PLC Systems, Inc. Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.
The FDA also approved PLC's request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are very pleased with the FDA's full approval to the Investigational Device Exemption (IDE) supplement we filed in February to study RenalGuard in the U.S. While we have deferred the onset of the trial pending receipt of funding to complete it, the investigator-sponsored clinical trial at the Cardiologico Centrino Monzino (CCM) - University of Milan in Italy is continuing, as are our commercialization efforts in Europe, under the CE Mark we received in late 2007. Full FDA approval of the IDE supplement is another major milestone on our path forward to commercializing RenalGuard(TM) in the U.S., and with its receipt, we are well-positioned to begin the trial with our targeted study sites, once we have the needed funding."
Mr. Tauscher added, "We remain very confident that RenalGuard is a highly promising therapy addressing a large, unmet market need. We are optimistic that the results from the CCM study will provide critical validation for our technology, and support our efforts to raise funding for the U.S. pivotal study as well."
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. The Company's U.S. pivotal study, under the supervision of principal investigators Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine, is designed as a randomized controlled trial at up to 30 sites in the U.S. Enrollment in the trial will now include 406 patients.
Contrast-Induced Nephropathy
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. 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%.
About RenalGuard
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.
PLC's newest product, RenalGuard, is approved for sale in the EU as a general fluid balancing device. The RenalGuard System consists of a unique, proprietary, closed loop, software-controlled console and accompanying single-use sets that can be used by physicians and nurses to balance patient fluid levels during a variety of medical procedures. With its automated matched fluid replacement capability, RenalGuard is intended to minimize the risk to patients of over- or under-hydration while also largely eliminating what can be an intensive and time consuming manual fluid balancing task for physicians and nurses.
Headquartered in Franklin, Massachusetts, 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 C02 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 distribution within the EU.
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 be able to obtain funding sufficient to conduct our pivotal trial and additional risk factors described in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2008, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC and CO2 Heart Laser, and RenalGuard are trademarks of PLC Systems Inc.
Contact: Mary T. Conway Conway Communications 617-244-9682 mtconway@att.net
Source: PLC Systems Inc.