Adagio Medical Holdings, Inc. 8K

Adagio Medical furnished an investor presentation outlining its VT ablation technology, clinical results, regulatory and reimbursement outlook, and capital structure, including a milestone-based PIPE financing of up to $50 million.

The Form 8-K includes as Exhibit 99.1 an investor presentation by Adagio Medical describing its proprietary ultra-low temperature cryoablation (ULTA) technology and vCLAS catheter systems for ventricular tachycardia (VT) ablation, highlighting pivotal FULCRUM‑VT trial data, anticipated FDA PMA timelines (submission in Q2 2026 and expected approval for first‑generation vCLAS around Q4 2026 / Q1 2027, and next‑gen vCLAS Ultra in Q1 2028), established U.S. reimbursement dynamics (including potential NTAP benefits under Breakthrough Device Designation), and a previously announced October 2025 PIPE financing of up to $50 million structured in tranches tied to clinical and regulatory milestones, along with summary balance sheet and capitalization data as of June 30, 2026.

Filing Facts

CIK

2006986

Ticker

-

Form

8K

Source Type

sec

Accession

0001104659-26-095987

Alert Tier

6