Adagio Medical Holdings, Inc. — Form 8-K
Filed August 11, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
Adagio Medical (market cap ~$7M) submitted a Premarket Approval application to the FDA in May 2026 for its vCLAS Ventricular Ablation System, supported by FULCRUM-VT pivotal trial data (209 patients, 84% ICD shock freedom at 6 months, 2.4% major adverse events). Q2 2026 net loss was $6.7M ($0.30/share) on zero revenue, versus $3.9M loss in Q2 2025; cash declined from $17.1M (Dec 2025) to $7.7M (June 2026). The company paused European commercial activity and remains pre-revenue in the U.S.
Why this rating
FDA submission is major clinical milestone for pre-revenue $7M company; cash burn rate (~$6.7M/quarter) versus $7.7M remaining is existential pressure demanding near-term capital raise or approval.
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