FRANKLIN, Mass., October 24, 2006 --- PLC Systems Inc. (Amex: PLC), a company focused on innovative cardiac and vascular medical device-based technologies, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a conditionally approved investigational device exemption (IDE) to conduct a pilot clinical trial to evaluate the safety of the Renal Guard™ system and its ability to accurately measure and balance fluid inputs and outputs on patients undergoing a catheterization procedure where contrast media will be administered.
The initial trial will be limited to 40 patients at up to four clinical sites in the U.S. PLC expects its first patient enrollment in the trial in early November, pending final approval by the Institutional Review Board (IRB) at the selected investigator sites.
“We are very pleased to have received permission to begin the study from the FDA as it is a key milestone in our product development plan for this critical technology,” stated Mark R. Tauscher, President and CEO of PLC Systems Inc. “We plan to move ahead with this initial human clinical trial utilizing our Renal Guard system and we expect to collect sufficient data to fully design our planned multi-center, U.S. pivotal trial which we hope will commence in 2007.”
PLC hopes to be able to demonstrate through its future clinical trials that its Renal Guard therapy effectively limits kidney exposure to toxins in contrast media by generating a high urine flow in treated patients. Renal Guard is a fully-automated, real-time fluid measurement and replacement system intended to provide balanced replacement hydration therapy to high risk patients undergoing imaging procedures where contrast agents are administered. The real-time measurement and matched fluid replacement ability of the Renal Guard system is designed to ensure a patient is kept appropriately hydrated during interventional cardiology or radiology procedures where contrast agents are routinely administered. It is estimated that more than 7 million such procedures are performed annually on a worldwide basis.
Contrast Induced Nephropathy
A significant adverse effect of contrast agents is Contrast Induced Nephropathy (CIN), a form of Acute Renal Failure. For at-risk patients, CIN can lead to prolonged hospital stays, extended intensive care unit stays, dialysis, increased mortality and significantly higher healthcare costs.
“Studies indicate that approximately 15 percent of all patients undergoing image guided cardiology and radiology procedures, or almost 1 million people annually, are at risk of developing CIN,” continued Tauscher. “We believe the growth of less invasive, image-guided procedures that require a contrast agent will only increase the total number of at-risk patients.”
Following the first patient trial in November 2006, PLC plans to seek FDA approval to initiate a U.S. multi-center randomized clinical trial to demonstrate the system’s ability to help protect high risk patients from developing CIN as a result of contrast media used during their diagnostic and interventional procedures. This trial is expected to begin in 2007 and continue through 2008. PLC is targeting its U.S. commercial launch in late 2008 or early 2009, subject to the receipt of necessary regulatory approvals. The company hopes to obtain CE Mark approval in the first half of 2007, which PLC expects would lead to commercial launch in Europe in the summer of 2007.
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. Coronary artery disease is expected to increase as the worldwide population continues to age. Working with leading researchers and premier heart centers around the world, PLC developed the CO2 Heart Laser, which is the world's first TMR angina relief device approved by both the U.S. Food and Drug Administration and Japanese Ministry of Health, Labor and Welfare. In a move to broaden its market, the company recently announced its intention to initiate clinical studies for Renal Guard, a fully-automated, real-time fluid measurement and replacement system intended to provide balanced replacement hydration therapy to high risk patients undergoing imaging procedures where contrast agents are administered.
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 Renal Guard product, the clinical trials for that product may not be successful, the Renal Guard 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, 2005, and our other SEC reports.
PLC Systems, PLC Medical Systems, PLC, CO2 Heart Laser and Renal Guard are trademarks of PLC Systems Inc.