Adagio Medical Taps Veteran Leaders for Cardiac Tech Commercial Push

LAGUNA HILLS, CA – December 23, 2025 – Adagio Medical Holdings, Inc. (NASDAQ: ADGM) has signaled a decisive shift from research and development to aggressive commercialization with the strategic appointment of two seasoned industry executives. The medical device company announced it has hired Marie-Claude Jacques as Senior Vice President, Global Sales, and Antwan Gipson as Senior Vice President, Manufacturing and Operations, moves designed to accelerate the market launch of its proprietary Ultra-Low Temperature Cardiac Ablation (ULTC) technology.

The appointments come at a critical juncture for Adagio, as it prepares to navigate the final regulatory hurdles in the United States for its vCLAS™ Cryoablation System and scale its operations to compete in the burgeoning multi-billion-dollar cardiac ablation market.

A Calculated Move for Market Execution

The recruitment of Jacques and Gipson is a clear statement of intent from Adagio's leadership, underscoring a strategic pivot toward execution and scale. The company is betting that their combined expertise will be the catalyst needed to transition its promising technology from clinical trials to widespread clinical use.

Marie-Claude Jacques brings over 15 years of formidable commercial leadership in the electrophysiology space. Her track record is highlighted by her tenure as Vice President of Sales and Marketing at Baylis Medical, where she was instrumental in scaling the company’s electrophysiology portfolio to over $170 million in annual revenue. Her experience in building and leading a 100-person commercial organization and driving the adoption of disruptive technology in an established market was a key factor in her recruitment, positioning her perfectly to spearhead Adagio's global sales strategy.

Complementing this commercial firepower is Antwan Gipson, an operations veteran with more than two decades of experience leading manufacturing, quality, and supply chain logistics for high-growth medical technology firms. Gipson’s career includes senior leadership roles at companies like Candesant Biomedical and Nano Precision Medical, where he specialized in building scalable, compliant manufacturing infrastructures for complex energy-based and catheter-based devices. His role will be crucial in ensuring Adagio can meet anticipated demand for the vCLAS system, optimizing production for cost-efficiency and quality control as the company prepares for a full-scale commercial launch.

According to company statements, these hires are central to a strategy focused on "disciplined commercialization" heading into 2026 and beyond, ensuring the operational and sales infrastructure is in place to support a successful product rollout.

Innovating in a Crowded and Competitive Arena

Adagio is entering a dynamic and highly competitive market. The global cardiac ablation sector, valued at over $5.8 billion in 2025, is projected by some analysts to exceed $19 billion by 2034, fueled by an aging population and a rising incidence of cardiac arrhythmias like atrial fibrillation (AF) and ventricular tachycardia (VT).

The market is currently dominated by a handful of MedTech giants, including Medtronic, Boston Scientific, and Johnson & Johnson's Biosense Webster, which collectively hold a commanding market share. These incumbents have established robust portfolios built around radiofrequency (RF) and conventional cryoablation technologies. More recently, pulsed field ablation (PFA) has emerged as a major area of innovation and investment.

Against this backdrop, Adagio aims to carve out a significant niche with its Ultra-Low Temperature Cardiac Ablation (ULTC) technology. The company's flagship vCLAS™ Cryoablation System is engineered to address key limitations of existing treatments, particularly for complex arrhythmias like scar-mediated VT. The technology’s primary differentiator is its ability to create large, deep, and durable lesions that can penetrate through the entire thickness of the heart tissue. This is critical for successfully treating VT, which often originates from deeper scar tissue that can be difficult to reach with conventional RF catheters.

The vCLAS catheter itself is a 9Fr, bi-directional deflectable tool with a 15-millimeter ULTC ablation element. This design allows it to create lesions with a titratable depth exceeding 10 millimeters, making it uniquely suited for endocardial ablation strategies. Furthermore, the system's use of cryogenic energy provides cryoadhesion, which enhances catheter stability during the procedure. A key advantage is the absence of saline irrigation, which simplifies patient management, a significant benefit for VT patients who often have compromised heart function.

Paving the Way with Strong Clinical Evidence

Before Jacques and Gipson can bring the vCLAS system to the broader market, Adagio must clear the final and most stringent regulatory hurdle: U.S. Food and Drug Administration (FDA) approval. The company is building a strong case based on compelling clinical data and a strategically managed regulatory pathway.

The system has already earned a CE Mark in Europe for the treatment of monomorphic VT, allowing for commercial sales in select European centers and providing early real-world validation. In the United States, Adagio is pinning its hopes on the FULCRUM-VT pivotal trial, which has now fully enrolled 209 patients across 19 leading medical centers in the U.S. and Canada. The trial's rapid 11-month enrollment period suggests strong physician interest and a significant unmet need for more effective VT treatments.

In October 2025, Adagio presented promising preliminary acute data from the FULCRUM-VT study. The results showed an acute clinical success rate of 97.4%, meaning the target ventricular arrhythmias could not be induced post-procedure. Furthermore, all clinically relevant VTs were eliminated in 96.7% of patients. While the long-term data is still pending, these initial outcomes provide a powerful foundation for the company's Premarket Approval (PMA) submission to the FDA. The FDA has already granted the vCLAS system a Breakthrough Device Designation, a status that provides for a more collaborative and potentially expedited review process.

The company's financial strategy appears aligned with these ambitious goals. In October 2025, Adagio secured up to $50 million in a private placement financing round, with an initial $19 million upfront. These funds are explicitly earmarked to support the final push for FDA submission, continued development of next-generation catheters, and the commercial-readiness activities now being spearheaded by its new executive team. While the company has operated at a net loss, a common reality for clinical-stage MedTech firms, this fresh capital injection from institutional investors signals confidence in Adagio's technology and its pathway to market. With its leadership team fortified, its clinical case strengthening, and its finances shored up, Adagio Medical appears poised to transition from a developer of innovative concepts to a formidable commercial competitor in the fight against cardiac disease.