Conor Medsystems Receives CE Mark for CoStar(TM) Drug-Eluting Stent
February 17 2006 - 9:04AM
PR Newswire (US)
First Reservoir-Based Controlled-Release Drug Delivery Stent with
Bioresorbable Polymer to be Launched in Europe MENLO PARK, Calif.,
Feb. 17 /PRNewswire-FirstCall/ -- Conor Medsystems, Inc.,
(NASDAQ:CONR), a pioneer in next generation drug-eluting stents,
today announced that it received Conformite Europeen (CE) Mark
approval for its CoStar(TM) cobalt chromium paclitaxel-eluting
stent for the treatment of coronary artery disease. CE Mark
approval enables Conor Medsystems to commercialize its CoStar stent
in the European Union and other countries accepting CE Mark.
Beginning immediately, Conor's CoStar stent will be marketed and
distributed in these markets by Biotronik AG, a leading
manufacturer and global distributor of devices in the area of
interventional cardiology. "Clinical studies of the CoStar stent
have shown significant patient benefits and demonstrated the
importance of controlled drug delivery for the treatment of
restenosis," said Keith D. Dawkins, M.D., FRCP, FACC, Director of
Cardiac Interventions at Southampton University Hospital,
Southampton, United Kingdom. "In addition to positive clinical
results, the CoStar stent has consistently demonstrated an
excellent safety profile, and the use of bioresorbable polymers
ensures that no permanent polymer residue or drug remains at the
target site." In contrast to conventional surface-coated stents,
Conor's CoStar cobalt chromium paclitaxel-eluting coronary stent
has been specifically designed for vascular drug delivery. The
CoStar stent differs from conventional surface- coated drug-eluting
stents as it is not coated. Instead, Conor's 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
or drug at the target site. The British Standards Institute (BSI)
issued CE Mark approval of the CoStar stent based on a review of
the preclinical and clinical data indicating the safety and
efficacy of the CoStar stent in the treatment of coronary artery
disease and reducing the rate of restenosis. In particular, CE Mark
approval of Conor's CoStar stent was supported by data from the
company's pivotal EuroSTAR clinical trial, as well as other
supporting clinical trials including the PISCES and COSTAR I
studies. The CoStar stent is being commercially manufactured at
Conor's ISO-certified facility in Ireland. "We are very pleased to
achieve this significant milestone and begin commercialization of
our CoStar stent in Europe," said Azin Parhizgar, Ph.D., Chief
Operating Officer of Conor. "We believe that the unique design and
technology of Conor's drug-eluting stent represents a significant
innovation in the treatment of patients with coronary artery
disease and that the use of Conor's CoStar stent will lead to
improved patient care." "With more than 800,000 angioplasty
procedures performed each year in Europe and the market growing at
a rate of almost 10 percent annually, there is tremendous
commercial potential for Conor's CoStar stent," said Marlou
Janssen, Vice President, Sales and Marketing of Biotronik Vascular
Intervention, Biotronik AG. "We are pleased to begin marketing and
distribution of Conor's pioneering vascular drug delivery
technology." Biotronik has the right to market and distribute the
CoStar stent in Europe, Latin America and certain countries in
Asia. Interventional Technologies, Pvt., Ltd. has the right to
distribute the CoStar stent in India, and affiliates of St. Jude
Medical, Inc. have the right distribute the CoStar stent in Japan
and several countries in the Pacific Rim, subject to receipt of
regulatory approval. Conor is currently conducting a U.S. pivotal
clinical trial, COSTAR II, to support its application for U.S.
regulatory approval of the CoStar stent. 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
http://www.conormed.com/. About Biotronik Biotronik is a leading
European manufacturer of biomedical technology with a worldwide
market presence. The company offers a complete line of products for
diagnosis, treatment, and advanced therapy support in the areas of
cardiac rhythm management, electrophysiology and vascular
intervention. The field of vascular intervention consists of guide
wires, balloon catheters and stent systems for coronary and
peripheral applications. For more information, visit Biotronik's
website at http://www.biotronik.com/. This press release contains
certain forward-looking statements that involve risks and
uncertainties, including without limitation, the statements related
to the marketing and distribution of, and the commercial potential
for, the company's CoStar stent and the use of company's CoStar
stent leading to improved patient care. 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
September 30, 2005 filed with the SEC on November 14, 2005,
including (i) risks related to the commercialization of company's
CoStar stent, including, among other things (a) the risk that the
company's CoStar stent may never achieve market acceptance, (b) the
risk that the company's manufacturing facilities may be unable to
provide an adequate supply of its CoStar stent, (c) the risk that
the loss of the company's single source suppliers could interrupt
or delay the company's commercialization efforts, (d) the risk that
company's distributors' sales and marketing strategies may fail to
generate meaningful revenues from sales of the company's CoStar
stent, (e) the risk that the company may fail to comply with
ongoing regulatory requirements, or that the company may experience
unanticipated problems with its CoStar stent, (f) the risk that the
company may not obtain adequate levels of reimbursement for its
CoStar stent by third-party payors and (g) the risk that the
company's competitors may develop and market products that are
safer and more effective than the CoStar stent; (ii) 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, including
the company's CoStar stent, that infringe the patent rights of
others, (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; and (iii) 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.
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 September 30, 2005. First Call Analyst: FCMN
Contact: DATASOURCE: Conor Medsystems, Inc. CONTACT: Investors:
Michael Boennighausen, Chief Financial Officer of Conor Medsystems,
Inc., +1-650-614-4100; or Media: Karen L. Bergman, +1-650-575-1509,
or Nan Foster, +1-415-307-6955, both of BCC Partners, for Conor
Medsystems, Inc. Web site: http://www.conormed.com/
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