Reprieve Cardiovascular Attracts New Funding, Begins Study Enrollment

Reprieve Cardiovascular Inc. has closed an oversubscribed $61 million Series B financing led by Deerfield Management with participation from Arboretum Ventures, Lightstone Ventures, Sante Ventures, Genesis Capital, Rex Health Ventures, and Cadence Capital, as well as an undisclosed strategic investor. The financing combined equity investment with a debt facility to support the company’s growth.

“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,” Reprieve Cardiovascular CEO Mark Pacyna said. “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.”

Proceeds from the Series B financing will help fund key commercial readiness activities as well as the global FASTR II pivotal clinical trial, which has now enrolled its first patient.

“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 Reprieve Cardiovascular board member.

Intended to personalize decongestion management and quickly, thoroughly remove excess fluid, the Reprieve system works to remove fluid and sodium through precise diuretics administration, rapidly finding the optimal dose while replenishing the body with saline to support optimal kidney function. The Reprieve system 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 therapy is designed to integrate seamlessly into existing clinical workflows, streamline patient care, and reduce the workload for clinicians treating heart failure patients.

“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,” stated Anita Watkins, managing director, Rex Health Ventures, a corporate venture fund of UNC Health. “We see unique opportunities to strategically partner with Reprieve to enhance and accelerate this innovative therapy.”

The initiation of the FASTR II pivotal study follows the successful completion of the company’s FASTR randomized pilot study late last year, which met both primary efficacy and safety endpoints. The company intends to build upon these strong initial results through the larger FASTR II randomized pivotal study.

The FASTR II study will evaluate the Reprieve system’s efficacy compared to optimal diuretic therapy in hospitalized acute decompensated heart failure (ADHF) patients. The primary objective is to determine whether the Reprieve system can decongest patients more effectively than the current care standard. The study will enroll up to 400 patients in the United States and Europe and will support a future premarket approval submission in the United States. Related:

Related: Reprieve Cardiovascular Emerges From Stealth Mode With $42M Financing

“Congrats to Dr. Ali Javaheri and the team at WashU Medicine on the first patient enrolled in the FASTR II study,” 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 FASTR II study investigator. “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. 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.”

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.¹ Nearly one in four patients are readmitted to the hospital within 30 days to address fluid volume overload, and approximately half are readmitted within six months.² 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’s proprietary Reprieve system manages fluid removal in patients experiencing ADHF, delivering safer, more effective, and personalized decongestion therapy. Headquartered in Milford, Mass., Reprieve Cardiovascular is a privately held medical device company.

References
¹ Truveta Real-World Analysis: 262,673K Patient Cohort
² American Heart Association. “Heart Failure Statistics.” Circulation Research, 2021. Accessed December 3, 2024. https://www.ahajournals.org/doi/pdf/10.1161/CIRCRESAHA.121.318186