News Release

CHF Solutions and RenalSense Enter Distribution Partnership to Offer Ultrafiltration and Real-Time Renal Diagnostics

July 8, 2020

EDEN PRAIRIE, Minn., July 08, 2020 (GLOBE NEWSWIRE) -- CHF Solutions (Nasdaq: CHFS) and RenalSense, Ltd., today announced the signing of a distribution agreement to offer complementary solutions for fluid management. The agreement allows CHF Solutions to market and sell RenalSense’s Clarity RMS™ (real-time monitoring system) in certain U.S. territories.  Clarity RMS is a critical care monitoring system that continuously measures urine flow rates and automatically transmits real-time data and fluctuation notifications to medical staff on a 24/7 basis. This information reflects changes in renal function and provides an early sign of acute kidney injury (AKI) risk, enabling rapid intervention with therapeutic solutions such as CHF Solutions’ Aquadex SmartFlow™ ultrafiltration system.

Fluid overload (hypervolemia) is a major issue among critically ill children and adults, including patients hospitalized with COVID-19, heart failure and kidney disease. When untreated, it can lead to AKI, which is associated with longer length of hospital stays, increased costs and high mortality rates and complications.1,2,3 Early identification and treatment of fluid overload and AKI is vital for reducing mortality, complications and costs.

Clarity RMS and the Aquadex SmartFlow system offer complementary solutions for clinicians to quickly and effectively manage fluid overload in patients. Clarity RMS provides continuous, automatic monitoring of urine flow rates to provide essential information that can help identify AKI earlier, giving providers insight that can prompt early intervention with fluid management therapies. The Aquadex SmartFlow system offers a simple, flexible and smart method for removing excess fluid in patients to help mitigate adverse outcomes related to hypervolemia.

“At CHF Solutions, we continue to evaluate innovative products and tools that advance the quality of care clinicians can offer their patients,” said John Erb, CEO of CHF Solutions. “Early intervention saves lives, and RenalSense has developed a solution that allows healthcare providers to initiate preventive clinical action early. Partnering with RenalSense demonstrates our commitment to collaboration and improving patient care.”

"Our common goal is for urine output and fluid status to be electronically monitored in real-time, as is the standard practice for other vital signs in the OR and ICU.” said Avi Kleiman, CEO of RenalSense. “With help from CHF Solutions, we can expand distribution of Clarity RMS in the U.S. and bring monitoring of real-time urine output to physicians and medical staff treating fluid-overloaded patients.”


About the Aquadex SmartFlow System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).  The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics.  All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

About Clarity RMS
Clarity RMS is a critical care monitoring system that continuously measures urine flow, automatically transmitting to the medical staff real-time data, and notifications of fluctuations, on a 24/7 basis. This information, which reflects changes in renal function, provides an early sign of acute kidney injury (AKI) risk and facilitates rapid intervention. In addition, the information is invaluable for monitoring treatment efficacy and managing fluid balance.

About CHF Solutions 
CHF Solutions, Inc. (CHFS) is a medical device company dedicated to changing the lives of patients suffering from fluid overload through science, collaboration, and innovation.  The company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow system for ultrafiltration therapy. CHF Solutions is headquartered in Minneapolis, Minn., with wholly-owned subsidiaries in Australia and Ireland.  The company has been listed on the Nasdaq Capital Market since February 2012.

About RenalSense
RenalSense is a privately owned medical device company dedicated to real-time renal diagnostics. The company's first product, Clarity RMS, provides continuous, automatic monitoring of urine flow, enabling better patient care and ICU economics. RenalSense's next generation products are intended to provide additional real-time parameters and expanded diagnostic capabilities, to further improve critical care management in the ICU and peri-operative setting.

Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements about the distribution partnership and the clinical use of Clarity RMS™.  Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, the risks associated with our expectations regarding the potential impacts of the COVID-19 pandemic on our business operations, the risks associated with our ability to execute on our commercial strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. CHF Solutions does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Claudia Napal Drayton
Chief Financial Officer, CHF Solutions, Inc.

Christopher Strafaci
VP, Sales and Marketing

Jessica Stebing


Source: CHF Solutions, Inc.