CHF Solutions

About CHF Solutions

CHF Solutions, Inc., now operating as Nuwellis, Inc. (NASDAQ: NUWE) since April 2021, is a medical technology company focused on fluid overload management. Founded in 1999 and headquartered in Eden Prairie, Minnesota, the company has a complex history involving multiple corporate transactions. The original entity was acquired by Gambro in 2010, which was subsequently bought by Baxter International in 2012. In a significant turn of events, the business was re-acquired from Baxter in 2016 for $4 million by a team led by John Erb, who had been the first CEO of the original venture capital-backed startup in 2001. This move re-established the company as an independent, publicly traded entity (NASDAQ: CHFS) and brought manufacturing back in-house to its Minnesota facility.

The company's core business revolves around the development, manufacturing, and commercialization of its Aquadex™ systems—the Aquadex FlexFlow® and the more recent Aquadex SmartFlow®. These systems provide ultrafiltration therapy, a medical procedure that removes excess salt and water from patients suffering from fluid overload, also known as hypervolemia. The therapy is specifically indicated for patients who have not responded to traditional diuretic treatments. The business model is based on the sale of the Aquadex console, a machine roughly the size of a coffee maker, and recurring revenue from single-use, disposable blood circuit sets required for each procedure. The company targets hospitals and clinics, utilizing a direct sales force in the United States and a network of independent specialty distributors for international markets.

The Aquadex SmartFlow® system is designed for precise and predictable fluid removal, with the ability to extract up to 500 mL of excess fluid per hour without significantly impacting the patient's blood pressure, heart rate, or electrolyte balance. Initially focused on congestive heart failure patients, the company has broadened its commercial strategy to include critical care and pediatric patients (weighing 20 kg or more), a shift that prompted the rebranding to Nuwellis. This expansion addresses fluid overload resulting from trauma, burns, and acute kidney injury. Under the leadership of CEO Nestor Jaramillo, Jr., who joined in 2019, the company has focused on expanding its therapeutic applications and market access, including pushing for use in outpatient settings to reduce costly hospital readmissions.