LA JOLLA, Calif., July 26 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and Smith & Nephew plc (NYSE: SNN) today announced that
enrollment in the pivotal clinical trial of Dermagraft(R) for the treatment of
hard-to-heal diabetic foot ulcers has been completed, and the Company
currently expects to submit its Pre-Market Approval (PMA) application to the
Food and Drug Administration (FDA) by the end of the summer.
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 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 global medical device company employing 12,000 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. No assurances can be given that the Company will obtain FDA
approval, if any, 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, without limitation, Advanced
Tissue Sciences' Quarterly Report on Form 10-Q for the quarter ended
March 31, 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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Related links:
http://www.advancedtissue.com
Company News On-Call:
http://www.prnewswire.com/comp/532975.html or fax,
800-758-5804, ext. 532975
CONTACT:
Jana Stoudemire, Senior Director, Corporate
Communications of Advanced Tissue Sciences, 858-713-7802
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