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Radiance Medical Systems, Inc.
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[RADIANCE MEDICAL SYSTEMS, INC. LOGO]
FOR FURTHER INFORMATION
CONTACT JEFF THIEL, PRESIDENT & CEO
TELEPHONE: 1-800-983-2284
RADIANCE SIGNS DEFINITIVE AGREEMENT TO MERGE
WITH ENDOLOGIX, A DEVELOPER OF ENDOLUMINAL
STENT GRAFT FOR THE TREATMENT OF
ABDOMINAL AORTIC ANEURYSMS (AAAS)
IRVINE, CA -- (BW Healthwire) -- February 11, 2002, Radiance Medical
Systems, Inc. (Nasdaq RADX-news) today announced that it signed a definitive
merger agreement with Endologix, Inc. Endologix is a developer and manufacturer
of minimally invasive treatment of vascular diseases. Endologix' first
technology is the PowerLink System, an endoluminal stent graft (ELG) for the
treatment of abdominal aortic aneurysms (AAAs). Endologix intends to use the
technology to develop other novel devices for treatment of other vasculature.
The conventional treatment of aortic aneurysms involves a one to two
hour open surgical procedure, followed by a lengthy hospitalization and
recuperative period. The use of endoluminal stent grafts is a breakthrough
technology that provides a minimally invasive procedure, resulting in a shorter
hospital stay and recuperative period. Published reports indicate that there are
over 600,000 patients diagnosed annually in the United States alone with
aneurysms of the aorta. According to a Merrill Lynch report published in
December 2001, the market for minimally invasive endoluminal stent grafts for
the treatment of AAA is expected to show rapid growth to almost $700 million by
the end of 2004.
Endologix has received CE Mark approval for the PowerLink System and is
currently selling the device in Europe. The clinical trial has been completed
for Japan, and the filing for approval to sell in Japan was submitted in August
2001. Endologix is currently conducting its pivotal trial in the United States
and expects to complete enrollment in the second half of 2002.
Radiance currently owns 4% of Endologix, and under the terms of the
merger agreement Radiance will pay shareholders of Endologix $0.75 in cash and
one share of Radiance stock for each share of Endologix stock for an aggregate
cash consideration of approximately $8.4 million and a total of approximately
11.1 million shares of Radiance Common Stock. In addition, Endologix
shareholders may receive milestone payments of up to $0.50 payable in cash or
stock for each share of Endologix stock in the event regulatory approval is
received by certain dates, for an aggregate total possible milestone payment of
approximately $5.6 million.
In addition to the merger, Radiance has agreed to loan Endologix up to
$3 million dollars in the event the merger is not completed. The loan will be
secured by a first priority security interest on all of Endologix' intellectual
property, and will be due on the earlier of October 1, 2003 or upon the closing
by Endologix of certain other transactions.
Jeff Thiel, President & CEO of Radiance stated, "We are pleased that we
have been able to acquire this unique technology. We believe that Endologix
offers the Radiance shareholders an opportunity to participate in the rapidly
growing AAA market."
As announced in January 2002, Radiance has completed enrollment in the
BRITE II trial for the treatment of in-stent restenosis with the RDX, a vascular
brachytherapy device. The follow up on the patients is to be completed in Q4
2002, with submission of the PMA currently scheduled for early 2003.
Franklin D. Brown, Chairman and CEO of Endologix will remain in that
capacity of the merged entity, which will be named Endologix. Mr. Thiel will
continue as a member of the Board of Directors of the merged companies.
The merger is subject to Radiance and Endologix shareholder approval
and other customary closing conditions.
A.G. Edwards issued a fairness opinion to the Special Committee of the
Board of Directors of Radiance as to the fairness from a financial point of view
to Radiance's shareholders of the consideration to be received in the
Transaction.
Radiance Medical Systems develops radiation delivery catheters for use
in the treatment of coronary and peripheral vascular systems to prevent
restenosis following the interventional treatment of atherosclerosis. For more
information about Radiance, please visit the Company's web site at
www.radiance.net.
Except for historical information contained herein, this news release contains
forward-looking statements, the accuracy of which are necessarily subject to
risks and uncertainties, and which may be affected by, among other things, risks
and uncertainties related to the effects of the transaction on Radiance, the
ability of Radiance to successfully integrate Endologix's and Radiance's
operations and business strategies, future economic, competitive and market
conditions, including those in Europe and Asia and those related to Radiance's
and Endologix's strategic markets, whether the products offered will achieve
acceptance in the marketplace and future business decisions, all of which are
difficult or impossible to predict accurately and many of which are beyond the
control of Radiance. In addition, the accuracy of the forward-looking statements
in this news release are necessarily subject to other risks and uncertainties,
and may be affected by, among other things, risks and uncertainties involving
new product development and introduction cycles, research and development
activities, including failure to demonstrate clinical efficacy, delays by
regulatory authorities, scientific and technical advances by third parties,
introduction of competitive products, third party reimbursement and physician
training, and other risk factors, and matters set forth in the Company's Annual
Report on Form 10-K for the year ended December 31st, 2000 and the Company's
Quarterly Report on Form 10-Q for the quarter ended September 30th, 2001.
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