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Ortec's OrCel Use on Premature Infant with Skin Injury Featured in "Ostomy/Wound Management"; Peer-Reviewed Journal Reports Favorable Outcome On Use of OrCel.


Business Editors & Health/Medical Writers

BIOWIRE2K

NEW YORK--(BW HealthWire)--April 17, 2002

Ortec International (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 ORTC Old Republic Title Company
ORTC Operational Readiness Training Complex
) today announced that in a peer-reviewed article appearing in the April, 2002 journal, "Ostomy/Wound Management", OrCel(TM) is featured in a case study in repairing skin loss of a premature infant.

The article, "A Premature Infant with Skin Injury Successfully Treated with Bilayered Cellular Matrix", is authored by Rockne Stephens; Kenna Wilson, RN, BSN BSN
abbr.
Bachelor of Science in Nursing
; and Paul Silverstein, MD, all affiliated with the Paul Silverstein Burn Center, Integris Baptist Medical Center, Oklahoma City, Oklahoma “OKC” redirects here. For the airport, see Will Rogers World Airport.

Oklahoma City is the capital of the U.S. state of Oklahoma. The county seat of Oklahoma County, the city is the 30th largest city in the U.S.
. According to the published article, this case study represents the first report of a specific biologic dressing with viable cells being used to treat an isolated skin wound in a pre-term infant.

The 17-week premature newborn treated with OrCel suffered from a denuded left hip wound and a tear involving the right axilla axilla /ax·il·la/ (ak-sil´ah) pl. axil´lae   [L.] the armpit.ax´illary

ax·il·la
n. pl. ax·il·lae
See armpit.
. Closure of the wounds was essential to prevent the loss of heat, electrolytes, as well as to prevent infection. Without immediate closure of these wounds, the newborn was in danger of dying.

As described in the article, the treatment involved a single application of OrCel to a 2.0 c.m. x 1.5 c.m. hip wound. By day 4 post application, the wound was reduced to 1.0 c.m. x .5 c.m. and clean granulation tissue was present. The wound was completely healed 10 days later. No signs or symptoms of infection were evident during the follow-up period and no adverse events were recorded. The baby was released 3-l/2 months after birth and upon discharge the cosmetic outcome was evaluated. The OrCel treated area was fully epithelialized, some slight hypo-pigmentation was noted, and no scar tissue was evident. In addition, the article indicated that the attending clinicians felt that OrCel facilitated wound healing when compared to the healing times of similar lesions seen in the neonatal intensive care unit Noun 1. neonatal intensive care unit - an intensive care unit designed with special equipment to care for premature or seriously ill newborn
NICU

ICU, intensive care unit - a hospital unit staffed and equipped to provide intensive care
.

The patient involved in the procedure was treated with OrCel as a result of Dr. Paul Silverstein, Director of the Burn Center at Integris Baptist Medical Center, approaching Ortec requesting an emergency release of OrCel to treat this newborn. Dr. Silverstein had previous experience utilizing OrCel in clinical trials for the treatment of donor sites in burn patients and chronic venous stasis ulcers, and had been pleased with these results. Based on his observations of the performance of OrCel in the adult clinical trials, Dr. Silverstein believed OrCel offered this newborn the best chance to heal and survive these wounds.

Commenting on the novel application of OrCel, Steven Katz, Ph.D., Chairman and 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, "We are obviously pleased to have been able to help this infant. We would expect that as the greater medical community becomes more aware of OrCel's efficacy and versatility, we will see additional novel applications in acute and chronic wounds of the skin."

About Ortec International, Inc.

Ortec International, Inc., (NASDAQ:ORTC), 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) (Bilayered Cellular Matrix) to heal chronic and acute wounds. OrCel is composed of a collagen sponge seeded with allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik)
1. having cell types that are antigenically distinct.

2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically
 epidermal Epidermal
Referring to the thin outermost layer of the skin, itself made up of several layers, that covers and protects the underlying dermis (skin).

Mentioned in: Antiangiogenic Therapy, Histiocytosis X


epidermal
 and dermal dermal /der·mal/ (der´mal) pertaining to the dermis or to the skin.

der·mal or der·mic
adj.
Of or relating to the skin or dermis.
 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 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.
 approvals during 2001 for the treatment of 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.
 and donor sites in burn patients, Ortec is also pursuing FDA approvals for venous and diabetic skin ulcers and is in the midst Adv. 1. in the midst - the middle or central part or point; "in the midst of the forest"; "could he walk out in the midst of his piece?"
midmost
 of clinical trials for these indications. 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 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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No portion of this article can be reproduced without the express written permission from the copyright holder.
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Publication:Business Wire
Geographic Code:1USA
Date:Apr 17, 2002
Words:870
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