Adagio Medical Holdings, a leading innovator in catheter-based ablation technologies for the treatment of cardiac arrhythmias, announced the closing of a $19 million private placement led by existing and new healthcare-focused institutional investors.
The funding positions the company to accelerate the development, regulatory submission, and commercialization of its proprietary Ultra-Low Temperature Cryoablation (ULTC) systems, designed specifically for patients with ventricular tachycardia (VT).
Proceeds from the financing will support several key initiatives, including:
- Submission activities related to the FULCRUM-VT pivotal clinical study for Premarket Approval (PMA) of Adagio’s vCLAS ULTC System with the U.S. Food and Drug Administration (FDA).
- Advancement of clinical studies and regulatory submissions for the company’s next-generation ULTC catheter, which offers faster performance, smaller size, and greater flexibility.
- Expanded awareness and education around ULTC’s unique advantages as a purpose-built solution for VT and the complex ventricular anatomy.
- Manufacturing scale-up and readiness for eventual commercialization.
- Strengthening of corporate operations and extension of financial runway into key growth milestones.
Adagio’s ULTC platform is engineered to create large, durable lesions that penetrate both diseased and healthy cardiac tissue, offering a new standard for safety and efficacy in cardiac ablation. The company’s technology has already been utilized to treat more than 350 patients, including those in regulatory studies, commercial settings, and compassionate-use cases.
The company’s latest progress follows the presentation of acute results from the FULCRUM-VT study at the recent VT Symposium, where Adagio received strong feedback from clinical experts and electrophysiologists. The new funding provides the financial flexibility needed to advance FDA approval and position the company for global expansion.
Adagio Medical’s vCLAS Cryoablation System has already achieved CE Mark approval and continues to be evaluated in the company’s U.S. IDE pivotal trial. The system’s ultra-low temperature precision and catheter design make it well-suited for addressing the unmet needs of patients suffering from VT, one of the most challenging and life-threatening cardiac arrhythmias.
KEY QUOTE:
“Closing this financing on the heels of sharing the acute results from our FULCRUM-VT clinical study at the recent VT Symposium is further validation of the positive feedback we received both from the podium and the electrophysiologists in attendance. We have treated over 350 patients, including those from our two regulatory studies, combined with commercial and compassionate use cases, which supports the potential of our Ultra Low ablation technology for VT to improve clinical outcomes and safety. I want to thank our investors for their support and partnership. We believe we now have the financial flexibility to unlock the full potential of our portfolio of ULTC therapies to transform treatment for the large, underserved population of patients with ventricular tachycardia.”
Todd Usen, Chief Executive Officer of Adagio Medical
