Reprieve Cardiovascular has announced the close of a US$61 million Series B financing, alongside enrolment of the first patient in its global FASTR II pivotal trial, evaluating the efficacy of its Reprieve system compared to optimal diuretic therapy in patients hospitalised with acute decompensated heart failure (ADHF).
The oversubscribed financing round was led by Deerfield Management and joined by Arboretum Ventures, Lightstone Ventures, Sante Ventures, Genesis Capital, Rex Health Ventures, and Cadence Capital, as well as an undisclosed strategic investor. Proceeds will support the rapid execution of the pivotal clinical trial as well as key commercial readiness activities.
“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 commercialisation. We believe our personalised approach to decongestion management can enable better outcomes for both patients and healthcare systems around the world.”
“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, 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 initiation of the FASTR II pivotal study follows the successful completion of the Company’s FASTR randomised pilot study late last year, which met both primary efficacy and safety endpoints.
The study will evaluate the efficacy of the Reprieve system compared to optimal diuretic therapy in patients hospitalised with ADHF. The primary objective is to determine whether the Reprieve system can decongest patients more effectively than today’s standard of care. The study plans to enrol up to 400 patients across the USA and Europe and will support a future premarket approval submission in the USA.
“Congrats to Dr Ali Javaheri and the team at WashU Medicine on the first patient enrolled in the FASTR II study,” said Javed Butler, president of the Baylor Scott and White Research Institute, Senior Vice President for Baylor Scott and White Health (Dallas, USA), and global principal investigator of the FASTR II study. “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 enrolment in the study and collectively contributing critical insights to help fundamentally change the standard of care for acute heart failure.”
