Endologix Provides Update on Japanese Approval.Business Editors/Health/Medical Writers IRVINE, Calif.--(BUSINESS WIRE)--Oct. 13, 2003 Endologix, Inc. (Nasdaq:ELGX) today announced its progress in obtaining the Shonin, the Japanese regulatory approval to import and sell its PowerWeb(R) endoluminal stent graft Difference Between a Stent Graft and a Stent A stent graft is a tubular device, which is composed of special fabric supported by a rigid structure, usually metal. The rigid structure is called a stent. for treatment of abdominal aortic aneurysms abdominal aortic aneurysm A focal aortic dilation of ≥ 50% ↑ in diameter, accompanied by distension and weakened aortic wall Epidemiology Incidence is rising 12/105–1951; 36/105 (AAAs) in Japan. Medical Industries Corporation (MIC), Endologix's regulatory intermediary for Japan, reported it expects the PowerWeb to be reviewed by the Japanese Ministry of Health, Labour and Welfare (MHLW MHLW Ministry of Health, Labor and Welfare (Japan; formerly Ministry of Health and Welfare, MHW) MHLW Mean High Low Water (tide level) ) panel of experts during the first quarter of 2004, and projects that it may obtain the Shonin in the first half of 2004. In a parallel effort, MIC plans to prepare documentation to establish and obtain reimbursement from hospitals in Japan upon performing PowerWeb procedures. MIC plans to file the reimbursement dossier immediately upon receipt of the Shonin with approval expected within three to six months following its filing. Paul McCormick, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , commented, "We have made good progress in our pursuit to introduce the first commercially available endoluminal graft in Japan. We are the first company to complete an all-Japanese patient clinical trial, and our technology should be the first of this type to be reviewed by MHLW. If our progress continues as planned in Japan and the U.S., Endologix will be the first company to obtain market clearance for an AAA AAA: see American Automobile Association. (Triple A) A common single-cell battery used in a myriad of electronic devices of all variety. Like its double A (AA) cousin, it provides 1.5 volts of DC power. When used in series, the voltage is multiplied. endoluminal graft in Europe, Japan and the U.S." A recent market analysis by the Millennium Research Group (MRG MRG Merge MRG Minority Rights Group International MRG Mad River Glen (Vermont) MRG Mouvement des Radicaux de Gauche (French: Left Radical Movement) MRG Manyetik Rezonans Görüntüleme ) estimates that following introduction of AAA endoluminal grafts in Japan, the market for endoluminal grafts will grow to more than $58 million by the year 2007. About Endologix Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases vascular diseases, n.pl diseases of the peripheral circulatory system. . AAA, a life-threatening condition, is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAAs is approximately 75%, making it the 13th leading cause of death in the United States. Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which is necessarily subject to risks and uncertainties, including risks related to clinical trials and the regulatory approval process, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2002, and the Company's other filings with the Securities and Exchange Commission. |
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