Market reactionShares fell 29% on Nov 5.
Adagio Medical makes a cryoablation catheter system for ventricular tachycardia, a dangerous heart rhythm; it is CE-marked in Europe and under FDA review in the United States.
Adagio's case rests on vCLAS, whose single-arm FULCRUM-VT trial showed 84% freedom from ICD shock at six months with a 2.4% major adverse event rate. FDA is reviewing the PMA, with a decision expected in the fourth quarter of 2026. Cash of $7.7 million at June 30 lasts only into that quarter, and the company is exploring a sale, merger or other transaction. Nasdaq has flagged both the share price and stockholders' equity, and noteholders are converting at about $0.13 to $0.16 per share.
Thesis checklist
2 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: FDA approves vCLAS
Does FDA approve vCLAS for drug-refractory monomorphic VT on the single-arm FULCRUM-VT data?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
vCLAS awaits a Q4 2026 FDA decision while Adagio seeks a buyer or financing
Pivotal data in hand and PMA filed, but $7.7M of cash makes reaching the Q4 approval decision depend on financing
Pivotal data strong, PMA filed, but $7.7M of cash may not last to a Q4 2026 approval decision
vCLAS PMA pivotal data met endpoints; FDA approval decision determines whether cryoablation captures the refractory VT market
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Obesity, diabetes and heart disease
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
vs. direct competitors
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.