Adagio Medical Inc., a company focused on the treatment of atrial fibrillation (AF) and ventricular tachycardia (VT), has scooped up $42.5 million in a series E equity financing. The funds are earmarked for the ongoing IDE trial of its intelligent Continuous Lesion Ablation System (iCLAS). They will also be used to accelerate the European VT CE mark study, advance the commercialization of iCLAS in CE-mark countries and further development and clinical validation of its pulsed field cryoablation technology.

New investors Arrowmark Partners, RA Capital Management and Perceptive Advisors participated in the round, along with existing investors Jmr Capital and Fjord Ventures. In conjunction with the series E, Tuan Huynh, equity analyst at Arrowmark Partners, and Zach Scheiner, principal at RA Capital Management, joined Adagio’s board of directors.

“We are excited to have this world-class syndicate be a part of transforming the treatment of cardiac arrhythmias,” said Olav Bergheim, Adagio’s president and CEO.

Founded in 2011, Adagio’s iCLAS technology uses ultra-low temperature cryoablation to create continuous, transmural lesions in endocardial applications, including paroxysmal and persistent AF, atrial flutter and VT. The energy to make the lesions comes from near critical nitrogen (NCN), which delivers the same cryogen power as liquid nitrogen but without the problem of volume expansion – a factor that has prevented liquid nitrogen from being used as an endocardial cryogen. Adagio acquired the NCN cryoablation technology from Alex Babkin, who developed it and is now chief technology officer of the Laguna Hills, Calif.-based company.

IDE trial

Adagio won the U.S. FDA’s nod to conduct its iCLAS IDE study in August 2019, and enrolled the first patient in December. The nonrandomized, single-arm trial aims to assess iCLAS’ safety and efficacy in about 200 patients with symptomatic, persistent AF that failed at least one class I or class III anti-arrhythmic drug with no prior history of ablation. Primary outcomes include the proportion of patients who are free from device- or procedure-related major adverse events that occur after the cryoablation procedure and the proportion of subjects receiving a single cryoablation who are free from undocumented left atrial arrhythmia at 12 months.

The study will support a PMA submission for the treatment of patients with AF that has lasted longer than seven days but less than 12 months who have not had prior AF ablation therapy. It is slated for completion in December 2021.

Adagio scored CE mark approval for the iCLAS system in June 2019 for the treatment of paroxysmal AF, persistent AF and atrial flutter.

In August, Adagio reported preclinical data showing the effectiveness of its ultra-low temperature cryoablation (ULTC) catheter is also capable of ablating tissue through pulsed field ablation (PFA) delivered via the existing array of electrodes. By combining the two platforms, the company was able to overcome such issues as musculoskeletal contractions and ablation of adipose tissue during PFA treatment and the risk of unintended damage to the esophagus and phrenic nerve with the use of ULTC technology.

Ra Capital Management’s Scheiner expressed his enthusiasm for the iCLAS technology, saying it “has shown the potential to become the best-in-class cardiac ablation system and improve outcomes for the most difficult to treat AF patients. In addition to ultra-low temperature cryoablation, Adagio can deliver pulsed field ablation in the same catheter … which offers advantages over either modality alone.”

Competitive field

Adagio faces competition from a number of companies in the cardiac ablation space. Galaxy Medical Inc., of San Carlos, Calif., is looking to address the needs of electrophysiologists with its Centauri system. The pulsed electric field technology is currently being evaluated in the ECLIPSE-AF study for the treatment of cardiac arrhythmias, with the aim of supporting a CE mark.

In August, Carlsbad, Calif.-based Acutus Medical Inc. raised $159 million in a Nasdaq IPO, as it strives to make its mark in cardiac electrophysiology. Earlier this year, it won FDA clearance for its second-generation cardiac mapping software, Supermap, which works in conjunction with its next-gen Acqmap 3D Imaging and Mapping System.

And in June, Boston Scientific Corp. launched its Directsense technology, a tool to help electrophysiologists measure tissue response to radiofrequency waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system.

Other competitors in the space include Johnson & Johnson’s Biosense Webster division and Abbott Laboratories.

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