NEW YORK, Sept. 29 /PRNewswire-FirstCall/ -- Ortec International, Inc. , a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, has been notified by the Food and Drug Administration (FDA) that its HDE Supplement is approvable subject to an inspection by the FDA of its commercial manufacturing facility. In July 2006 Ortec submitted an HDE Supplement application requesting FDA approval to market cryopreserved OrCel(R), its lead product, for use in Epidermolysis Bullosa (EB) patients who suffer from Recessive Dystrophic Epidermolysis Bullosa (RDEB) undergoing hand reconstruction, a well as to cover donor sites (the area from where skins was removed from another part of the patient's body) created during the surgery. RDEB, the most severe form of Epidermolysis Bullosa (EB), is a devastating congenital skin disorder characterized by painful ulcerations and widespread, permanent scarring resulting in deformity of the hands and feet which require repeated surgeries and result in a need for replacement skin, such as OrCel(R).
This will be the first product approval Ortec will receive involving its cryopreserved (frozen) version of OrCel(R). Ortec has recently announced positive preliminary results of a Phase III confirmatory trial evaluating the use of cryopreserved OrCel(R) in the treatment of venous leg ulcers (VLU) and expects to submit during the 4th quarter of 2006 a Pre Market Approval (PMA) application seeking a second FDA approval for cryopreserved OrCel(R) for the VLU indication, a market projected to be in excess of $500 million in the United States.
OrCel(R) will be distributed by Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation . Cambrex Bio Science and Ortec previously signed a multi-year agreement for Cambrex to manufacture, market, and distribute OrCel(R) in the United States. Following FDA approval of its manufacturing facility, it is expected that Cambrex will begin marketing the product.
Ron Lipstein, Ortec's Vice Chairman and CEO, commenting on receiving the approvable letter from the FDA, said, "We are delighted that we can soon make this product available to this very needy patient population and that we have received our first approval for cryopreserved OrCel(R). We believe being able to manufacture and provide OrCel(R) as a frozen product provides us with the ability to make the product more readily and consistently available to physicians, reduces capital and facility costs, and minimizes logistical issues associated with the production and distribution of a non-frozen product."
An HDE is an FDA clearance that allows medical devices that provide safe treatment to be available in a prescribed manner for patients with rare medical conditions. An HDE application is similar in both form and content to a Pre-Market Approval (PMA) application, but approval can be granted by the FDA based on more limited clinical experience than that required for a PMA.
About Ortec International, Inc.
Ortec International, Inc. (OTCI) is a company focused on advancing regenerative medicine and stem cell therapy through the development and commercialization of innovative products by combining advanced cell technology and advanced biomaterials. Ortec's lead product is OrCel(R) (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a collagen sponge seeded with allogeneic epidermal and dermal 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.
A pivotal clinical trial evaluating a cryopreserved version of OrCel(R) in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Ortec has completed a confirmatory trial requested by the FDA, and the data from this trial are expected to be integrated with the results of the pivotal clinical trial and submitted as a clinical supplement to its PMA filing. Ortec has already obtained FDA approvals for use of a non-frozen version of OrCel(R) in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Ortec approval to initiate a pivotal (Phase III) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial technologies, Fibrin MB and Haptides(TM). Fibrin MB has the potential to play a significant role in advancing stem cell therapy having demonstrated the ability to efficiently recover adult stem cells and allow for their growth, differentiation, and potential reimplantation into the patient. Haptides(TM) utilize proprietary synthetic peptides that mimic the mechanism of cell attachment to fibrin. These peptides have demonstrated the ability to significantly enhance cell attraction and attachment providing the potential to use Haptides(TM) in the development of product opportunities applicable to the cosmetic tissue augmentation, wound healing, orthopedics, and drug delivery markets.
This news release may contain "forward-looking statements" for the purposes of the United States Securities and Exchange Commission's "safe harbor" provisions under the Private Securities Litigation Reform Act of 1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements regarding expected FDA approvals, clinical trial results, product performance, expectations with respect to sales, gross margins, research and development expenditures, earnings per share, capital expenditures, collaborations, or other expansion opportunities would be "forward-looking statements." These statements may be identified by words such as "expects", "anticipates", "intends", "estimates", "believes" or similar expressions in connection with any discussion of future financial and operating performance. The forward- looking statements contained herein involve risks and uncertainties that may cause results to differ materially from the Company's expectations including but not limited to, global economic trends, competitive pricing or product developments, government legislation and/or regulations, technology, manufacturing, legal and patent issues, suppliers, capital availability, personnel changes, cancellation or delays in renewal of contracts, and lack of suitable raw materials or packaging materials. Investors are cautioned to review risk factors in the Company's filings with the United States Securities and Exchange Commission.
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