secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2026-08-11T12:30:36+00:00
Accession:  0001104659-26-093791
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adagio Medical posts Q2 2026 net loss of $6.7M; submits PMA for VT ablation system
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- Net loss widened to $6.7M ($0.30/share) from $3.9M ($0.26) a year ago; revenue nil.
- R&D spend $2.5M vs $2.0M; SG&A $2.5M vs $2.4M; cash $7.7M at June 30.
- FULCRUM-VT trial (209 pts): 2.4% MAE, 84% freedom from ICD shock, 78% reduced/discontinued antiarrhythmics.
- Submitted PMA to FDA for vCLAS Ventricular Ablation System for monomorphic VT in structural heart disease.
- First patient treated with next-gen vCLAS Ultra catheter under FDA Expanded Access at Penn.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926093791/0001104659-26-093791-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465926093791/tm2622801d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-093791

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