LA JOLLA, Calif., Feb. 21 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) announced today that it has received a letter from the U.S.
Food and Drug Administration (FDA), stating that the FDA has completed its
initial review of the Pre-Market Approval (PMA) application for Dermagraft(R)
in the treatment of diabetic foot ulcers, asking for clarification and
additional information. The Company is continuing to work interactively with
the FDA to provide the additional information requested.
As previously reported, the PMA containing data from the additional
controlled clinical trial of Dermagraft in the treatment of diabetic foot
ulcers, was submitted to the FDA in August 2000.
"We and our partner, Smith & Nephew, are pleased that the initial review
of our application has been completed, and we are continuing our ongoing
dialogue with FDA," said Gail K. Naughton, Ph.D., President, Advanced Tissue
Sciences.
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(R) 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 http://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. No assurances can be given that the Company will provide the
additional information and clarification requested by FDA or can obtain
regulatory approval in a reasonable timeframe, or at all, 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' Annual Report on Form 10-K for the year ended
December 31, 1999 and subsequent quarterly reports on Form 10-Q. 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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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, Inc., 858-713-7802
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