Conor Medsystems Receives Approval for One-Year Shelf Life for CoStar(R) Stent in the European Union
05 Outubro 2006 - 10:50AM
PR Newswire (US)
MENLO PARK, Calif., Oct. 5 /PRNewswire-FirstCall/ -- 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(R) 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 http://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. DATASOURCE: Conor Medsystems, Inc. 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; or Nan Foster, +1-415-307-6955, both for Conor
Medsystems, Inc. Web site: http://www.conormed.com/
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