SCHEDULE 14A
(Rule 14a-101)
INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE
SECURITIES EXCHANGE ACT OF 1934
(AMENDMENT NO. )
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[ ] Definitive Proxy Statement
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Radiance Medical Systems, Inc.
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(Name of Registrant as Specified In Its Charter)
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[RADIANCE MEDICAL SYSTEMS, INC. LOGO] FOR FURTHER INFORMATION
CONTACT JEFF THIEL, PRESIDENT & CEO
TELEPHONE: 1-800-983-2284
New Clinical Data Presented at International Congress
Confirming the Clinical Value of Endoluminal Graft
Technology to be Acquired by Radiance
IRVINE, CA--(BW Healthwire)--February 19, 2002, Radiance Medical Systems,
Inc. (Nasdaq RADX-news) today announced that Endologix, Inc. made two
presentations at the 15th annual International Congress of Endovascular
Interventions, held February 10th - 14th in Phoenix, AZ, on data from two
clinical trials using Endologix's endoluminal stent grafts for the treatment of
abdominal aortic aneurysms (AAA).
Dr. Shin Ishimaru from Tokyo Medical University presented data on 68
patients treated at five centers in the clinical study conducted in Japan. Data
from this study was submitted as part of the package seeking approval to sell
products in Japan. To date, Endologix is the only company to have completed
their clinical trial in Japan and submitted their data for approval.
In a second presentation, Marcelo Cerezo, M.D. of Hospital Espanol de La
Plata in Argentina, discussed interim results from a five center 60 patient
study conducted in Argentina. Dr. Cerezo provided detailed information on the
technical success and low complication rate with the PowerLink system.
On February 12, 2002, Dr. Edward B. Diethrich, a founder of Endologix,
performed a successful implant of the PowerLink system, which was broadcast live
to a public forum at the meeting.
Commenting on the presentations of Endologix's clinical trials, Radiance
President and CEO Jeff Thiel said, "These clinical studies show the benefits of
Endologix's AAA technology to the physician and patient. We expect the PowerLink
system to be a very competitive solution in the large and growing AAA market."
As announced previously, Radiance has signed a definitive merger agreement
with Endologix. The merger is subject to shareholder approval from both
companies and the satisfaction of other customary conditions of closing.
Radiance expects the transaction to close in the second quarter of 2002.
According to published reports the market for endoluminal stent grafts for
the treatment of AAAs is expected to grow to over $700 million in the next five
years.
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, visit the company's web site at www.radiance.net.
-- more --
13900 Alton Parkway, Suite 122 - Irvine, CA 92618
1.800.983.2284 - 949.457.9546 - Fax: 949.457.9561
www.radiance.net
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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 shareholder approval of the
merger with Endologix, the effects of the merger with Endologix 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.
Radiance will be filing documents concerning the merger transaction
mentioned above with the Securities and Exchange Commission. RADIANCE URGES
INVESTORS AND SECURITYHOLDERS TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME
AVAILABLE, INCLUDING THE PROXY STATEMENT RELATED TO THE MERGER, BECAUSE THEY
CONTAIN IMPORTANT INFORMATION. Investors and securityholders may obtain these
documents and others related to Radiance free of charge at the SEC's web site at
www.sec.gov. In addition, documents filed by Radiance with the SEC will be
available for free by directing a request to the Secretary of Radiance, at 13900
Alton Parkway, Suite 122, Irvine, CA 92618, telephone (949) 457-9546. Radiance,
its directors and executive officers and other employees may participate in the
solicitation of proxies on behalf of the merger. The information concerning the
participants will be included in the proxy statement on Schedule 14A to be filed
with the SEC.
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