A company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, Ortec International, Inc. (OTC: OTCI), announced the positive results of its preliminary review of the un-audited data of all the patients treated in its recently completed confirmatory trial which indicated that OrCel® healed more wounds and achieved 100% wound closure of those wounds sooner as compared to the control group.
OrCel® (Bilayered Cellular Matrix) is Ortec's lead product for the healing of chronic and acute wounds, composed of a collagen sponge seeded with allogeneic epidermal and dermal cells. These cells secrete growth factors and cytokines normally found in acute human wounds, believed to have a beneficial role in promoting tissue repair.
According to Ron Lipstein, Ortec's Vice Chairman and CEO:
"The data generated in this trial supports and confirms the positive results achieved by OrCel® in the Phase III trial we previously completed.
In addition, the trial results confirm OrCel®'s superiority over the standard of care in accelerating the healing of venous ulcers and appear to achieve the clinical and statistical thresholds required for FDA approval.
We look forward to compiling the final statistical data and submitting our Pre Market Approval (PMA) supplement application to the FDA, which is expected to occur during the 4th quarter."
The said trial, conducted in 12 sites across the United States, was a 12-week confirmatory trial that confirmed the superiority of cryopreserved OrCel® in the healing of difficult to heal venous leg ulcers in comparison to standard of care therapy.
Find more details from the press release.
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