Business Editors & Health/Medical Writers BIOWIRE2K
NEW YORK--(BUSINESS WIRE)--Aug. 30, 2002--Ortec International, Inc. announced today that NASDAQ has denied Ortec's appeal for continued inclusion on the NASDAQ Small CAP Market. Ortec was advised last evening after the close of the Market, that effective with the open of business on August 30, Nasdaq will delist the Company's securities from the NASDAQ Stock Market. Accordingly, Ortec securities will begin to trade on the OTC Bulletin Board. Steven Katz, Ph.D., Chairman and CEO, said, "Nasdaq's denial of our appeal necessitating our transferring to the OTC Bulletin Board does not impact our ability to execute our business plan and near term milestones. We will continue on the path of completing our venous pivotal clinical trial this year and filing of our Pre-Market Approval (PMA) application in the 1st quarter of 2003 and the consummation of a corporate partner deal."
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) (Bi-layered Cellular Matrix) to heal chronic and acute wounds. Ortec 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 during 2001 for the treatment of Epidermolysis Bullosa and donor sites in burn patients, a pivotal clinical trial is ongoing in 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 http://www.ortecinternational.com
Certain statements made in this news release that express the belief, potential anticipation or expectations, 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 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 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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CONTACT: Ortec International, Inc. Ron Lipstein, 212/740-6999, ext. 204
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