Reprieve Cardiovascular Shares Favorable Study Results for its ADHF Decongestion Treatment

Published study data suggest that Reprieve Cardiovascular Inc.’s Reprieve Therapy promotes faster decongestion with no increased safety risk or worsening kidney function compared with optimal diuretic therapy (ODT) in acute decompensated heart failure (ADHF).

The publication of the company’s FASTR randomized pilot study results in JACC: Heart Failure further support the ongoing FASTR II randomized pivotal trial, which is currently enrolling patients in the United States and Europe.

According to the FASTR pilot trial, compared with ODT, patients with ADHF and significant fluid volume overload who received Reprieve Therapy demonstrated:

• Twenty-four hour total natriuresis was significantly greater (P < 0.001)
• Significantly greater rate of weight loss (P = 0.002), net fluid loss (P = 0.03), and net natriuresis (P < 0.001)
• No differences in the primary safety endpoint (P = 0.42) or change in serum creatine levels between the groups (P = 0.07)

“In FASTR, patients achieved similar levels of decongestion in roughly half the time compared to usual care, with significantly improved diuretic efficiency and no signal of kidney injury,” said James E. Udelson, M.D., chief of the Division of Cardiology at Tufts Medical Center and principal FASTER trial investigator. “These findings support a more individualized, physiologically guided strategy that has the potential to improve the effectiveness and consistency of care while maintaining renal safety. I’d like to thank the investigators and study teams for their dedication to this important work.”

The peer-reviewed publication of these findings provides important validation of Reprieve Therapy’s potential to address longstanding challenges in decongestion management and supports the ongoing FASTR II pivotal trial, which is designed to further evaluate these results, company executives claim.

Reprieve Therapy works to remove fluid and sodium through precise administration of diuretics, rapidly finding the optimal dose while replenishing the body with saline to support optimal kidney function. Reprieve Therapy uniquely combines real-time physiological monitoring with recommendations to escalate or end therapy, enabling physicians to tailor treatment to each patient’s specific needs during therapy. This innovative therapy is designed to integrate seamlessly into existing clinical workflows, streamline patient care, and reduce the workload for clinicians treating heart failure patients.

“This moment reflects meaningful progress toward rethinking how acute heart failure is managed,” Reprieve Cardiovascular CEO Mark Pacyna stated. “For decades, clinicians have faced a fundamental trade-off between achieving effective decongestion and protecting kidney function. The FASTR results show that a different approach may be possible. Investing in a large, randomized, U.S. pilot study set the foundation for the FASTR II pivotal trial, where enrollment is expected to be completed later this year. These clinical milestones advance Reprieve’s path toward redefining the standard of care in ADHF.”

The FASTR pilot trial was a multicenter, randomized, controlled trial designed to evaluate the Reprieve Therapy in optimizing decongestion in ADHF patients. The trial enrolled a total of 100 patients, 96 of whom were randomized one to one to receive treatment with Reprieve Therapy or optimal diuretic treatment based on best-practice dosing.

Patients with ≥10 lbs (4.5 kg) of estimated volume overload were included in the trial. The primary efficacy endpoint was total urine sodium output at 24 hours post-treatment initiation, while the primary safety endpoint was the composite of acute kidney injury, severe electrolyte abnormalities, symptomatic hypotension, and hypertensive emergencies.

Acute decompensated heart failure is characterized by the sudden or gradual onset of symptoms such as difficulty breathing, leg or feet swelling, and fatigue, often requiring unplanned office visits, emergency room care, or hospitalizations, with an average stay of more than five days. Nearly one in four patients is readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months. Managing fluid removal in ADHF patients has been a persistent challenge, as the primary treatment of diuretics is difficult to administer precisely without real-time information on patient response. This can lead to an increased risk of kidney injury, prolonged hospital stays, inadequate fluid removal at discharge, and frequent readmissions.

Reprieve Cardiovascular is advancing heart failure treatment by developing technologies that bring intelligence to decongestion management. The company’s therapies aim to improve the lives of more than 25 million heart failure patients worldwide. Headquartered in Milford, Mass., Reprieve Cardiovascular is pioneering solutions that address the complex challenges of heart failure management.

The Reprieve System is an investigational device limited by U.S. law to investigational use only. The Reprieve System does not bear CE marking under the EU Medical Device Regulation and is not available for commercial distribution in the European Union or European Economic Area.