---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-049436"
form_type: "8-K"
ticker: "ADGM"
cik: "0002006986"
company_name: "Adagio Medical Holdings, Inc."
filed_at: "2025-05-15T23:59:59+00:00"
generated_at: "2026-05-21T06:06:28.886388+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Adagio Medical Q1 net loss $7.7M; FDA breakthrough device designation

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-049436
- form_type: 8-K
- ticker: ADGM
- cik: 0002006986
- company_name: Adagio Medical Holdings, Inc.
- filed_at: 2025-05-15T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/2006986/000110465925049436/0001104659-25-049436-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/2006986/000110465925049436/tm2515197d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-049436
- JSON: https://secwatch.observer/filing/0001104659-25-049436.json
- Plain text: https://secwatch.observer/filing/0001104659-25-049436.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.