LA JOLLA, Calif., Dec. 4 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and Smith & Nephew plc announced today that Advanced Tissue
Sciences has been notified by the U.S. Food and Drug Administration (FDA)
that Dermagraft has been tentatively placed on the January 29, 1998 agenda for
review by the General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee currently scheduled to be held on January 29 and 30, 1998.
As previously announced, the Premarket Approval (PMA) application for
Dermagraft is being reviewed by the FDA under its expedited review process.
FDA panel review is customary for products utilizing novel technology such as
Dermagraft. Dermagraft is a bioengineered, living, human dermal tissue for
the treatment of diabetic foot ulcers.
Advanced Tissue Sciences and Smith & Nephew are pursuing the worldwide
commercialization of Dermagraft for the treatment of diabetic foot ulcers
through a fifty-fifty joint venture.
Advanced Tissue Sciences, Inc. is a tissue engineering company utilizing
its proprietary core technology to develop and manufacture human tissue
products for tissue repair and transplantation. In addition to developing
Dermagraft, the Company is currently marketing Dermagraft-TC(TM), a temporary
covering for severe and partial-thickness burns, under approval from the FDA.
The Company also is developing products for cartilage and cardiovascular
applications.
Smith & Nephew, a leading worldwide healthcare company with more than
$1.5 billion in annual sales, has 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 has extensive
marketing and distribution capabilities and sales in more than 90 countries.
The discussion contained in this press release relating to approval and
commercialization of the Company's products, market opportunities and
therapeutic benefits involves risks and uncertainties. No assurance can be
given that the Company will successfully obtain Food and Drug Administration
or other regulatory approvals of Dermagraft (or that any such approvals will
be obtained on a timely basis), scale up manufacturing processes, launch its
products within indicated timeframes, or successfully commercialize any such
products. These and other risks are detailed in the Company's publicly
available filings with the Securities and Exchange Commission including the
Company's Annual Report on Form 10-K for the year ended December 31, 1996.
Actual results may differ materially from those currently anticipated as a
result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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CONTACT: Beth A. Kriegel, Director of Investor Relations for Advanced Tissue Sciences, Inc., 619-450-5802
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