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Conor Medsystems Announces Positive Six-Month Follow-Up Data from EuroSTAR Pivotal Study
Results Support Safety and Efficacy of the CoStar® Cobalt Chromium Paclitaxel-Eluting Coronary Stent
MENLO PARK, Calif., Feb. 17 /PRNewswire-FirstCall/ - Conor Medsystems, Inc. (Nasdaq: CONR) today announced six-month follow-up data from demonstrate favorable clinical results for the treatment of single or multiple de novo lesions in native coronary arteries.
Clinical data from the pan-European study is being presented by Keith D. Dawkins, MD, Director, Cardiac Interventions at Southampton University Hospital, Southampton, United Kingdom, at the Joint Interventional Meeting in Rome, Italy, a leading international conference in interventional cardiology. Dr. Dawkins and Antonio Columbo, 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 over approximately 30 days (based on in vitro measurements). Complex characteristics of the patient group include an average vessel diameter of 2.64 millimeters, and more than 50 percent of patients had multi-vessel disease. Approximately 52 percent of the lesions were treated by direct stenting. At six-month follow-up, the target lesion revascularization (TLR) rate was 1.7 percent and the rate of cumulative major adverse cardiac events (MACE) was 4.8 percent.
"We are excited about the encouraging clinical safety and efficacy results from the first arm of the EuroSTAR trial. The CoStar stent has been specifically designed for optimized vascular drug delivery and mechanical performance, and the combination of the low paclitaxel dose with the absence of a polymer surface coating on the thin cobalt chromium struts has lived up to our expectations," said Frank Litvack, MD, Chairman and CEO of Conor. "The dose used in this arm of the EuroSTAR study extended the positive four-month follow-up data first observed in the same formulation delivered from our stainless steel stent in our PISCES study. We believe that pairing the 10mcg, long-release formulation with our cobalt chromium platform may have further enhanced clinical results. We look forward to sharing complete clinical and angiographic results from our EuroSTAR study in March."
"The Conor CoStar stent has performed well in treating a complex patient population," said Dr. Dawkins. "The novel design of these stents and the use of cobalt chromium results in a lower profile making them more easily deliverable to small vessels in the coronary anatomy. In addition, the continued demonstration of safety and the controlled release of the drug and erosion of the polymer over a predictable time frame improves cardiologists' comfort with the level of prescribed treatment."
Complete six-month angiographic results and clinical data from the first arm of the EuroSTAR study will be presented at the Cardiovascular Research Foundation-sponsored symposium immediately preceding the American College of Cardiology (ACC) meeting in Orlando, Florida, in March 2005. In addition, twelve-month follow-up data from the company's PISCES (Paclitaxel In-Stent Controlled Elution Study) study will be presented at ACC.
EuroSTAR (EUROpean cobalt chromium STent with Antiproliferative for Restenosis) is a prospective, multi-center, two-arm dose-ranging pivotal study evaluating the safety and performance of Conor Medsystem's CoStar stent for the treatment of restenosis. The study is scheduled to sequentially enroll patients from 18 European centers into one of two registry arms with two different dose formulations of paclitaxel. The six-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, evaluating a 30mcg dose formulation, is currently being enrolled.
In contrast to conventional surface-coated stents, Conor's CoStar cobalt chromium paclitaxel-eluting coronary stent has been specifically designed for vascular drug delivery. CoStar differs from conventional surface-coated stents as it incorporates hundreds of small holes, each acting as a reservoir into which drug-polymer compositions can be loaded. Conor's stent design enables a wider range of drug therapies — including combinations of multiple compounds — and provides greater control over the direction and rate of drug release, which Conor believes allows for more targeted treatment within the artery and more efficient use of the therapeutic agent.
The CoStar stent is not available for sale in the United States and is undergoing clinical investigation in the EU.
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 product development and regulatory approval. 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 prospectus filed with the SEC on December 14, 2004 pursuant to Rule 424(b), 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, and (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 and that longer-term results the Company obtains with its CoStar stent may not show similar effectiveness, (b) the risk that the third parties on whom the Company relies to conduct its clinical trials may not perform as contractually required or expected, (c) the risk that the Company's clinical trials may not be completed on schedule, or at all, and (d) the risk that the Company may never obtain FDA and equivalent foreign market 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 prospectus and the Company's future periodic reports to be filed with the SEC.
SOURCE Conor Medsystems, Inc.
02/17/2005
CONTACT: Michael Boennighausen, Chief Financial Officer, of Conor Medsystems, Inc., +1-650-614-4100
Web site: http://www.conormed.com
(CONR)

