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Adagio Medical to Participate at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference

MWN-AI** Summary

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced its participation in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, set to take place on February 10, 2026, in Snowbird, UT. Adagio is recognized for its innovative catheter ablation technologies specifically designed for treating cardiac arrhythmias, a condition that affects the heart's rhythm.

The company's flagship product, the vCLAS™ Cryoablation System, utilizes its proprietary Ultra-Low Temperature Cardiac (ULTA) technology to create extensive and durable lesions in both diseased and healthy cardiac tissue. This technology is particularly relevant for addressing ventricular arrhythmias—a critical area of focus for Adagio. The vCLAS™ system has already received the CE Mark, allowing for its commercial availability in Europe and select other markets, while it remains under investigation in the United States.

The vCLAS™ system is currently being evaluated in the FULCRUM-VT clinical trial, a multi-center, open-label study designed to assess its efficacy in patients with recurring monomorphic ventricular tachycardia (VT). Enrolling a total of 209 patients with structural heart disease, the trial aims to study the system's performance in those who are resistant to drug therapies. The outcomes from this pivotal study are crucial as they will be submitted for FDA premarket approval (PMA), potentially providing the broadest indication in the industry for endocardial ablation targeting scar-mediated VT.

Overall, Adagio is poised for significant advancements in the cardiac treatment landscape, with its innovative approach and ongoing clinical trials paving the way for enhanced patient outcomes in the future.

MWN-AI** Analysis

As Adagio Medical Holdings, Inc. (Nasdaq: ADGM) prepares to participate in the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference, investors should consider key factors influencing the company's trajectory and stock performance. Adagio, a pioneering entity in catheter ablation technologies targeting cardiac arrhythmias, has positioned itself strategically in a growing market. The upcoming discussions at the conference could provide critical insights into the company's ongoing trials and future commercial strategies.

Central to Adagio's growth narrative is its vCLAS™ Cryoablation System, which utilizes Ultra-Low Temperature (ULTA) technology. This innovation addresses a significant medical need in treating ventricular arrhythmias, a condition often resistant to traditional therapies. The CE Mark approval and the advancement of the FULCRUM-VT trial, which is now fully enrolled, highlight the company’s commitment to rigorous clinical validation. Notably, positive outcomes from this trial could unlock FDA premarket approval (PMA), which would not only enhance credibility but expand market potential in the lucrative U.S. healthcare landscape.

Investors should pay special attention to any updates from the conference concerning trial results, regulatory pathways, and strategic partnerships. These factors can drastically influence investor sentiment and the stock's performance. Given the increasing focus on cardiac health and significant advancements in medical technologies, Adagio's niche positioning presents an attractive investment opportunity.

Nevertheless, investors should remain cautious, considering the inherent risks associated with medical device trials and market entry. A thorough assessment of the company’s financial health, competitive landscape, and potential FDA responses is essential. Overall, maintaining a close watch on developments surrounding Adagio will be vital for gauging the stock's future movement and its potential as a long-term investment in the growing MedTech space.

**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.

Source: Business Wire

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 that management will be participating at the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Tuesday, February 10, 2026 in Snowbird, UT.

About Adagio Medical Holdings, Inc.

Adagio is a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Cardiac (ULTA) ablation technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. Pivotal IDE Trial.

About FULCRUM VT

FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial, which has fully enrolled 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. The results of the study will be used to apply for FDA premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System, potentially leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.

Adagio’s vCLAS™ Cryoablation System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational use in the United States.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260202579985/en/

Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com

Caroline Corner, PhD
ICR Healthcare
IR@adagiomedical.com

FAQ**

How does Adagio Medical Holdings Inc ADGM plan to leverage the results from the FULCRUM-VT trial to expedite FDA premarket approval for the vCLAS™ Cryoablation System?

Adagio Medical Holdings Inc plans to use the positive results from the FULCRUM-VT trial to demonstrate the safety and efficacy of the vCLAS™ Cryoablation System, thereby strengthening its case for expedited FDA premarket approval.

Can you elaborate on the competitive advantages of Adagio Medical Holdings Inc ADGM's ULTA technology compared to existing catheter ablation solutions in the market?

Adagio Medical Holdings Inc's ULTA technology offers competitive advantages such as enhanced precision, reduced procedure times, and improved patient outcomes in catheter ablation, positioning it favorably against existing solutions in the market.

What are the key milestones that Adagio Medical Holdings Inc ADGM aims to achieve in the coming year regarding the commercialization of the vCLAS™ Cryoablation System?

Adagio Medical Holdings Inc. (ADGM) aims to achieve regulatory approvals, initiate clinical trials, expand market partnerships, and successfully launch the vCLAS™ Cryoablation System in key markets over the coming year to drive commercialization and enhance operational growth.

How is Adagio Medical Holdings Inc ADGM addressing the regulatory challenges and risks associated with the investigational use of its products in the U.S. market?

Adagio Medical Holdings Inc. (ADGM) is proactively engaging with regulatory agencies, conducting comprehensive clinical trials, and ensuring compliance with safety standards to address regulatory challenges and mitigate risks associated with the investigational use of its products in the U.S. market.

**MWN-AI FAQ is based on asking OpenAI questions about Adagio Medical Holdings Inc (NASDAQ: ADGM).

Adagio Medical Holdings Inc

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