LA JOLLA, Calif., Jan. 29 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and its partner, Smith & Nephew plc, announced today that the
General and Plastic Surgery Devices Panel of the Medical Devices Advisory
Committee to the U.S. Food and Drug Administration (FDA) recommended that the
agency approve Dermagraft, a living human dermal replacement for the treatment
of diabetic foot ulcers, with the condition that the Company perform a post
marketing study.
    "The panel's favorable recommendation represents another major step
forward in the commercialization of unique, human-based tissue engineering
solutions for the treatment of diabetic foot ulcers," said Gail K. Naughton
Ph.D., President and Chief Operating Officer of Advanced Tissue Sciences.  "As
the first human dermal skin replacement, Dermagraft can provide a significant
new treatment alternative for the more than 400,000 patients in the United
States who suffer from chronic, hard-to-heal diabetic foot ulcers each year."
    Chris O'Donnell, Chief Executive of Smith & Nephew said, "This confirms
our confidence in Dermagraft and is a significant milestone in our worldwide
roll-out of this biological wound healing product.  With the recent expansion
of our joint venture, this strengthens our leadership position within the U.S.
and global wound management market."
    "Based on my experience in treating diabetic foot ulcers, I was quite
impressed with the clinical data and increased rate of healing achieved with
Dermagraft, a very important factor in preventing amputation," said Marvin
Levin M.D., Professor of Clinical Medicine Emeritus and Associate Director of
the Diabetes, Endocrinology and Metabolism Clinic, Washington University
School of Medicine in St. Louis and Editor of The Diabetic Foot.
    In the United States, diabetic foot ulcers affect approximately 15% of the
16 million diabetic patients in their lifetime.  The vote to recommend
approval was made after the Company presented pivotal and supplemental
clinical trial data demonstrating the safety and effectiveness of Dermagraft
in reaching its primary endpoint, complete healing of the diabetic foot ulcers
within twelve weeks.
    Dermagraft is a living, human dermal replacement produced by culturing
human dermal fibroblasts (a type of cell commonly found in the dermal layer
and in connective tissue) onto a biosynthetic scaffold.  As the fibroblasts
proliferate on the scaffold, they secrete important structural proteins and
growth factors, generating a three-dimensional human dermis.  Dermagraft is
then frozen for storage and shipment to the treating physicians for
implantation into patients.
    Advanced Tissue Sciences and Smith & Nephew are pursuing the worldwide
commercialization of Dermagraft through a fifty-fifty joint venture.  The
joint venture was recently expanded to include the worldwide development and
marketing of Dermagraft and Dermagraft-TC(TM), and future product
developments, for venous ulcers, pressure sores, burns and other skin wounds.
Advanced Tissue Sciences will continue to market Dermagraft-TC for the
treatment of full and partial-thickness burns in the United States under
marketing approvals from the FDA.
    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 Dermagraft and
Dermagraft-TC, the Company also is developing products for cartilage and
cardiovascular applications.
    Smith & Nephew, a leading worldwide healthcare company with more than
$1.7 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 FDA will follow the recommendation made by the Advisory Panel
described above, or that the Company will successfully obtain FDA or other
regulatory approvals of other products (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 or
significantly penetrate the markets for any of its products.  These and other
risks are detailed in the Company's publicly available filings with the
Securities and Exchange Commission including its Annual Report on Form 10-K.
Actual results may differ materially from those currently anticipated as a
result of such risks.

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