SOURCE: RenalGuard Solutions, Inc.

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January 04, 2016 10:42 ET

AKIGUARD Trial Demonstrates Significant Reduction in Mortality and Hospital Costs When Using RenalGuard® vs. Standard Therapy

MILFORD, MA--(Marketwired - January 04, 2016) - RenalGuard Solutions™, Inc., an innovative renal protection company, today announced that an investigator-sponsored study (AKIGUARD) reported that RenalGuard Therapy® was more effective than standard therapy in preventing Contrast-Induced Acute Kidney Injury (CI-AKI). A one year follow-up showed that this therapy was also associated with limited chronic kidney disease progression, and major adverse cardiac and cerebrovascular events and hospitalizations. The study, "AKIGUARD (Acute Kidney Injury GUARding Device) trial: in-hospital and one-year outcomes," was published December 15, 2015 in the Journal of Cardiovascular Medicine, by Dr. Tullio Usmiania, Cardiovascular and Thoracic Department, A.O.U. Citta` della Salute e della Scienza di Torino-Molinette, Turin, Italy.

The 113-patient AKIGUARD trial was conducted October 2011 - April 2014, with enrolled patients randomly assigned to either standard therapy (control group) or high-volume forced diuresis with matched hydration administered through RenalGuard® prior to and during coronary angiography/PCI. Post-procedural CI-AKI incidence after coronary angiography/PCI in the two samples differed significantly, with 16/65 (25%) of control group patients developing CI-AKI versus 4/59 (7%) matched hydration group patients. Severe CI-AKI was diagnosed in 5 out of 16 (31%) control group patients against 0 of 4 in the matched hydration group. After one year, four patients in the matched hydration group experienced adverse cardiac and cerebrovascular events vs. 21 patients in the control group. Patients in the control group had 4.9±12.5 days in hospital during the year following their catheterization, while patients treated with RenalGuard during their procedure only required 1.0±3.8 days in hospital, an 80% reduction in hospital stays.

The data from this trial show that high-volume forced diuresis with matched hydration is well tolerated and feasible, and can effectively reduce CI-AKI incidence in high-risk patients undergoing coronary angiography or PCI. The beneficial effects extend to the 1-year follow-up, with improvement in slowing down chronic kidney disease and lessening major adverse cardiac and cerebrovascular events, reducing the number and duration of hospital readmissions.

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. The AKIGUARD study follows a number of other studies that 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, and 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.

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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