LA JOLLA, Calif., Feb. 29 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and Smith & Nephew plc (NYSE: SNN) today announced that the
Food and Drug Administration (FDA) has approved an application for an
amendment to the Investigational Device Exemption (IDE) for the clinical trial
of Dermagraft(R) in the treatment of diabetic foot ulcers. Based on
previously announced data presented to the FDA in December from the planned
intent-to-treat interim analysis, the IDE has been amended to revise the
enrollment criteria and the statistical plan for data analysis. The amended
IDE modifies the study inclusion criteria to limit future enrollment to
patients with ulcers of greater than six weeks duration. In addition, the
amended statistical plan allows the Company to integrate the interim analysis
data presented to the FDA in December with additional data generated since
that time from patients with ulcer duration of greater than six weeks. If
these additional data confirm the treatment benefit that was seen in the
interim analysis for patients with ulcer duration greater than six weeks, the
Company believes it could submit an amendment to the Pre-Market Approval (PMA)
application to the FDA as early as mid-year.
A conference call will be held on Wednesday, March 1, 2000, at 11 a.m.
Eastern Standard Time (EST). To participate in the conference call, please
dial (800) 633-8942 on Wednesday, March 1, 2000, prior to 11 a.m. EST.
International callers, please dial (415) 904-7370. A continuous replay of the
call will be available after the conclusion of the call until 8:00 p.m. EST on
Friday, March 3, 2000. To listen to the replay, please dial (800) 633-8284.
International callers, please dial (858) 812-6440. Additionally, you may
visit our web site at http://www.advancedtissue.com to hear a replay of this call.
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(R) for the treatment of diabetic foot ulcers, TransCyte(TM) 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.
Smith & Nephew is a global medical device company employing 12,000 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. The statements reported in this release are based on an
interim data analysis of a controlled clinical trial. These results are not
necessarily indicative of the results which might be obtained following
completion of the full trial. Further, the Company cannot predict with any
certainty potential outcomes or resulting data of ongoing clinical trials,
whether such clinical trials will support the filing of a PMA application or
that the FDA will approve such an application, if any. No assurances can be
given that the Company will successfully complete this additional controlled
clinical trial of Dermagraft(R) in the treatment of diabetic foot ulcers, that
the clinical trial will be completed within any specific timeframe or that
there will not be any delays in enrollment or other factors which may not be
within the control of the Company, that the data from the trial will be
statistically significant or otherwise consistent with the results of the
Company's earlier clinical trials, or that the Company will obtain FDA
approval on a timely basis. In addition, if approved, there can be no
assurance that the Company can 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 any of its products. These and other
risks are detailed in the Company's publicly available filings with the
Securities & Exchange Commission such as Advanced Tissue Sciences' Quarterly
Report on Form 10-Q for the quarter ended September 30, 1999. 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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Related links:
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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