Ortec Initiates Premarket Approval -PMA- Application Filing Seeking Approval for OrCel in Treating Venous Leg Ulcers.
NEW YORK--(BUSINESS WIRE)--Dec. 23, 2003
Approval Would Open U.S. Market Potential Estimated in Excess of $500
Ortec International, Inc. (ORTN) announced today that it has initiated the filing of its Premarket Approval (PMA) application requesting permission from the Food and Drug Administration (FDA) to market its tissue engineered product, OrCel(R), for the treatment of venous leg ulcers, an estimated $500 million market in the U.S. Ortec submitted today the Manufacturing and Controls (CMC) section, the first of two modules of the application. The final section of the PMA, which will include a summary of safety and effectiveness in the clinical studies and device labeling, is expected to be filed with the FDA at the end of January 2004.
Ortec recently announced that in agreement with the FDA to expedite the review process, it is filing its PMA on a modular basis, wherein each section of the PMA is filed with the FDA as it is completed.
Ortec previously announced that in an analysis of the data from its Phase III clinical trial evaluating the cryopreserved version of OrCel in the treatment of chronic hard to heal venous leg ulcers, OrCel demonstrated a 64% improvement over standard of care and achieved statistically significant differentials for both the primary and secondary endpoints of the trial, time to 100% healing and the percentage of patients achieving 100% wound closure.
Ron Lipstein, Chief Executive Officer and Vice Chairman of Ortec International, commenting on the initiation of the filing of the PMA said, "The initiation of the PMA process is an achievement of a very significant milestone for Ortec towards gaining access to the venous leg ulcer market, a very sizeable population with unmet needs. Over the last few months, Ortec has accomplished a number of very critical value enhancing milestones including executing a commercial manufacturing agreement with Cambrex (NYSE: CBM), completion of our Phase III clinical trial for venous leg ulcers, and now filing our PMA for that indication. Looking forward to 2004, we expect to continue to successfully implement our business plan, gain approval from the FDA to market OrCel for venous leg ulcers, initiate commercial sales of OrCel for that market, and initiate a Phase III clinical trial for the use of OrCel in diabetic foot ulcers."
About Ortec International, Inc.
Ortec International, Inc., (ORTN), 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(R) (Bilayered Cellular Matrix) to heal chronic and acute wounds. OrCel is 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 and are believed to have a beneficial role in promoting tissue repair. In addition to having received FDA approvals for the treatment of Epidermolysis Bullosa and donor sites in burn patients, a pivotal clinical trial has been completed for venous ulcers and the FDA has granted Ortec approval to initiate a pivotal trial in diabetic foot ulcers. 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. For more information, visit Ortec's website at http://www.ortecinternational.com.
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.
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|Date:||Dec 23, 2003|
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