LA JOLLA, Calif., Oct. 20 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) announced today that the U.S. Food and Drug Administration
(FDA) has approved Dermagraft-TC for marketing as a temporary wound covering
for partial-thickness burns. Dermagraft-TC was first approved for marketing
in March 1997 as a temporary wound covering for severe burns. Approximately
1,500 people are severely burned each year and require extensive skin grafting
while 30,000 to 40,000 patients each year seek medical treatment for partial-
thickness burns. As a result, the potential market for Dermagraft-TC is
substantially expanded.
Dermagraft-TC is the first human, fibroblast-derived temporary skin
substitute for the treatment of partial-thickness burns that has been approved
for marketing by the FDA. Partial-thickness burns, or second degree burns,
are those in which there is damage to the epidermis (the upper layer of the
skin) and the upper portion of the dermis (the lower layer of the skin).
However, a portion of the dermis remains intact. Partial-thickness burns are
the most common type of burn injury requiring medical attention. These burns
frequently result from household hazards such as scalding from hot liquids,
faulty heating pads or misuse of ignition fluids.
Advanced Tissue Sciences 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 Dermagraft-TC for
burns, Advanced Tissue Sciences has filed a premarket approval application for
Dermagraft(R) for the treatment of diabetic foot ulcers under the FDA's
expedited review process. The Company is also developing products for
cartilage and cardiovascular applications.
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, or
successfully commercialize any such products. These and other risks are
detailed in publicly available filings with the Securities and Exchange
Commission such as the Company's Annual Report on Form 10-K and in a
Registration Statement on Form S-3 (File No. 333-01185). 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, Investor Relations of Advanced Tissue Sciences, Inc., 619-450-5802
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