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Conor Medsystems Announces Positive Twelve-Month Follow-Up Data From EuroSTAR Pivotal Study
Results Reported at EuroPCR Meeting Demonstrate Long-term Safety and Efficacy of the CoStar™Cobalt Chromium Paclitaxel-Eluting Coronary Stent MENLO PARK, Calif., May 24 -- Conor Medsystems, Inc. (Nasdaq: CONR - News), a developer of innovative, controlled vascular drug delivery technologies, today announced positive twelve-month follow-up clinical data from its pivotal EuroSTAR study evaluating the company's CoStar cobalt chromium stent for the treatment of de novo lesions in single- and multi-vessel coronary artery disease. The clinical results are being presented today by Keith D. Dawkins, MD, FRCP, FACC, Director of Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom, at the Paris Course on Revascularization (EuroPCR), a leading international conference in interventional cardiology, in Paris, France. "Positive findings for the twelve-month follow-up clinical evaluation of the CoStar stent include low incidence of target lesion revascularization and major adverse cardiac events," said Dr. Dawkins. "With its low profile and high radiopacity, the CoStar stent is highly deliverable and permits direct stenting even in narrow and tortuous vasculature. In addition, the use of bioresorbable polymers ensures that no permanent polymer residue or drug remains at the target site." Dr. Dawkins and Antonio Colombo, MD, Director of the Cardiac Catheterization Laboratory at Emo Centro Cuore Columbus, Milan, Italy, are principal investigators for the trial. A total of 176 lesions were treated in 145 patients using the CoStar stent formulated to release a therapeutic dose of 10mcg of paclitaxel per 17 mm stent over approximately 30 days (based on in vitro measurements). Complex characteristics of the patient group include an average vessel diameter of 2.62 millimeters and multi-vessel disease in more than 50 percent of patients. Approximately 52 percent of the lesions were treated by direct stenting. At twelve-month follow-up, the target lesion revascularization (TLR) rate was 2.9 percent and the rate of cumulative major adverse cardiac events (MACE) was 7.6 percent. There were no reported cases of stent thrombosis between the cessation of anti-platelet therapy at six months and twelve-month follow-up. "We are very pleased with the consistent clinical results for the CoStar stent, which after twelve-months continues to demonstrate a positive safety and efficacy profile," said Frank Litvack, MD, Chairman and CEO of Conor. "A low-dose, long-release formulation of paclitaxel proved to be efficacious over the long-term, reinforcing our earlier positive clinical findings." EuroSTAR trial and CE Mark Application EuroSTAR (EUROpean cobalt chromium STent with Antiproliferative for Restenosis) is a prospective, multi-center, sequentially enrolled, non- randomized, two-arm dose-ranging pivotal study evaluating the safety and performance of Conor's CoStar stent for the treatment of restenosis. The study sequentially enrolled patients from 18 European centers into one of two registry arms with two different dose formulations of paclitaxel. The twelve- month follow-up data reflects the first arm of the study which evaluated the clinical performance of a 10mcg dose formulation per 17mm stent released over approximately 30 days among 145 patients. The second arm of the study, employing a 30mcg dose formulation released over approximately 30 days, completed enrollment in March 2005. Data from Conor's EuroSTAR trial was used to support the company's CE Mark application filed earlier this year. The company anticipates receiving CE Mark approval of the CoStar stent in late 2005. Pending regulatory approval, the CoStar stent will be marketed in Europe, Latin America and parts of Asia by one of the company's distribution partners, Biotronik AG. In March, a limited market release of the CoStar stent began in India through Conor's South Asia distribution partner, Interventional Technologies, Pvt, Ltd. 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 clinical development, potential regulatory approval of the CoStar stent 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 Quarterly Report on Form 10- Q for the quarter ended March 31, 2005, filed with the SEC on May 16, 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) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including, among other things (a) the risk that clinical results reported to date may not be indicative of future clinical results the company obtains with its CoStar stent, (b) the risk that issues in the company's manufacturing processes could delay or impede the company's clinical development plans, (c) the risk that the third parties on whom the company relies to conduct its clinical trials may not perform as contractually required or expected, and (d) risks related to regulation by the FDA and foreign regulatory authorities and the company's limited experience in regulatory affairs, including the risk that that the company may never obtain FDA and equivalent foreign market approvals, including approval to market the CoStar stent in the European Community; (iv) the risk that the company's CoStar stent may not achieve market acceptance, even if the company obtains necessary regulatory approvals; (v) the risk that the loss of the company's single source suppliers could prevent or delay commercialization of the CoStar stent; (vi) 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; and (vi) the risk that the company may not be able to maintain arrangements with third parties to market and sell the CoStar stent. 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 periodic reports filed with the SEC, including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. 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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