Ortec's Tissue-Engineered Product Featured in JAMA.Business Editors & Health/Medical Writers BIOWIRE2K NEW YORK--(BW HealthWire)--April 6, 2001 Ortec International, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ORTC) announced today that the recent approval of its Composite Cultured Skin composite cultured skin Dermatology A skin substitute used to cover burn wounds and epidermolysis bullosa. See Artificial skin. (CCS (1) (Common Channel Signaling) A communications system in which one channel is used for signaling and different channels are used for voice/data transmission. Signaling System 7 (SS7) is a CCS system, also known as CCS7. See SS7. ) product by the Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) was featured in the April 4th, 2001 edition of the Journal of American Medical Association American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science. (JAMA JAMA abbr. Journal of the American Medical Association ) (Volume 285, No. 13). The approval was for use of CCS for patients with Recessive Dystrophic dystrophic pertaining to or emanating from dystrophia. dystrophic calcification mineralization of soft tissues can occur in hyperadrenocorticism, vitamin d toxicity, and hypervitaminosis A. See also calcification. Epidermolysis Bullosa Epidermolysis Bullosa Definition Epidermolysis bullosa (EB) is a group of rare inherited skin diseases that are characterized by the development of blisters following minimal pressure to the skin. (RDEB) undergoing hand reconstruction, as well as to cover donor sites (the area from where skin was removed from another part of the patient's body created during the surgery). The article, authored by Bernard A. Schwetz, Ph.D., Acting Principal Deputy Commissioner of the FDA, highlights CCS' approval, the product's description, and the clinical experience to date using CCS on Epidermolysis Bullosa (EB) patients. RDEB, the most severe form of Epidermolysis Bullosa, is a devastating congenital skin disorder characterized by painful ulcerations Ulcerations Breaks in skin or mucous membranes that are often accompanied by loss of tissue on the surface. Mentioned in: Hypersplenism and widespread, permanent scarring resulting in deformity of the hands and feet. As a result, many RDEB patients require surgeries to allow greater use of their extremities resulting in a need for replacement skin. As previously announced, Ortec expects that the product will be available through designated regional centers with expertise in treating EB patients. It is expected that these centers will be able to treat EB patients within three months. In addition, Ortec's product will be introduced to the wound care clinical community at the upcoming Annual Symposium on Advanced Wound Care and Medical Research Forum on Wound Repair, April 30th - May 3rd, 2001 in Las Vegas, Nevada. 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 Composite Cultured Skin (CCS) product to heal chronic and acute wounds. Ortec believes that its platform technology may extend to the development 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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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