After enrolling the first patient at the top of this year in a pivotal trial of its ventricle-reshaping heart failure treatment, Ancora Heart has netted $80 million in funding to carry its device across the finish line at the FDA.
The company’s transcatheter approach targets symptomatic patients with reduced ejection fraction, where the muscles of the left ventricle have enlarged and make it harder for the heart to effectively pump out blood to the rest of the body.
Ancora’s AccuCinch system anchors a cable around the walls of the chamber from the inside and then tightens it to help reshape and support the heart’s structure.
Of the 6.5 million adults living with heart failure in the U.S., Ancora estimates about half have an enlarged left ventricle. The company sees its device serving as an option between early treatment with medications and pacemakers and the late-stage reliance on implanted heart pumps and organ transplants.
Now, the latest investments “will help us prepare for potential launch and subsequent commercialization,” President and CEO Jeff Closs said in a statement. The $80 million in equity financing was backed by Sands Capital, Sio Capital and an undisclosed investor plus the company’s previous investors including Savitr Capital.
The proceeds will also help speed up the company’s open-label CORCINCH-HF study, which picked up its first of an expected 400 patients in January from among a planned 80 international centers. The trial is slated to deliver its first analysis to support an FDA product submission after 250 patients have reached six months of follow-up. A second analysis will be completed after all patients are examined after one year, with an estimated completion date set for mid-2024.
“Previously collected data on early feasibility implants suggests that the AccuCinch System may afford significant clinical benefits to patients suffering from heart failure with reduced ejection fraction,” Closs said earlier this year, adding that the company expects to see its treatment “halt or even reverse the progression of heart failure in many patients.”
Meanwhile, a second study is being conducted in Europe, which aims to enroll a total of 132 patients at up to 40 centers, with data expected in mid-2022.
Other companies are taking a somewhat similar approach to repairing an enlarged heart muscle—including after a heart attack—which can affect the overall shape of the organ.
BioVentrix’s transcatheter Revivent procedure embeds a series of anchors in the ventricle wall to help stitch up excess scar tissue, a method that secured a CE mark and an FDA breakthrough designation.