ADGM · Adagio Medical Holdings, Inc.

Adagio Medical reported first quarter 2026 results with no revenue, consistent with the prior year, as the company paused commercial activity in Europe. Cost of revenue was nil, down from $0.3 million in Q1 2025, due to the absence of console depreciation allocated to cost of revenue (now classified as R&D). Research and development expenses decreased to $2.7 million from $3.7 million, driven by lower clinical trial and product development costs, partially offset by higher operational costs including depreciation. Selling, general and administrative expenses fell to $2.5 million from $3.5 million, primarily due to lower professional services, regulatory reporting, and payroll expenses. Net loss improved to $7.0 million from $7.7 million, reflecting disciplined cost management. The company ended the quarter with $12.9 million in cash and equivalents, with potential for up to $31 million in additional proceeds from milestone-based warrant exercises. Management highlighted the FULCRUM-VT pivotal trial results presented at Heart Rhythm 2026, which demonstrated 84% freedom from ICD shock at six months, a 2.4% major adverse event rate, and 72% reduction in antiarrhythmic drug use. The FDA also approved an IDE expansion for the next-generation vCLAS Ultra System. These milestones position Adagio to submit for PMA approval, though no specific timeline was provided. The company's focus remains on advancing its ULTA platform for ventricular tachycardia, with no near-term revenue expected.