Healthcare Industry News: RenalGuard Therapy
News Release - March 28, 2008
PLC Systems Announces First International Distribution Agreement for RenalGuard(TM)Agreement Includes First Order for RenalGuard
FRANKLIN, Mass., March 28 (HSMN NewsFeed) -- 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.
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 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.
Source: PLC Systems
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