Like a focused Medtronic or Abbott Laboratories, but solely dedicated to developing next-generation ablation devices for cardiac arrhythmias.

A specialized Boston Scientific, pioneering innovative cryoablation and pulsed-field systems for heart rhythm disorders.

• iCLAS atrial ultra-low temperature cryoablation (ULTC) catheter and accessories: This catheter system uses ultra-low temperature cryoablation to treat atrial cardiac arrhythmias.
• vCLAS ventricular ULTC catheter: This catheter is designed for ultra-low temperature cryoablation to treat ventricular cardiac arrhythmias.
• Cryopulse atrial pulsed-field cryoablation catheter and accessories: This catheter system employs pulsed-field cryoablation specifically for atrial arrhythmias.

Adagio Medical (ADGM) is a developmental stage medical device company specializing in ablation technologies for cardiac arrhythmias. Its products, such as various types of ablation catheters, are designed for use in medical procedures performed in healthcare settings by medical professionals.

Therefore, Adagio Medical primarily sells its products to other organizations and institutions within the healthcare sector, rather than directly to individuals.

Due to Adagio Medical's developmental stage and the typical distribution model for specialized medical devices, specific "major customer companies" that are publicly identifiable, with associated stock symbols, are not publicly disclosed or readily apparent. Sales in this sector are often made to numerous individual hospitals, clinics, and healthcare systems, rather than to a few large, publicly traded corporate entities that would be considered "major customers" in the traditional sense.

However, the categories of institutional customers that would typically purchase and utilize Adagio Medical's products include:

• Hospitals (specifically cardiology departments and electrophysiology labs)
• Specialized Cardiac Clinics
• Academic and Research Institutions (for clinical trials and advanced medical research)

Todd Usen, Chief Executive Officer

Todd Usen was appointed CEO and Director of Adagio Medical on December 13, 2024. Prior to joining Adagio Medical, he served as President & CEO of Minerva Surgical, where he successfully restructured the company, completed successful financings, and drove significant top-line growth. He was also CEO of Activ Surgical, overseeing FDA/CE clearance of advanced surgical imaging technology and leading four fundraising rounds totaling over $92 million. Usen led a $2B+ business as President of the Medical Systems Group at Olympus Corporation, where he was instrumental in strategic expansion, operational restructuring, and mergers and acquisitions. His career also includes executive roles at Smith & Nephew and Boston Scientific Corporation. He currently serves as Executive Chairman of Rob Surgical, Chairman of NeoPredics, and Director of Alesi Surgical.

Deborah Kaster, Chief Financial Officer and Chief Business Officer

Deborah Kaster's responsibilities were expanded to include the role of Chief Financial Officer, effective September 5, 2025, succeeding Dan George, the interim CFO. She joined Adagio Medical in March 2025 as Chief Business Officer. From 2020 to 2024, Kaster served as Vice President of Investor Relations at Shockwave Medical, until the company's acquisition by Johnson & Johnson. She was a Managing Director at Gilmartin Group, an investor relations and strategic advisory firm focused on healthcare, from 2016 to 2020. Earlier in her career, she spent five years as Director of Business Development at Kyphon and was a Vice President in the Medical Technology Investment Banking Group at Piper Jaffray. Kaster began her Wall Street career in Equity Research at JPMorgan.

Nabil Jubran, Chief Compliance Officer

Nabil Jubran serves as the Chief Compliance Officer of Adagio Medical. He has also been noted as the Vice President of QA/RA for Adagio Medical.

Alex Babkin, Chief Technical Officer

Alex Babkin serves as the Chief Technical Officer of Adagio Medical Inc.

Antwan Gipson, Senior Vice President of Manufacturing and Operations

Antwan Gipson joined Adagio Medical as Senior Vice President of Manufacturing and Operations on December 22, 2025. He brings over two decades of experience leading manufacturing, quality, supply chain, and logistics across high-growth medical technology companies. Most recently, he served as Vice President of Operations and Quality Sciences at Decobolus Consultancy Group.

Adagio Medical Holdings, Inc. (ADGM) faces several key risks inherent to its nature as a developmental stage medical device company.

1. Regulatory Approval and Commercialization Challenges: As a company focused on developing and commercializing ablation technologies for cardiac arrhythmias, Adagio Medical's success is highly dependent on obtaining necessary regulatory approvals and achieving successful market adoption of its products. While some products, like the vCLAS Cryoablation System, have received CE Mark approval for use in Europe, they are still under investigational evaluation in the United States, such as in the FULCRUM-VT U.S. Pivotal IDE Trial. The company reported zero GAAP revenue in Q2 2025, emphasizing its pre-commercial stage in the U.S. and its focus on clinical development rather than commercialization. Failure to secure FDA approval in the U.S. and widespread commercial success in key markets could significantly hinder its business.
2. Capital Requirements and Funding Dependence: Adagio Medical is a developmental stage company that has consistently reported net losses and a decline in its cash and cash equivalents. Although the company recently secured a private placement for upfront proceeds, its ongoing clinical trials, product development, and future commercialization efforts will require substantial capital. The ability to raise additional funds on favorable terms, or at all, is critical to its continued operations and growth.
3. Product Liability Exposure: The design, development, testing, manufacturing, and marketing of medical devices inherently expose Adagio Medical to the risk of product liability claims. Any alleged manufacturing or design defects, or even misuse by trained professionals, could lead to patient injury or death, potentially resulting in costly litigation, significant financial damages, and reputational harm, even if a device is cleared or approved by regulatory bodies.

The rapid commercialization and adoption of Pulsed Field Ablation (PFA) technologies by major medical device companies such as Medtronic (PulseSelect), Boston Scientific (FARAPULSE), and Johnson & Johnson (VARIPULSE, HELIOSTAR). These well-resourced competitors are aggressively bringing PFA systems to market, which are increasingly perceived to offer significant safety, efficacy, and procedural advantages over traditional ablation methods. While Adagio Medical also has a pulsed-field cryoablation catheter, the swift establishment of market dominance by these larger players could marginalize Adagio Medical's product offerings, including its ultra-low temperature cryoablation (ULTC) catheters, as PFA potentially becomes the new standard of care in cardiac arrhythmia treatment, making it challenging for ADGM to secure significant market share.

• The global atrial fibrillation devices market was valued at USD 12.9 billion in 2025 and is projected to reach USD 40.2 billion by 2035. North America accounted for 40.6% of this market in 2025, and the European market was valued at USD 3.6 billion in the same year.
• The global atrial fibrillation surgery market was valued at USD 3.92 billion in 2025 and is estimated to grow to USD 8.39 billion by 2031.
• The global pulsed field ablation (PFA) market, which is particularly relevant for Adagio Medical's Cryopulse, is projected to grow from USD 110.8 million in 2023 to USD 2,127.9 million by 2032. Another estimate places the global PFA market size at USD 913.1 million in 2024, expected to reach USD 6.2 billion by 2030. Furthermore, the global PFA market is anticipated to be valued at US$1.6 billion in 2026 and projected to reach US$11.9 billion by 2033. PFA is forecast to capture over 70% of the global atrial fibrillation treatment market by 2028, exceeding $7 billion in market value. North America is a dominant region in the PFA market, expected to capture approximately 52% of the market share in 2026.
• For cryoablation devices, including Adagio Medical's iCLAS ULTC catheter, the global cryoballoon ablation system market was valued at USD 1.43 billion in 2025 and is projected to reach approximately USD 2.49 billion by 2035. North America leads this market, holding a 44% share in 2025. The broader global cryoablation devices market was estimated at USD 466.1 million in 2025 and is expected to reach USD 1,181.4 million by 2032. North America accounted for an estimated 40.7% of this market in 2025.
• The atrial flutter market across seven major markets is expected to exhibit a compound annual growth rate (CAGR) of 4.56% during 2025-2035, with the United States representing the largest market for its treatment.

• The global ventricular tachycardia ablation market is estimated to be valued at USD 16.21 billion in 2026 and is expected to reach USD 23.58 billion by 2033. North America is projected to lead this market, holding a 39.4% share in 2026.
• Another estimate values the global ventricular tachycardia market size at USD 14.64 billion in 2024, projected to increase to USD 24.51 billion by 2034. North America dominated the ventricular tachycardia market in 2024.

Expected Drivers of Future Revenue Growth for Adagio Medical (ADGM)

Over the next 2-3 years, Adagio Medical (ADGM) is expected to drive future revenue growth through the following key initiatives:

1. U.S. Commercialization of the vCLAS Cryoablation System: Adagio Medical is strategically focused on obtaining U.S. Food and Drug Administration (FDA) approval for its vCLAS Cryoablation System, designed for treating ventricular tachycardia (VT). The system has received Breakthrough Device designation from the FDA, which is intended to expedite its development and review process. The ongoing pivotal FULCRUM-VT study is crucial, as its data will support the premarket approval application, paving the way for the system's commercial availability in the United States.
2. European Commercial Launch of the iCLAS Cryoablation System: The company has received CE Mark approval for its iCLAS ultra-low temperature intelligent Continuous Lesion Ablation System (iCLAS) for the endocardial treatment of paroxysmal and persistent atrial fibrillation and atrial flutter. Adagio Medical was preparing for a limited European commercial launch of iCLAS, which is anticipated to be a source of revenue growth from market expansion outside the U.S.
3. Advancement and Optimization of Ultra-Low Temperature Cryoablation (ULTC) Technology: Adagio Medical's core focus on proprietary Ultra-Low Temperature Cryoablation (ULTC) technology is a foundational driver. Continued investment in product design optimization and the potential expansion of its application across a broader spectrum of cardiac arrhythmias, including through products like the Cryopulse atrial pulsed-field cryoablation catheter, are expected to contribute to sustained revenue growth by enhancing existing systems and introducing new therapeutic options.

Share Issuance

• Adagio Medical completed a private placement on October 20, 2025, generating gross proceeds of up to $50 million, with initial proceeds of approximately $19 million.
• The company underwent a business combination with ARYA Sciences Acquisition Corp IV on July 31, 2024, resulting in Adagio Medical Holdings, Inc. shares commencing trading on Nasdaq.
• As of December 2025, the total number of shares held by institutions increased to 16.65 million, marking a net change of 5.24 million shares quarter-on-quarter and 5.84 million shares year-over-year.

Inbound Investments

• A private placement completed on October 20, 2025, secured up to $50 million in gross proceeds, with upfront proceeds of approximately $19 million, from a syndicate of healthcare-dedicated institutional investors.
• Institutional holdings in Adagio Medical increased significantly, with 21 institutional firms collectively holding 110.2% of the company's total shares outstanding in December 2025, up from 77.1% in September 2025.
• PERCEPTIVE ADVISORS LLC emerged as the primary institutional investor, owning 65.39% of the stock with 9.88 million shares as of December 31, 2025.

Capital Expenditures

• The company's balance sheet reported physical assets valued at $2.5 million.
• Proceeds from a recent financing round are allocated to support FDA submission activities and the ongoing development of next-generation catheters.
• Research and development expenses were $2.8 million for the three months ended September 30, 2025, an increase from $2.5 million for the same period in 2024, reflecting continued investment in product development.