RenalGuard System Demonstrates Promising Results from First-in-Man Studies to Evaluate Technology for Heart Failure Patients

MILFORD, Mass.–(BUSINESS WIRE)– RenalGuard Solutions, Inc., a medical device company focused on innovative technologies for the cardiac and vascular markets, today reported positive results from a first-in-man feasibility study focusing on a novel use of the RenalGuard System^® to manage fluids during diuretic therapy in congestive heart failure patients suffering from fluid overload. The results were recently presented at the annual Devices in Heart Failure (D-HF) congress in Berlin, Germany, by Prof. Piotr Ponikowski, M.D., of the Wroclaw Medical University, Poland, and Prof. Felix Mahfoud, M.D., of the Saarland University Hospital, Homburg, Germany.

The presentation reviewed the ways in which current treatment strategies for hospitalized patients with heart failure remain inadequate. Annual hospitalizations for heart failure exceed one million in both the United States and Europe, and more than 90% are due to symptoms and signs of fluid overload. Recurrent fluid overload in heart failure patients has uniformly been associated with worse outcomes independent of age and renal function; 25% of hospitalized patients will be re-hospitalized within three months, with a one-year mortality rate of 26%.

The presenters also identified the drawbacks of diuretic therapy, the cornerstone therapy for fluid overload, which acts primarily by inducing fluid loss. An individual patient’s response to diuretic therapy is often variable and unpredictable. If the patient sees excessive urine output due to the diuretic, this rapid fluid loss can induce a condition termed “diuretic resistance,” which blunts the continued function of diuretics and may result in acute kidney injury.

Originally developed for the treatment of contrast-induced acute kidney injury (CI-AKI), RenalGuard Therapy^® offers a potential solution to improve the impact of diuretic therapy in the treatment of fluid overload in heart failure patients. The results presented at D-HF followed the treatment of 10 diuretic resistant patients with heart failure symptoms receiving diuretic therapy while their fluid management was controlled by the RenalGuard System.

“None of the patients we treated experienced a fluid loss rate greater than the settings we established,” said Prof. Ponikowski, who also serves as the Chairman of the European Society of Cardiology 2016 Heart Failure Guidelines Committee. “RenalGuard Therapy is remarkably simple and safe, and works automatically to carefully achieve and control the desired fluid balance.”

The RenalGuard System measures the patient’s urine output, then infuses a volume of saline to maintain the desired fluid balance. The clinician can set a maximum fluid loss rate, beyond which RenalGuard will not allow the patient’s fluid balance to drop, thus limiting the potential of excessive fluid loss. This may allow clinicians to increase the dose of diuretic without increasing the risk of diuretic resistance.

“There is a clear unmet clinical need for alternative methods of fluid removal with superior efficacy in patients with heart failure. This first-in-man study demonstrated that RenalGuard can safely be used in these patients while maintaining the proper conditions to both prevent diuretic resistance, and increase the removal of excess fluid from the patient,” said Prof. Mahfoud. “Our initial experience with the RenalGuard System in heart failure patients is very promising, and we look forward to advancing our understanding of the benefits of this therapy to patients at risk.”

“These presentations demonstrate that the RenalGuard Therapy is a viable potential treatment for patients suffering from fluid overload from congestive heart failure,” said Jim Dillon, CEO of RenalGuard Solutions. “The results add to a growing body of evidence supporting the use of RenalGuard as a platform technology to improve cardiac and renal care for a wide range of patients, including cath lab, cardiac surgery, and now congestive heart failure.”

The RenalGuard System is CE-marked and commercially available in Europe. A pivotal study is underway in the United States to support a planned Premarket Approval filing with the U.S. Food and Drug Administration in 2018 for the prevention of CI-AKI.

Key members of RenalGuard Solutions, Inc. will be attending the upcoming J.P. Morgan Annual Healthcare Conference in San Francisco and the Leipzig Interventional Course (LINC) in Leipzig, Germany.

About RenalGuard Therapy

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 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. Two meta-analysis of these results (Putzu and Mattathil) found RenalGuard consistently reduced kidney injury, dialysis, adverse events and mortality 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. The company’s lead product, RenalGuard^®, is designed to protect patients from acute kidney injury (AKI), including contrast-induced AKI. Investigator-sponsored studies in Europe have demonstrated RenalGuard’s effectiveness at preventing CI-AKI in at-risk patients. RenalGuard is CE-marked and is sold in Europe and certain countries around the world via a network of distributors. The CIN-RG RenalGuard pivotal study is underway in the United States to support a planned Premarket Approval filing with the U.S. Food and Drug Administration in 2018. For further information, please visit the company’s website at http://www.renalguard.com.