Navigation Links
PLC Announces Ministry of Health Approval to Distribute RenalGuard® in Israel Through A.M.I. Technologies, Ltd.
Date:3/14/2012

MILFORD, Mass., March 14, 2012 /PRNewswire/ -- PLC Systems Inc. (OTC: PLCSF), a company focused on innovative medical device technologies, today announced that it had received approval from the Israeli Ministry of Health to market its innovative RenalGuard System™ in that country.  The company also announced it has signed a distribution agreement with A.M.I. Technologies, Ltd.  Under the terms of the agreement, A.M.I. will be the exclusive distributor of PLC's RenalGuard® in Israel, expanding RenalGuard's distribution to the Middle East.  As part of the agreement, A.M.I. has agreed to purchase an initial stocking order of RenalGuard consoles and single use sets. 

PLC also announced that Dr. Eugenia Nikolsky, Director, Cardiovascular Research Unit, Rambam Medical Center, Haifa, Israel, has successfully completed the first patient case in Israel using RenalGuard for the prevention of Contrast-Induced Nephropathy (CIN).

Dr. Nikolsky, a noted expert on CIN, commented, "RenalGuard offers us a potential method to reduce the incidence of CIN, a major issue when performing interventional procedures requiring contrast agents with high-risk patients.  I am very pleased to have the opportunity to utilize RenalGuard Therapy®, especially after seeing the positive results presented in both the REMEDIAL II and MYTHOS trials, and look forward to continued use of the system."

"Today's news enables PLC to expand the use of RenalGuard into the Middle East," said Mark R. Tauscher, President and Chief Executive Officer of PLC Systems. "A.M.I. is an established, successful distributor and will help in our efforts to increase worldwide adoption of RenalGuard. Many Israeli cardiologists, such as Dr. Nikolsky, are considered thought leaders in interventional cardiology worldwide. Our success in receiving approval to market RenalGuard in Israel should help us continue to drive adoption of RenalGuard worldwide."

PLC already has distribution agreements for RenalGuard in Germany, France, Italy, Spain, Portugal, The Netherlands, Austria, Belgium, Croatia, Luxembourg, Monaco and Switzerland in Europe, as well as in select other countries around the world. PLC's U.S. pivotal trial of RenalGuard, which is required to secure approval from the U.S. Food & Drug Administration to market and sell RenalGuard in the U.S., began in late 2011.

About PLC Systems

PLC Systems Inc., headquartered in Milford, 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 cardiac and vascular 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 U.S. clinical trial for RenalGuard may not be completed in a timely fashion, if at all, or, if this clinical trial is completed, it may not produce clinically significant or meaningful results, the RenalGuard product may not be commercially accepted, operational changes, the need for additional financing, 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 on file with the SEC.

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

Contact:

Mary T. Conway

 

508-520-2545

 

mconway@plcmed.com


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

Related medicine technology :

1. CardioInsight Announces Closing of $7.5 Million Equity Financing
2. Generex Subsidiary Antigen Express Announces Publication of Review Showcasing its Proprietary Therapeutic Vaccine Technology in the Journal Vaccine
3. Heborium Group Announces 23% Increase in 1st Quarter 2012 Revenue
4. S1 Pharmaceuticals Announces New Executive Management and Scientific Advisory Board Appointments
5. Sosei Announces Initiation of Phase I Study for SO-1105
6. Prime Therapeutics Announces CareCentered Contract™ with EMD Serono, Inc. for MS Drug Rebif®
7. ThermoGenesis Announces Webcast of Presentation at Roth Capital Conference
8. Patented Protection Against Counterfeit Pharmaceuticals and Retail Fraud. ICAP Patent Brokerage Announces for Auction a Patented System for Verification of Purchase and Product Legality
9. CVS Caremark Corporation Announces Quarterly Dividend
10. SIRO Clinpharm Announces Appointment of Gopakumar Menon as Chief Executive Officer to Lead the Global Clinical Research Organization
11. Gamma Pharmaceuticals, Inc. Announces Key Appointment in Sales and Marketing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... LONDON , January 19, 2017 ... Grothey ; European Oncology & Haematology, 2016;12(Suppl 2):3-8; ... ... http://photos.prnewswire.com/prnh/20151014/276718LOGO) Published recently in ... the peer-reviewed journal from touchONCOLOGY, an article by ...
(Date:1/19/2017)... , Jan. 19, 2017 ViewRay, Inc. ... a federal institution supporting research in Germany ... and patient treatments at the University Clinic Heidelberg as ... The MRIdian Linac program will be headed by ... also heads radiation oncology at the German Cancer Research ...
(Date:1/19/2017)... Calif. , Jan. 19, 2017   Science ... is excited to announce that the first five ... Biology  (RP:CB) have been published in eLife today. ... project represents the first practical evaluation of reproducibility ... in reproducible studies. Unlike other assessments of reproducibility, ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... Source Vitál Apothecary, a skin and ... essential oils, announced the company had a successful visit to the 2017 ECRM Diet, ... gives companies that work in the nutritional, sports and health industries a chance to ...
(Date:1/20/2017)... FL (PRWEB) , ... January 20, 2017 , ... International ... of nutritional and bodybuilding supplements, announced it attended the January ECRM trade show in ... bodybuilder and nutritional scientist who was determined to create a line of products that ...
(Date:1/20/2017)... ... January 20, 2017 , ... “The Angel”: a heartwarming and earnest tale ... each of his children. “The Angel” is the creation of published author, Marjorie Lund-Fontaine, ... City, and impassioned writer. , When asked of her new book, Marjorie says, “‘The ...
(Date:1/20/2017)... ... ... to Christmas:” a beautiful and enchanting tale that teaches children the true meaning of Christmas. ... in Oklahoma City, and a devoted woman of faith. , “Becoming a parent changes ... back of my mind for years, but actually doing it might have been a while ...
(Date:1/19/2017)... ... January 19, 2017 , ... ... E-learning system for Clinical and Regulatory education for Physicians, Physician Advisors, Case ... successful education methodology of Disease Specific Documentation Improvement. , The Aerolib Learning ...
Breaking Medicine News(10 mins):