NEW YORK, May 30 /PRNewswire-FirstCall/ -- Ortec International, Inc. , a company focused on development and commercialization of products applicable to regenerative medicine and stem cell therapy, today announced that as a result of ongoing discussions with the Food and Drug Administration (FDA), Ortec expects to file an HDE supplement to obtain marketing approval for use of OrCel(R) in RDEB patients by mid-July 2006. In February 2001, the FDA previously granted Ortec an HDE for this indication to market the non-frozen version of OrCel(R).
The FDA has advised Ortec that it could approve, without the need for additional clinical data, an HDE supplement allowing for the use of cryopreserved OrCel(R) in patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB) undergoing hand reconstruction as well as to cover donor sites created during the surgery (the area where skin was removed from another part of the patient's body).
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. As a result, many RDEB patients require surgeries to allow greater use of their extremities resulting in a need for replacement skin.
An HDE is a FDA clearance that allows medical devices that provide safe treatment to be available in a prescribed manner for patients with rare medical conditions that affect fewer than 4,000 individuals in the U.S. per year. 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. (ORTN) 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 recently completed patient enrollment in a confirmatory trial 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 Microbeads (FMB) and Haptides(TM). FMB have 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, proliferation, 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.
For more information, visit Ortec's website at http://www.ortecinternational.com .
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.
FOR MORE INFORMATION, PLEASE CONTACT Elite Financial Communications Group, LLC Dodi Handy, 407-585-1080 or via email at ortn@efcg.net
Ortec International, Inc.CONTACT: Dodi Handy, Elite Financial Communications Group, LLC,+1-407-585-1080, or ortn@efcg.net, for Ortec International
Web site: http://www.ortecinternational.com/
