Adagio Medical has decided to reduce its workforce and pause an early rollout of its cryoablation catheter in Europe to free up resources for an ongoing pivotal trial in the US, following a strategic review.
Shares in the NASDAQ-listed company, which has a $20.5m market cap, opened 3.2% following the announcement on 28 February. Stock price continued to fall as much as 19% by mid-morning.
Go deeper with GlobalData
Adagio did not provide context for the streamlining of company operations, giving only the consequences of narrowing down on key initiatives.
Adagio’s CEO Todd Usen said: “We are doubling down on the priorities that will drive the most meaningful impact for physicians, patients, and shareholders.”
The limited launch of the vCLAS catheter in Europe will be paused to give time and resources to the product design optimisation programme. Adagio’s device was approved in Europe in March 2024 and has already been used in procedures in hospitals such as in England’s University Hospitals Coventry and Warwickshire.
The restructuring will also include a “reduction in force”, effective as of today (28 February). The company did not disclose details on numbers or departments affected, saying only it will enable additional investments in other critical priorities.
“We believe that this focused approach is crucial to position Adagio as a leader in ventricular tachycardia solutions,” Usen added, who only joined the company as CEO in December 2024.
Adagio reported total revenue of $185,000 in Q3 2024, up from $41,000 in the same period in 2023. The company went public via a special purpose acquisition company (SPAC) in August 2024.
The pivotal study in the US, called FULCRUM-VT (NCT05675865), is currently the primary focus of the company in the US. The trial, being conducted under an investigational device exemption (IDE) from the Food and Drug Administration (FDA), is evaluating the safety and effectiveness of the Adagio VT cryoablation system in the ablation treatment of sustained monomorphic ventricular tachycardia (SMVT).
The prospective, multi-centre, open-label, single-arm study is slated to enrol 206 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy. Adagio stated it has completed more than 35% of enrollment and has been “encouraged” by early performance.
Results from the study will be used to support premarket approval of the VT cryoablation system with the vCLAS catheter.
Adagio designed its vCLAS catheter specifically for the treatment of VT – a fast and abnormal heart rhythm caused by faulty electrical signalling in the ventricles. Cryoablation uses extreme cold to destroy abnormal tissue.
Whilst cryoablation and thermal ablation devices have endured market dominance in many indications, the emergence of pulsed-field ablation (PFA) is poised to disrupt this. In cardiovascular disease, for example, PFA is associated with improved safety over its traditional counterparts. By 2030, PFA will be used in 75% to 80% of electrophysiology ablation procedures, according to an analysis by GlobalData. Over the last year, the PFA market has grown to be worth more than $500m, also as per GlobalData.
