Navigation Links
PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.
Date:7/21/2008

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."

About RenalGuard

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.

Contrast-Induced Nephropathy

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

Conway Communications

617-244-9682

mtconway@att.net


'/>"/>
SOURCE PLC Systems Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. GeneGo is Awarded NCI Grant for Development of Systems Biology Platform for Integrative Data Analysis in Cancer
2. PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)
3. PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.
4. PLC Systems Reports Fourth Quarter 2007 Results
5. Pharmatech Teams up With Systems Medicine LLC and the Sarcoma Foundation of America for a Phase II Myxoid Liposarcoma Trial
6. PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)
7. PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial
8. Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
9. Imaging Diagnostic Systems CTLM Technology Presented at Congress of World Society for Breast Health
10. BD and PEPFAR Collaborate to Strengthen Laboratory Systems in Fight Against HIV/AIDS and TB
11. Boston Scientific to Release Broad Range of Clinical Trial Data Reinforcing Safety and Efficacy of Taxus(R) Coronary Stent Systems at TCT 2007
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... Mar. 24, 2017 Research and Markets ... the U.S.: Consumer Strategies" report to their offering. ... Pain ... approach and treat their physical pain, emphasizing consumer survey analysis, ... pain sufferers and adults who have selected illnesses/conditions strongly associated ...
(Date:3/24/2017)... NEW YORK , March 24, 2017 /PRNewswire/ ...  a leading organization within medical affairs in the ... as the chair of a newly formed ... additional board members to form the first ever ... For more information about the ACMA, ...
(Date:3/24/2017)... March 24, 2017 FinancialBuzz.com News Commentary  ... According ... of cannabis market research, the legal cannabis market is projected ... 2021, despite conflicting signals from the current presidential administration. The ... the two biggest drivers of growth in this industry are ...
Breaking Medicine Technology:
(Date:3/24/2017)... ... March 24, 2017 , ... In ... innovative EcoQube Frame vertical micro-veggies garden on Kickstarter . Surpassing the $100,000 ... – with nearly 2,000 consumers (and counting) already backing the campaign. , ...
(Date:3/24/2017)... ... 2017 , ... The law firm of Enea, Scanlan & Sirignano, LLP, ... resident Lauren C. Enea has joined the firm as an associate attorney. Ms. Enea, ... in elder law, Medicaid planning and applications, and Wills, Trusts and Estates. Samantha ...
(Date:3/24/2017)... ... March 24, 2017 , ... Judy Buchanan, co-owner of Serenity ... MD. Judy says, “I am passionate about sharing Reiki as a holistic, complementary ... and challenging time.” , A Certified Medical Reiki™ Master trained by Raven Keys ...
(Date:3/24/2017)... ... March 24, 2017 , ... “The Communion of Saints: ... of God in congregations across the United States. “The Communion of Saints” ... 1964 who has served congregations in seven states throughout his long career of ...
(Date:3/23/2017)... ... , ... The physicians of KSF Orthopaedic Center PA are proud to announce ... is located at 2255 E. Mossy Oaks Rd., Suite 440, Spring, Texas 77389 inside ... patients living in the north Houston area (The Woodlands, Conroe, Magnolia, Kingwood, Humble) with ...
Breaking Medicine News(10 mins):