secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2026-05-12T12:05:25+00:00
Accession:  0001104659-26-059026
Event type: earnings
Sentiment:  positive
Materiality: 0.85
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adagio Medical reports Q1 2026 net loss $7.0M, cash $12.9M; FULCRUM-VT shows 84% freedom from ICD shock
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- Net loss of $7.0M for Q1 2026 vs $7.7M in Q1 2025; no revenue; R&D expense $2.7M, SG&A $2.5M.
- Cash and equivalents of $12.9M as of March 31, 2026; up to $31M additional from milestone-based warrants.
- FULCRUM-VT pivotal trial: 84% freedom from ICD shock at 6 months, 2.4% MAE, 72% reduction in antiarrhythmic drug use.
- FDA approved IDE to expand FULCRUM-VT trial to evaluate next-generation vCLAS Ultra System.
- Successfully completed 13 cases under FDA Expanded Access in patients who failed prior ablation therapies.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926059026/0001104659-26-059026-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926059026/tm2614299d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-059026

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer