Clinical study and limited launch in Italy continue
FRANKLIN, Mass., July 21 /PRNewswire-FirstCall/ -- PLC Systems Inc. (Amex: PLC) announced today that it will defer the commencement of the U.S. pivotal trial of its RenalGuard(TM) System in the prevention of Contrast-Induced Nephropathy (CIN). The company continues to support the investigator-sponsored clinical trial now ongoing in Milan, Italy as well as the limited market launch of RenalGuard in Europe, which began in the first quarter of this year, both of which are focused on the CIN prevention market.
Mark R. Tauscher, President and Chief Executive Officer of PLC, said, "We are taking this action now because, while we have sufficient funds to commence the U.S. pivotal trial at this time, we believe we will be in a better position to successfully raise the funding necessary to complete the trial and prepare for U.S. market launch in the future, once we have the expected positive clinical data from the study currently underway in Italy at the Centro Cardiologico Monzino-University of Milan (CCM). For these reasons, after consultation with our lead U.S. investigators, we have elected to postpone the start of the U.S. pivotal trial. We anticipate that this deferral will reduce the expected increase in our research and development costs that we had previously estimated for the remainder of 2008, as we lower our expenses associated with clinical trial oversight and management."
Mr. Tauscher added, "In the meantime, we are continuing our dual commercialization strategy for RenalGuard. First and foremost, we are continuing to work with the U.S. Food and Drug Administration to secure a full approval of our RenalGuard study protocol so that we are well-positioned to start the trial with our targeted study sites. We remain very confident that RenalGuard is a highly promising therapy addressing an unmet market need and are optimistic that the results from the CCM study will provide critical validation for our technology.
"In addition, beyond our focus on the CIN market in 2009, with a CE Mark in hand we plan to focus on several new applications for RenalGuard in the European Union (EU) capitalizing on the automated fluid balancing capabilities of our system. Specifically, there are several medical applications, such as cisplatin chemotherapy, where inducing high urine flow rates is beneficial for patients and is a standard of care. High urine flow rates are also frequently seen in post kidney transplant patients, where the careful monitoring and replacement of fluid losses helps avoid the risk of damage to the transplanted kidney. Accurate and timely matching of replacement fluids is important in these instances in order to best preserve and/or optimize kidney function. RenalGuard provides an automated method of measuring urine outputs and then matching these outputs with replacement fluid inputs, eliminating to a large degree what is otherwise an intensive and time-consuming manual balancing task for physicians and nurses in these situations. We plan to aggressively investigate these new market opportunities for RenalGuard throughout the EU in the coming year as part of our broader EU launch."
RenalGuard is designed to reduce the potentially toxic effects that contrast media can have on the kidneys when it is administered to patients undergoing image-guided procedures, such as those performed when placing drug-eluting stents. It is believed that allowing contrast media to dwell in the kidneys can lead to CIN. By inducing and maintaining a high urine flow rate before, during and after these image-guided procedures, it is believed the incidence rates of CIN in at-risk patients can be reduced. RenalGuard facilitates this increased urine clearance enabling the body to more rapidly void the contrast media, thereby reducing its overall resident time and toxic effects in the kidney.
CIN is a major and growing problem worldwide 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 undergo interventional procedures that use radiographic contrast media. 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 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. The RenalGuard System, with its matched fluid replacement capability, is intended to minimize the risk of over- or under-hydration during medical procedures where creating and maintaining high urine outputs is deemed beneficial to patients.
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 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.
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 or that such approvals may be withdrawn, we may be unable to raise sufficient funds in the future to implement our business plan and/or commence our planned U.S. clinical trial for RenalGuard, the current CCM clinical trial and the planned future U.S. clinical trial for RenalGuard as a safe and effective CIN prevention device may not be completed in a timely fashion if at all, or, if these clinical trials are completed, they may not produce clinically significant or meaningful results, 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 Annual 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, and
RenalGuard, are trademarks of PLC Systems Inc.
Contact: Mary T. Conway
|SOURCE PLC Systems Inc.|
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