Reprieve Cardiovascular said Wednesday it closed a $61 million Series B financing that will fund its pivotal clinical trial and preparations to commercialize its heart failure fluid management system.
The Milford, Massachusetts-based company is developing a system for removing excess fluid in patients with acute decompensated heart failure. The goal is to personalize decongestion management by removing fluid and sodium through precise administration of diuretics.
„Reprieve Cardiovascular is addressing a significant unmet need in today’s heart failure management paradigm,” Anita Watkins, managing director of Rex Health Ventures, said in a statement. Rex Health is the corporate venture fund of UNC Health and a Reprieve investor.
CEO Mark Pacyna said the funding will help Reprieve generate the clinical and economic evidence needed to pursue regulatory approval and commercialization of the system. He said the company believes its approach to decongestion management can lead to better outcomes for both patients and healthcare systems.
The randomized pivotal FASTR II trial will compare the Reprieve system to optimal diuretic therapy in patients hospitalized with ADHF to assess whether the device can decongest patients more effectively than the standard of care. The study plans to enroll up to 400 patients across the U.S. and Europe and will be used to support a Food and Drug Administration premarket approval submission. The first patient has been enrolled by a team at the Washington University School of Medicine in St. Louis.
The FASTR II trial follows the completion late last year of the FASTR randomized pilot study, which met its primary efficacy and safety endpoints.
The company’s oversubscribed Series B round was led by Deerfield Management. Along with Rex Health, other backers were Arboretum Ventures, Lightstone Ventures, Sante Ventures, Genesis Capital, Cadence Capital and an undisclosed strategic investor. The financing combined equity investment with a debt facility.
Reprieve’s Series A financing raised $42 million in 2024.
Conformal aims to advance left atrial appendage occlusion
Conformal Medical said Tuesday it raised $32 million in a Series D extension round to fund an ongoing pivotal trial and pre-commercialization work for its left atrial appendage occlusion system.
The device, called CLAAS AcuFORM, is designed to seal the left atrial appendage in patients with atrial fibrillation not caused by a heart valve problem, to reduce the risk of stroke without long-term anticoagulants. The foam-based architecture is intended to work in a broad range of LAA anatomies with just two sizes.
The company said its technology could make left atrial appendage closure a same-day, single-operator procedure and eliminate the need for general anesthesia and intubation.
The CONFORM pivotal trial is evaluating the safety and efficacy of the system compared to other commercially available LAAO devices and will be used to support FDA pre-market approval, the company said in the funding announcement. The study, which is expected to randomize about 1,600 patients at sites worldwide, is now more than 30% enrolled.
Nashua, New Hampshire-based Conformal said a new partner joined inside investors in the latest funding round.
