Reprieve Cardiovascular has secured $61 million in Series B financing and enrolled the first patient in its pivotal FASTR II clinical trial, marking significant progress for the company's intelligent decongestion management therapy targeting acute decompensated heart failure (ADHF). The oversubscribed funding round was led by Deerfield Management and included participation from Arboretum Ventures, Lightstone Ventures, Sante Ventures, Genesis Capital, Rex Health Ventures, Cadence Capital, and an undisclosed strategic investor.
The financing combines equity investment with a debt facility and will support rapid execution of the global FASTR II pivotal clinical trial, which enrolled its first patient at Washington University School of Medicine in St. Louis. The funding will also enable key commercial readiness activities as the company advances toward regulatory approval.
"We are pleased to close this latest financing round, which reflects the strong continued support of our existing investors, as well as the addition of new investors, who each bring unique strategic insights to Reprieve," said Mark Pacyna, Chief Executive Officer of Reprieve Cardiovascular. "This capital ensures we are positioned to generate the clinical and economic evidence essential for regulatory approval and commercialization. We believe our personalized approach to decongestion management can enable better outcomes for both patients and healthcare systems around the world."
FASTR II Trial Design and Objectives
The FASTR II pivotal study builds upon the successful completion of the company's FASTR randomized pilot study, which met both primary efficacy and safety endpoints late last year. The larger randomized pivotal study will evaluate the efficacy of the Reprieve system compared to optimal diuretic therapy in patients hospitalized with ADHF.
The study's primary objective is to determine whether the Reprieve system can decongest patients more effectively than current standard of care. The trial plans to enroll up to 400 patients across the United States and Europe and will support a future premarket approval submission in the United States.
"On behalf of all the investigators in the study, we believe the Reprieve system represents a promising advancement for heart failure patients and physicians who currently face significant challenges with conventional approaches to decongestion," said Javed Butler, M.D., M.P.H., M.B.A., President of the Baylor Scott and White Research Institute, Senior Vice President for Baylor Scott and White Health, and Global Principal Investigator of the FASTR II study. "We look forward to rapid enrollment in the study and collectively contributing critical insights to help fundamentally change the standard of care for acute heart failure."
Addressing Critical Unmet Medical Need
Acute decompensated heart failure presents significant clinical challenges, characterized by sudden or gradual onset of symptoms including difficulty breathing, leg or feet swelling, and fatigue. These symptoms often require unplanned office visits, emergency room care, or hospitalizations, with an average stay of more than five days.
The current treatment landscape reveals concerning readmission rates, with nearly 1 in 4 patients readmitted to the hospital within 30 days to address fluid volume overload, and approximately half 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 increased risk of kidney injury, prolonged hospital stays, inadequate fluid removal at discharge, and frequent readmissions.
Innovative Technology Platform
The Reprieve system is designed to personalize decongestion management and safely, quickly, and thoroughly remove excess fluid to improve patient outcomes and prevent hospital readmissions. The system 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.
The technology uniquely combines real-time physiological monitoring with automated recommendations to escalate or end therapy, enabling physicians to tailor treatment to each patient's specific needs during therapy. This innovative approach is designed to integrate seamlessly into existing clinical workflows, streamline patient care, and reduce the workload for clinicians treating heart failure patients.
Investor Confidence and Market Opportunity
The strong investor support reflects confidence in the company's approach to addressing heart failure management challenges. "We continue to be encouraged by the company's clinical data and look forward to supporting their progress through this critical next stage of clinical and commercial development," said David Neustaedter, Ph.D., Venture Partner at Deerfield Management and member of the Board of Directors.
"Reprieve Cardiovascular is addressing a significant unmet need in today's heart failure management paradigm, and the results from the FASTR pilot study underscore the potential of the Reprieve system to reimagine the standard of care for treating ADHF," said Anita Watkins, Managing Director, Rex Health Ventures, corporate venture fund of UNC Health. "We see unique opportunities to strategically partner with Reprieve to enhance and accelerate this innovative therapy."
The company is focused on improving the lives of more than 25 million patients globally who suffer from heart failure. Headquartered in Milford, Massachusetts, Reprieve Cardiovascular is a privately held medical device company developing what it positions as safer, more effective, and personalized decongestion therapy for the substantial heart failure patient population.
