Adagio Medical (ADGM 1.57%), a medical technology company developing treatments for cardiac arrhythmias, released its second quarter 2025 results on August 13, 2025. The company reported no GAAP revenue as it continues to focus on clinical development rather than commercialization. Operating losses narrowed as research and administration expenses fell compared to the same period in 2024, while cash and cash equivalents (GAAP) decreased sharply from $20.6 million to $8.2 million. No analyst estimates were available for the quarter. Overall, the period reflected disciplined cost management, advancement in clinical programs, and persistent financial risks tied to the lack of revenues and reliance on ongoing funding.

MetricQ2 2025Q2 2024Y/Y Change
Revenue (GAAP)$0$0.25 million(100%)
Net Loss$(3.95 million)$(5.73 million)N/A
EPS (GAAP, Diluted)$(0.35)$(7.35)N/A
Research and Development Expense$1.97 million$2.87 million(31.2%)
Selling, General, and Administrative Expense$2.40 million$3.37 million(28.6%)

Source: Adagio Medical.

Business Overview and Recent Focus

Adagio Medical develops advanced ablation technologies for the treatment of cardiac arrhythmias, which are disruptions to the normal rhythm of the heart. Its focus is on innovative solutions like the vCLAS cryoablation system and ultra-low temperature cryoablation (ULTC) catheters. These products are designed to improve the safety and effectiveness of treating conditions such as atrial fibrillation and ventricular tachycardia, which are forms of irregular heartbeat.

In recent quarters, Adagio Medical concentrated on progressing its pivotal clinical trials and refining its core cryoablation technology. The company has focused on reaching clinical and regulatory milestones, supporting peer-reviewed publication of early human data, and optimizing its product pipeline to meet physician and patient needs. The ability to secure timely regulatory approvals and advance through late-stage trials remains a key driver for future commercial progress.

Quarterly Highlights: Operations and Financials

Adagio Medical’s GAAP revenue was $0, down from $0.25 million in Q2 2024. The drop underscores the company's pre-commercial status in the U.S. and minimal sales overseas. Research and development expenses fell by 31% and selling, general and administrative expenses fell by 29% compared to the same period in 2024, helping narrow its net loss. Research and development spending fell to $2.0 million from $2.9 million (GAAP). Selling, general, and administrative costs (GAAP) were $2.40 million, down from $3.4 million. Management attributes these savings to a corporate initiative that reallocated resources to the highest-priority programs, particularly late-stage clinical activities. Operational costs were lower compared to the same period in 2024. There was a $1.8 million improvement in net loss compared to the same period in 2024.

No commercial revenue was reported from the U.S, and European or other international sales remained negligible. To focus its business, Adagio Medical dedicated most resources to advancing its FULCRUM-VT pivotal trial, targeting completion of patient enrollment in the second half of 2025. The company received the U.S. Food and Drug Administration’s Breakthrough Device Designation for its vCLAS system, which is designed to treat drug-resistant, recurrent ventricular tachycardia using a specialized catheter. This status is intended to speed up regulatory review and facilitate feedback from the FDA.

Operational progress centered on clinical data and peer-reviewed validation. First-in-human results from the company’s Pulsed Field Cryoablation (PFCA) technology were published in a leading cardiology journal. The publication and ongoing momentum in the 206-patient FULCRUM-VT pivotal study—now past 85% enrollment—are critical as the company moves towards potential regulatory submission in the U.S. Management stated, “we saw continued strong momentum in the enrollment of our FULCRUM-VT study, which we believe validates the market need for our purpose-built technology and brings us one step closer to offering our proprietary ULTC solutions.”

Cash consumed by operations caused cash and equivalents to fall to $8.2 million, down from $20.59 million. At this spend rate, Adagio Medical’s current liquidity covers less than two quarters of operations.

Looking Ahead: Outlook and Key Considerations

Management did not provide financial guidance for the next quarter or for fiscal 2025. The company’s plans continue to center on completing enrollment in the pivotal FULCRUM-VT study in the second half of 2025. This milestone remains crucial for subsequent regulatory submissions and any future commercial launch.

Cash reserves were $8.2 million.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.