Advanced Tissue Sciences Announces PMA Submission For Dermagraft(R) in the Treatment of Diabetic Foot Ulcers

Aug 25, 2000, 01:00 ET from Advanced Tissue Sciences, Inc.

    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
     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
     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
     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.