Healthcare Industry News: COSTAR II
News Release - October 5, 2006
Conor Medsystems Receives Approval for One-Year Shelf Life for CoStar(R) Stent in the European UnionMENLO PARK, Calif., Oct. 5 (HSMN NewsFeed) -- Conor Medsystems, Inc. (Nasdaq: CONR ), a developer of innovative, controlled vascular drug delivery technologies, today announced that the company has received regulatory approval for extending the shelf life of Conor's CoStar® cobalt chromium paclitaxel-eluting stent in the European Union to twelve months from the current shelf life of six months.
"We are pleased to provide health care professionals the CoStar stent with this extended shelf life, which we believe will allow hospitals and our distributors to better manage their inventory," said Azin Parhizgar, Ph.D., Chief Operating Officer of Conor.
In contrast to conventional surface-coated stents, Conor's stents have been specifically designed for vascular drug delivery. Conor's CoStar 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 primarily 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 the ability of hospitals and distributors to manage their purchasing decisions and inventory of the CoStar stent. 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 "Item 1A. Risk Factors" in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with the SEC on August 9, 2006, including (i) risks related to the commercialization of the company's CoStar stent, including, among other things (a) the risk that the company will not be able to generate meaningful revenues without successful commercialization of company's CoStar stent in major markets, (b) the risk that the company's manufacturing facilities are unable to provide an adequate supply of its CoStar stent, (c) the risk that company's CoStar stent may never achieve market acceptance, (d) the risk that company's distributors' sales and marketing strategies fail to generate sales of company's CoStar stent, (e) the risk that Conor fails to comply with ongoing regulatory requirements, or Conor experiences unanticipated problems with its CoStar stent and (f) the risk that Conor will not obtain adequate level of reimbursement for its CoStar stent by third-party payors; (ii) 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 COSTAR II trial may not be completed on schedule, or at all, including as a result of the recall or removal from the market of the control stent to be used in the COSTAR II trial, or as a result of patients experiencing adverse side effects or events related to the CoStar stent, which could result in substantial delays and a redesign of the trial, (c) the risk that issues in the company's manufacturing processes could delay or impede the company's clinical development plans, (d) 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 (e) risks related to regulation by the FDA and the company's limited experience in regulatory affairs, including the risk that that the company may never obtain FDA approval; and (iii) risks related to patent infringement, including, among other things, (a) the risk that if any patent infringement claims or other intellectual property claims against the company are successful, the company may, among other things (1) 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, (2) 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 (3) be required to obtain licenses to the infringed intellectual property, which may not be available to the company on acceptable terms, or at all, and (b) 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 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 June 30, 2006, filed with the SEC on August 9, 2006.
Source: Conor Medsystems
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