Adagio Medical (Nasdaq:ADGM) announced today that it plans a corporate restructuring and realignment of resources.
The Laguna Hills, California–based company, which develops catheter ablation technologies for treating cardiac arrhythmias, wants to prioritize its FULCRUM-VT pivotal FDA investigational device exemption (IDE) clinical trial activities and its new product design optimization program.
“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 Todd Usen, the Chief Executive Officer of Adagio. “Our resources are now focused on the completion of the FULCRUM-VT Pivotal IDE trial and subsequent premarket approval of the VT Cryoablation System with vCLAS catheter from the [FDA].”
As a result of this shift, Adagio said its restructuring includes a reduction in workforce, effective today, Feb. 28. The company did not disclose how many employees are included in the reduction. It believes this move enables additional investment in its critical priorities.
“The decision to part with valued colleagues is difficult, and we have deep gratitude for their contributions,” Usen said. “We wish them the very best and will strive to build upon their efforts. I have tremendous confidence in Adagio’s future, and believe that our highly differentiated and validated technology will drive the best clinical results for our physicians and, ultimately, the best outcomes for ventricular tachycardia patients.”
The company also paused its limited European launch of vCLAS as it institutes a product design optimization program. Adagio said its launch provided valuable insights from European electrophysiology professionals, though. It believes the product design program allows for more efficient designing, iteration and innovation.
“We believe that this focused approach is crucial to position Adagio as a leader in ventricular tachycardia solutions, which has been a historically underserved market.”
The news of job cuts at Adagio comes on top of other recently announced layoffs in Southern California from medtech companies, including Staar Surgical, BD, and Acutus Medical.
More about Adagio Medical’s technology and recent developments
Adagio built its VT system on its proprietary ultra-low-temperature cryoablation (ULTC) technology. It specifically designed VT to address both safety and effectiveness challenges of VT ablation. It does this by creating large and deep endocardial lesions with minimal attenuation by scar tissue without the need for catheter irrigation.
The company’s offerings include cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias. Those include paroxysmal and persistent AFib, atrial flutter, and ventricular tachycardia.
Adagio picked up FDA investigational device exemption (IDE) for the study of its VT cryoablation system in May 2024. It then reported the first case in the study in October.
In between those milestones, the company also went public through a SPAC merger.
Meanwhile, Usen took over the corner office at Adagio at the end of last year. His track record includes the corner office at multiple companies. Most recently, he served as president and CEO of Minerva Surgical and, before that, he was CEO of Activ Surgical. Prior to his CEO posts, he led the Medical Systems Group at Olympus as president. Other roles include executive positions at Smith+Nephew and Boston Scientific.
