Adagio Medical Holdings Inc
ADGM evidence brief
What we can confirm
- BioSniper Score:
- 5.5 / 10
- Market Cap:
- $10.7M
- Lead Asset:
- pfca (Preclinical)
What it means
What to watch
Prepared research question
What matters most for ADGM—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · ADGM
Adagio Medical Holdings Inc (ADGM) is a clinical-stage medical device company developing cryoablation and pulsed-field ablation technologies for ventricular tachycardia, currently facing a going-concern risk with cash runway only through Q4 2026.
Key risk: Going concern risk
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$10.7M
Cash Runway
—
Lead Asset
pfca (Preclinical)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 3 pipeline candidates · 4 clinical trials for Adagio Medical Holdings Inc.
Adagio Medical Holdings Inc (ADGM) is a clinical-stage medical device company developing cryoablation and pulsed-field ablation technologies for ventricular tachycardia, currently facing a going-concern risk with cash runway only through Q4 2026.
- Cash & equivalents of $7.7M as of 2026-06-30, with net income of -$6.7M and shareholders' equity of -$0.4M [sec].
- Company expects sufficient resources to fund operations only into Q4 2026, raising substantial doubt about going concern [sec_mda · as of 2026-08-11].
- FULCRUM-VT pivotal IDE trial for vCLAS Ventricular Ablation System reported 97.4% acute clinical success and a 2.4% major adverse event rate including 1.9% peri-procedural deaths [sec_mda · as of 2026-08-11].
- Next-generation ULTA technology combining cryoablation and pulsed-field ablation (PFA) is in preclinical development for ventricular tachycardia [pipeline].
- Company has no revenue ($0.0M) and relies on equity/debt financings to fund operations, with no assurance of availability on acceptable terms [sec_mda · as of 2026-08-11].
What works
- Preliminary FULCRUM-VT data showed 97.4% acute clinical success and elimination of all clinically-relevant VTs in 96.7% of patients, suggesting strong efficacy [sec_mda · as of 2026-08-11].
- First-in-human CRYOCURE-VT trial reported 0% major adverse events and 94% acute procedural success, supporting CE Mark approval [sec_mda · as of 2026-05-12].
- Company is developing a next-generation ULTA technology that combines cryoablation with pulsed-field ablation, potentially offering a differentiated treatment approach [pipeline].
What to weigh
- Cash runway only through Q4 2026, with substantial doubt about ability to continue as a going concern [sec_mda · as of 2026-08-11].
- No revenue generated ($0.0M) and accumulated deficit not disclosed but net loss of $6.7M in latest quarter [sec].
- FULCRUM-VT trial reported a 2.4% major adverse event rate including 1.9% peri-procedural deaths, with one death adjudicated as definitely device-related [sec_mda · as of 2026-08-11].
- Company may need to delay or reduce development activities if additional financing is not secured on acceptable terms [sec_mda · as of 2026-08-11].
From the filings
Quoted directly from source documents.
Cash runway only through Q4 2026
“Based on our current research and development plans, we expect to have sufficient resources to fund our planned operations into the fourth quarter of 2026.”
SEC MD&A · August 11, 2026
Going concern risk
“We do not believe our existing cash and cash equivalents will be sufficient to fund operations for at least the next twelve months from the issuance date of the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. We believe that this raises substantial doubt about our ability to continue as a going concern.”
SEC MD&A · August 11, 2026
FULCRUM-VT acute clinical success rate
“acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant VTs eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation.”
SEC MD&A · August 11, 2026
FULCRUM-VT safety findings
“Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device.”
SEC MD&A · August 11, 2026
Risks & what to watch (4)›
Key risks
- Going concern risk — Cash only through Q4 2026; substantial doubt about ability to continue as a going concern [sec_mda · as of 2026-08-11]
- No revenue and negative equity — Zero revenue, net loss of $6.7M, and negative shareholders' equity of -$0.4M as of 2026-06-30 [sec]
- Device-related deaths in pivotal trial — FULCRUM-VT trial had 1.9% peri-procedural deaths, one definitely device-related [sec_mda · as of 2026-08-11]
- Dependence on future financing — No assurance additional financing will be available on acceptable terms; may need to suspend activities [sec_mda · as of 2026-08-11]
What to watch
- Ability to secure additional equity or debt financing to extend cash runway beyond Q4 2026 [sec_mda · as of 2026-08-11]
- FDA submission and review of vCLAS Ventricular Ablation System based on FULCRUM-VT results [sec_mda · as of 2026-05-12]
- Six-month primary efficacy endpoint results from FULCRUM-VT trial, expected to be shared at Heart Rhythm 2026 Conference [sec_mda · as of 2026-05-12]
- Progress of next-generation ULTA technology combining cryoablation and PFA in preclinical development [pipeline]
Sources: Pipeline · SEC MD&A · Generated October 8, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
Net income -$7M
Lead: Phase 3
3 candidates
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Short Interest
as of May 12, 2026- % of float
- 0.5%
- Days to cover
- 0.3
- Shares short
- 62,765
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
ADGM short interestGovernance
Frequently asked questions
What is the AI investment thesis for Adagio Medical Holdings Inc?
Adagio Medical Holdings Inc (ADGM) is a clinical-stage medical device company developing cryoablation and pulsed-field ablation technologies for ventricular tachycardia, currently facing a going-concern risk with cash runway only through Q4 2026.
What is Adagio Medical Holdings Inc's lead drug candidate?
Adagio Medical Holdings Inc's most advanced tracked candidate is pfca (Preclinical) for Ventricular tachycardia (VT) ablations.
Who is the CEO of Adagio Medical Holdings Inc?
Mr. Todd Usen is the chief executive officer of Adagio Medical Holdings Inc (ADGM).
Where is Adagio Medical Holdings Inc headquartered?
Adagio Medical Holdings Inc (ADGM) is headquartered in Laguna Hills, CA, United States.
What therapeutic areas does Adagio Medical Holdings Inc focus on?
Adagio Medical Holdings Inc develops therapies across Cardiovascular.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.