PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial
29 Novembro 2007 - 11:05AM
PR Newswire (US)
FRANKLIN, Mass., Nov. 29 /PRNewswire-FirstCall/ -- PLC Systems Inc.
(AMEX:PLC) today reported that it has discussed the results of its
pilot safety study of the RenalGuard System(TM) and Therapy with
the U.S. Food and Drug Administration. Based upon the positive
safety data already collected in the pilot study and its
discussions with FDA, PLC has stopped enrolling new patients in the
pilot study and will submit a request to transition into a new
pivotal trial protocol. The pilot trial was originally designed as
a safety study for up to 40 patients; PLC has successfully enrolled
and treated 23 patients in the pilot study at five approved sites
to date. The company concluded that finishing the total planned
enrollment was now unnecessary based upon the initial review of
safety data already obtained. Mark R. Tauscher, president and chief
executive officer of PLC Systems, said, "We are very pleased with
the successful early conclusion to our pilot safety trial. This
enables us to move forward expeditiously with our planned pivotal
trial for this innovative therapy. Our pivotal trial is expected to
be a multi-center, randomized controlled study designed to
demonstrate that RenalGuard is effective in reducing the incidence
of Contrast-Induced Nephropathy (CIN) in at-risk patients
undergoing cardiovascular imaging procedures. The results from this
pivotal trial will be used to support the regulatory approval
process needed to market RenalGuard as a CIN prevention device. We
expect to enroll patients at up to 30 sites throughout the country
in this trial." He added, "With the number of cardiovascular
imaging procedures expected to grow in the future and more patients
being deemed at risk of CIN due to underlying health conditions, we
believe the need for a product such as RenalGuard is more critical
than ever in preventing this expensive and potentially life
threatening condition." 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 has been conducting 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,
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,
Web site: http://www.plcmed.com/
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