Adagio Medical Stock Price, News & Analysis

Adagio Medical (Nasdaq: ADGM) said management will present at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025 at 10:30 a.m. ET at the Lotte Palace in New York.

A live and recorded webcast will be available at the event webcast page: https://event.webcasts.com/starthere.jsp?ei=1742138&tp_key=f2a06e9abc.

Adagio Medical (Nasdaq: ADGM) announced on October 20, 2025 the closing of a private placement that generated $19 million upfront in net proceeds. The company said it will use the funds to support submission activities for the FULCRUM-VT pivotal study and a PMA filing for the vCLAS ULTC System, advance clinical experience and FDA submission work for a next-generation ULTC catheter, build awareness of ULTC for ventricular tachycardia (VT), expand manufacturing and commercial readiness, and strengthen corporate operations. Adagio noted it has treated over 350 patients across regulatory studies, commercial use, and compassionate cases and said the financing is expected to de-risk execution and extend its cash runway into key inflection points.

Adagio Medical (Nasdaq: ADGM) announced a private placement expected to provide approximately $19 million in upfront proceeds and up to $31 million of additional proceeds if warrants are exercised, for a combined potential of ~$50 million.

The company will issue an aggregate of 9,792,506 shares (or pre-funded warrants) and three warrant tranches of 6,012,943 warrants each, at a combined purchase price of $1.9403 per share and an accompanying warrant exercise price of $1.71. Warrants are exercisable immediately and expire on the earlier of five years or specified clinical/FDA milestone windows. Piper Sandler is sole placement agent; Lake Street is financial advisor. Proceeds are for working capital and clinical/product development. Closing expected the week of October 13, 2025, subject to customary conditions.

Adagio Medical (Nasdaq: ADGM) reported preliminary acute (within 7 days) results from the FULCRUM-VT pivotal study presented October 10, 2025. The multi‑center trial enrolled 207 patients at 19 US and Canadian sites with ischemic and nonischemic cardiomyopathy (mean LVEF 35%±10%).

Key acute outcomes: mean procedure duration 206±68 minutes, 97.4% acute clinical success (non‑inducibility) and 96.7% elimination of clinically relevant VTs. Safety: 2.5% major adverse event rate, including four peri‑procedural deaths (1.9%) and one death (0.5%) adjudicated as definitely device‑related. Six‑month primary efficacy results are planned for Heart Rhythm 2026.

Adagio Medical (NASDAQ:ADGM) has completed enrollment for its pivotal FULCRUM-VT clinical trial, evaluating the vCLAS Cryoablation System for treating ventricular tachycardia. The trial, which enrolled 208 patients across 20 centers in the US and Canada, was completed in just 11 months.

The vCLAS System, granted FDA Breakthrough Device Designation, utilizes ultra-low temperature cryoablation technology and is the first VT-specific ablation technology to complete enrollment in a pivotal IDE study in the United States. The study's primary endpoint measures six-month freedom from recurring monomorphic ventricular tachycardia without increased antiarrhythmic drugs.

The company expects to complete the PMA process by year-end 2026. The system is already commercially available in Europe and select other regions, while remaining investigational in the US.

Adagio Medical (Nasdaq: ADGM) announced that acute results from its FULCRUM-VT U.S. pivotal study will be presented at The 20th Annual International Symposium on Ventricular Arrhythmias in October 2025. The IDE study is evaluating the safety and effectiveness of Ultralow Temperature Cryoablation (ULTC) for treating Sustained Monomorphic Ventricular Tachycardia in patients with ischemic and nonischemic cardiomyopathy.

The company's ULTC technology will be featured in three presentations at the symposium, including a late-breaking session on acute outcomes from the FULCRUM-VT trial, initial clinical experience with Ultracool Cryoablation for VT, and research on Pulse Field Ultra-Low Temperature Cryoablation in a swine model.

Adagio Medical (Nasdaq: ADGM), a cardiac arrhythmia treatment technology company, has expanded Chief Business Officer Deborah Kaster's role to include Chief Financial Officer responsibilities, effective September 5, 2025. Ms. Kaster replaces interim CFO Dan George, who served since April 2025.

In her expanded position, Kaster will maintain oversight of business development, corporate strategy, and investor relations while taking on responsibility for financial operations, including accounting, treasury, and financial planning. She will continue reporting to CEO Todd Usen, who praised her impact on strategic initiatives and partnership building during her four-month tenure at Adagio.

Adagio Medical (Nasdaq: ADGM), a cardiac arrhythmia treatment technology company, reported its Q2 2025 financial results. The company achieved 85% enrollment in its FULCRUM-VT pivotal study for the vCLAS™ Cryoablation System, targeting completion in H2 2025. The study involves 206 patients across 20 U.S. and Canadian centers.

Financial highlights include a reduced net loss of $3.9 million ($0.26 per share) compared to $5.7 million in Q2 2024. The company reported cash holdings of $8.2 million as of June 30, 2025, with decreased operational expenses across all categories due to corporate prioritization initiatives.

Notable achievements include the publication of first-in-human results from the PARALELL study, evaluating their novel Pulsed Field Cryoablation (PFCA) technology in the Journal of Cardiovascular Electrophysiology.

Adagio Medical (NASDAQ: ADGM) reported Q1 2025 financial results and significant operational progress. The company received FDA Breakthrough Device Designation for its vCLAS™ Cryoablation System for treating ventricular tachycardia. The FULCRUM-VT pivotal study has surpassed 50% enrollment of its targeted 206 patients across U.S. and Canadian centers.

Financial highlights include a net loss of $7.7 million ($0.50 per share), compared to $8.0 million loss in Q1 2024. The company reported cash reserves of $13.0 million. Operating expenses included $3.7 million in R&D and $3.5 million in SG&A costs.

Notable developments include hiring Deborah Kaster as Chief Business Officer and implementing a corporate prioritization initiative focused on FULCRUM-VT trial activities and product design optimization.