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Biotech / Medical : ORTC Ortec International -- Ignore unavailable to you. Want to Upgrade?

To: Jake who wrote (36)	12/27/1997 7:15:00 PM
From: fut_trade	Respond to of 272

Ortec Granted European Patent; Ortec Continues to Expand Pivotal Clinical Trial of Burn Study PR Newswire - December 17, 1997 08:58 NEW YORK, Dec. 17 /PRNewswire/ -- Ortec announced today that it has been notified that its European patent application will be granted on December 29, 1997 and will be assigned patent number 0526550. In addition to the European Patent, Ortec previously was granted a U.S. patent for its CCS product in February of 1994. As a result of a challenge by one of Ortec's competitors, Ortec's patent was subjected to a re-examination procedure in the U.S. Patent Office. After a successful defense of the patent, Ortec's patent was reissued on December 10, 1996. Aside from United States and Europe, Ortec has been granted patents in the following countries; Israel, Australia, Taiwan and Thailand. Ortec is in the process of validating its patent in a number of European states as well as in South America and the Far East. In another development, Ortec announced today the approval by the FDA of New York Hospital Cornell Medical Center Burn Unit as a clinical site in Ortec's multi-center U.S. pivotal clinical trial of its Composite Cultured Skin (CCS). The addition of New York Hospital Cornell Medical Center Burn Unit brings the total number of centers currently involved in Ortec's trial of its CCS product for the treatment of severe burns to five. Commenting on the addition of New York Hospital Cornell Medical Center Burn Unit, Steven Katz, Ph.D., CEO of Ortec said, "We are very satisfied to have a premier burn center such as Cornell involved in our clinical trial and together with the other recent additions of quality burn centers Ortec will be able to increase patient enrollment and thereby adhere to our time line for the completion of the study." Ortec International is a biotechnology medical company focused on the development and commercialization of a propriety and patented biologically active wound dressing (CCS) to stimulate wound repair and regeneration of human tissues. CCS is a composite skin substitute consisting of a bioengineered bovine collagen matrix seeded with epidermal and dermal cells. CCS is currently in pivotal clinical trials for the treatment of severe burns and in pilot trials for the treatment of chronic dermal ulcers of Epidermolysis Bullosa (EB) patients. CCS may have wide commercial applications for the treatment of burns, skin ulcers and serious skin diseases, such as EB, as well as for reconstructive and cosmetic surgeries. Certain statements made in this press release which express the "belief", "anticipation" or "expectation", as well as other statements which are not historical fact, and statements relating to the clinical trials and their results, design, 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 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. SOURCE Ortec International Inc. /CONTACT: Ron Lipstein, CFO of Ortec International, 212-740-6999/