Newton, Mass. — AQUAPASS has completed enrollment in its pivotal REFORM-HF clinical trial evaluating the company’s ECCON System for removing excess fluid in patients with acute heart failure, marking a key step toward potential FDA marketing clearance.
The company is developing ECCON as a noninvasive, kidney-independent treatment for fluid overload in patients with heart failure and chronic or end-stage kidney disease. The wearable system is designed to remove excess fluid through the skin rather than relying on kidney function.
Fluid overload is a common complication of heart failure and kidney disease and can contribute to hospitalizations and readmissions. AQUAPASS said many patients hospitalized with fluid overload remain congested when they are discharged despite existing treatments.
The REFORM-HF trial is evaluating net fluid loss in patients with acutely decompensated heart failure who have not responded adequately to current medical treatment.
The study enrolled patients at 11 clinical sites in the United States and Israel, with each participant serving as their own control. U.S. trial locations include sites in New York, North Carolina, Minnesota, Ohio, Texas and California, while Israeli sites are located in Petach Tikva and Haifa.
“This is a major milestone for AQUAPASS and for the patients we aim to serve,” said Noam Josephy, M.D., M.Sc., MBA, Chief Executive Officer of AQUAPASS. “We’re now focused on completing our data analysis, preparing for presentation and publication, and advancing our discussions with the FDA on the next steps toward clearance.”
AQUAPASS expects to present topline results from REFORM-HF at a major heart failure conference this fall. The company also plans to submit the findings for publication in a peer-reviewed heart failure journal.
“Completing enrollment in REFORM-HF is a significant milestone toward bringing a noninvasive, kidney-independent decongestion option to patients who often have few good choices left,” said Dr. Feitell, Director of Advanced Heart Failure and Transplant Cardiology at Rochester Regional Health and Principal Investigator of the trial.
AQUAPASS said it will use the trial data to support discussions with the FDA regarding potential clearance of the ECCON System.
