By Melane Sampson
Adagio Medical (NASDAQ: ADGM) is innovating catheter ablation technologies for the treatment of one of the most challenging and underserved areas in electrophysiology—ventricular tachycardia (VT), a dangerous type of cardiac arrhythmia that causes chest pain, fainting and sudden cardiac arrest.
“While the broader cardiac ablation market has seen rapid innovation in atrial fibrillation (AFib), treatment options for ventricular arrhythmias remain limited, leaving a significant clinical and commercial gap,” Todd Usen, CEO of Adagio, says in an interview with BioTuesdays.
He explains that VT is treated today using a combination of Implantable Cardioverter-Defibrillators (ICDs) to prevent sudden death and antiarrhythmic drugs (AADs) to reduce episodes, and while effective, both carry significant limitations: ICD shocks are emotionally distressing and damaging to the heart, while AADs offer poor long-term efficacy and serious toxicity.
“Defibrillators keep patients alive, but the shocks are painful and scary,” Mr. Usen notes. “Being able to reduce those shocks would be a major quality-of-life improvement for patients.”
In the U.S. alone, more than 300,000 people die each year from sudden cardiac death, with the number one cause being ventricular arrhythmias.
Mr. Usen clarifies that VT originates in the heart’s lower chambers—the ventricles—which are responsible for pumping blood throughout the body. Unlike atrial (upper chamber) arrhythmias, VT often involves deeper, more complex mechanisms within thick myocardial tissue, making it significantly harder to treat with conventional ablation technologies. Current ablation approaches, primarily radiofrequency (RF) ablation and off-label pulsed field ablation (PFA), were originally designed for thinner atrial tissue and fall short in many ventricular applications.
“There has not been a lot of technology developed specifically for the ventricles,” Mr. Usen notes. “That’s why we’re dealing with such low penetration of this $6 billion addressable global market.”
Adagio’s solution is its proprietary Ultra-Low Temperature Ablation (ULTA) platform, which uses liquid nitrogen to achieve temperatures near -196°C. This enables the creation of deeper, more durable lesions through a fully endocardial—inside-the-heart—approach, a much more favorable approach versus the more invasive epicardial method required with existing RF technologies to reach many VTs.
“The aim of VT treatment is to interrupt the abnormal electrical circuits that cause the heart rhythm to go out of control,” Mr. Usen says. “What differentiates us is how safely and effectively we can do that.”
The company’s lead product, the vCLAS Ventricular Ablation System, is purpose-built for VT. Unlike traditional cryoablation systems that rely on nitrous oxide, are in a balloon, built for thin tissue, and reach a maximum temperature of -85°C, Mr. Usen points out that Adagio’s ULTA technology uses liquid nitrogen, which enables the catheter to penetrate deeper into thick ventricular tissue. The result is the unique ability to treat all VTs, including deep arrhythmogenic tissue, all from within the heart, or endocardially.
“Today, physicians can only treat a portion of VT patients from an endocardial approach,” he says. “For the rest of the cases, they often need to perform an epicardial procedure, which requires a more risky and invasive procedure that accesses the heart from outside the chest cavity and requires navigation around the coronary arteries. This limits adoption and concentrates procedures in tertiary centers that are equipped for the potential increased risk. Our technology is designed to eliminate that barrier by democratizing procedures with a very common, likely safer approach that most EPs are comfortable with.”
Mr. Usen highlights that clinical data to date has been encouraging. The company’s CRYOCURE-VT study, conducted across nine sites with 64 patients, demonstrated a 94% acute success rate with zero major adverse events. These results supported CE Mark approval in Europe making
Adagio the first company to achieve regulatory clearance for a VT-specific ablation technology.
“We are the first purpose-built VT ablation technology to have regulatory approval anywhere in the world,” Mr. Usen says.
The company is now advancing its U.S. regulatory strategy through its FULCRUM-VT pivotal trial, which enrolled 209 patients across 20 leading electrophysiology centers in just 11 months—a pace that Mr. Usen emphasizes underscores both clinical demand and physician interest.
Recently reported results from FULCRUM-VT demonstrated that in addition to a low 1% device-related event rate, the study showed 98% acute success, 84% freedom from shock, 62% freedom from any ICD Therapy at six months, and most notably, 72% reduction in the most common AAD, amiodarone. “What we found to be uniquely compelling was that our results were equal in both nonischemic—which is deeper and harder to treat—and ischemic patients,” Mr. Usen says.
He adds that Adagio believes it has about a two- to two-and-a-half-year lead over any competitor to have an FDA-approved, commercial, purpose-built VT ablation catheter. “No other company is this far along in the IDE pivotal trial process for VT ablation.”
Beyond clinical performance, Adagio’s technology addresses several limitations associated with existing ablation modalities. Mr. Usen explains that other technology approaches such as RF or off-label pulsed field (PFA) ablation require irrigation to prevent overheating, which can be problematic in heart failure patients who are sensitive to fluid overload. RF and PFA ablation are also associated with complications such as steam pops, hemolysis, vasospasm, and instability during energy delivery.
“With ULTA, there is no need for irrigation, which simplifies hemodynamic management, and we do not need to use nitroglycerin to address risk of vasospasm,” he asserts. “We also achieve catheter stability through cryoadhesion—the catheter effectively adheres to the tissue, which is critical when working in a moving structure with constant blood flow like the ventricle of the heart.”
He adds that this stability, combined with deeper lesion formation, allows for more predictable and comprehensive treatment of VT problem areas.
“Roughly 30% of VT ablations today are performed at approximately 50 sites in the U.S.,” Mr. Usen notes. “By simplifying the procedure and eliminating the need for epicardial access, we can open up to a much larger group of electrophysiologists.”
Adagio is also investing in advancing the development of its platform. The next-generation vCLAS ULTRA system features improved maneuverability, a smaller and more flexible catheter design, and shorter freeze times with only a single freeze versus the freeze-thaw-freeze cycle of the first generation vCLAS—reducing ablation duration by up to 75% while increasing lesion depth.
“Our next-generation system was built to address the usability needs of our physician customers and to enable broader adoption across all electrophysiology practices,” Mr. Usen says. “When an electrophysiologist begins a VT ablation procedure, they should have the confidence that one catheter system and one approach, whether a quick ischemic cardiomyopathy or a deeper non-ischemic cardiomyopathy, is all they will need.”
Joining BioTuesdays is Debbie Kaster, CFO and chief business officer of Adagio, who highlights several key value drivers including established reimbursement pathways and the potential for New Technology Add-On Payments (NTAP) designation. “From a commercial standpoint, we are well positioned.”
“Our VT ablation procedures are already covered by existing reimbursement codes in both inpatient and outpatient settings,” she adds. “We also have Breakthrough Device designation, which has the potential to streamline certain regulatory requirements. And, we are optimistic about securing NTAP, which could cover up to 65% of costs above the standard diagnosis-related group.”
Ms. Kaster indicates that financially, the company has structured its capital strategy to align with key milestones. It recently completed a financing that includes $19 million upfront, with additional tranches tied to clinical and regulatory achievements, bringing total potential proceeds to $50 million.
“We ended 2025 with about $17 million in cash,” she says. “The first tranche is tied to the presentation of our pivotal data, which we accomplished on April 26, followed by milestones related to regulatory approvals for both our first- and next-generation devices.”
Adagio expects to be granted PMA approval for its first-generation system by the end of 2026, followed by a planned limited market release in early 2027. A full commercial launch, incorporating the next-generation system, is anticipated in early 2028.
“We are in a strong position with a meaningful technology lead in a large, underpenetrated market,” Ms. Kaster says. “Our clinical data spans ischemic and non-ischemic VT, as well as compassionate use cases in PVCs, which translates to our ability to treat the broadest population of VTs, and exemplifying a real-world patient population.”
Mr. Usen adds that the broader market dynamics further support Adagio’s strategy. He draws attention to recent studies, including VANISH 2 and PAUSE-SCD, that suggest ablation may be more effective than anti-arrhythmic drugs and ICDs as a first-line treatment for VT. This mirrors the evolution seen in AFib treatment over the past decade, where ablation has largely replaced drug therapy.
“Fifteen years ago, AFib was primarily treated with drugs,” Mr. Usen reflects. “Once clinical data demonstrated the superiority of ablation, the market took off. We believe VT is at a similar inflection point—but it is waiting for the right technology.”
Adagio believes that ULTA is that enabling technology—a purpose-built solution designed to overcome the limitation of traditional approaches while improving outcomes for a broad, high-risk patient population.
“With our system, physicians can get in, perform the ablation efficiently, and get out—without many of the compromises of current standard of care,” Mr. Usen says. “Additionally, we do not require the same deep sedation required of some of the other ablation technologies being used for VT. If we can deliver VT ablation without those trade-offs, that’s a win for patients, physicians, and the healthcare system. The clinically proven reduction in shock, AAD use, less anesthesia, and no need for irrigation or nitroglycerin, puts the patient back at the forefront of what we are trying to accomplish.”
As Adagio approaches key clinical and regulatory milestones, Mr. Usen is confident that investor attention is likely to intensify. “With a differentiated technology platform, early clinical validation, and a clear path to commercialization, we intend to redefine the standard of care in VT treatment—an opportunity spun from significant unmet need and substantial market potential.”
• • • • •
To connect with Adagio Medical or any other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com.
