Adagio Completes Enrollment of 209 Patients in FULCRUM-VT Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy ADGM?
"2025 marked a pivotal year for Adagio as our first full year as a public company. We delivered a number of important milestones across the organization, which we believe significantly strengthen our position as we advance our ULTA technology towards commercialization," said Todd Usen, Chief Executive Officer of Adagio. "Importantly, we completed enrollment of the 209-patient FULCRUM-VT pivotal IDE trial in just eleven months, studying a real-world population of patients with both ischemic and non-ischemic cardiomyopathy, all of whom were treated with an endocardial approach. With enrollment now complete, we look forward to presenting pivotal results at the Heart Rhythm Society conference next month. As we advance toward the potential approval of vCLAS, our team is focused on preparing for commercialization while continuing to develop our next generation vCLAS technology. We remain committed to bringing our differentiated and proprietary solutions to the large and underserved population of patients living with ventricular tachycardia."
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Analyst Views on ADGM
Wall Street analysts forecast ADGM stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.080
Low
4.00
Averages
4.00
High
4.00
Current: 1.080
Low
4.00
Averages
4.00
High
4.00
About ADGM
Adagio Medical Holdings, Inc. is a commercial stage medical device company. It is focused on developing proprietary Ultra-Low Temperature Cryoablation technology that creates contiguous, transmural lesions to treat cardiac arrhythmias, with an emphasis on ventricular tachycardia. It is developing and placing on the European Union (EU) market ablation technologies for the treatment of cardiac arrhythmias, including atrial fibrillation, atrial flutter, and ventricular tachycardia. Its product portfolio consists of three product families: iCLAS atrial ULTC catheter and accessories, vCLAS ventricular ULTC catheter, and Cryopulse atrial PFCA catheter and accessories. All of these catheters share the same ULTC cryoablation console. The iCLAS system is CE-marked with the indication for treatment of paroxysmal atrial fibrillation, persistent atrial fibrillation and atrial flutter. The vCLAS ventricular catheter has been specifically designed for the treatment of ventricular arrhythmia.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Adagio Medical Q4 Earnings Beat Expectations
- Earnings Performance: Adagio Medical Holdings reported a Q4 GAAP EPS of -$0.21, beating market expectations by $0.10, indicating an improving trend in financial performance.
- Significant Cost Reduction: The cost of revenue for Q4 2025 was $58,000, a substantial decrease from $1.5 million in Q4 2024, demonstrating the company's effective cost control measures.
- R&D Spending Decrease: Research and development expenses for Q4 2025 were $2.2 million, down from $3.4 million in Q4 2024, reflecting optimization in resource allocation that may impact future innovation capabilities.
- Net Loss Reduction: The net loss for Q4 2025 was $3.3 million, significantly reduced from $57.4 million in Q4 2024, showcasing positive progress in the company's financial health.
See More
Adagio Completes 13 Ventricular Ablation Procedures Using ULTA Technology
- Technological Breakthrough: Adagio Medical has successfully completed 13 ventricular ablation procedures using its proprietary Ultra-Low Temperature Ablation (ULTA) technology at leading institutions, marking a significant advancement in treating patients with no satisfactory treatment options, showcasing the technology's potential in managing refractory arrhythmias.
- Patient Benefits: These procedures targeted patients who had previously failed conventional and experimental ablation therapies, indicating the effectiveness of ULTA technology in handling complex cases, which may provide new treatment options for cardiac patients and enhance the company's competitiveness in the cardiac ablation market.
- Clinical Need: Under the FDA's Expanded Access authorization, ULTA technology offers treatment opportunities for patients facing serious or life-threatening diseases, emphasizing its importance in managing ventricular arrhythmias and potentially transforming existing treatment paradigms.
- Future Outlook: Adagio plans to apply for FDA approval of its vCLAS™ Cryoablation System by the end of 2026, which is expected to provide broader industry indications for the treatment of ventricular arrhythmias, further solidifying its market position.
See More
Highlights from the Small Cap Growth Virtual Investor Conference
- On-Demand Viewing: Presentations from the Small Cap Growth Virtual Investor Conference held on February 5, 2026, are now available for on-demand viewing for 90 days, enhancing investor engagement and understanding of participating companies.
- 1x1 Meeting Requests: Selected companies are accepting one-on-one management meeting requests until February 10, providing investors with direct access to executives, which could facilitate informed investment decisions and potential capital inflows.
- Diverse Company Participation: The conference featured presentations from various companies, including Betolar Oyj, Envoy Medical Inc., and C-COM Satellite Systems Inc., showcasing a wide range of investment opportunities in the small-cap growth sector, attracting diverse investor interest.
- Advantages of Virtual Conferences: Virtual Investor Conferences offer a real-time interactive platform that enhances connections between companies and investors, improving the investor experience and creating more efficient fundraising and marketing opportunities for participating firms.
See More
Highlights from the Small Cap Growth Virtual Investor Conference
- On-Demand Content: Presentations from the Small Cap Growth Virtual Investor Conference held on February 5, 2026, are now available for on-demand viewing, allowing investors to access content 24/7 for 90 days, thereby increasing attention on small-cap growth companies.
- Investor Participation: The conference invites individual and institutional investors, advisors, and analysts to participate, providing an interactive platform that facilitates direct communication between investors and companies, enhancing investor relations management.
- One-on-One Meeting Opportunities: Selected companies are accepting one-on-one management meeting requests until February 10, offering investors a chance to engage directly with company executives, which deepens investor engagement and trust.
- Advantages of Virtual Conferences: Virtual Investor Conferences replicate the components of on-site investor meetings through real-time investor engagement solutions, enhancing the efficiency of connections between companies and investors and modernizing investor communications.
See More
Agenda Released for Small Cap Growth Virtual Investor Conference
- Conference Schedule: The Small Cap Growth Virtual Investor Conference is set for February 5, featuring a diverse lineup of innovative companies, aimed at providing investors direct access to the small-cap market, thereby enhancing interaction and engagement with companies.
- Participant Invitation: The conference invites individual investors, institutional investors, advisors, and analysts to attend at no cost, aiming to streamline the registration process and system checks to enhance participation efficiency and ensure timely updates for investors.
- Company Showcase Opportunity: Jason Paltrowitz, Executive Vice President at OTC Markets Group, emphasized that the conference will highlight a diverse roster of companies, showcasing innovation in the small-cap market and helping firms effectively communicate their growth narratives to bolster investor confidence.
- Investor Relations Facilitation: Virtual Investor Conferences provide a real-time investor engagement solution, allowing companies to communicate directly with a global investor audience, schedule one-on-one meetings, and enhance presentation effectiveness, thus accelerating the next phase of investor participation.
See More
Insider Buying Update for Wednesday, December 17: SRRK, ADGM
Insider Purchase at Scholar Rock: Srinivas Akkaraju bought 29,599 shares of Scholar Rock Holding (SRRK) for $1.18M at $39.92 each, seeing a 13.5% gain during the trading session.
Previous Investment by Akkaraju: Prior to this purchase, Akkaraju had acquired $18.81M worth of shares at $37.58 each within the last year.
Adagio Medical Holdings CEO Purchase: Todd Usen, CEO of Adagio Medical Holdings, purchased 207,315 shares for $225,973 at $1.09 each, while the stock was down about 2.5% on the day.
Market Performance: Scholar Rock Holding's stock was up approximately 0.4% on Wednesday, with SRRK reaching a high of $45.32 during trading.
See More
Adagio Medical Q4 Earnings Beat Expectations
- Earnings Performance: Adagio Medical Holdings reported a Q4 GAAP EPS of -$0.21, beating market expectations by $0.10, indicating an improving trend in financial performance.
- Significant Cost Reduction: The cost of revenue for Q4 2025 was $58,000, a substantial decrease from $1.5 million in Q4 2024, demonstrating the company's effective cost control measures.
- R&D Spending Decrease: Research and development expenses for Q4 2025 were $2.2 million, down from $3.4 million in Q4 2024, reflecting optimization in resource allocation that may impact future innovation capabilities.
- Net Loss Reduction: The net loss for Q4 2025 was $3.3 million, significantly reduced from $57.4 million in Q4 2024, showcasing positive progress in the company's financial health.
See More
Adagio Completes 13 Ventricular Ablation Procedures Using ULTA Technology
- Technological Breakthrough: Adagio Medical has successfully completed 13 ventricular ablation procedures using its proprietary Ultra-Low Temperature Ablation (ULTA) technology at leading institutions, marking a significant advancement in treating patients with no satisfactory treatment options, showcasing the technology's potential in managing refractory arrhythmias.
- Patient Benefits: These procedures targeted patients who had previously failed conventional and experimental ablation therapies, indicating the effectiveness of ULTA technology in handling complex cases, which may provide new treatment options for cardiac patients and enhance the company's competitiveness in the cardiac ablation market.
- Clinical Need: Under the FDA's Expanded Access authorization, ULTA technology offers treatment opportunities for patients facing serious or life-threatening diseases, emphasizing its importance in managing ventricular arrhythmias and potentially transforming existing treatment paradigms.
- Future Outlook: Adagio plans to apply for FDA approval of its vCLAS™ Cryoablation System by the end of 2026, which is expected to provide broader industry indications for the treatment of ventricular arrhythmias, further solidifying its market position.
See More
Highlights from the Small Cap Growth Virtual Investor Conference
- On-Demand Viewing: Presentations from the Small Cap Growth Virtual Investor Conference held on February 5, 2026, are now available for on-demand viewing for 90 days, enhancing investor engagement and understanding of participating companies.
- 1x1 Meeting Requests: Selected companies are accepting one-on-one management meeting requests until February 10, providing investors with direct access to executives, which could facilitate informed investment decisions and potential capital inflows.
- Diverse Company Participation: The conference featured presentations from various companies, including Betolar Oyj, Envoy Medical Inc., and C-COM Satellite Systems Inc., showcasing a wide range of investment opportunities in the small-cap growth sector, attracting diverse investor interest.
- Advantages of Virtual Conferences: Virtual Investor Conferences offer a real-time interactive platform that enhances connections between companies and investors, improving the investor experience and creating more efficient fundraising and marketing opportunities for participating firms.
See More
Highlights from the Small Cap Growth Virtual Investor Conference
- On-Demand Content: Presentations from the Small Cap Growth Virtual Investor Conference held on February 5, 2026, are now available for on-demand viewing, allowing investors to access content 24/7 for 90 days, thereby increasing attention on small-cap growth companies.
- Investor Participation: The conference invites individual and institutional investors, advisors, and analysts to participate, providing an interactive platform that facilitates direct communication between investors and companies, enhancing investor relations management.
- One-on-One Meeting Opportunities: Selected companies are accepting one-on-one management meeting requests until February 10, offering investors a chance to engage directly with company executives, which deepens investor engagement and trust.
- Advantages of Virtual Conferences: Virtual Investor Conferences replicate the components of on-site investor meetings through real-time investor engagement solutions, enhancing the efficiency of connections between companies and investors and modernizing investor communications.
See More
Agenda Released for Small Cap Growth Virtual Investor Conference
- Conference Schedule: The Small Cap Growth Virtual Investor Conference is set for February 5, featuring a diverse lineup of innovative companies, aimed at providing investors direct access to the small-cap market, thereby enhancing interaction and engagement with companies.
- Participant Invitation: The conference invites individual investors, institutional investors, advisors, and analysts to attend at no cost, aiming to streamline the registration process and system checks to enhance participation efficiency and ensure timely updates for investors.
- Company Showcase Opportunity: Jason Paltrowitz, Executive Vice President at OTC Markets Group, emphasized that the conference will highlight a diverse roster of companies, showcasing innovation in the small-cap market and helping firms effectively communicate their growth narratives to bolster investor confidence.
- Investor Relations Facilitation: Virtual Investor Conferences provide a real-time investor engagement solution, allowing companies to communicate directly with a global investor audience, schedule one-on-one meetings, and enhance presentation effectiveness, thus accelerating the next phase of investor participation.
See More
Insider Buying Update for Wednesday, December 17: SRRK, ADGM
Insider Purchase at Scholar Rock: Srinivas Akkaraju bought 29,599 shares of Scholar Rock Holding (SRRK) for $1.18M at $39.92 each, seeing a 13.5% gain during the trading session.
Previous Investment by Akkaraju: Prior to this purchase, Akkaraju had acquired $18.81M worth of shares at $37.58 each within the last year.
Adagio Medical Holdings CEO Purchase: Todd Usen, CEO of Adagio Medical Holdings, purchased 207,315 shares for $225,973 at $1.09 each, while the stock was down about 2.5% on the day.
Market Performance: Scholar Rock Holding's stock was up approximately 0.4% on Wednesday, with SRRK reaching a high of $45.32 during trading.
See More
