Adagio Medical Holdings, INC 8-K filings

Adagio Medical Holdings, Inc. provided an updated corporate presentation detailing advancements in its Ultra Low Temperature Cryoablation (ULTA) technology for Ventricular Tachycardia (VT) ablation, with key regulatory milestones and product launches on the horizon.

Adagio Medical Holdings announced second quarter 2026 financial results, highlighting progress in its vCLAS Ultra catheter and FULCRUM-VT trial, alongside an increased net loss.

Adagio Medical Holdings, Inc. successfully concluded its 2026 Annual Meeting with the election of two directors and the ratification of its independent auditor.

Adagio Medical Holdings, Inc. has been notified by Nasdaq of non-compliance with the minimum $1.00 bid price requirement.

Adagio Medical Holdings, Inc. has submitted a Premarket Approval (PMA) application to the FDA for its vCLAS Ventricular Ablation System, a purpose-built solution for treating ventricular tachycardia.

Adagio Medical announced first quarter 2026 financial results and significant clinical advancements for its Ultra-Low Temperature Ablation (ULTA) technology, particularly for ventricular tachycardia.

Adagio Medical announced positive six-month results from its FULCRUM-VT pivotal IDE trial for the vCLAS Ventricular Ablation System, meeting safety and effectiveness endpoints.

Adagio Medical Holdings, Inc. has scheduled its 2026 Annual Meeting of Stockholders for June 16, 2026.

Adagio Medical announced FDA Investigational Device Exemption approval to evaluate its next-generation vCLAS Ventricular Ablation System for treating ventricular tachycardia.

Adagio Medical Holdings, Inc. announced its fourth quarter and full year 2025 financial results, highlighting significant progress in its ULTA technology and clinical trials.

Adagio Medical Holdings, Inc. announced the successful election of two directors and the ratification of its independent registered public accounting firm at its 2025 Annual Meeting of Stockholders.

Adagio Medical Holdings, Inc. expanded its Board of Directors to seven members, appointing former Medtronic executive Sean Salmon as a Class II director.

Adagio Medical announced its third quarter 2025 financial results, highlighted by a significant private placement and positive clinical trial data for its vCLAS System.

Adagio Medical Holdings, Inc. announced the date for its 2025 Annual Meeting of Stockholders and critical deadlines for shareholder proposals and director nominations.

Adagio Medical Holdings, Inc. announced the closing of a $19 million private placement to fund the development and FDA submission of its ultralow cryoablation technologies for ventricular tachycardia.

Adagio Medical Holdings, Inc. announced a private placement raising $19 million upfront, with potential for an additional $31 million from warrant exercises, to fund clinical and product development.

Adagio Medical announced preliminary acute safety and efficacy results from its FULCRUM-VT Study for treating Sustained Monomorphic Ventricular Tachycardia, demonstrating 97% acute effectiveness.

Adagio Medical Holdings, Inc. announced the completion of enrollment for its FULCRUM-VT Pivotal U.S. FDA IDE study for its vCLAS Cryoablation System.

Adagio Medical Holdings, Inc. announced the expansion of Chief Business Officer Deborah Kaster's role to include Chief Financial Officer responsibilities, effective September 5, 2025.

Adagio Medical announced its second quarter 2025 financial results, highlighting reduced cash burn and significant progress in its FULCRUM-VT pivotal study for ventricular tachycardia treatment.

Adagio Medical announced its Q1 2025 financial results, reporting a net loss of $7.7 million and highlighting the FDA's Breakthrough Device Designation for its vCLAS Cryoablation System.

Adagio Medical Holdings appoints Daniel George as Interim Chief Financial Officer, effective April 17, 2025.

Adagio Medical Holdings, Inc. announced its FY2024 financial results, highlighted by increased revenue and progress in its FULCRUM-VT pivotal study, and the appointment of Deborah Kaster as Chief Business Officer.

Adagio Medical Holdings, Inc. announces the resignation of its CFO, John Dahldorf, while providing updates on its ventricular tachycardia (VT) solutions, including progress on the FULCRUM-VT trial and presentations at the European Heart Rhythm Association Annual Meeting.

Adagio Medical Holdings, Inc. announced the departure of Chief Operating Officer Hakon Bergheim as part of a corporate restructuring, effective February 28, 2025.

Adagio Medical Holdings, Inc. announces a corporate restructuring to prioritize its FULCRUM-VT US pivotal IDE clinical trial and product design optimization program.

Adagio Medical Holdings, Inc. has provided notice to terminate its Facilities and Services Agreement with Fjord Ventures LLC, effective July 30, 2025, due to the company no longer needing the services provided.

Adagio Medical Holdings has obtained a limited waiver from its debt holders regarding defaults stemming from misstated financials, while also facing a potential delisting from Nasdaq due to an audit committee vacancy.

Adagio Medical Holdings has notified Nasdaq that it will not meet audit committee requirements due to a director's resignation, effective January 1, 2025.

Adagio Medical Holdings has appointed Todd Usen as its new CEO and director, succeeding founder Olav Bergheim, who will transition to an advisory role.