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Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress

ADGM
  • Adagio Medical Holdings reported first quarter 2026 financial results for the period ended March 31, 2026.
  • Late-breaking FULCRUM-VT trial results presented at Heart Rhythm Society 2026 showed 84% freedom from ICD shock at six months.
  • The FULCRUM-VT trial demonstrated a 2.4% rate of protocol-defined Major Adverse Events \& a 72% discontinuation or reduction in antiarrhythmic drug use.
  • Results were consistent across patients with both ischemic \& non-ischemic cardiomyopathies using the Ultra-Low Temperature Ablation (ULTA) technology.
  • The FDA granted Investigational Device Exemption (IDE) approval to expand the FULCRUM-VT trial for the next-generation vCLAS Ultra System.
  • Pre-clinical results published in the Journal of Cardiovascular Electrophysiology indicated titratable lesion depth exceeding 10 millimeters.
  • The next-generation ULTA technology showed potential for a 50-75% reduction in ablation time compared to the first generation.
  • Adagio completed 13 cases under FDA Expanded Access using the vCLAS System in patients with recurrent VT who failed prior therapies.
  • Cost of revenue was nil for the quarter, compared to $0.3 million in the same period in 2025 due to a pause in European commercial activity.
  • Research and development expenses decreased to $2.7 million from $3.7 million, driven by lower clinical trial \& product development costs.
  • Selling, general, \& administrative expenses fell to $2.5 million from $3.5 million, attributed to reduced professional services \& payroll expenses.
  • The company reported a net loss of $7.0 million for the quarter, compared to $7.7 million in the prior year period.
  • Cash \& cash equivalents stood at $12.9 million as of March 31, 2026, with potential for an additional $31 million from warrant exercises.
  • Weighted average shares outstanding were 22,210,459 as of March 31, 2026.
  • Adagio is advancing toward a Premarket Approval (PMA) submission for the vCLAS Cryoablation System based on the FULCRUM-VT data.
  • The vCLAS System is commercially available in Europe but remains under investigational use in the United States.