RenalGuard Clinical Data Presented at International Conference of the Israel Heart Society
MILFORD, MA--(Marketwired - May 07, 2013) - PLC Systems Inc. (
Dr. Eyal Ben-Assa of Tel Aviv Medical Center presented a poster reporting the results from 25 patients using RenalGuard® at his center.
Dr. Ben-Assa commented, "Our experience with RenalGuard, as reported in our paper, has been very positive. The incidence of CIN is much lower than would otherwise be expected and there was no need for dialysis among this very high risk patient population. Based on these results, RenalGuard has become the standard of care for at-risk patients at our center."
Also at the conference, Dr. Eyal Nacum of Sheeba Hospital in Petah Tikvah presented at a session entitled, "Incidence of Acute Kidney Injury in the Patients Undergoing Surgical TAVI". Dr. Nacum's presentation included reports of his initial experiences using RenalGuard in patients undergoing Surgical Transcatheter Aortic Valve Implantation (TAVI) to protect them from acute-kidney injury (AKI).
Mark R. Tauscher, President and CEO of PLC Medical commented, "Dr. Nacum's experience using RenalGuard in TAVI patients is an important contribution supporting the need to protect TAVI patients from AKI. TAVI is a large and growing market for RenalGuard. A number of clinical trials have shown that patients who undergo TAVI have significantly improved outcomes overall. It has also been reported that many TAVI patients develop AKI, and these patients go on to have increased mortality and longer hospital stays, thereby diminishing the benefits of the groundbreaking procedure. We believe that RenalGuard has the potential to protect TAVI patients from acute kidney injury and help them to enjoy the full benefits of the TAVI procedure."
Transcatheter aortic valve implantation (TAVI) is a non-surgical method for replacing diseased aortic valves in patients where conventional open heart surgery is not an option. Until a few years ago, there were no therapeutic options for these patients. The procedure involves inserting a replacement valve into the heart where the failing valve is pushed out of the way and replaced.
RenalGuard therapy is designed to rapidly remove contrast dyes that are potentially toxic to patients with impaired kidney function. Contrast dyes are used in many cardiovascular diagnostic and interventional imaging procedures to facilitate the capture and display of x-ray images. Approximately 10% to 20% of patients that undergo these procedures are at-risk of developing Contrast-Induced Nephropathy (CIN), a form of acute kidney injury resulting from toxic contrast dye. No other product on the market has been shown to consistently reduce the incidence of CIN. In two investigator-sponsored clinical trials, RenalGuard Therapy has reduced the incidence of acute renal failure. We believe that RenalGuard may help reduce morbidity and mortality, as well as hospital costs for the high-risk patients.
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 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. PLC is conducting a pivotal clinical study to assess the safety and effectiveness of RenalGuard in reducing the rates of Contrast-Induced Nephropathy (CIN) in at-risk patients to potentially obtain U.S. Food and Drug Administration (FDA) pre-market approval in order to market RenalGuard in the United States.
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.