AQUAPASS Achieves Major Enrollment Milestone in REFORM-HF Trial for Heart Failure Management

AQUAPASS Completes Enrollment in REFORM-HF Pivotal Trial

AQUAPASS, a pioneer in developing noninvasive therapies for fluid overload management, recently announced the successful completion of patient enrollment in its pivotal REFORM-HF clinical trial. This trial aims to evaluate the use of AQUAPASS's innovative ECCON System for patients suffering from heart failure and kidney-related conditions. This development is a significant milestone as AQUAPASS gears up for the next steps towards FDA marketing clearance.

Fluid overload poses a significant challenge in modern medicine, particularly affecting patients with heart failure. The condition, which is characterized by an excessive accumulation of fluid in the body, leads to increased healthcare costs, lengthy hospital stays, and higher rates of readmission. Despite extensive clinical research efforts, more than 40% of patients remain congested upon discharge, highlighting a critical gap in current treatment methodologies. AQUAPASS's non-invasive and kidney-independent approach aims to bridge this gap by providing an innovative solution for effective fluid management.

The REFORM-HF trial (NCT06360380) focuses on assessing net fluid removal in patients experiencing acute decompensated heart failure who are not responding adequately to existing medical treatments. Conducted across 11 sites in the United States and Israel, this trial incorporates a unique study design where each participant acts as their own control. Notable trial locations include hospitals in New York, North Carolina, and California, complemented by sites in Israel.

Dr. Noam Josephy, CEO of AQUAPASS, emphasized the significance of reaching this milestone, stating, "Completing enrollment in REFORM-HF is a massive step forward in providing the patients we serve with a novel, non-invasive option for fluid management.” The next crucial phase will involve data analysis in preparation for presentation at a significant heart failure conference this fall, as the company hopes to share insights into the trial findings.

Dr. Feitell, the Principal Investigator for REFORM-HF from Rochester Regional Health, reflects on the importance of the research, saying, "This trial is crucial as it aims to offer a noninvasive, kidney-independent solution to patients facing limited treatment options. We eagerly await the data results this fall."

AQUAPASS expresses its gratitude to everyone involved in the REFORM-HF trial, from participating patients to research staff and clinical sites for their unwavering dedication and commitment, which have made this study feasible.

AQUAPASS's vision for the future revolves around redefining fluid overload therapy. With its non-invasive ECCON System, the company aspires to alleviate fluid excess directly from the extravascular space through the skin, offering a much-needed option for patients burdened by heart failure and kidney disease. With a growing portfolio of intellectual property and two granted FDA Breakthrough Device Designations, AQUAPASS is positioned at the forefront of medical innovation in this critical area.

For more details about AQUAPASS and its groundbreaking work, visit AQUAPASS Medical.

As the REFORM-HF results approach, the medical community remains hopeful for the advancements that AQUAPASS could bring to heart failure management once the data is publicly disclosed and analyzed.