PLC Systems Receives CE Mark Approval for RenalGuard(TM)
2007年12月21日 - 10:55PM
PRニュース・ワイアー (英語)
FRANKLIN, Mass., Dec. 21 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(AMEX:PLC) announced today that it has received the CE Mark
Certificate for its RenalGuard System(TM), clearing the way for the
Company to begin its initial launch of the product in the European
Union. The Company expects to initiate a limited launch of
RenalGuard(TM) in the first quarter of 2008 in Italy, targeting
early adoptors who recognize the benefits of utilizing the unique
fluid balancing capabilities of the RenalGuard System in a cath lab
setting during cardiovascular imaging procedures for patients at
higher risk of Contrast-Induced Nephropathy (CIN). PLC's President
and Chief Executive Officer, Mark R. Tauscher, said, "Receiving the
CE Mark for RenalGuard is an important milestone for PLC in the
development of our new product initiative. We are very enthusiastic
about the potential opportunity for the RenalGuard System in Europe
and look forward to working with leading practitioners there to
introduce it to the market." Mr. Tauscher added, "Our initial
launch in Italy will be supported by the previously announced
planned clinical trial at the Centro Cardiologico Monzino
(CCM-University of Milan) in Milan, Italy, led by Drs. Antonio
Bartorelli and Giancarlo Marenzi, two of the world's leading
experts in the prevention of CIN. We anticipate that this study
will receive final approval by the ethics committee at CCM and will
greatly increase the visibility of our RenalGuard System and that
the data gathered from the study will enable us to seek expanded
claims in order to market RenalGuard as a CIN prevention device
throughout the European Union." Having secured CE Mark approval for
RenalGuard, PLC expects to conclude negotiations with an Italian
distribution partner shortly. Finalization of a distribution
agreement is expected to include an initial stocking order of
product from the distributor to support the initial sales launch of
RenalGuard at select hospital sites throughout Italy.
Contrast-Induced Nephropathy Approximately seven million patients
worldwide undergo interventional cardiovascular therapeutic and
diagnostic imaging procedures each year. Contrast-induced
nephropathy, or CIN, is a major and growing problem due to the
increasing number of older patients, diabetics and patients with
pre- existing renal failure -- all of whose conditions make them at
risk for CIN when they require interventional procedures that use
radiographic contrast media. CIN is the third most common cause of
in-hospital acute renal failure. It is associated with significant
in-hospital mortality rates, and increases in long-term mortality
rates, major in-hospital adverse cardiac events, and the risk of
having to undergo renal dialysis therapy. Any of these can result
in prolonged hospital stays and increased medical costs. Studies
indicate that approximately 15-20% of all patients undergoing
image-guided cardiology and radiology procedures are at risk of
developing CIN. The estimated mortality rate for patients that
acquire CIN may be as high as 35%. RenalGuard is based on existing
pre-clinical study data that suggests that initiating and
maintaining high urine output during imaging procedures allows the
body to rapidly eliminate toxins in contrast media, reducing their
harmful effects. RenalGuard is a fully-automated, real-time matched
fluid replacement device intended for interventional cardiology and
radiology patients undergoing imaging procedures using contrast
media. About PLC Systems Inc. PLC Systems Inc. is a medical
technology company specializing in innovative technologies for the
cardiac and vascular markets. Headquartered in Franklin, Mass., PLC
pioneered the CO2 Heart Laser System, which cardiac surgeons use to
perform CO2 transmyocardial revascularization (TMR) to alleviate
symptoms of severe angina. CO2 TMR offers a treatment option for
angina patients who suffer from severe coronary artery disease. The
CO2 Heart Laser is the world's first TMR angina relief device
cleared for commercial distribution by both the U.S. Food and Drug
Administration and Japanese Ministry of Health, Labor and Welfare,
and to obtain a CE Mark for European distribution. The company
recently concluded a pilot clinical safety study of its RenalGuard
Therapy(TM) and RenalGuard System. RenalGuard Therapy is designed
to reduce the toxic effects that contrast media can have on the
kidneys. This therapy is based on the theory that creating and
maintaining a high urine output is beneficial to patients
undergoing imaging procedures where contrast agents are used. The
real-time measurement and matched fluid replacement design of the
RenalGuard System is intended to ensure that a high urine flow is
maintained before, during and after these procedures. This should
allow the body to rapidly eliminate contrast, reducing its toxic
effects. The RenalGuard System, with its matched fluid replacement
capability, is intended to minimize the risk of over- or
under-hydration. Additional company information can be found at
http://www.plcmed.com/. This press release contains
"forward-looking" statements. For this purpose, any statements
contained in this press release that relate to prospective events
or developments are deemed to be forward-looking statements. Words
such as "believes," "anticipates," "plans," "expects," "will" and
similar expressions are intended to identify forward-looking
statements. Our statements of our objectives are also
forward-looking statements. While we may elect to update
forward-looking statements in the future, we specifically disclaim
any obligation to do so, even if our estimates change, and you
should not rely on these forward-looking statements as representing
our views as of any date subsequent to the date of this press
release. Actual results could differ materially from those
indicated by such forward-looking statements as a result of a
variety of important factors, including that we may not receive
necessary regulatory approvals to market our RenalGuard product or
that such approvals may be withdrawn, the clinical trials for that
product may not be successful, the RenalGuard product may not be
commercially accepted, operational changes, competitive
developments may affect the market for our products, regulatory
approval requirements may affect the market for our products, and
additional risk factors described in our Report on Form 10-Q for
the quarter ended September 30, 2007, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser,
RenalGuard, RenalGuard Therapy and RenalGuard System are trademarks
of PLC Systems Inc. Contact: Mary T. Conway Conway Communications
617-244-9682 DATASOURCE: PLC Systems Inc. CONTACT: Mary T. Conway
of Conway Communications, +1-617-244-9682, , for PLC Systems Inc.
Web site: http://www.plcmed.com/
Copyright
P L C Systems (AMEX:PLC)
過去 株価チャート
から 11 2024 まで 12 2024
P L C Systems (AMEX:PLC)
過去 株価チャート
から 12 2023 まで 12 2024