SOURCE: RenalGuard Solutions, Inc.

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October 28, 2016 08:00 ET

Increased Focus on RenalGuard® and the Prevention of Contrast-Induced Nephropathy at Transcatheter Cardiovascular Therapeutics 2016

MILFORD, MA--(Marketwired - October 28, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that its innovative RenalGuard System™ will be presented at two sessions during Transcatheter Cardiovascular Therapeutics (TCT), the annual meeting of the Cardiovascular Research Foundation, and the premier conference on interventional vascular medicine. The meeting takes place October 29 - November 2, 206 in Washington, DC. More than 11,000 clinicians and professionals are expected to attend this event. RenalGuard® will also be featured in the exhibit hall in booth 1554.

RenalGuard® will be included as part of a sponsored breakfast session on Contrast-Induced Acute Kidney Injury (CK-AKI) on Sunday, October 30, 6:30 AM. The event, Contrast-Induced Acute Kidney Injury: Focus on Hydration and Dye Saving, features some of the world's top CI-AKI experts discussing their research and experience around protecting patients from this damaging condition. Data from a number of clinical trials, utilizing a variety of different therapies will be discussed. The session is chaired by Roxana Mehran, MD, FSCAI, Mount Sinai Medical Center, New York. More information and registration details are available at www.crf.org/tct/agenda/satellite-programs?programid=220.

On Tuesday, November 1, RenalGuard will be featured as part of the Hot Topic Lunch, Focus on Chronic Kidney Disease and Contrast Nephropathy. The session, moderated by Richard Solomon, MD and Somjot S. Brar, MD, features a set of topics related to treating cardiovascular patients with chronic kidney disease to reduce the incidence of mortality and morbidity and preventing the incidence of CI-AKI in high-risk patients during cardiovascular procedures. The discussion panel is made up of experts in both cardiology and nephology, including: Antonio L. Bartorelli, MD, Carlo Briguori, MD, Anuj Gupta, MD, Roxana Mehran, MD, and Anand Prasad, MD.

"Awareness of the clinical and economic impact of Contrast-Induced Acute Kidney Injury continues to rise," said Andrew Halpert, President, RenalGuard Solutions, Inc. "The inclusion of two sessions on CI-AKI demonstrates the robust interest in kidney protection by the leading physicians in the field. We look forward to the discussion of fascinating new results during the meeting. This new data will bring the total number of positive RenalGuard clinical trials to seven, providing what we believe to be overwhelming evidence of the ability of RenalGuard to protect patients at risk of acute kidney injury following interventional cardiology procedures. We look forward to hearing from clinicians about how they treat patients at high-risk of CI-AKI and the potential for RenalGuard to address this important and growing patient population."

To date, 1455 patients have been included in seven published trials that have all demonstrated the safety and efficacy of RenalGuard in preventing Contrast-Induced Acute Kidney Injury. Over 10,000 procedures using RenalGuard have been performed worldwide. A major pivotal trial is currently underway in the United States.

RenalGuard measures a patient's urine output and automatically infuses hydration fluid based on that urine output. The system is designed to induce high urine rates, which have been shown to protect the kidney from a range of insults. A number of clinical studies have demonstrated RenalGuard's ability to protect patients from AKI following catheterization procedures when compared to the standard of care, including: MYTHOS, which found RenalGuard to be superior to overnight hydration; REMEDIAL II, which found RenalGuard to be superior to sodium bicarbonate hydration; Protect-TAVI, which reported a significant reduction in post-procedural acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR) when using RenalGuard during the procedure, compared to standard therapy; and AKIGUARD, which showed significant improvement in long-term outcomes when using RenalGuard vs. standard therapy.

About RenalGuard Solutions, Inc.

RenalGuard Solutions, Inc. is a medical device company focused on innovative technologies for the cardiac and vascular markets. Our lead product, RenalGuard, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Two investigator-sponsored studies in Europe have demonstrated RenalGuard's effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is being sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the U.S. to support a planned Premarket Approval filing with the U.S. Food and Drug Administration. For further information, please visit the website at www.RenalGuard.com.

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