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Thursday January 29, 3:39 pm Eastern Time
Company Press Release
SOURCE: Advanced Tissue Sciences, Inc.
FDA Advisory Panel Recommends Approval of Dermagraft(R)
for the Treatment of Diabetic Foot Ulcers
LA JOLLA, Calif., Jan. 29 /PRNewswire/ -- Advanced Tissue Sciences, Inc. (Nasdaq: ATIS - news) 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.
SOURCE: Advanced Tissue Sciences, Inc.
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