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:4/27/2016)... PARIS , le 27 Avril 2016 /PRNewswire/ ... chiffre d,affaires a progressé de +5% sur le ... ventes récurrentes de consommables  Croissance de ... Mauna Kea Technologies (Euronext : ... multidisciplinaire d,endomicroscopie confocale laser, annonce aujourd,hui son chiffre ...
(Date:4/27/2016)... 2016   Zillion Group today announced ... platform, which specializes in live video consultation. Turning ... products, Zillion enables companies to realize the true ... take control of their health. ... including one-to-one, group and webcast scheduled or on-demand ...
(Date:4/27/2016)... , April 27, 2016 ... of the  "Global Anesthesia Disposables Market 2016-2020" ... http://photos.prnewswire.com/prnh/20160330/349511LOGO ) ,The global anesthesia disposables ... CAGR of 4.03% during the period 2016-2020.  ... major threat to patients, safety. Organizations like ...
Breaking Medicine Technology:
(Date:4/28/2016)... ... 29, 2016 , ... Sublime Beauty® is offering a special deal on its webstore. , Buy ... discount is applied to the product with lesser value. In addition, a free bonus ... or more in products. , "So many women (men, too) love our products and get ...
(Date:4/28/2016)... , ... April 28, 2016 , ... ... the world stage this week. A group of researchers and leaders from Sanford ... Progress of Regenerative Medicine and Its Cultural Impact ” and receive the 2016 ...
(Date:4/28/2016)... ... April 28, 2016 , ... La Sirena Foods provides premium ... Central America and is looking to grow their market share in the USA. , ... brand as La Sirena Foods and indirectly with Otis McAllister , ...
(Date:4/28/2016)... ... , ... Head Over Heels Athletic Arts’ gymnast, Brooklyn Varize, has qualified to ... at the University of Montana on April 28-May 1. Varize will compete on Saturday ... order to qualify, Varize needed to place top seven all-around in her respective age ...
(Date:4/28/2016)... ... April 28, 2016 , ... ... availability of a new CDISC standard, Clinical Trial Registry (CTR) XML. Clinical ... innovative standard will make it possible to build applications that generate submissions ...
Breaking Medicine News(10 mins):