CHF Solutions (NSDQ:CHFS) said yesterday that a U.S. Veterans Administration hospital in Florida received approval to begin an outpatient study using its Aquadex FlexFlow system for fluid overload in patients with heart failure.
The study, approved by Tampa’s James Haley Veterans’ Hospital & Clinics institutional review board, will be the first of its kind to run exclusively through the VA.
In July 2018, the department awarded a blanket purchase agreement worth up to $6.5 million for CHF Solutions to supply the Aquadex FlexFlow system for a period of up to five years.
Eden Prairie, Minn.-based CHF Solutions’ Aquadex FlexFlow is an ultrafiltration system designed to remove excess fluid in patients suffering from fluid overload. The platform is indicated for temporary (up to eight hours) and extended (more than eight hours in a hospital setting) ultrafiltration of patients with fluid overload who have failed diuretic therapy.
In March, CHF Solutions touted data from a study that indicated that while the costs of ultrafiltration therapy were higher, fluid removal with ultrafiltration resulted in reduced hospital readmissions and cost savings of approximately $3,975, or 15%, when compared to diuretic therapy. The company acquired the Aquadex device in 2016 for $5 million from Baxter (NYSE:BAX).
CHF Solutions said it submitted an application to the FDA requesting 510(k) clearance for the system to include pediatric patients weighing 44.1 lbs (20 kg) or more.
“We are grateful to be working with JAHVH to initiate a study of the benefits of aquapheresis to manage fluid overload in our nations’ veterans suffering from heart failure,” chairman & CEO John Erb said in prepared remarks. “Currently, heart failure patients suffering from fluid overload are re-admitted into the hospital, placing a heavy economic burden to the healthcare system. We look forward to collaborating with the Veterans Administration to offer this treatment in their facilities for heart patients in the out-patient setting and demonstrating the potential savings to the Veterans Health Administration.”
“We are excited about providing great care to our Veterans suffering from fluid overload with the use of ultrafiltration therapy in an outpatient setting,” added JAHVH advanced heart failure program director Ramona Gelzer Bell. “We believe that in addition to improving quality of life, we are reducing the cost of treating patients suffering from fluid overload. The scientific literature is filled with evidence of the clinical and economic benefits offered by ultrafiltration.”
Shares of CHFS were down -1.4% at $1.44 per share in mid-afternoon trading today.