Adagio Medical Holdings, Inc. - Ultra-Low Temperature Cryoablation Pioneer for Ventricular Tachycard

Company Overview (Updated April 2026)

Adagio Medical Holdings, Inc. is a medical device company headquartered in Laguna Hills, California, USA, focused on developing catheter-based ablation technologies for the treatment of cardiac arrhythmias. Founded in 2011, the company leverages its proprietary Ultra-Low Temperature Ablation (ULTA) technology to create large, durAble lesions extending through the depth of both diseased and healthy cardiac tissue using a purely endocardial approACH.

Corporate Information:

- Company Type: Public company (NASDAQ: ADGM)

- Founded: 2011

- Headquarters: Laguna Hills, California, USA

- Employees: Approximately 41 (as of 2025)

- Industry: Medical Devices / Electrophysiology / Interventional Cardiology

Historical Evolution:

- 2011: Company founded to develop ultra-low temperature cryoablation technology for cardiac arrhythmias

- 2024: vCLAS Cryoablation System received CE Mark and launched commercially in Europe for monomorphic VT

- July 31, 2024: Completed business combination with ARYA Sciences Acquisition Corp IV (SPAC)

- August 1, 2024: Began trADINg on Nasdaq Capital Market under ticker ADGM

- October 2024: FULCRUM-VT pivotal IDE trial initiated with first procedures at Vanderbilt University Medical Center and Texas Cardiac Arrhythmias Institute

- April 2025: FDA granted Breakthrough Device Designation for vCLAS Cryoablation System

- October 2025: FULCRUM-VT trial completed enrollment of 209 patients

- February 2026: Published U.S. Early Feasibility Study results demonstrating consistent safety and efficacy

- March 2026: Published pre-clinical results for next-generation vCLAS ULTRA catheter; announced 13 Expanded Access procedures completed

- April 2026: FDA IDE approval for next-generation vCLAS ULTRA system; FULCRUM-VT Late-Breaking presentation scheduled for April 26 at HRS 2026

Proprietary Technology & Products

Ultra-Low Temperature Ablation (ULTA) Technology

Core Mechanism:

- Utilizes near-critical nitrogen to achieve temperatures approaching -196°C

- Creates deeper and potentially transmural lesions compared with radiofrequency and other ablation modalities

- Single-freeze applications produce 5mm-deep lesions in 15 seconds and 12.5mm-deep lesions in ~120 seconds in pre-clinical models

- No catheter irrigation required, potentially reducing risk of acute heart failure during procedures

- Purely endocardial approach eliminates need for ePicardial access or surgical intervention

vCLAS™ Cryoablation System

Current Generation:

- Purpose-built system for ventricular tachycardia ablation

- CE Marked and commercially available in Europe and select other geographies for monomorphic VT

- Limited to investigational use in the United States

Next-Generation vCLAS ULTRA (FDA IDE Approved April 2026):

- Smaller 8.5 French catheter with handling characteristics equivalent to standard radiofrequency catheters

- Enhanced handling and compatibility with standard laboratory practices

- Potential for 50-75% reduction in ablation time and up to 30-minute procedure time reduction vs. first-generation

- Maintains same titratable lesion depth exceeding 10 millimeters

Clinical Development & Regulatory Pathway

FULCRUM-VT Pivotal IDE Trial

Trial Design:

- Full Name: Feasibility of Ultralow Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia

- Type: Prospective, multi-center, open-label, single-arm pivotal trial

- Enrollment: 209 patients with structural heart disease (both ischemic and non-ischemic cardiomyopathy)

- Indication: Drug-refractory VT patients indicated for catheter ablation per current treatment guidelines

- First Procedures: October 2024 at Vanderbilt University Medical Center and Texas Cardiac Arrhythmias Institute

- Enrollment Completion: October 2025

- Centers: Expanded to 20 centers across the U.S. and Canada

- Primary Objective: Evaluate safety and effectiveness to support FDA PMA application

- HRS 2026 Presentation: Late-Breaking Clinical Trial, Sunday April 26, 2026, 8:30 AM ET, Boston

- Expected FDA PMA: Year-end 2026, potentially leading to broadest industry indication for purely endocardial ablation of scar-mediated VT

Expanded Access Program (March 2026)

- In March 2026, Adagio announced completion of 13 Expanded Access ventricular ablation procedures

- Procedures performed under FDA authorization for patients who had failed previous conventional and investigational ablation therapies

- Demonstrates continued clinical demand and physician confidence in ULTA technology for difficult-to-treat cases

FDA Breakthrough Device Designation (April 2025)

- Granted for vCLAS Cryoablation System for drug-refractory, recurrent, sustained monomorphic VT

- Covers both ischemic and non-ischemic structural heart disease patients

- Only technology granted Breakthrough Device label for endocardial treatment of both patient populations with sustained monomorphic VT

- Provides priority review and enhanced FDA interaction during premarket review phase

Financial Performance (2024-2025)

Post-IPO Financials

FY 2025 Full Year (Year Ended December 31, 2025):

- Revenue: $0

- Net Loss: $(25.1) million

- Research & Development: ~$10.6 million

- Selling, General & Administrative: Included in net loss figure

- Basic Net Loss Per Share: $(0.66) (for nine-month successor period; full year EPS comparable)

Q4 2025 Performance:

- Net Loss: $(3.3) million (vs. $(57.4) million in Q4 2024)

- Significant year-over-year improvement reflecting reduced one-time costs

2024 Full Year (Predecessor/Successor Combined):

- Revenue: $465K (Predecessor Jan-July 2024: $333K; Successor Aug-Dec 2024: $132K)

- Net Loss: $(25.1) million

Balance Sheet (As of December 31, 2025):

- Total Assets: $43.3 million

- Total Debt: $21.8 million

- Cash Position: Strong liquidity with more cash than debt on balance sheet (per Q3 2025)

Stock Performance (April 2026):

- Ticker: ADGM (Nasdaq Capital Market)

- Share Price: ~$1.52 (April 17, 2026)

- 52-Week Range: $0.74 - $2.87

- Market Cap: ~$34.4 million

- EPS (TTM): -$1.51

Leadership Team (2025-2026)

Executive Management

Chief Executive Officer: Todd Usen

- Led company through FDA Breakthrough Device designation and FULCRUM-VT trial execution

- Previously held leadership roles at major medical device companies

Chief Financial Officer & Chief Business Officer: Debbie Kaster

- Oversees financial operations, investor relations, and business development

Senior Vice President, Global Sales: Marie-Claude Jacques (appointed December 2025)

- Extensive commercial leadership experience in electrophysiology and cardiac rhythm management

Senior Vice President, Manufacturing & Operations: Antwan Gipson (appointed December 2025)

- Responsible for scaling manufacturing operations and supply chain in preparation for potential U.S. commercial launch

Market Context & Competitive Landscape

Target Market

Ventricular Tachycardia (VT) Ablation Market:

- VT is a life-threatening arrhythmia affecting hundreds of thousands of patients annually

- Associated with high morbidity and mortality when left untreated

- Current treatment options include antiarrhythmic drugs (often ineffective or poorly tolerated) and radiofrequency catheter ablation (limited efficacy in thicker/diseased tissue)

- Significant unmet need for durable, deep lesions in scar-mediated VT

Key Competitors:

- Boston Scientific: Market leader in electrophysiology with RF and Pulsed field ablation platforms

- Medtronic: Cryoablation and RF ablation technologies (Arctic Front cryoballoon for AFib)

- Biosense Webster (Johnson & Johnson): CARTO mapping and THERMOCOOL RF ablation catheters

- Acutus Medical: Focused on electrophysiology mapping and ablation

Competitive Differentiation

- Deepest Lesions: ULTC creates 10mm+ depth lesions, potentially transmural, exceeding RF capabilities

- No Irrigation Required: Reduces risk of acute heart failure during VT ablation procedures

- Endocardial Only: Eliminates need for epicardial access or surgical hybrid approaches

- Single-Freeze Efficiency: Rapid lesion creation (15 seconds for 5mm depth) vs. multiple RF applications

- Breakthrough Designation: Only technology with FDA Breakthrough status for both ischemic and non-ischemic VT

Strategic Outlook & 2026 Milestones

Near-Term Catalysts

- April 26, 2026: FULCRUM-VT pivotal trial results presented as Late-Breaking Clinical Trial at HRS 2026, Boston

- 2026: FDA PMA submission for vCLAS Cryoablation System

- Year-End 2026: Potential FDA approval for broadest industry indication for purely endocardial scar-mediated VT ablation

- Commercial Launch Preparation: Building U.S. commercial infrastructure in anticipation of PMA approval

- Next-Generation Development: Advancing vCLAS ULTRA with improved catheter design and faster ablation times

Contact Information

Headquarters

Address: Adagio Medical Holdings, Inc., Laguna Hills, California, USA
   Website: www.adagiomedical.com
   Investor Relations: investors.adagiomedical.com
   CFO/CBO Contact: Debbie Kaster, dkaster@adagiomedical.com

Investor Information

Stock Ticker: ADGM (Nasdaq Capital Market)
   IPO Date: August 1, 2024 (via SPAC merger with ARYA Sciences Acquisition Corp IV)
   52-Week Range: $0.74 - $2.87
   Shares Outstanding: ~22.2 million
   Market Cap: ~$34.4 million (April 2026)
   EPS (TTM): -$1.51

Keywords: Adagio Medical Holdings, ADGM, Nasdaq, vCLAS, vCLAS ULTRA, cryoablation, ultra-low temperature ablation, ULTA, ULTC, ventricular tachycardia, VT, FULCRUM-VT, FDA Breakthrough Device, IDE approval, HRS 2026, Late-Breaking Clinical Trial, cardiac arrhythmia, Todd Usen, Debbie Kaster, Laguna Hills, 2011, SPAC, Expanded Access