed more wounds and achieved 100% wound closure of those wounds sooner in comparison to the control group.

Statistical significance was achieved for the primary clinical endpoints of incidence of patients achieving 100% wound closure as well as acceleration of wound closure with the OrCel-treated patients as early as the third week and was maintained from week five through week eleven using the statistical approach required and approved by the U.S. Food and Drug Administration...

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Source: Medical Letter on the CDC and FDA (2006-10-15)

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