V-Wave has raised $98 million to complete the clinical testing of its implant for severe heart failure and pulmonary arterial hypertension, as well as set up the device for FDA review.
The company’s Ventura interatrial shunt creates a small passageway between the heart’s two upper chambers, allowing excess blood to flow between them. This can release the high-pressure build-ups in the atria, which can cause fluid to collect in the lungs and lead to difficulty breathing.
The hourglass-shaped tube—which previously received an FDA breakthrough designation—is currently being tested in an international, randomized trial in about 500 medicated heart failure patients with either reduced or preserved ejection fraction, which measures the cardiac muscle’s ability to pump out blood to the body with each heartbeat.
In addition, an secondary, open-label arm of the study—including about 100 of the first participants implanted with the minimally invasive device—has completed enrollment and is expected to deliver one-year follow-up data in 2022, according to V-Wave CEO Neal Eigler.
“The open-label arm demonstrated the ease and success of the implantation procedure, as well as safety, shunt durability, patency and improvement in quality-of-life metrics,” Eigler said in a statement.
The latest proceeds will continue to fund work on Ventura, in addition to supporting the development of a new, adjustable-size version of the shunt.
The company’s extended series C round was led by Deerfield Management, with additional backing from Aperture Venture Partners, BRM Group, Endeavour Vision, Johnson & Johnson Innovation, Pontifax, Pura Vida Investments, GHS Fund, Triventures and Israel Secondary Fund.
“We are excited about the advancement of the next-generation precision shunt which will tailor the degree of shunting at the time of implant and will continue over time in correlating to the severity of heart failure,” said Deerfield partner Andrew ElBardissi.
V-Wave’s Ventura shunt previously received a CE mark approval in Europe in early 2020.