Reprieve Cardiovascular announced the publication of results from a pilot study of its heart failure therapy.
Milford, Massachusetts-based Reprieve Cardiovascular develops the Reprieve Therapy. It designed the system to personalize decongestion management. The technology safely, quickly and thoroughly removes excess fluid to improve patient outcomes and prevent hospital readmissions. Through the precise administration of diuretics, the system aims to remove fluid and sodium. It also replenishes the body with saline to support optimal kidney function.
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The Reprieve system combines real-time physiological monitoring with automated recommendations to escalate or end therapy. It allows physicians to tailor treatment to each patient’s specific needs during therapy. This streamlines patient care and reduces workload for clinicians treating heart failure patients.
Today, the company said its results from the FASTR randomized pilot study, published in JACC: Heart Failure, support the ongoing FASTR II randomized pivotal trial, currently enrolling in the U.S. and Europe. It closed a $61 million Series B financing last year to support the trial.
Results shared today showed that Reprieve Therapy produced faster decongestion than optimal diuretic therapy (ODT), without an increased risk of safety events or worsening kidney function.
In patients with ADHF and significant fluid volume overload, Reprieve Therapy, when compared to ODT, demonstrated greater 24-hour total natriuresis, plus significantly greater rate of weight loss net fluid loss (P = 0.03), and net natriuresis. The therapy produced no differences in the primary safety endpoint or change in serum creatine levels between groups.
Mark Pacyna, CEO of Reprieve Cardiovascular, said:
“This moment reflects meaningful progress toward rethinking how acute heart failure is managed. 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, US 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.”
Dr. James E. Udelson, chief of the division of cardiology at Tufts Medical Center and principal investigator of FASTR, said:
“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. 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.”
