Micrus Endovascular Receives Approval To Market Cerecyte Microcoils In Japan

Main Category: Neurology / Neuroscience
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Jul 2008 - 2:00 PDT

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Micrus Endovascular Corporation (Nasdaq: MEND) announced receipt of Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) to market in Japan its Cerecyte® microcoil product line, including the MicruSphere®, Presidio®, HeliPaq® and UltiPaq® Cerecyte embolic coils, for the endovascular treatment of cerebral aneurysms. Sales of the Company's Cerecyte microcoils will be managed by Goodman Co., Ltd., Micrus Endovascular's exclusive distributor in the Japanese market.

"The approval of our Cerecyte line of microcoils represents a major opportunity for Micrus. We can now provide the Japanese neurointerventionalists with a full line of both platinum and Cerecyte coils for the treatment of cerebral aneurysms. Coming on the heels of our recently approved Cashmere and Ultipaq stretch-resistant coils, we believe that the approval of our Cerecyte coils will further enable us to build upon our growing market share in Japan - one of the fastest-growing markets for embolic coils in the world," said John Kilcoyne, Chairman and CEO of Micrus Endovascular.

About Micrus Endovascular Corporation

Micrus develops, manufactures and markets implantable and disposable medical devices for use in the treatment of cerebral vascular diseases. Micrus products are used by interventional neuroradiologists, interventional neurologists and neurosurgeons to treat both cerebral aneurysms responsible for hemorrhagic stroke and intracranial atherosclerosis, which may lead to ischemic stroke. Hemorrhagic and ischemic stroke are both significant causes of death and disability worldwide. The Micrus product line enables physicians to gain access to the brain in a minimally invasive manner through the vessels of the circulatory system. Micrus' proprietary, three-dimensional microcoils automatically deploy within the aneurysm, forming a scaffold that conforms to a wide diversity of aneurysm shapes and sizes. Micrus also sells accessory devices and products used in conjunction with its microcoils.

Forward-Looking Statements

Micrus, from time to time, may discuss forward-looking information, including estimated fiscal 2009 revenues. Except for the historical information contained in this release, all forward-looking statements are predictions by the Company's management and are subject to various risks and uncertainties that may cause results to differ from management's current expectations. Such factors include the Company's dependence upon the continued growth in embolic coiling as a procedure to treat cerebral aneurysms, the Company's ability to obtain, and the timing of, regulatory approvals and clearances for its products, product enhancements or future products, the Company's involvement in patent litigation with Boston Scientific Corporation, the Company's limited operating history and history of significant operating losses, fluctuations in quarterly operating results, which are difficult to predict, the Company's dependence on developing new products or product enhancements, challenges associated with complying with applicable state, federal and international regulations related to sales of medical devices and governing Micrus' relationships with physicians and other consultants, the Company's ability to compete with large, well-established medical device manufacturers with significant resources and other risks as detailed from time to time in risk factors and other disclosures in the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2008, and other filings with the Securities and Exchange Commission. All forward-looking statements in this release represent the Company's judgment as of the date of this release. The Company disclaims, however, any intention or obligation to update forward-looking statements.

Micrus Endovascular Corporation