PLC Systems Files IDE Supplement to Begin Pivotal Study of RenalGuard(TM) and
Provides Update on Planned Development Timeline
FRANKLIN, Mass., Feb. 15 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(Amex: PLC) announced today that it has submitted an Investigational Device
Exemption (IDE) supplement with the U.S. Food & Drug Administration (FDA) for
its RenalGuard Therapy(TM) and RenalGuard System(TM). This supplement seeks
approval to move to a pivotal trial to study the effectiveness of the
Company's RenalGuard Therapy and RenalGuard System in the prevention of
Contrast-Induced Nephropathy.
According to the current timetable, PLC expects to commence the pivotal
trial after receipt of FDA approval. 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 impairment -- all of whose
conditions make them at risk for CIN when they require interventional
procedures that use radiographic contrast media. This study is designed as an
adaptive, randomized control trial, with potentially up to 30 sites in the
U.S. Enrollment in the trial is expected to last through 2009, and to include
at least 250 patients. PLC is continuing discussions with FDA on metrics and
endpoints to be used in the study, in addition to sample size and other
aspects of the study design, which is currently expected to cost approximately
$3 million.
This trial design builds upon the successful completion of the company's
pilot trial in December, a study that was designed to preliminarily evaluate
safety associated with Renal Guard Therapy and RenalGuard System. A total of
23 patients were enrolled in the study.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We
are very pleased with the continued progress on our RenalGuard studies.
Submitting the IDE for the pivotal trial is an important milestone. We are
working diligently to recruit sites for the pivotal trial, and anticipate
continued positive interest from medical specialists who currently have no
proven method to address the continued high incidence of CIN in their
patients. At the same time, we are also pleased by our progress with
RenalGuard in Europe. We anticipate that the planned Italian clinical trial of
RenalGuard at the Centro Cardiologico Monzino (CCM-University of Milan) will
begin in March, following receipt of final approval from the ethics committee
at the institution. We expect that this effort, under the leadership of two
renowned worldwide experts on CIN, Drs. Antonio Bartorelli and Giancarlo
Marenzi, will provide additional confidence to early adopters who recognize
the potential 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 CIN. This study is expected to
include 120 patients, and compare RenalGuard against overnight hydration, the
prevalent standard of care currently in Europe."
In addition to the CCM study, PLC continues to work towards a limited
launch of RenalGuard in Italy, following receipt of CE Mark certification in
late 2007. The initial launch will focus on early adopters in that country at
approximately 10 sites in Italy. A more expanded all-European Union launch
for RenalGuard is contemplated for 2009.
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 impairment -- 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 and RenalGuard System. In late 2007, the company received
its CE Mark Certificate for 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 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
mtconway@att.net
SOURCE PLC Systems Inc.
Mary T. Conway of Conway Communications, +1-617-244-9682, mtconway@att.net,
for PLC Systems Inc.
