MILFORD, MA--(Marketwired - October 16, 2013) - PLC Systems Inc. (PLCSF), a company focused on innovative medical device technologies, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the initiation of a clinical trial in Japan using RenalGuard Therapy®. The Japanese MHLW granted this approval after reviewing previously published studies of RenalGuard Therapy and data from two cases where Japanese physicians used RenalGuard® to protect patients at risk of Contrast-Induced Acute Kidney Injury (CI-AKI). RenalGuard is currently CE-Marked and being distributed throughout Europe to prevent AKI.
"We are very excited to begin clinical studies with RenalGuard in Japan," commented Mark R. Tauscher, President and Chief Executive Officer of PLC Medical Systems. "The Japanese market has the potential to be the second largest market in the world for RenalGuard, based upon the number of cath lab procedures and patients undergoing these procedures with existing at-risk conditions for CI-AKI. Once the study is concluded, the results will be submitted to the Japanese MHLW as part of a package for shonin approval from the agency. Completion of this process, if successful, would allow the importation of RenalGuard for sales and marketing in Japan."
This single-arm clinical trial is designed to enroll 60 patients at two sites. The objective of the study is to evaluate the ability of RenalGuard Therapy to reduce the incidence of CI-AKI in at risk patients when compared to the expected rate of CI-AKI. The study will enroll patients with pre-existing kidney dysfunction that are undergoing a catheterization procedure using contrast dye. The primary endpoint is combined incidence of CI-AKI and serious in-hospital therapy-related adverse events compared to the expected rate based on the patients' risk factors.
Dr. Ichiro Michishita, a leading Japanese cardiologist and expert in CI-AKI, has successfully completed two cases utilizing RenalGuard for the prevention of CI-AKI at Yokohama Sakae Kyosai Hospital, Yokohama, Japan, where Dr. Michishita serves as Director of the hospital's Cardiovascular Division.
In regards to the two cases, Dr. Michishita previously commented, "I am very pleased that the very first cases utilizing RenalGuard in Japan to prevent CI-AKI were successful. I am very impressed with the ease of use of the system, and how it works to maintain the fluid balance of the body. Once it is approved by the MHLW, I believe that RenalGuard will be a great benefit for patients undergoing PCI requiring contrast media."
Dr. Michishita worked with the Japanese MHLW to outline a process for RenalGuard evaluation and approval in Japan. Following the initial two cases, Dr. Michishita met with the MHLW to present his findings and request approval for the initiation of this 60-patient study.
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.