FDA Advisory Panel Unanimously Recommends Approval of Ortec's Tissue Engineered Prodcut, OrCel for Treatment of Donor Site Wounds in Burn Victims
If approved, OrCelÂ will be the second product of this kind to market, after Organogenesis' Apligraf product. Ortec believes OrCelÂ has three major advantages over Apligraf. First is distribution, Ortec is the only company in its field with the ability to cryopreserve its products. This will increase Ortec's ability to penetrate the market, reduce overhead and manufacturing costs for the company and competitively compete price wise. Ortec's product is much easier to use, without complicated preparation and application procedures. Thirdly, Ortec's technology demonstrated superior clinical results in reports submitted to the FDA earlier this year.
(PRWEB) July 26, 2001
New York, NY - (BUSINESSWIRE) - July 17th, 2001 - Ortec International, Inc. (NASDAQ: ORTC) announced today that The General and Plastic Surgery Devices Advisory Panel of the U. S. Food and Drug Administration (FDA) unanimously recommended approval of OrtecÂs substitute engineered skin, OrCelÃ, for use in treatment of donor site wounds in burn victims. The panel recommended further histology characterizations and label clarifications for specific use with in certain patient populations.
In March of this year, Ortec filed a Pre-Market Approval (PMA) application with the FDA requesting permission to market its product for the treatment of donor site wounds in burn patients. On April 4th, 2001, the FDA notified Ortec that its PMA application was accepted. On May 14th, 2001, the FDA notified Ortec that its product was placed on the agenda for review by the General and Plastic Surgery Devices Panel.
Commenting on the panel's recommendation, Steven Katz, Ph. D. Chairman and CEO said, "This is clearly an achievement of a significant milestone for Ortec. We are obviously pleased by the panel's favorable recommendation and look forward to working with the FDA towards obtaining a final marketing approval and making our product commercially available for this significant medical need."
John Griswald, M. D., F. A.C. S., Peter Canizarrow Professor of Surgery, Medical Director Burn Center, Texas Tech University Health Sciences Center, one of the clinical investigators who participated in the donor site trial, presented to the panel the clinical need for new technologies to treatment donors site wounds and his experience with OrCelÃ. Commenting on his experience Griswald said, OrCelÃ, represents a significant advance in the treatment of donor site wounds in burn patients, and I am looking forward to the FDA approval of OrCelÃ and its availability for use on burn victims.
Over 1.25 million people are treated annually for burns at medical facilities across the U. S. Donor site wounds, a market estimated to be in excess of $1 million, are wounds created where skin is taken from an uninjured part of the body to cover a burned area on another part of the body.
In addition to the donor site indication, Ortec is pursuing the application of its product to other medical indications estimated to be in excess of $1 billion. Ortec recently received FDA approval under a Humanitarian Device Exemption for hand reconstruction and donor sites created in this procedure for victims of Epidermolysis Bullosa. In addition, Ortec is pursuing FDA approvals for venous and diabetic skin ulcers and is in the midst of clinical trials for those indications.
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. OrtecÂs 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. Ortec recently received FDA approval under a Humanitarian Device Exemption for hand reconstruction and donor sites created in this procedure for victims of Epidermolysis Bullosa. Ortec is also pursuing FDA approvals for venous and diabetic skin ulcers and is in the midst of clinical trials for those indications.
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 Reform Act of 1995 and involve risks and uncertainties. The CompanyÂs 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 CompanyÂs competitors of new technologies or products that are more effective than the CompanyÂs, 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 CompanyÂs products, availability of product liability insurance in the event of commercialization of the CompanyÂs 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 CompanyÂs products, if and when commercially available.
FOR MORE INFORMATION, PLEASE CONTACT:
Ron Lipstein, CFO At Ortec International, Inc. (212) 740-6999, ext. 204
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