Healthcare Industry News: RenalGuard Therapy
News Release - October 22, 2007
PLC Medical Systems to Introduce RenalGuard(TM) at TCT 2007RenalGuard - An Innovative Approach to Preventing Kidney Damage during Imaging Procedures
FRANKLIN, Mass., Oct. 22 (HSMN NewsFeed) -- PLC Systems Inc. (Amex: PLC ), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that it will introduce the RenalGuard System(TM) at TCT 2007, sponsored by the Cardiovascular Research Foundation, October 20-25, 2007, in Washington, DC. This is the first public showing for this technology in the United States.
RenalGuard(TM) is an investigational system and therapy that targets patients with compromised renal function who may be at risk for Contrast- Induced Nephropathy, or CIN, when undergoing cardiovascular imaging procedures. RenalGuard Therapy(TM) is based on initial 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. The RenalGuard System is a fully- automated, real-time matched fluid replacement device intended for the at-risk segment of the millions of interventional cardiology and radiology patients undergoing these procedures.
"We are very pleased to have the opportunity to introduce our innovative RenalGuard System at TCT 2007 this year," stated Mark R. Tauscher, President and CEO of PLC Systems Inc. "TCT is one of the most important meetings in the field of Interventional Cardiology. They have been a leader in bringing the issues of CIN to the medical community. This will be an excellent opportunity for us to meet with a large number of interventional cardiologists who are potential investigators, and we are looking forward to the feedback we will receive on RenalGuard Therapy and the RenalGuard System."
Earlier this year, the company announced the successful enrollment of the first patients in its FDA-approved pilot clinical trial designed to evaluate the safety of its RenalGuard System. Safety results were favorable, and there were no adverse renal events related to the device recorded.
Approximately seven million patients worldwide undergo interventional cardiovascular therapeutic and diagnostic imaging procedures each year. 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%.
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 is currently conducting a pilot clinical safety study of its RenalGuard Therapy 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 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," "estimates," "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 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 Quarterly Report on Form 10-Q for the three months ended June 30, 2007, and our other reports filed with the Securities and Exchange Commission.
PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser, RenalGuard, RenalGuard System and RenalGuard Therapy are trademarks of PLC Systems Inc.
Source: PLC Systems
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