Advanced Tissue Sciences Announces PMA Submission For Dermagraft(R) in the Treatment of Diabetic Foot Ulcers
LA JOLLA, Calif., Aug. 25 /PRNewswire/ -- Advanced Tissue Sciences, Inc. (Nasdaq: ATIS) and Smith & Nephew plc (NYSE: SNN) reported that statistical significance was reached for the primary endpoint in their additional clinical trial of Dermagraft(R) for the treatment of diabetic foot ulcers and that a Pre-Market Approval (PMA) application has been submitted to the U.S. Food and Drug Administration (FDA). The data demonstrated that in difficult-to-heal chronic ulcers, with duration greater than six weeks at the time of screening, Dermagraft healed significantly more ulcers than the control treatment (p-value = 0.023). "We are pleased to report that statistical significance has been reached in this clinical trial," said Gail K. Naughton, Ph.D., President and Chief Operating Officer of Advanced Tissue Sciences, Inc. "In addition to data from this trial, positive feedback from clinicians using the product in international markets where it is commercially available continues to support our belief that Dermagraft will provide patients in the United States with an important alternative to current treatment options." Dermagraft was applied weekly until the ulcer healed, or up to a maximum of eight applications. In all other respects, Dermagraft patients and control patients received the same treatment. Data demonstrating statistical significance was based on an intent-to-treat analysis of patients with ulcer duration of greater than six weeks at the time of screening, as specified in the amended statistical plan. In the clinical trial, Dermagraft demonstrated significantly improved healing over conventional treatment. For the primary endpoint of complete wound closure by twelve weeks, 30% of patients treated with Dermagraft healed (39/130) compared to 18% of patients receiving control treatment (21/115). These results, from patients with difficult-to-heal ulcers, were achieved in a study designed to simulate a real world treatment environment as closely as possible. While investigators encouraged patients to stay off their feet as much as they could, the study allowed patients to be ambulatory during treatment. Secondary endpoint data demonstrated that Dermagraft patients also achieved complete wound closure significantly faster than control patients, and experienced a significantly higher percentage of wound closure by week twelve than control patients. Data from the clinical trial will be presented at an upcoming clinical symposium. "Diabetic foot ulcers represent a tremendously difficult medical problem for both patients and the health care system," said Jason R. Hanft, D.P.M., FACFAS, Director of the Diabetes Care Center Foot Clinic, South Miami Hospital. "The trial has demonstrated that Dermagraft can provide patients with chronic ulcers the opportunity for faster healing even in a real life setting where strict compliance with non-weight bearing regimens isn't always possible." Advanced Tissue Sciences is a tissue engineering company utilizing its proprietary core technology to develop and manufacture human-based tissue products for tissue repair and transplantation. The Company has two joint ventures with Smith & Nephew, plc. The first covers the application of Advanced Tissue Sciences' tissue engineering technology for skin wounds and includes Dermagraft for the treatment of diabetic foot ulcers, TransCyte(TM) for the temporary covering of second and third-degree burns, and future developments for venous ulcers, pressure ulcers, burns and other non-aesthetic wound care treatments. The second joint venture is developing tissue-engineered orthopedic cartilage, initially focusing on the repair of cartilage in knee joints. The Company also has a strategic alliance with Inamed Corporation for the development and marketing of several of Advanced Tissue Sciences' human-based, tissue-engineered products for aesthetic and certain reconstructive applications. In addition, the Company is developing products for cardiovascular applications. For more information on Advanced Tissue Sciences visit our web site at www.advancedtissue.com. Smith & Nephew is a global medical device company employing 10,000 people with operations in 36 countries and established sales in 90 countries. Smith & Nephew markets technically innovative products principally in the areas of orthopedics, endoscopy, and wound management to deliver cost effective solutions, significant physician advantages and real patient benefits. With the introduction early this year of the Collagenase enzymatic debriding product, Smith & Nephew is now ranked number one in the global wound management market. The discussions contained in this press release that are not strictly historical may be "forward-looking" statements which involve risks and uncertainties. The Company cannot predict with any certainty that the FDA will accept its PMA application filing, or that the FDA will ever approve any such application, or approve it on a timely basis. In addition, if approved, there can be no assurance that the Company can manufacture commercial quantities of Dermagraft at a reasonable cost, launch its products within indicated timeframes, successfully commercialize or significantly penetrate the market or that it will obtain adequate reimbursement for its products. These and other risks are detailed in publicly available filings with the Securities & Exchange Commission including but without limitation to Advanced Tissue Sciences' Quarterly Report on Form 10-Q for the quarter ended June 30, 2000. The Company undertakes no obligation to release publicly the results of any revision to these forward-looking statements to reflect events or circumstances arising after the date hereof.
SOURCE Advanced Tissue Sciences, Inc.
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