Cryoablation devicemaker Adagio Medical has opted to pause the European launch of one of its catheters, currently in the early stages, and will instead focus efforts on obtaining approval in the U.S.
The company will also lay off staff and streamline operations as it aims to get its ventricular tachycardia treatment across the finish line at the FDA.
“After a comprehensive strategic review, we are doubling down on the priorities that will drive the most meaningful impact for physicians, patients, and shareholders,” said Adagio CEO Todd Usen, who took the helm of the company in December, not long after it went public last summer through a SPAC deal.
Adagio will now put its resources toward completing the pivotal U.S. trial of its vCLAS catheter and its subsequent marketing submission to the FDA. The ultralow-temperature device uses liquid nitrogen to reach -196 degrees Celsius and rapidly freeze the heart tissue that drives potentially fatal VT rhythms in patients with cardiomyopathy.
“With over 35% enrollment complete, we, along with our physicians, are very encouraged by the system’s performance and early outcomes,” said Usen, who previously served as CEO at Minerva Surgical and Activ Surgical. “The decision to part with valued colleagues is difficult, and we have deep gratitude for their contributions.”
The company’s vCLAS system—as well as its iCLAS catheter, aimed at atrial ablations—previously received a CE mark approval in Europe. A clinical study of vCLAS on the continent demonstrated 97.1% acute elimination of clinical VT cases, with 81.0% of patients receiving no shocks from an implanted defibrillator in the six months following the procedure.
The device had been undergoing a limited European commercial launch alongside a product design optimization program. Usen said Adagio would “dedicate the appropriate resources” to that program, to continue iterating the hardware with insights from European electrophysiology professionals.
In the U.S., the FULCRUM-VT study aims to recruit more than 200 patients with ischemic and non-ischemic cardiomyopathy and recurring VT arrhythmias that have not responded to drug-based therapies. Adagio said the study had completed its first procedures last October.