Ortec International, Inc.(OTC Bulletin Board: ORTN), a company focused on development andcommercialization of products applicable to regenerative medicine and stemcell therapy, today announced that as a result of ongoing discussions withthe Food and Drug Administration (FDA), Ortec expects to file an HDEsupplement to obtain marketing approval for use of OrCel(R) in RDEBpatients by mid-July 2006. In February 2001, the FDA previously grantedOrtec an HDE for this indication to market the non-frozen version ofOrCel(R).

The FDA has advised Ortec that it could approve, without the need foradditional clinical data, an HDE supplement allowing for the use ofcryopreserved OrCel(R) in patients with Recessive Dystrophic EpidermolysisBullosa (RDEB) undergoing hand reconstruction as well as to cover donorsites created during the surgery (the area where skin was removed fromanother part of the patient's body).

RDEB, the most severe form of Epidermolysis Bullosa (EB), is adevastating congenital skin disorder characterized by painful ulcerationsand widespread, permanent scarring resulting in deformity of the hands andfeet. As a result, many RDEB patients require surgeries to allow greateruse of their extremities resulting in a need for replacement skin.

An HDE is a FDA clearance that allows medical devices that provide safetreatment to be available in a prescribed manner for patients with raremedical conditions that affect fewer than 4,000 individuals in the U.S. peryear. An HDE application is similar in both form and content to aPre-Market Approval (PMA) application, but approval can be granted by theFDA based on more limited clinical experience than that required for a PMA.

Ortec International, Inc. (ORTN) is a company focused on advancingregenerative medicine and stem cell therapy through the development andcommercialization of innovative products by combining advanced celltechnology and advanced biomaterials. Ortec's lead product is OrCel(R)(Bilayered Cellular Matrix). Ortec's current focus is the application ofOrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of acollagen sponge seeded with allogeneic epidermal and dermal cells. Thesecells secrete growth factors and cytokines normally found in acute humanwounds and are believed to have a beneficial role in promoting tissuerepair.

A pivotal clinical trial evaluating a cryopreserved version of OrCel(R)in the treatment of venous leg ulcers has been completed and a Pre-MarketApproval (PMA) application has been filed. Ortec has recently completedpatient enrollment in a confirmatory trial and the data from this trial areexpected to be integrated with the results of the pivotal clinical trialand submitted as a clinical supplement to its PMA filing. Ortec has alreadyobtained FDA approvals for use of a non-frozen version of OrCel(R) in thetreatment of Epidermolysis Bullosa and donor sites in burn patients. Inaddition, the FDA has granted Ortec approval to initiate a pivotal (PhaseIII) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.

Ortec recently acquired two fibrin derived advanced biomaterialtechnologies, Fibrin Microbeads (FMB) and Haptides(TM). FMB have thepotential to play a significant role in advancing stem cell therapy havingdemonstrated the ability to efficiently recover adult stem cells and allowfor their growth, proliferation, and potential reimplantation into thepatient. Haptides(TM) utilize proprietary synthetic peptides that mimic themechanism of cell attachment to fibrin. These peptides have demonstratedthe ability to significantly enhance cell attraction and attachmentproviding the potential to use Haptides(TM) in the development of productopportunities applicable to the cosmetic tissue augmentation, woundhealing, orthopedics, and drug delivery markets.

This news release may contain "forward-looking statements" for thepurposes of the United States Securities and Exchange Commission's "safeharbor" provisions under the Private Securities Litigation Reform Act of1995 and Rule 3B-6 under The Exchange Act. Without limitation, statementsregarding expected FDA approvals, clinical trial results, productperformance, expectations with respect to sales, gross margins, researchand development expenditures, earnings per share, capital expenditures,collaborations, or other expansion opportunities would be "forward-lookingstatements." These statements may be identified by words such as "expects,""anticipates," "intends," "estimates," "believes" or similar expressions inconnection with any discussion of future financial and operatingperformance. The forward- looking statements contained herein involve risksand uncertainties that may cause results to differ materially from theCompany's expectations including but not limited to, global economictrends, competitive pricing or product developments, government legislationand/or regulations, technology, manufacturing, legal and patent issues,suppliers, capital availability, personnel changes, cancellation or delaysin renewal of contracts, and lack of suitable raw materials or packagingmaterials. Investors are cautioned to review risk factors in the Company'sfilings with the United States Securities and Exchange Commission.

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