Adagio Medical Holdings, Inc. ADGM
Adagio Medical Holdings, Inc. (Nasdaq: ADGM) is a cardio-renal-metabolic medical device company.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| vCLAS Ventricular Ablation System (first generation) | Sustained monomorphic VT | device-combination | NA_NON_THERAPEUTIC |
| vCLAS Ultra Ventricular Ablation System | Sustained monomorphic VT | device-combination | NA_NON_THERAPEUTIC |
| Pulsed Field Cryoablation (PFCA) | Atrial fibrillation / VT | device-combination | NA_NON_THERAPEUTIC |
Recent results and decisions
- May 21, 2026submitted PMA application submitted to FDA for vCLAS, supported by FULCRUM-VT (n=209; 97.4% acute success, 84.3% freedom from ICD shock at 6 months).
Adagio Medical Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced the submission of its Premarket Approval (“PMA”) application to the U.S. Food and Drug Administration (“FDA”) for t
Filing - Apr 26, 2026met FULCRUM-VT pivotal single-arm IDE (n=209) met safety and effectiveness endpoints: 84% freedom from ICD shock and 59% freedom from VT recurrence at 6 months, 2.4% major adverse events.
Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System 84% Freedom From Shock and 59% Freedom from VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results
Filing - Apr 8, 2026approval FDA granted IDE approval to expand FULCRUM-VT with a 55-patient sub-study of the next-generation vCLAS Ultra system (investigational study approval, not marketing approval).
The approval for IDE expansion enables Adagio to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System including the next generation vCLAS Ultra catheter
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other cardio-renal-metabolic companies
- DexCom, Inc. DXCM
- Penumbra Inc PEN
- Insulet Corp PODD
- MiniMed Group, Inc. MMED
- Heartflow, Inc. HTFL
- iRhythm Holdings, Inc. IRTC
- Pulse Biosciences, Inc. PLSE
- AtriCure, Inc. ATRC
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.