PLC Systems Announces First International Distribution Agreement for RenalGuard(TM)
28 März 2008 - 1:05PM
PR Newswire (US)
Agreement Includes First Order for RenalGuard FRANKLIN, Mass.,
March 28 /PRNewswire-FirstCall/ -- PLC Systems Inc. (AMEX:PLC), a
company focused on innovative cardiac and vascular medical
device-based technologies, announced today that it has entered into
a 3-year exclusive agreement with Artech s.r.l., Cavezzo, Italy for
distribution of its RenalGuard System(TM) into Italy. Artech is one
of Italy's leading distributors of interventional
cardiology-related medical devices, doing business with most of
Italy's major interventional cardiology centers. Artech will target
early adopters who recognize the benefits of utilizing the unique
fluid balancing capabilities of RenalGuard System in a cath lab
setting during cardiovascular imaging procedures for patients at
higher risk of Contrast- Induced Nephropathy (CIN). As part of this
agreement, Artech placed an initial stocking order for 90,000 Euros
(approximately $144,000) for RenalGuard Consoles and Single Use
Sets to support the initial sales launch of RenalGuard at selected
major cardiology centers throughout Italy. PLC's President and
Chief Executive Officer, Mark R. Tauscher, said, "We are extremely
pleased with our new agreement with Artech in Italy. 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. This study, which will
be led by Drs. Antonio Bartorelli and Giancarlo Marenzi, two of the
world's leading experts in the prevention of CIN, is expected to
receive final approval by the ethics committee at CCM this spring
and lead to increased market visibility for our RenalGuard System."
Artech's President, Emilio Contini, added, "RenalGuard offers
Artech the opportunity to represent an innovative new therapy that
can potentially improve the outcomes in interventional procedures
requiring contrast for high risk patients. We are excited about the
potential for the RenalGuard System in the Italian market, and we
look forward to undertaking a successful launch here." PLC received
the CE Mark Certificate for the RenalGuard System in late December
2007, and concluded its pilot safety trial in the U.S. late in
2007. The company has received conditional approval from the FDA to
commence a U.S. pivotal trial to study the effectiveness of its
RenalGuard Therapy and RenalGuard System in the prevention of CIN.
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
completed a pilot clinical safety study of its RenalGuard
Therapy(TM) and RenalGuard System, and has received its CE Mark
Certificate for RenalGuard System. PLC recently received FDA
conditional approval to commence a U.S. pivotal trial to study the
effectiveness of its RenalGuard Therapy and RenalGuard System in
the prevention of Contrast-Induced Nephropathy (CIN). 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-K for
the year ended December 31, 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/
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