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ORTEC COMPLETES PATIENT ENROLLMENT IN DONOR SITE STUDY.


Ortec International, Inc. (Nasdaq:ORTC ORTC Old Republic Title Company
ORTC Operational Readiness Training Complex
), New York, has met its projected enrollment goals and completed enrollment in its pivotal donor site study. The preliminary results indicate that 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.  effectively accelerated wound closure in comparison to standard of care in the treatment of donor sites of burn patients. Allowing time for patient follow-up, Ortec expects to file a Pre-Market Approval Application (PMA PMA (papillary-marginal-attached),
n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation.

PMA Progressive muscular atrophy
) with the 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.
 during the fourth quarter of this year.

Commenting on the clinical trial, Steven Katz, Ph.D., CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Ortec said, "A preliminary evaluation of results of 62 of the 82 patients who have completed follow-up confirms our earlier findings that CCS heals wounds faster." Commenting further, Dr. Katz said, "The ability of CCS to accelerate wound closure of donor site burn patients may significantly shorten the length of hospital stays and decrease the incidence of infections for this patient population. In addition, it provides to the burn surgeon the ability to recrop CCS treated donor sites earlier than donor sites treated with standard of care, which is essential for the survival of critically ill burn patients."

Donor site wounds are created when healthy skin is taken from an undamaged part of the patient's body (autograft autograft: see transplantation, medical. ) and transplanted onto an existing wound site, thereby creating an additional wound at the donor site. Treatment of donor sites has particular application to burn victims and reconstructive surgery.

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 composite cultured skin Dermatology A skin substitute used to cover burn wounds and epidermolysis bullosa. See Artificial 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.

For more information, call 212/740-6999.
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Comment:ORTEC COMPLETES PATIENT ENROLLMENT IN DONOR SITE STUDY.
Publication:Biotech Business
Article Type:Brief Article
Geographic Code:1USA
Date:Jul 1, 2000
Words:308
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