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Conor Medsystems Receives CE Mark Approval for
UniStar™ Cobalt Chromium Stent Company Also Receives ISO Certification for European Manufacturing Facility MENLO PARK, Calif., May 10 -- Conor Medsystems, Inc. (Nasdaq: CONR) today announced that its UniStar™ cobalt chromium bare-metal coronary stent received CE Mark approval in the European Community for the treatment of de novo coronary artery lesions. Conor also announced today that the company has received ISO certification of its facility in Athlone, Ireland for the commercial manufacturing of its proprietary coronary stents including the UniStar stent and the CoStar™ cobalt chromium paclitaxel-eluting coronary stent. "We are delighted to have received CE Mark approval for UniStar, which lays the foundation for European regulatory approval of our CoStar stent," said Frank Litvack, M.D., Chairman and CEO of Conor. "In addition, the ISO certification of our manufacturing facility in Ireland provides assurances that the manufacture of our UniStar and CoStar stents conforms to high quality standards and European regulatory requirements." Conor does not plan to immediately commercialize the UniStar stent, but may introduce the product through distributors later this year in countries where bare-metal coronary stents continue to be widely used. In February, Conor filed a CE Mark application for its CoStar cobalt chromium paclitaxel-eluting stent. The company anticipates receiving CE Mark approval of the CoStar stent in the second half of 2005. Pending regulatory approval, the CoStar stent will be marketed in Europe, Latin America and parts of Asia by the company's distribution partner, Biotronik AG. In March, a limited market release of the CoStar stent began in India through Conor's South Asian distribution partner, Interventional Technologies, Pvt, Ltd. ISO Certification Conor's ISO 13485 certification was extended for the company's 27,000 square foot manufacturing facility in Athlone, Ireland which became operational in the first quarter of this year. The International Organization for Standardization (ISO) represents national standards bodies from 150 countries and provides a harmonized model for quality management system requirements. This ISO 13485 certification reflects that the facility meets the international standards for medical device quality systems applicable to the manufacture of medical devices for clinical use and commercial sale. In contrast to conventional surface-coated stents, Conor's stents have been specifically designed for vascular drug delivery. The company's CoStar cobalt chromium paclitaxel-eluting stent incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. In addition, the CoStar stent uses bioresorbable polymers that are absorbed by the body after the drug is released, leaving no permanent residual polymers at the target site. The CoStar stent is not available for sale in the United States where it is an investigational device limited by law to investigational use. About Conor Medsystems Conor Medsystems, Inc. develops innovative controlled vascular drug delivery technologies, and has initially focused on the development of drug eluting stents to treat coronary artery disease. For further information on Conor Medsystems and controlled vascular delivery, visit www.conormed.com. Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to regulatory approval and the company's commercialization plans. All forward-looking statements and other information included in this press release are based on information available to Conor Medsystems as of the date hereof, and the Company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2004, filed with the SEC on March 31, 2005, including (i) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (a) be enjoined from, or required to cease, the development, manufacture, use and sale of products that infringe the patent rights of others, including the company's CoStar stent, (b) be required to expend significant resources to redesign its technology so that it does not infringe others' patent rights, which may not be possible, and/or (c) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all; (ii) the risk that intellectual property litigation against the company could significantly disrupt the company's development and commercialization efforts, divert management's attention and quickly consume the company's financial resources; (iii) the risk that the loss of the company's single source suppliers could prevent or delay commercialization of the CoStar stent; (iv) the risk that the company or its suppliers may not achieve or maintain required regulatory approvals for manufacturing operations, which could delay or impede the company's commercialization efforts; (v) the risk that quality issues in the company's manufacturing processes, including contamination problems, could delay or impede the company's commercialization efforts, (vi) the risk that the company may not be able to maintain arrangements with third parties to market and sell the CoStar stent; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including, among other things, the risk that the company could be delayed by adverse results or regulatory complications and may never obtain FDA and equivalent foreign market approvals for the commercialization of its CoStar stent; and (viii) the risk that the company's products may not achieve market acceptance, even if the company obtains necessary regulatory approvals. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the company's Annual Report on Form 10-K and the company's future periodic reports to be filed with the SEC. CONTACT: investors, Michael Boennighausen, Chief Financial Officer, of Conor Medsystems, Inc., +1-650-614-4100; or media, Karen L. Bergman of BCC Partners, +1-650-575-1509, for Conor Medsystems, Inc.; or Nan Foster, +1-415-307-6955, for Conor Medsystems, Inc. Web site: http://www.conormed.com SOURCE: Conor Medsystems, Inc. |
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