Corvia Medical snagged $54 million, which it hopes will help it complete clinical testing for its minimally invasive implant to keep symptoms from worsening in patients with heart failure.
Even though a large phase 3 trial failed to show a benefit, the company at the time said the results pointed toward potential success in a narrower patient population. That analysis seems to have impressed investors, considering they're back to fund Corvia since its last financing round—a series D for 34 million—was in 2014, back when the company went by the named DC Devices.
The company’s shunt device was designed for people with preserved or mildly reduced ejection fraction, or those whose hearts are still able to push a normal amount of blood out to the body with each beat.
Placed within the wall separating the heart’s atria, the implant creates an 8-mm opening that allows excess blood pressure in the left chamber to spill over into the right, lessening the overall burden on the heart muscle. In 2019, the FDA granted the device a breakthrough designation.
The company's phase 3 study, known as REDUCE LAP-HF II, was conducted in heart failure patients with preserved ejection fraction. The study’s overall results did not demonstrate a reduction in the total rate of heart failure events compared to a sham procedure, nor did it improve the health of the study’s total population, according to a publication in The Lancet.
However, Corvia put forward data from the clinical trial based on a pre-specified subgroup showing that responding participants saw 45% fewer heart-failure-related events per year compared to a sham device. Those events included decreases in hospital admissions, unscheduled doctor’s visits or increases in their medications.
The group included patients who have not yet received a pacemaker and have normal pulmonary vascular resistance during exercise—or the body’s ability to handle increases in blood flow between the lungs and the heart. The global, randomized trial, which enrolled 626 patients, found about half of those participants fit into this narrower category.
Corvia estimates that more than 26 million people worldwide are living with heart failure, with more than half of them having preserved ejection fraction.
The company's latest proceeds, which it described as “equity financing from its existing investor syndicate,” will be used to power a new confirmatory trial built on the results from REDUCE LAP-HF II, which were also published in May in the American Heart Association journal Circulation.
Though the specific investors in the latest round were not disclosed, Corvia's previous backers include Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures and Edwards Lifesciences, among others.
A company developing a similar atrial shunt, V-Wave, raised $98 million in a series C round last December to help set its device up for FDA review. Its minimally invasive, CE marked Ventura device, with a 5 mm opening, is being studied in heart failure patients with either reduced or preserved ejection fraction.
In May, the company announced that patients in a yearlong, open-label arm of a pivotal study saw initial improvements in both right-side and left-side ventricular ejection fraction. V-Wave is now recruiting the same patient population in a randomized, controlled trial, with enrollment slated to be completed by this fall.