secwatch.observer — SEC 8-K summary
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Issuer:     Adagio Medical Holdings, Inc. (ADGM)
CIK:        0002006986
Form:       8-K
Filed at:   2025-05-15T23:59:59+00:00
Accession:  0001104659-25-049436
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Adagio Medical Q1 net loss $7.7M; FDA breakthrough device designation
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- Net loss of $7.7M ($0.50 per share) vs $8.0M ($10.28 per share) in Q1 2024.
- Cash and cash equivalents $13.0M as of March 31, 2025.
- FDA granted Breakthrough Device Designation for vCLAS Cryoablation System for ventricular tachycardia.
- FULCRUM-VT pivotal study surpassed 50% enrollment; completion on track for H2 2025.
- Hired Deborah Kaster as Chief Business Officer; corporate prioritization on FULCRUM-VT trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925049436/0001104659-25-049436-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2006986/000110465925049436/tm2515197d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-049436

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