FRANKLIN, Mass., March 28 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 for90,000 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