Navigation Links
PLC Ramps Up for U.S. Clinical Trial of RenalGuard®
Date:6/2/2011

FRANKLIN, Mass., June 2, 2011 /PRNewswire/ -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that it is preparing to commence the pivotal trial in the U.S. for the company's innovative product, RenalGuard®, to seek approval for sales and marketing in the U.S. from the U.S. Food & Drug Administration.  RenalGuard has already obtained the CE Mark in the European Union.

As part of this effort, the company has added Roxana Mehran, MD, Professor of Medicine at Mount Sinai School of Medicine, as a Principal Investigator for the trial, joining Charles Davidson, MD, Professor of Medicine, Northwestern University Medical School and Richard J. Solomon, MD, Professor of Medicine, University of Vermont College of Medicine.  Dr. Mehran is well known worldwide for her work and leadership in the field of CIN prevention. She is internationally recognized for her work as a clinical trial specialist with complex data analyses and outcomes research within the field of interventional cardiology. She is recognized for her experience and expertise in working with regulatory agencies to conduct clinical trials.

Said Mark Tauscher, President and CEO, "We look forward to the commencement of our U.S. pivotal trial for RenalGuard.  This trial will be conducted to test the effectiveness of RenalGuard and the associated RenalGuard Therapy® in reducing the incidence of Contrast-Induced Nephropathy (CIN) in at-risk patients.  The Italian investigator-sponsored REMEDIAL II and MYTHOS clinical trial results have demonstrated meaningful reduction of CIN in at-risk patients using RenalGuard.   Dr. Mehran is a noted expert in the field of CIN prevention, and her clinical trials expertise will prove to be extremely valuable moving forward. We are working diligently to lay the foundation for the first patient enrollments for the U.S. pivotal trial for RenalGuard."  

RenalGuard has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures.  The RenalGuard System™ consists of a patented closed loop, software-controlled console and proprietary single-use sets that physicians and nurses use for automated matched fluid replacement to minimize over- or under-hydration of patients during medical procedures where creating and maintaining high urine outputs is beneficial.  

About PLC Systems Inc.

PLC Systems Inc., headquartered in Franklin, Mass., is a medical device company focused on innovative technologies for the cardiac and vascular markets. PLC's newest product, RenalGuard, has been developed to help prevent the onset of Contrast-Induced Nephropathy (CIN) in at-risk patients undergoing certain imaging procedures.  The Product is CE-marked and is being marketed in Europe and selected countries around the world. Two investigator-sponsored European studies have demonstrated RenalGuard's effectiveness at preventing CIN.  RenalGuard is being studied in a pivotal trial in the U.S., as required for approval by FDA.

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 current  clinical trials in Italy and the planned future U.S. clinical trial for RenalGuard 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 the "Forward Looking Statements" section of our Annual Report on Form 10-K for the year ended December 31, 2010, a copy of which is filed with the SEC.

PLC Systems, PLC Medical Systems, PLC, RenalGuard and RenalGuard System are trademarks of PLC Systems Inc.

Contact:  Mary T. Conway
Conway Communications
508-520-2545
marytconway@comcast.net


'/>"/>
SOURCE PLC Systems Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Lloydspharmacy Reveals Couples Beleaguered by Monthly Cramps
2. FDA Consumer Health Information: Using Malaria Medication For Leg Cramps Is Risky
3. Salt Lake City Medical Research Center Tests New Drug To Treat Painful Menstrual Cramps
4. Safe Life Ramps Production Capacity of Comfortable, Breathable N95 Respirator Amid Worldwide Shortage
5. Bionovo to Present the Clinical Promise of Menerba (MF101) for Postmenopausal Vasomotor Symptoms at World Congress on Menopause
6. Translational Sciences Corporation to Launch OncoTrac™ at the American Society of Clinical Oncology (ASCO) Annual Meeting
7. Argos Therapeutics Arcelis™ Immunotherapy for the Treatment of Renal Cell Carcinoma (RCC) in Combination With Sunitinib Demonstrates Strong Immunologic Response That Correlates to Improved Clinical Outcomes
8. Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity
9. United Kingdoms National Institute for Health and Clinical Excellence Issues Guidance on Percutaneous Tibial Nerve Stimulation for Faecal Incontinence
10. Reportlinker Adds Time and Cost Reduction in Clinical Trials- Outsourcing and IT to Optimize Patient Recruitment, Logistics, Data and Site Management
11. Cancer Research UK Signs Deal With Centella Therapeutics, Inc. to Launch Clinical Development of Radiotherapy-Enhancing Drug
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... Israel , May 4, 2016 ... today that BiondVax,s CEO, Dr. Ron Babecoff , will ... New York City . On Thursday, ... Pioneers 2016, a conference presented by Joseph Gunner ... The BiondVax presentation that Dr. Babecoff will be ...
(Date:5/4/2016)... D.C. , May 4, 2016 ... member companies concluded a series of free workshops ... in global requirements for Good Distribution ... of quality assurance which ensures that products are consistently stored, ... the marketing authorization (MA) or product specification. Only a ...
(Date:5/4/2016)... 2016 Research and ... Acute Ischemic Stroke Market and Competitive Landscape ...      (Logo: http://photos.prnewswire.com/prnh/20160330/349511LOGO ... Stroke Market and Competitive Landscape Highlights 2016, ... pipeline products, Acute Ischemic Stroke epidemiology, Acute ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... NCPDP ... opened on Tuesday with Frank Luntz, sharing a dynamic, bi-partisan environmental scan of ... deep dive on NCPDP’s model solution to help stem the tide of the ...
(Date:5/4/2016)... ... May 04, 2016 , ... The RIDER Institute announces ... of DRACO broad-spectrum antiviral therapeutics. DRACOs have proven effective against all 18 viruses ... 2016 at http://igg.me/at/EndTheVirus and runs for 60 days, we are raising ...
(Date:5/4/2016)... ... May 04, 2016 , ... a2z, ... Society™ and Canadian Association for Enterostomal Therapy (CAET) will be utilizing powerful ... planning tools to attendees and exhibitors for the 2016 WOCN Society & CAET ...
(Date:5/4/2016)... , ... May 04, 2016 , ... May kicked off ... people across the United States. Dermatologist Dr. Ellen Turner is encouraging her patients, as ... advice and focus on skin safety and health now and in the future. , ...
(Date:5/4/2016)... MO (PRWEB) , ... May 04, 2016 , ... Recognizing ... newly launched health brand, Verywell, have tapped David Katz, MD, MPH, president ... , “Our shared devotion to lifestyle medicine is especially gratifying,” said Katz. “There ...
Breaking Medicine News(10 mins):