Advanced Tissue Sciences Provides Dermagraft Clinical Update

Dec 21, 1999, 00:00 ET from Advanced Tissue Sciences, Inc.

    LA JOLLA, Calif., Dec., 21 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
 (Nasdaq:   ATIS) and Smith & Nephew plc (NYSE:   SNN) today announced the results
 of a planned interim analysis of data from a clinical trial of Dermagraft(R)
 in the treatment of diabetic foot ulcers.  These data showed that, although
 statistical significance was not achieved at the interim analysis, Dermagraft
 was healing more ulcers than the control treatment at twelve weeks for all
 patients and healed approximately twice as many ulcers as the control
 treatment in diabetic foot ulcers having a duration of greater than six weeks.
 The interim analysis has been presented to the Food and Drug Administration
 (FDA) and further discussions are planned, particularly on how a strong
 interaction between ulcer duration and healing (p value = 0.017) should be
 considered in the clinical trial.  These interim data are based on an
 intent-to-treat analysis.
     Specifically, the results for the endpoint of complete healing at twelve
 weeks were as follows:
      Complete             Interim                   Interim
     Healing at        Intent-to-Treat          Intent-to-Treat
      12 weeks            Dermagraft                 Control
                        %            N            %           N       p-value
     with ulcers
     > 6 weeks*        28%        20/72          14%        10/71       0.035
     All Patients      30%        27/90          23%        21/92       0.176
     *  At time of screening; minimum ulcer duration >8 weeks at time of
 treatment initiation.
     Gail K. Naughton, Ph.D., President and Chief Operating Officer, stated,
 "We are particularly encouraged that Dermagraft healed twice as many ulcers as
 the control group for patients with ulcers greater than six weeks duration,
 and four times as many ulcers as the control group for patients with ulcers
 approximately six months in duration.  We believe this trial has included a
 more difficult-to-heal patient population than in our previous diabetic foot
 ulcer studies as evidenced by the low number of healed ulcers in the control
     As previously reported, the FDA had requested an additional controlled
 clinical trial be completed for Dermagraft in the treatment of diabetic foot
 ulcers.  In January 1998, an FDA advisory panel in support of an earlier
 Pre-Market Approval (PMA) application, recommended approval of Dermagraft with
 the conditions that the Company perform a post-marketing study to confirm
 efficacy and provide physician training.  The FDA subsequently concluded that
 the PMA application was not approvable without supportive data from an
 additional clinical trial.
     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.  The first covers the application of Advanced
 Tissue Sciences' tissue engineering technology for skin wounds and includes
 Dermagraft(R) 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.
     Smith & Nephew is a leading worldwide medical device company with a highly
 successful track record in developing, manufacturing and marketing a wide
 variety of innovative and technologically advanced tissue repair products,
 primarily in the areas of bone, joints, skin and other soft tissue.  Smith &
 Nephew have extensive marketing and distribution capabilities, with an
 established sales force in more than 90 countries.
     The discussions contained in this press release that are not strictly
 historical may be "forward-looking" statements which involve risks and
 uncertainties.  The statistical results reported in this release are based on
 an interim data analysis of a controlled clinical trial.  These results are
 not necessarily indicative of the results which might be obtained following
 completion of the full trial.  Further, the Company cannot predict with any
 certainty potential outcomes of its discussions with the FDA which could
 include limiting subsequent enrollment to patients with ulcer duration in
 excess of six or more weeks upon entering the screening period, increasing the
 total number of patients to be enrolled, or analysis of data from this trial
 in conjunction with data from previous clinical trials of Dermagraft in
 diabetic foot ulcers, among others.  No assurances can be given that the
 statistical results reported in this release will not be modified, the Company
 will successfully complete this additional controlled clinical trial of
 Dermagraft in the treatment of diabetic foot ulcers, the clinical trial will
 be completed within any specific timeframe, the data from the trial will be
 statistically significant or otherwise consistent with the results of the
 Company's earlier clinical trials or that the Company will obtain FDA approval
 (or that such approval will be obtained on a timely basis).  In addition,
 there can be no assurance that the Company can manufacture commercial
 quantities of Dermagraft at a reasonable cost, launch its products within
 indicated timeframes, or successfully commercialize or significantly penetrate
 the market for any of its products.  These and other risks are detailed in the
 Company's publicly available filings with the Securities & Exchange Commission
 such as Advanced Tissue Sciences' Annual Report on Form 10-K for the year
 ended December 31, 1998 and its most recent Registration Statement on Form S-3
 filed on July 12, 1999, as amended.  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.