en.Wedoany.com Reported - AQUAPASS announced that it has completed patient enrollment in the pivotal clinical trial REFORM-HF for its ECCON system, designed to treat fluid overload in patients with heart failure and chronic or end-stage kidney disease. The trial represents a critical step in the U.S. Food and Drug Administration (FDA) marketing authorization pathway, marking a substantial advance toward commercialization of this non-invasive, kidney-independent fluid management device.
Fluid overload is one of the major challenges facing the current healthcare system, broadly affecting patients with heart failure and kidney disease, and serving as a core driver of hospitalizations and readmissions. Clinical data show that patients hospitalized for fluid overload often experience longer hospital stays and higher rates of adverse events; even after decades of clinical research, more than 40% of patients are discharged in a congested state and frequently readmitted. There remains a persistent gap in existing treatment modalities for reliably removing excess fluid, particularly in achieving safe decongestion without reliance on kidney function.
The ECCON system developed by AQUAPASS is a wearable therapeutic device whose technological approach directly removes excess fluid from the extravascular space through the skin. This compartment is the body's primary fluid reservoir in states of fluid overload, making this therapy a non-invasive adjunct to standard of care that does not depend on kidney function.
The REFORM-HF pivotal trial (NCT06360380) is designed to evaluate net fluid loss with the system in patients with acute decompensated heart failure who have an inadequate response to current pharmacological therapy. The study is being conducted at 11 clinical sites in the United States and Israel, using a self-controlled design in each patient. U.S. trial sites are located in Rochester, New York; New York, New York; Greensboro, North Carolina; Asheville, North Carolina; Minneapolis, Minnesota; Columbus, Ohio; Austin, Texas; San Diego, California; and San Francisco, California; Israeli sites are in Petah Tikva and Haifa. The full list of participating institutions is available on ClinicalTrials.gov (NCT06360380).
Noam Josephy (MD, MSc, MBA), Chief Executive Officer of AQUAPASS, stated that the company's focus has now shifted to data analysis, results presentation and publication, as well as advancing communications with the FDA regarding next steps for approval. Topline results from REFORM-HF are expected to be presented at a major academic conference this fall, and the data will also be submitted for publication in a leading peer-reviewed heart failure journal.
Dr. Feitell, Director of Advanced Heart Failure and Transplant Cardiology at Rochester Regional Health and Principal Investigator of REFORM-HF, stated that completing enrollment is an important milestone in providing a non-invasive, kidney-independent decongestion option for patients with limited existing treatment choices. AQUAPASS extends its gratitude to the patients, investigators, study coordinators, and clinical sites who participated in the trial.
AQUAPASS is focused on building a technology platform for the treatment of fluid overload. Its ECCON system has received two FDA Breakthrough Device Designations and holds a continuously expanding intellectual property portfolio. Company information is available at www.aquapass-medical.com.
