Adagio Medical Shifts Focus to U.S. Approval for Cryoablation Device, Streamlines Operations

Adagio Medical, a developer of cryoablation devices, has announced a strategic shift in its operations, prioritizing U.S. regulatory approval for its ventricular tachycardia (VT) treatment while scaling back its European initiatives. This move comes with significant changes to the company's structure and workforce.

Refocusing on U.S. Market and FDA Approval

Adagio Medical has decided to pause the early-stage European launch of its catheter and concentrate its efforts on obtaining FDA approval in the United States. The company will now direct its resources toward completing the pivotal U.S. trial of its vCLAS (ventricular cryoablation system) catheter and preparing the subsequent marketing submission to the FDA.

Todd Usen, who took over as CEO of Adagio in December, stated, "After a comprehensive strategic review, we are doubling down on the priorities that will drive the most meaningful impact for physicians, patients, and shareholders." This decision follows Adagio's public debut last summer through a SPAC deal.

Technology and Clinical Progress

The vCLAS catheter utilizes ultralow-temperature technology, employing liquid nitrogen to reach -196 degrees Celsius. This rapid freezing technique targets heart tissue responsible for potentially fatal VT rhythms in patients with cardiomyopathy.

Adagio's U.S. clinical trial, known as FULCRUM-VT, aims to enroll over 200 patients with ischemic and non-ischemic cardiomyopathy who have recurring VT arrhythmias resistant to drug-based therapies. The study, which began its first procedures in October, has already achieved over 35% enrollment.

Usen expressed optimism about the trial's progress, stating, "We, along with our physicians, are very encouraged by the system's performance and early outcomes."

Operational Changes and European Market

As part of its strategic realignment, Adagio Medical will implement staff layoffs and streamline its operations. While the company is reducing its European market focus, it will continue to allocate resources to optimize the product design based on insights from European electrophysiology professionals.

The vCLAS system, along with Adagio's iCLAS catheter for atrial ablations, had previously received CE mark approval in Europe. A European clinical study of vCLAS demonstrated promising results, with 97.1% acute elimination of clinical VT cases and 81.0% of patients receiving no shocks from implanted defibrillators in the six months following the procedure.

Addressing the difficult decision to reduce staff, Usen acknowledged, "The decision to part with valued colleagues is difficult, and we have deep gratitude for their contributions."