Ortec's Preliminary Data Using Frozen Form of OrCel in Venous Leg Ulcers Demonstrates 69% of Patients Achieved 100% Wound Closure in 12 Weeks
NEW YORK -- Ortec International, Inc.(NASDAQ:ORTC) announced that a preliminary review of the first thirteen patients completing its pivotal venous leg ulcer trial using its frozen (cryopreserved) form of OrCel(TM) indicated that 69.2% (9/13) patients achieved 100% wound closure in 12 weeks.
Moreover, all of the four patients who had not achieved 100% wound closure within 12 weeks achieved at least 90% wound closure. The data also showed that no clinically relevant immune responses were evident in any of the patients treated with the frozen product.
Commenting on these results, Steven Katz, Ph.D., Chairman and CEO said: "We are quite excited about the preliminary data that has been generated using the cryopreserved version of OrCel(TM). While we always believed that the cryo form would in fact out perform the impressive results we generated in our pilot trial with the fresh version, it is quite significant that we have generated this preliminary data that appears to substantiate that belief. We look forward to the completion of the pivotal trial since we believe that the launch of the frozen version of OrCel(TM) will be another significant marketing advantage in penetrating the venous leg ulcer market".
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(TM). 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 3.54 cm2. All patients were screened to have hard-to-heal wounds. Patients were treated with a single application of OrCel(TM) per week, for up to four weeks.
About Ortec International, Inc.
Ortec International, Inc. is a tissue-engineering company involved in the commercialization of a proprietary and patented technology to stimulate the repair and regeneration of human tissue. Ortec's current focus is the application of its OrCel(TM) to heal chronic and acute wounds. Ortec believes that its platform technology may extend to the regeneration of other human tissue, such as tendons, ligaments, cartilage, bone, muscle and blood vessels.
Certain statements made in this news release that express the belief, potential anticipation or expectation, as well as other statements which are not historical fact, and statements relating to the clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance insofar as they may apply prospectively, are "forward looking" statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties. The Company's actual results may differ significantly from the results discussed in this news release or in other "forward looking" statements presented by management. Factors that might cause such a difference include, but are not limited to, development by the Company's competitors of new technologies or products that are more effective than the Company's, risks of failure of clinical trials, dependence on and retention of key personnel, protection of proprietary technology, compliance with U.S. Food and Drug Administration regulations, continued availability of raw material for the Company's products, availability of product liability insurance in the event of commercialization of the Company's products, ability to effect transition from pilot-scale manufacturing to large-scale commercial production of products, uncertainty as to the availability of additional capital on acceptable terms, if at all, and the demand for the Company's products, if and when commercially available.