LA JOLLA, Calif., Oct. 12 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) announced today that the U.S. Food and Drug Administration
(FDA) has approved the Company's application for a Treatment Investigational
Device Exemption (IDE) for Dermagraft, a living human-based dermal replacement
for diabetic foot ulcers. The Treatment IDE allows the Company to make
Dermagraft available to selected centers in the United States under an
approved clinical protocol.
The Treatment IDE is a new regulatory provision for devices that permits
companies to make available promising new products to patients with serious
diseases for which there is no satisfactory alternative. The Treatment IDE
will be conducted concurrently, under a similar clinical protocol, with the
ongoing U.S. pivotal clinical trial of Dermagraft in the treatment of diabetic
foot ulcers.
"We are very pleased to be able to provide Dermagraft to patients in need
under the FDA's new Treatment IDE program," said Dr. Gail K. Naughton,
President and Chief Operating Officer of Advanced Tissue Sciences. "This
important new program will make Dermagraft available on a case-by-case basis
outside the pivotal clinical trial to patients with hard-to-heal foot ulcers."
The Company will initially focus on a small number of centers, while
working with the Health Care Financing Administration (HCFA) and other payors
to address reimbursement. Under a Treatment IDE, companies are allowed to
recover the costs of manufacturing and distributing the product.
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. The Company, through its joint venture
with Smith & Nephew plc, currently has two products on the market,
TransCyte(TM) (formerly Dermagraft-TC(R)), for full and partial-thickness
burns, and Dermagraft for the treatment of diabetic foot ulcers (currently
available in Canada and the United Kingdom). In addition to TransCyte and
Dermagraft, the Company is also developing products for cartilage and
cardiovascular applications.
The matters discussed in this press release involve risks and
uncertainties. In particular, the Company will need to successfully complete
an additional controlled clinical trial of Dermagraft in the treatment of
diabetic foot ulcers and submit a revised premarket approval application to
the FDA. No assurance can be given that the Company will successfully
complete the additional clinical trial, the clinical trial will be completed
within any specific timeframe, that the data from the trial will be
statistically significant or otherwise consistent with the results of the
Company's earlier pivotal trial or that the Company will obtain FDA or other
regulatory approvals of Dermagraft (or that any such approvals will be
obtained on a timely basis). In addition, there can be no assurance the
Company will successfully enroll centers and patients, or obtain adequate
reimbursement, if any, under the Treatment IDE. These and other risks are
detailed in the Company's publicly available filings with the Securities and
Exchange Commission including the Company's Annual Report on Form 10-K for the
year ended December 31, 1997. Actual results may differ materially from those
currently anticipated as a result of such risks.
SOURCE Advanced Tissue Sciences, Inc.
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http://www.prnewswire.com/comp/532975.html or fax,
800-758-5804, ext. 532975
CONTACT:
Jack D. Strube, Executive Director, Finance,
of Advanced Tissue Sciences, 619-450-5802
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