Healthcare Industry News: Venous Leg Ulcer
News Release - February 26, 2007
Ortec Initiates Premarket Approval (PMA) Application Filing Seeking Approval for OrCel(R) in Treating Venous Leg UlcersNEW YORK, NY--(Healthcare Sales & Marketing Network)--Feb 26, 2007 -- Ortec International, Inc. (OTC BB:OTCI.OB ), a company focused on advancing regenerative medicine through the development of cellular technology and advanced biomaterial products, announced today that it has initiated the filing of its Pre Market Approval (PMA) supplement application requesting permission from the Food and Drug Administration (FDA) to market its tissue engineered product, OrCelŪ, for the treatment of Venous Leg Ulcers, an estimated $500 million market in the U.S. by submitting to the FDA the Manufacturing and Controls (CMC) section, the first of two modules of the application. The final section of the application, which will include a summary of safety and effectiveness in the clinical studies and device labeling, is expected to be filed with the FDA in the second quarter. These filings will be amendments to our PMA application filed in February 2004.
In September 2006, Ortec announced that a preliminary review of the un-audited data of all the patients treated in a 12-week confirmatory trial indicated OrCelŪ healed more wounds and achieved 100% wound closure of those wounds sooner in comparison to the control group, and that statistical significance was achieved for the primary clinical endpoints of incidence of patients achieving 100% wound closure as well as acceleration of wound closure. These statistically significant differentials in favor of the OrCelŪ treated patients were evident 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). Upon the completion of the closeout of the three remaining clinical centers required by the clinical protocol, the unaudited data collected will be finalized and analyzed culminating in the submission of that data to the FDA.
Ron Lipstein, Chief Executive Officer and Vice Chairman of Ortec International, commenting on the initiation of the filing of the PMA said, "The initiation of the PMA process is a significant milestone for Ortec and begins the process towards gaining access to the Venous Leg Ulcer market, a very sizeable population with unmet needs. We look forward to finalizing the positive data generated in the confirmatory trial, preparing the clinical section of the PMA, and submitting it to the FDA."
About Ortec International, Inc.
Ortec International, Inc. (OTC BB:OTCI.OB ) 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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