Healthcare Industry News: diabetic foot ulcers
News Release - September 12, 2006
Ortec Announces Positive Results in Confirmatory Venous Leg Ulcer TrialPre Market Approval Supplement Application Expected to be Filed with FDA During 4th Quarter
NEW YORK, Sept. 12 (HSMN NewsFeed) -- Ortec International, Inc. (OTC Bulletin Board: OTCI ), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that a preliminary review of the un- audited data of all the patients treated in its recently completed confirmatory trial indicates OrCelŪ healed more wounds and achieved 100% wound closure of those wounds sooner in comparison to the control group. Statistical significance was achieved for the primary clinical endpoints of incidence of patients achieving 100% wound closure as well as acceleration of wound closure with the OrCelŪ-treated patients as early as the third week and was maintained from week five through week eleven using the statistical approach required and approved by the Food and Drug Administration (FDA).
Ron Lipstein, Ortec's Vice Chairman and CEO, commenting on the results, said, "The data generated in this trial supports and confirms the positive results achieved by OrCelŪ in the Phase III trial we previously completed. In addition, the trial results confirm OrCel's superiority over the standard of care in accelerating the healing of venous ulcers and appear to achieve the clinical and statistical thresholds required for FDA approval. We look forward to compiling the final statistical data and submitting our Pre Market Approval (PMA) supplement application to the FDA, which is expected to occur during the 4th quarter."
The 12-week confirmatory trial, which was recently completed, was designed to confirm the superiority of cryopreserved OrCel in the healing of difficult to heal venous leg ulcers in comparison to standard of care therapy. The trial was conducted in 12 clinical centers located throughout the United States.
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 OrCelŪ (Bilayered Cellular Matrix). Ortec's current focus is the application of OrCelŪ to heal chronic and acute wounds. OrCelŪ 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 OrCelŪ 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 OrCelŪ 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 OrCelŪ 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.
Source: Ortec International
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