PLC's RenalGuard System Used in Two Live Cases That Were Broadcast at TCT 2013 Meeting
Data From Survey Shows Use of RenalGuard as Standard of Care Is Growing in Italy
MILFORD, MA -- (Marketwired) -- 11/05/13 -- PLC Systems Inc. (OTCBB: PLCSF), a company focused on innovative medical device technologies, today announced that its lead product, RenalGuard® System was successfully used in two live cases that were transmitted via satellite to an audience of several hundred interventional cardiologist at the annual Transcatheter Cardiovascular Therapeutics (TCT) 2013 meeting in San Francisco last week. This marks the first time PLC's RenalGuard System was demonstrated on a live case at TCT. TCT is the world's largest educational meeting focused on interventional cardiovascular medicine and showcases the latest advances in current therapies and clinical research to improve patient care.
"We are extremely excited, that for the first time, RenalGuard has been showcased in two live cases at TCT," commented, Mark R. Tauscher, President and Chief Executive Officer of PLC Medical Systems. "There is an increased focus on the serious and potentially deadly outcomes associated with contrast-induced Acute Kidney Injury (CI-AKI) and the need for a therapy to reduce the incidence of this condition in at-risk patients. The opportunity to highlight RenalGuard to the interventional cardiovascular community further enhances the awareness of RenalGuard's benefits in addressing CI-AKI."
The first live transmission case occurred at the Tel-Aviv Sourasky Medical Center where RenalGuard System was used to protect the kidneys of a patient with severe aortic stenosis and chronic kidney disease that underwent transcatheter-aortic valve replacement (TAVR) using Medtronic's CorValve. In addition to performing the procedure, Drs. Ariel Finkelstein and Eyal Ben-Assa described the ongoing study at their center where RenalGuard is being used to prevent CI-AKI in patients undergoing TAVR.
The second live transmission case occurred at the ICPS Institut Hospitalier Jacques Cartier in Massy, France. In this case, Dr. Lefeve was performing a stent procedure on a patient with chronic kidney disease and RenalGuard System was used to protect the patient from developing CI-AKI. Throughout the procedure, RenalGuard created and maintained high urine flow rates to rapidly clear the renal toxins and avoid injury to the patient's kidneys.
Also at the TCT meeting, data supporting the increased use of RenalGuardTherapy® as standard of care was presented during a session entitled, Focus on Chronic Kidney Disease and Contrast-Induced Nephropathy. Professor Antonio Bartorelli, principal investigator of the MYTHOS trial, conducted a survey among Italian Cardiologists to better understand how they protect their patients from CI-AKI. Based on his findings, Dr. Bartorelli reported that the use of RenalGuard to protect patients at-risk of CI-AKI is growing among Italian Cardiologist. The survey was conducted by the Italian Society of Invasive Cardiology (GISE).
Mr. Tauscher continued, "We are grateful for the support our RenalGuard System is receiving from the Italian Cardiology community. Data from our MYTHOS and REMEDIAL II trials conducted in Italy showed that patients treated with RenalGuard had a lower incidence rate of CI-AKI compared with those treated with the current standard of care. With this data and the continued enthusiasm of Dr. Bartorelli and Dr. Carlo Briguori, principal investigator of the REMEDIAL II trial, we intend to continue to expand the awareness and use of RenalGuard throughout Europe."
About PLC Systems Inc.
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 rapidly remove contrast dyes that are potentially toxic to 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 Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard is being studied in a pivotal trial in the U.S., as part of the FDA approval process. For more information, visit www.plcmed.com, or connect with the Company on Facebook, Twitter, LinkedIn, YouTube and Google+.
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, 2012, 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.
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Source: PLC Systems Inc.
Released November 5, 2013