ADGM
Adagio MedicalDDocument history
Earnings documents stored for ADGM.
Investor releaseQuarter not tagged2026-08-11Adagio Medical Reports Second Quarter 2026 Results
Business Wire
Adagio Medical Reports Second Quarter 2026 Results
LAGUNA HILLS, Calif., August 11, 2026--(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 financial results for the second quarter ended June 30, 2026. Recent Business Highlights: Announced the successful treatment at the Hospital of University of Pennsylvania of the first patient with the Company’s next-generation vCLAS™ Ultra Ultra-Low temperature ablation catheter ("ULTA"), which is designed to be faster and more maneuverable than the first generation vCLAS™ Ventricular Ablation System catheter, under Expanded Access authorization from the U.S. Food and Drug Administration ("FDA") Announced pivotal results from the 209-patient FULCRUM-VT trial, which were presented in a late-breaking session at Heart Rhythm Society 2026, demonstrating a promising safety profile with only 2.4% protocol-defined Major Adverse Events and six-month results of 84% freedom from implantable cardioverter defibrillator ("ICD") shock and a 78% discontinuation or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with the Company's proprietary ULTA technology Submitted Premarket Approval ("PMA") application, supported by the FULCRUM-VT pivotal IDE trial, to the FDA for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease "This quarter marked an inflection point for Adagio as our team continues to execute and deliver on our critical milestones. The enthusiastic physician reception of our FULCRUM-VT late-breaking data at HRS reinforced what we have long believed about the potential for this technology, and the successful treatment of the first patient with vCLAS Ultra — a particularly complex case — was a powerful proof point for our next-generation system," said Todd Usen, Chief Executive Officer of Adagio Medical. "We believe our progress — combined with the breadth of our clinical evidence for both ischemic and non-ischemic patients — positions our fully-endocardial ULTA platform as a uniquely differentiated solution capable of treating the entire spectrum of cases in an addressable market that has long n…Read full documentShow less
LAGUNA HILLS, Calif., August 11, 2026--(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 financial results for the second quarter ended June 30, 2026. Recent Business Highlights: Announced the successful treatment at the Hospital of University of Pennsylvania of the first patient with the Company’s next-generation vCLAS™ Ultra Ultra-Low temperature ablation catheter ("ULTA"), which is designed to be faster and more maneuverable than the first generation vCLAS™ Ventricular Ablation System catheter, under Expanded Access authorization from the U.S. Food and Drug Administration ("FDA") Announced pivotal results from the 209-patient FULCRUM-VT trial, which were presented in a late-breaking session at Heart Rhythm Society 2026, demonstrating a promising safety profile with only 2.4% protocol-defined Major Adverse Events and six-month results of 84% freedom from implantable cardioverter defibrillator ("ICD") shock and a 78% discontinuation or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with the Company's proprietary ULTA technology Submitted Premarket Approval ("PMA") application, supported by the FULCRUM-VT pivotal IDE trial, to the FDA for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease "This quarter marked an inflection point for Adagio as our team continues to execute and deliver on our critical milestones. The enthusiastic physician reception of our FULCRUM-VT late-breaking data at HRS reinforced what we have long believed about the potential for this technology, and the successful treatment of the first patient with vCLAS Ultra — a particularly complex case — was a powerful proof point for our next-generation system," said Todd Usen, Chief Executive Officer of Adagio Medical. "We believe our progress — combined with the breadth of our clinical evidence for both ischemic and non-ischemic patients — positions our fully-endocardial ULTA platform as a uniquely differentiated solution capable of treating the entire spectrum of cases in an addressable market that has long needed a purpose-built solution. We remain focused on executing against the milestones ahead as we work to bring our proprietary technology to the many patients who suffer from VT." Second Quarter 2026 Financial Results Cost of revenue was nil for the three months ended June 30, 2026, compared to $0.3 million for the three months ended June 30, 2025. The decrease was primarily attributable to the pause in commercial activity in Europe. Depreciation expense related to consoles loaned to customers is generally classified within cost of revenue; however, because the Company did not generate revenue during the three months ended June 30, 2026, such depreciation expense is reflected within research and development expenses for the period. Research and development expenses were $2.5 million for the three months ended June 30, 2026, compared to $2.0 million for the three months ended June 30, 2025. The increase was primarily attributable to higher product development costs, including consulting and prototyping expenses, and higher operational costs, including the aforementioned depreciation expense, partially offset by lower clinical trial expenses. Selling, general and administrative expenses were $2.5 million for the three months ended June 30, 2026, compared to $2.4 million for the three months ended June 30, 2025. The increase was primarily attributable to higher stock-based compensation expenses, partially offset by lower professional services expenses. Net loss for the three months ended June 30, 2026, was $6.7 million, or $(0.30) per share (Basic), compared to a net loss of $3.9 million, or $(0.26) per share (Basic), for the three months ended June 30, 2025. Weighted average shares of common stock outstanding, basic and diluted, were 22,210,459 as of June 30, 2026. The Company's fully diluted share count includes all outstanding warrants; however, for purposes of calculating net loss per share, warrants and certain other potentially dilutive securities are excluded as their inclusion would be anti-dilutive. Cash and cash equivalents were $7.7 million as of June 30, 2026. 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 ablation ("ULTA," formerly known as ULTC) technology. ULTA is designed to create large footprint, titratable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach. The Company is currently focused on the treatment of ventricular arrhythmias with its purpose-built vCLAS Ventricular Ablation System, which is CE Marked, and in May 2026 the Company submitted the results of the FULCRUM-VT pivotal study to support its PMA application to the FDA for the vCLAS Ventricular Ablation System. The Company is also developing a next-generation vCLAS Ultra catheter, designed to support faster ablation procedures with a smaller and more flexible form factor than its predecessor vCLAS device. 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. FULCRUM-VT 6-month primary chronic effectiveness was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in the absence of new or increase in antiarrhythmic drug therapy beyond previously failed dose. The FDA has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra catheter for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT). Adagio’s vCLAS™ Ventricular Ablation 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: Adagio’s strategy, future operations, future financial position, and projected expenses; the expected timing and results of Adagio's clinical trials, including the reproducibility of the favorable results initially seen in Adagio’s FULCRUM-VT pivotal data and the evaluation of the vCLAS Ultra catheter under the expanded IDE approval; the potential for ULTA technology to address unmet needs in the treatment of VT, including across both ischemic and non-ischemic cardiomyopathy substrates; and the potential for FDA approval of Adagio’s product candidates, including the PMA application for the vCLAS Ventricular Ablation System. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260811176104/en/ Contacts Debbie KasterChief Business [email protected]
Investor releaseQuarter not tagged2026-05-12Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress
Business Wire
Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress
Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data LAGUNA HILLS, Calif., May 12, 2026--(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 financial results for the first quarter ended March 31, 2026. Recent Business Highlights: Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator ("ICD") shock at six months, a promising safety profile with 2.4% protocol-defined Major Adverse Events, and a 72% discontinuation or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with the Company's proprietary Ultra-Low Temperature Ablation ("ULTA") technology Received Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") approval to expand the FULCRUM-VT trial to evaluate the safety and effectiveness of the next-generation vCLAS Ultra System, which is designed to be faster, colder and deeper, with improved usability, compared to the first generation vCLAS catheter, underscoring the depth and durability of the Company's ULTA platform for the treatment of Sustained Monomorphic Ventricular Tachycardia Featured in over a dozen well-attended events, presentations, and posters at Heart Rhythm Society's 47th Annual Scientific Sessions—Heart Rhythm 2026—highlighting ULTA as a purpose-built endocardial solution for ventricular tachycardia ("VT") Announced the publication of pre-clinical results of the Company’s next generation ULTA technology in the Journal of Cardiovascular Electrophysiology, which describe titratable lesion depth exceeding 10 millimeters as well as significant functional improvements in catheter performance compared to first-generation ULTA, including improved handling characteristics, better compatibility with standard laboratory practices and the potential for 50-75% reduction in ablation time Successfully completed 13 cases under FDA Expanded Access using the vCLAS System in patients with recurrent VT and premature ventricular contra…Read full documentShow less
Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data LAGUNA HILLS, Calif., May 12, 2026--(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 financial results for the first quarter ended March 31, 2026. Recent Business Highlights: Pivotal results from the FULCRUM-VT trial presented in late-breaking session at Heart Rhythm Society 2026 – the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies—which demonstrated 84% freedom from implantable cardioverter defibrillator ("ICD") shock at six months, a promising safety profile with 2.4% protocol-defined Major Adverse Events, and a 72% discontinuation or reduced dose of antiarrhythmic drugs, as well as equivalent results across both ischemic and non-ischemic cardiomyopathy patients with the Company's proprietary Ultra-Low Temperature Ablation ("ULTA") technology Received Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") approval to expand the FULCRUM-VT trial to evaluate the safety and effectiveness of the next-generation vCLAS Ultra System, which is designed to be faster, colder and deeper, with improved usability, compared to the first generation vCLAS catheter, underscoring the depth and durability of the Company's ULTA platform for the treatment of Sustained Monomorphic Ventricular Tachycardia Featured in over a dozen well-attended events, presentations, and posters at Heart Rhythm Society's 47th Annual Scientific Sessions—Heart Rhythm 2026—highlighting ULTA as a purpose-built endocardial solution for ventricular tachycardia ("VT") Announced the publication of pre-clinical results of the Company’s next generation ULTA technology in the Journal of Cardiovascular Electrophysiology, which describe titratable lesion depth exceeding 10 millimeters as well as significant functional improvements in catheter performance compared to first-generation ULTA, including improved handling characteristics, better compatibility with standard laboratory practices and the potential for 50-75% reduction in ablation time Successfully completed 13 cases under FDA Expanded Access using the vCLAS System in patients with recurrent VT and premature ventricular contractions who had previously failed conventional and experimental ablation therapies, including radio frequency (RF) and pulsed field ablation (PFA), demonstrating real-world applicability and versatility of the ULTA platform Reported cash and cash equivalents of $12.9 million as of March 31, 2026, with potential for up to an additional $31 million of aggregate gross proceeds that may be received upon the cash exercise in full of milestone-based warrants "The first quarter of 2026 was a landmark period for Adagio during which we made exceptional progress advancing our Ultra-Low Temperature Ablation platform across both clinical development and real-world use," said Todd Usen, Chief Executive Officer of Adagio Medical. "The late-breaking results from the FULCRUM-VT trial represent a defining milestone for our endocardial-only ULTA platform, demonstrating best-in-class safety, 84% freedom from ICD shock at six months, meaningful reductions in antiarrhythmic drug use, and consistent results across both ischemic and non-ischemic cardiomyopathy patients—the broadest patient population studied in any VT ablation trial. The enthusiasm from physicians on the podium was remarkable, with leading electrophysiologists highlighting ULTA as a potentially transformative solution for ventricular tachycardia. As we look ahead, we have multiple additional meaningful milestones expected this year across our platform of technologies and we are more confident than ever in our mission to fundamentally change the treatment of VT with a safe, effective solution for a broad group of patients who suffer from this dangerous arrhythmia." First Quarter 2026 Financial Results Cost of revenue was nil for the three months ended March 31, 2026, compared to $0.3 million for the three months ended March 31, 2025. The decrease was primarily attributable to the pause in commercial activity in Europe. Depreciation expense related to consoles loaned to customers is generally classified within cost of revenue; however, because the Company did not generate revenue during the three months ended March 31, 2026, such depreciation expense is now reflected within research and development expenses for the period. Research and development expenses were $2.7 million for the three months ended March 31, 2026, compared to $3.7 million for the three months ended March 31, 2025. The decrease was primarily attributable to lower clinical trial expenses and lower product development costs, including consulting, prototyping, and project-related support, partially offset by higher operational costs, including the aforementioned depreciation expense. Selling, general and administrative expenses were $2.5 million for the three months ended March 31, 2026, compared to $3.5 million for the three months ended March 31, 2025. Selling, general and administrative expenses decreased primarily due to lower professional services expenses, regulatory reporting expenses, and payroll and personnel expenses. Net loss for the three months ended March 31, 2026 was $7.0 million, compared to a net loss of $7.7 million for the three months ended March 31, 2025. 22,210,459 weighted average shares of common stock outstanding, basic and diluted, as of March 31, 2026. The Company's fully diluted share count includes all outstanding warrants; however, for purposes of calculating net loss per share, warrants and certain other potentially dilutive securities are excluded as their inclusion would be anti-dilutive. Reported cash and cash equivalents of $12.9 million as of March 31, 2026. 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 Cryoablation (ULTC) technology. ULTC 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, enrolling 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential receipt of additional gross proceeds from the private placement if the issued warrants are exercised in full; Adagio’s intended use of the proceeds from the private placement; Adagio’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management; the reproducibility of any favorable results initially seen in Adagio’s FULCRUM-VT pivotal data; and the potential for FDA approval of Adagio’s product candidates. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260512085398/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2026-04-26Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System
Business Wire
Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System
84% Freedom From Shock and 59% Freedom From VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results First and Only Ablation Technology to Show Equivalent Effectiveness Across Ischemic and Non-Ischemic Cardiomyopathy All From Endocardial Approach LAGUNA HILLS, Calif., April 26, 2026--(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 reported six month results from its FULCRUM-VT Investigational Device Exemption ("IDE") clinical trial, which will be used to support the Company’s application for Food and Drug Administration ("FDA") Premarket Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart Rhythm Society 2026 conference. Key findings included: 98% non-inducibility of targeted ventricular tachycardias ("VT") at end of procedure Promising safety profile with 2.4% protocol-defined Major Adverse Events 84% freedom from implantable cardioverter defibrillator ("ICD") shock at 6 months 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug ("AAD") escalation1) Equivalent results for ischemic ("ICM") and non-ischemic cardiomyopathy ("NICM") patients Over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation 72% of patients discontinued or reduced dose of amiodarone at 6 months Low 1.9% rate of 30-day VT-related hospital readmission "FULCRUM-VT represents a seminal step forward in advancing ventricular tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an endocardial-only approach using Adagio’s purpose-built ventricular ablation technology," said Dr. Atul Verma, Director, Division of Cardiology, McGill University Health Centre in Montreal. "The results of the trial, which were consistent with earlier ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, inc…Read full documentShow less
84% Freedom From Shock and 59% Freedom From VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results First and Only Ablation Technology to Show Equivalent Effectiveness Across Ischemic and Non-Ischemic Cardiomyopathy All From Endocardial Approach LAGUNA HILLS, Calif., April 26, 2026--(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 reported six month results from its FULCRUM-VT Investigational Device Exemption ("IDE") clinical trial, which will be used to support the Company’s application for Food and Drug Administration ("FDA") Premarket Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart Rhythm Society 2026 conference. Key findings included: 98% non-inducibility of targeted ventricular tachycardias ("VT") at end of procedure Promising safety profile with 2.4% protocol-defined Major Adverse Events 84% freedom from implantable cardioverter defibrillator ("ICD") shock at 6 months 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug ("AAD") escalation1) Equivalent results for ischemic ("ICM") and non-ischemic cardiomyopathy ("NICM") patients Over 80% reduction in number of patients experiencing ICD shock over 6-months post ablation compared to equivalent time period pre-ablation 72% of patients discontinued or reduced dose of amiodarone at 6 months Low 1.9% rate of 30-day VT-related hospital readmission "FULCRUM-VT represents a seminal step forward in advancing ventricular tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an endocardial-only approach using Adagio’s purpose-built ventricular ablation technology," said Dr. Atul Verma, Director, Division of Cardiology, McGill University Health Centre in Montreal. "The results of the trial, which were consistent with earlier ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, including reductions in both ICD shocks and the use of toxic antiarrhythmic medication – outcomes that matter most to patients and physicians managing this complex disease. Additionally, the ability to ablate these already compromised patients without ever needing to irrigate or use nitroglycerin, both of which carry added risk, is a real benefit of ULTA. The FULCRUM-VT results are quite encouraging for the broad use of this technology as a long-term solution for patients suffering from VT." FULCRUM-VT (Feasibility of Ultra-Low Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm IDE study investigating the vCLAS Cryoablation System at 20 centers in the United States and Canada. The study enrolled 209 patients with structural heart disease, whether ischemic or non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance with current treatment guidelines. FULCRUM-VT is the first and only fully enrolled IDE clinical trial for VT to include patients with both ICM and NICM disease and includes one of the most challenging patient cohorts ever treated in a VT ablation trial. Ablation targets for VT associated with NICM disease tend to be in deeper myocardial substrate and therefore are more difficult to treat using an endocardial approach with currently approved technology. These two patient cohorts had equivalent outcomes, as measured by both freedom from VT recurrence and freedom from ICD shock, representing what the Company believes to be the first and only catheter ablation technology to show equivalent effectiveness in these distinct and historically challenging VT substrates. "These pivotal results represent a noteworthy milestone for Adagio and validate the potential for our ULTA technology to address a significant unmet need for treating one of the most complex and challenging arrhythmias," said Todd Usen, Chief Executive Officer of Adagio Medical. "In the United States alone, ventricular arrhythmias account for approximately 300,000 sudden cardiac deaths each year; VT is difficult to treat, and procedures performed with current devices can be overly complex, with sub-optimal outcomes in both effectiveness and safety. However, our FULCRUM-VT study demonstrated strong clinical effectiveness with a highly favorable safety profile with our vCLAS ablation catheter. Importantly, we achieved these results without compromising catheter stability and without the added risks of irrigation or nitroglycerin, thereby supporting the potential for a more streamlined workflow and reproducible approach to VT ablation. We believe ULTA has the potential to become a foundational ablation technology for treating the ventricle and we look forward to serving the large, underserved population of patients suffering from VT." FULCRUM-VT included patients with both ICM and NICM disease (LVEF=35+/-10%, 34% NICM, 79% with congestive heart failure). Freedom from device intervention (ATP or shock) at 6 months was 61% for ICM and 63% for NICM; freedom from ICD shock at 6 months was 84% for ICM and 85% for NICM. Mean ablation time per patient was 54 minutes. Mean lesions per patient: 11.5 ± 6. Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths, of which only two (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device. All safety and VT recurrence data were adjudicated by independent Event Committees. The study also demonstrated clinically meaningful de-escalation of the use of amiodarone, an important clinical goal, with a substantial proportion of patients reducing or discontinuing amiodarone therapy post-procedure. The results also showed a significant reduction in hospital readmission rates compared to those historically reported in the VT ablation literature, underscoring the potential clinical and economic impact of the therapy. "The FULCRUM-VT results are a significant clinical achievement and compare favorably against published RF (radiofrequency) benchmarks and the emerging PFA (pulsed field ablation) data for VT," said Dr. Matthew Hakimi, Medical Director at Adagio Medical. "It is the only pivotal IDE trial to show consistent endocardial-only outcomes across both ischemic and non-ischemic cardiomyopathy — and the combination of catheter stability, titratable lesion depth, and safe navigation near vulnerable structures such as the coronary arteries positions ULTA to address arguably the broadest spectrum of VT encountered in practice. FULCRUM-VT sets a new benchmark for VT ablation, and I want to commend the many physicians and their clinical coordinators for their diligent work in evaluating this novel technology." 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 Ablation ("ULTA", formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach. 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. FULCRUM-VT 6-month primary chronic effectiveness was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in the absence of new or increase in antiarrhythmic drug dose beyond previously failed ablation. The results of the study, which have not yet been reviewed or approved by the FDA, will be used to apply for U.S. Food and Drug Administration (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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," "potential," "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential for data from the FULCRUM-VT study to support an application for FDA premarket approval of the vCLAS Cryoablation System and the anticipated timing and outcome thereof; the potential for ULTA technology to address unmet needs in the treatment of VT, including across both ischemic and non-ischemic cardiomyopathy substrates; the potential for ULTA to become a foundational ablation technology for treating the ventricle; the potential for a more streamlined workflow and reproducible approach to VT ablation; the potential clinical and economic impact of ULTA, including reductions in hospital readmission rates; the possibility that FDA approval could lead to the broadest industry indication for purely endocardial ablation of scar-mediated VT; and Adagio's research, development and regulatory plans, including communications with, and submissions to, the FDA. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2025 , which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260426316811/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2026-04-01Adagio Medical Ultralow Temperature Ablation U.S. Pivotal Study Results to be Presented in Late-Breaking Session at Heart Rhythm Society 2026
Business Wire
Adagio Medical Ultralow Temperature Ablation U.S. Pivotal Study Results to be Presented in Late-Breaking Session at Heart Rhythm Society 2026
LAGUNA HILLS, Calif., April 01, 2026--(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 the pivotal results from the FULCRUM-VT study have been accepted for presentation in a late-breaking clinical science session at Heart Rhythm 2026 (HRS), the annual meeting of the Heart Rhythm Society. This is the first Investigational Device Exemption (IDE) study powered to evaluate the safety and effectiveness of Ultra-Low Temperature Ablation ("ULTA", formerly "ULTC") for the treatment of scar-related ventricular tachycardia (VT) in both ischemic and non-ischemic population. "Having FULCRUM-VT data selected for a late-breaking session at HRS is a testament to the significance of this work," said Matthew Hakimi, M.D., Cardiac Electrophysiologist, Cedars Sinai Medical Center and Medical Director at Adagio Medical. "On behalf of the entire Adagio team, I want to recognize the investigators, research coordinators, and patients whose dedication and perseverance made this study possible. Completing FULCRUM-VT marks a significant milestone — not just for Adagio, but for the millions of patients living with the burden of VT. We look forward to the results being shared by the investigators at HRS and the potential for these data to advance care for VT patients." The details of the late-breaking session are as follows: Adagio Medical will be hosting an event for analysts and institutional investors at 8:00 a.m. eastern time on Monday, April 27. During the webcast, Dr. Atul Verma, M.D. will present the results of the FULCRUM-VT study and then will be joined by Dr. William Stevenson, M.D., Professor of Medicine, Vanderbilt University Medical Center and Principal Investigator for FULCRUM-VT at Vanderbilt, and Dr. Matthew Hakimi, M.D. to discuss the results and answer questions from investors about the study. Investors and interested parties may join the live webcast through the registration link or by visiting the Investor Relations section of the Company's website at https://investors.adagiomedical.com. Pre-registration for the webcast is available beginning today. A replay of the webcast will be made available after the event. About Adagio Medical Holdings, Inc. Adagio is a medical device company focused on developing and co…Read full documentShow less
LAGUNA HILLS, Calif., April 01, 2026--(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 the pivotal results from the FULCRUM-VT study have been accepted for presentation in a late-breaking clinical science session at Heart Rhythm 2026 (HRS), the annual meeting of the Heart Rhythm Society. This is the first Investigational Device Exemption (IDE) study powered to evaluate the safety and effectiveness of Ultra-Low Temperature Ablation ("ULTA", formerly "ULTC") for the treatment of scar-related ventricular tachycardia (VT) in both ischemic and non-ischemic population. "Having FULCRUM-VT data selected for a late-breaking session at HRS is a testament to the significance of this work," said Matthew Hakimi, M.D., Cardiac Electrophysiologist, Cedars Sinai Medical Center and Medical Director at Adagio Medical. "On behalf of the entire Adagio team, I want to recognize the investigators, research coordinators, and patients whose dedication and perseverance made this study possible. Completing FULCRUM-VT marks a significant milestone — not just for Adagio, but for the millions of patients living with the burden of VT. We look forward to the results being shared by the investigators at HRS and the potential for these data to advance care for VT patients." The details of the late-breaking session are as follows: Adagio Medical will be hosting an event for analysts and institutional investors at 8:00 a.m. eastern time on Monday, April 27. During the webcast, Dr. Atul Verma, M.D. will present the results of the FULCRUM-VT study and then will be joined by Dr. William Stevenson, M.D., Professor of Medicine, Vanderbilt University Medical Center and Principal Investigator for FULCRUM-VT at Vanderbilt, and Dr. Matthew Hakimi, M.D. to discuss the results and answer questions from investors about the study. Investors and interested parties may join the live webcast through the registration link or by visiting the Investor Relations section of the Company's website at https://investors.adagiomedical.com. Pre-registration for the webcast is available beginning today. A replay of the webcast will be made available after the event. 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 Ablation (ULTA, formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue, all through an endocardial approach. 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 U.S. Food and Drug Administration (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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential for data from the FULCRUM-VT study to advance care for VT patients; Adagio’s research, development and regulatory plans for its product candidates; and communications with the FDA. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2025 , which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260401806541/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2026-03-27Adagio Medical Reports Fourth Quarter and Full Year 2025 Results
Business Wire
Adagio Medical Reports Fourth Quarter and Full Year 2025 Results
LAGUNA HILLS, Calif., March 27, 2026--(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 financial results for the fourth quarter ended December 31, 2025. Fourth Quarter and Recent Business Highlights: Announced the peer-reviewed publication in Circulation: Arrythmia and Electrophysiology, highlighting results from the U.S. Early Feasibility Study evaluating ultralow temperature cardiac ablation ("ULTA") for the treatment of scar-related ventricular tachycardia ("VT"), which demonstrated a favorable safety profile and no device- or procedure-related major adverse events in a real-world patient cohort of both ischemic and challenging non-ischemic patients Announced the successful completion of 13 cases with the vCLAS™ System under Expanded Access authorization from the U.S. Food and Drug Administration ("FDA"). The procedures, which included patients with premature ventricular contractions, were completed on patients who had previously failed ablations with conventional and/or experimental modalities Appointed industry veteran Sean Salmon to the Company’s Board of Directors, enhancing strategic and governance expertise; Sean recently retired from Medtronic, Inc after a distinguished 20+ year tenure, during which he held multiple senior global leadership roles across the company’s cardiovascular and diabetes businesses Strengthened executive leadership team with the appointments of Marie-Claude Jacques as Senior Vice President, Global Sales, and Antwan Gipson as Senior Vice President, Manufacturing & Operations, both seasoned senior executives who will help accelerate commercial readiness Attended multiple industry and investor conferences, which involved webcasts of the corporate presentation and multiple meetings with a large spectrum of investors Closed a private placement with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter development, with potential for up to $31 million in additional gross proceeds upon the exercise of outstanding warrants Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device…Read full documentShow less
LAGUNA HILLS, Calif., March 27, 2026--(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 financial results for the fourth quarter ended December 31, 2025. Fourth Quarter and Recent Business Highlights: Announced the peer-reviewed publication in Circulation: Arrythmia and Electrophysiology, highlighting results from the U.S. Early Feasibility Study evaluating ultralow temperature cardiac ablation ("ULTA") for the treatment of scar-related ventricular tachycardia ("VT"), which demonstrated a favorable safety profile and no device- or procedure-related major adverse events in a real-world patient cohort of both ischemic and challenging non-ischemic patients Announced the successful completion of 13 cases with the vCLAS™ System under Expanded Access authorization from the U.S. Food and Drug Administration ("FDA"). The procedures, which included patients with premature ventricular contractions, were completed on patients who had previously failed ablations with conventional and/or experimental modalities Appointed industry veteran Sean Salmon to the Company’s Board of Directors, enhancing strategic and governance expertise; Sean recently retired from Medtronic, Inc after a distinguished 20+ year tenure, during which he held multiple senior global leadership roles across the company’s cardiovascular and diabetes businesses Strengthened executive leadership team with the appointments of Marie-Claude Jacques as Senior Vice President, Global Sales, and Antwan Gipson as Senior Vice President, Manufacturing & Operations, both seasoned senior executives who will help accelerate commercial readiness Attended multiple industry and investor conferences, which involved webcasts of the corporate presentation and multiple meetings with a large spectrum of investors Closed a private placement with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter development, with potential for up to $31 million in additional gross proceeds upon the exercise of outstanding warrants Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device Exemption ("IDE") trial intended to support the premarket approval application for the vCLAS™ System for ablation of VT Announced preliminary results from the FULCRUM-VT trial demonstrating 97% acute effectiveness and a favorable safety profile with the Company’s proprietary ultralow temperature technology "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." Fourth Quarter and Full Year 2025 Financial Results Cost of revenue was $58 thousand for the three months ended December 31, 2025, compared to $1.5 million for the three months ended December 31, 2024. Cost of revenue was $0.7 million for the full year of 2025, compared to $3.3 million for the full year of 2024. Cost of revenue decreased year-over-year due to the pause of commercial activity in Europe and the related impact of an inventory buyback conducted in connection thereto. Research and development expenses were $2.2 million for the three months ended December 31, 2025, compared to $3.4 million for the three months ended December 31, 2024. Research and development expenses were $10.6 million for the full year of 2025, compared to $12.2 million for the full year of 2024. R&D expenses decreased year-over-year primarily due to a decrease in quality assurance costs, fewer research and development projects and reduced headcount. Selling, general and administrative expenses were $1.7 million for the three months ended December 31, 2025, compared to $4.1 million for the three months ended December 31, 2024. Selling, general and administrative expenses were $10.6 million for the full year of 2025, compared to $20.0 million for the full year of 2024. Selling, general and administrative expenses decreased year-over year primarily due to the absence of SPAC-related corporate expenses that were incurred in 2024 and a decrease in payroll and personnel expenses related to lower headcount during the year ended December 31, 2025. Net loss was $3.3 million for the three months ended December 31, 2025, compared to a net loss of $57.4 million for the three months ended December 31, 2024. Net loss was $25.1 million for the full year of 2025, compared to a net loss of $75.0 million for the full year of 2024. The year-over-year decrease in net loss related primarily to a $49.2 million non-cash Impairment of Goodwill and Intangibles in 2024, reduction of expenses as well as a decrease in interest expense and the fair value revaluation of notes and warrants. Cash and cash equivalents on December 31, 2025 were $17.1 million. 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 Ablation (ULTA) 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of Adagio’s ULTA technology; the reproducibility and durability of any favorable results seen in the U.S. Early Feasibility Study and other preliminary studies; the receipt of additional gross proceeds from the private placement if the issued warrants are exercised in full; Adagio’s intended use of the proceeds from the private placement; Adagio’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management; and the potential for FDA approval of Adagio’s product candidates. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2025 and subsequent reports filed with the U.S. Securities and Exchange Commission, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260327740735/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2026-03-24Adagio Medical Announces Publication of Pre-Clinical Results for Next Generation Ventricular Ablation Catheter
Business Wire
Adagio Medical Announces Publication of Pre-Clinical Results for Next Generation Ventricular Ablation Catheter
Highlights Improvements in Next Generation ULTA Catheter, Including Potential 50-75% Reduction in Ablation Time LAGUNA HILLS, Calif., March 24, 2026--(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 the publication of pre-clinical results of the Company’s next generation ultra-low temperature ablation ("ULTA") technology designed to treat ventricular arrhythmias. The publication, which is titled "Initial Pre‐Clinical Evaluation of the Augmented Ultra‐Low Temperature Cryoablation Catheter for Ventricular Ablation" was published in the Journal of Cardiovascular Electrophysiology and describes significant functional improvements in ablation catheter performance compared to the Company’s first generation vCLAS™ ULTA catheter, including improved handling characteristics, better compatibility with standard laboratory practices and potential for 50-75% reduction in ablation time. The publication is authored by physicians from several leading ventricular ablation programs in Germany, Belgium and Canada "The investigators in this study all have extensive experience performing procedures with first-generation vCLASTM catheters, which has provided us each with deep appreciation of the unique advantages of ULTA in ventricular ablation, including titratable lesion depth exceeding 10 millimeters," said Katia Dyrda MD FRCPC MSc Eng, Electrophysiologist Cardiologist, Montreal Heart Institute, Associate Clinical Professor, University of Montreal and a lead author of the study. "Remarkably, this next- generation ULTA system achieves these same advantages with more powerful and faster ablations using a smaller, 8.5 French-size catheter with handling characteristics equivalent to those of our standard RF catheters. These technical advances translate into a number of clinical advantages, including potential reduction in procedure time by as much as 30 minutes compared to first-generation of ULTA." Adagio’s next generation proprietary ULTA technology achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce 5-millimeter-deep lesions in as little as 15 seconds and 12.5-millimeter-deep lesions in approximately 120 seconds in pre-clinical models, as…Read full documentShow less
Highlights Improvements in Next Generation ULTA Catheter, Including Potential 50-75% Reduction in Ablation Time LAGUNA HILLS, Calif., March 24, 2026--(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 the publication of pre-clinical results of the Company’s next generation ultra-low temperature ablation ("ULTA") technology designed to treat ventricular arrhythmias. The publication, which is titled "Initial Pre‐Clinical Evaluation of the Augmented Ultra‐Low Temperature Cryoablation Catheter for Ventricular Ablation" was published in the Journal of Cardiovascular Electrophysiology and describes significant functional improvements in ablation catheter performance compared to the Company’s first generation vCLAS™ ULTA catheter, including improved handling characteristics, better compatibility with standard laboratory practices and potential for 50-75% reduction in ablation time. The publication is authored by physicians from several leading ventricular ablation programs in Germany, Belgium and Canada "The investigators in this study all have extensive experience performing procedures with first-generation vCLASTM catheters, which has provided us each with deep appreciation of the unique advantages of ULTA in ventricular ablation, including titratable lesion depth exceeding 10 millimeters," said Katia Dyrda MD FRCPC MSc Eng, Electrophysiologist Cardiologist, Montreal Heart Institute, Associate Clinical Professor, University of Montreal and a lead author of the study. "Remarkably, this next- generation ULTA system achieves these same advantages with more powerful and faster ablations using a smaller, 8.5 French-size catheter with handling characteristics equivalent to those of our standard RF catheters. These technical advances translate into a number of clinical advantages, including potential reduction in procedure time by as much as 30 minutes compared to first-generation of ULTA." Adagio’s next generation proprietary ULTA technology achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze applications that have been shown to produce 5-millimeter-deep lesions in as little as 15 seconds and 12.5-millimeter-deep lesions in approximately 120 seconds in pre-clinical models, as detailed in the published paper. "This publication highlights the continued successful evolution of our ULTA platform, the meaningful innovation behind our next-generation technology, and our team’s ability to quickly and efficiently work with our physician partners to adapt our purpose-built VT technologies to their needs," said Todd Usen, Chief Executive Officer of Adagio Medical. "By enabling faster, single-freeze ablation with a smaller, more maneuverable catheter, we believe this advancement has the potential to significantly improve procedural efficiency while maintaining all of the advantages that are core to our ULTA technology as we seek to provide a solution for the underserved population of patients who suffer from VT." 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 Ablation (ULTA, formerly known as ULTC) 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of Adagio’s ULTA technology, including the ability of Adagio’s next- generation ULTA system to provide clinical advantages; the reproducibility and durability of any favorable results initially seen in pre-clinical trails; Adagio’s strategy, future operations, the expected timing and results of clinical trials, prospects, plans and objectives of management; and the potential for FDA approval and commercialization of Adagio’s product candidates and whether, if approved, these product candidates will be successfully distributed and marketed and the potential market opportunity for Adagio’s product candidates. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260324055565/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2026-02-25Adagio Medical (ADGM) Announces Successful Results From US Cardiac Ablation Feasibility Study
Insider Monkey
Adagio Medical (ADGM) Announces Successful Results From US Cardiac Ablation Feasibility Study
Adagio Medical Holdings Inc. (NASDAQ:ADGM) is one of the best up and coming penny stocks to buy. On February 4, Adagio Medical Holdings announced the publication of results from its US Early Feasibility Study/EFS evaluating ultralow temperature cardiac ablation/ULTC for treating scar-related ventricular tachycardia. The multicenter study involved 20 patients with ischemic and non-ischemic cardiomyopathy across four US centers. The research focused on the acute safety and performance of ULTC in individuals with drug-refractory conditions, marking the first published US clinical experience for this technology under the FDA’s EFS framework. The study showed a favorable safety profile with no major adverse events recorded at 7 or 30 days, alongside strong clinical performance. Pixabay/Public domain Among tested patients, 92.9% achieved non-inducibility of the targeted clinical arrhythmia after ablation. At a 24-week follow-up, 72% of patients successfully reduced or discontinued antiarrhythmic medications, and 83.3% remained free from implantable cardioverter-defibrillator shocks. Investigators noted that the technology’s ability to create deep, titratable lesions is particularly effective for treating deep intramural substrates found in challenging patient populations. Adagio Medical Holdings Inc. (NASDAQ:ADGM) is a developmental-stage medical device company that develops and commercializes ablation technologies for the treatment of cardiac arrhythmias. While we acknowledge the potential of ADGM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you’re looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. Follow Insider Monkey on Google News.
Investor releaseQuarter not tagged2025-11-13Adagio Medical Reports Third Quarter 2025 Results
Business Wire
Adagio Medical Reports Third Quarter 2025 Results
Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif., November 12, 2025--(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 financial results for the third quarter ended September 30, 2025. Recent Business Highlights: Closed a private placement on October 20, 2025, with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter development, with potential for up to $31 million in additional gross proceeds Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device Exemption ("IDE") trial intended to support the premarket approval ("PMA") application for the vCLAS™ System for ablation of ventricular tachycardia ("VT") Announced preliminary results from the FULCRUM-VT trial demonstrating 97% acute effectiveness and a favorable safety profile with the Company’s proprietary ultralow temperature technology Strengthened executive leadership team with the appointment of Deborah Kaster as Chief Financial Officer, adding to her role as Chief Business Officer "Adagio made exceptional progress this quarter, with strong clinical momentum, a clear regulatory path and a solid pipeline," said Todd Usen, Chief Executive Officer of Adagio. "The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization. This financing also reflects the confidence leading healthcare investors have in our strategy and the potentially transformational impact of our proprietary ULTC technology to treat one of the broadest populations of patients with ventricular arrhythmias." Third Quarter 2025 Financial Results Cost of revenue was $31 thousand for the three months ended September 30, 2025, compared to $0.6 million for the three months ended September 30, 2024. Research and development expenses were $2.8 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024. Selling, general and administrative expenses wer…Read full documentShow less
Continued Momentum Toward PMA Submission of ULTC Technologies Recent Financing Positions Company to Execute Growth Strategy LAGUNA HILLS, Calif., November 12, 2025--(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 financial results for the third quarter ended September 30, 2025. Recent Business Highlights: Closed a private placement on October 20, 2025, with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter development, with potential for up to $31 million in additional gross proceeds Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device Exemption ("IDE") trial intended to support the premarket approval ("PMA") application for the vCLAS™ System for ablation of ventricular tachycardia ("VT") Announced preliminary results from the FULCRUM-VT trial demonstrating 97% acute effectiveness and a favorable safety profile with the Company’s proprietary ultralow temperature technology Strengthened executive leadership team with the appointment of Deborah Kaster as Chief Financial Officer, adding to her role as Chief Business Officer "Adagio made exceptional progress this quarter, with strong clinical momentum, a clear regulatory path and a solid pipeline," said Todd Usen, Chief Executive Officer of Adagio. "The successful completion of our financing provides the resources to advance our PMA submission for the vCLAS System and prepare for commercialization. This financing also reflects the confidence leading healthcare investors have in our strategy and the potentially transformational impact of our proprietary ULTC technology to treat one of the broadest populations of patients with ventricular arrhythmias." Third Quarter 2025 Financial Results Cost of revenue was $31 thousand for the three months ended September 30, 2025, compared to $0.6 million for the three months ended September 30, 2024. Research and development expenses were $2.8 million for the three months ended September 30, 2025, compared to $2.5 million for the three months ended September 30, 2024. Selling, general and administrative expenses were $2.9 million for the three months ended September 30, 2025, compared to $7.8 million for the three months ended September 30, 2024. Net loss for the three months ended September 30, 2025 was $10.1 million, compared to a net loss of $4.6 million for the three months ended September 30, 2024. Reported cash and cash equivalents of $4.7 million as of September 30, 2025. 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 Cryoablation (ULTC) technology. ULTC 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, enrolling 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. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the receipt of additional gross proceeds from the private placement if the issued warrants are exercised in full; Adagio’s intended use of the proceeds from the private placement; Adagio’s strategy, future operations, future financial position, projected expenses, expected timing and results of clinical trials, prospects, plans and objectives of management; the reproducibility of any favorable results initially seen in Adagio’s preliminary FULCRUM-VT acute data; and the potential for FDA approval of Adagio’s product candidates. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251112929137/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2025-10-11Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium
Business Wire
Adagio Medical Unveils Preliminary Acute Results from FULCRUM-VT U.S. Pivotal Study in Late Breaking Session at VT Symposium
97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tachycardia LAGUNA HILLS, Calif., October 10, 2025--(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 preliminary acute (within 7 days) safety and efficacy results from the Adagio’s FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation ("ULTC") for the treatment of Sustained Monomorphic Ventricular Tachycardia ("SMVT") in patients with both ischemic and nonischemic cardiomyopathy. The data are being presented by Travis Richardson, MD, Assistant Professor of Medicine, Clinical Cardiac Electrophysiology, Vanderbilt University Medical Center, in a Late Breaking Clinical Trials Session at the 20th Annual International Symposium on Ventricular Arrhythmias being held in Philadelphia on October 10, 2025. A total of 207 patients underwent ventricular tachycardia ("VT") ablation using Adagio’s ULTC system at 19 sites in the United States and Canada. The study included patients with both ischemic ("ICM") and non-ischemic ("NICM") cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). Mean procedure duration was 206+/- 68 minutes and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant ventricular tachycardias eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device. A presentation with additional details and accompanying figures are available on a Current Report on Form 8-K, which is being filed concurrently with this press release and available on the SEC’s website at www.sec.gov. "The patient profile in FULCRUM-VT is representative of what we see in real-world practice. The ability of Adagio’s ULTC system to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability make it a promising tool for a broad patient population. These factors, along with the broad inclusion criteria for the study, fueled swift…Read full documentShow less
97% Acute Effectiveness and Favorable Safety Results from Proprietary ULTC for Ventricular Tachycardia LAGUNA HILLS, Calif., October 10, 2025--(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 preliminary acute (within 7 days) safety and efficacy results from the Adagio’s FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation ("ULTC") for the treatment of Sustained Monomorphic Ventricular Tachycardia ("SMVT") in patients with both ischemic and nonischemic cardiomyopathy. The data are being presented by Travis Richardson, MD, Assistant Professor of Medicine, Clinical Cardiac Electrophysiology, Vanderbilt University Medical Center, in a Late Breaking Clinical Trials Session at the 20th Annual International Symposium on Ventricular Arrhythmias being held in Philadelphia on October 10, 2025. A total of 207 patients underwent ventricular tachycardia ("VT") ablation using Adagio’s ULTC system at 19 sites in the United States and Canada. The study included patients with both ischemic ("ICM") and non-ischemic ("NICM") cardiomyopathies (LVEF=35+/-10%, 33% NICM, 75% with congestive heart failure). Mean procedure duration was 206+/- 68 minutes and acute clinical success, defined as non-inducibility of target ventricular arrhythmias, was 97.4%, with all clinically-relevant ventricular tachycardias eliminated in 96.7% of patients tested by post-ablation programmed electrical stimulation. Key safety findings included a 2.5% rate of major adverse events including four (1.9%) peri-procedural deaths, of which one (0.5%) was adjudicated by an independent clinical events committee as definitely related to the investigational device. A presentation with additional details and accompanying figures are available on a Current Report on Form 8-K, which is being filed concurrently with this press release and available on the SEC’s website at www.sec.gov. "The patient profile in FULCRUM-VT is representative of what we see in real-world practice. The ability of Adagio’s ULTC system to produce deep, titratable endocardial lesions without irrigation and without concerns for catheter stability make it a promising tool for a broad patient population. These factors, along with the broad inclusion criteria for the study, fueled swift enrollment," said Dr. Richardson. "FULCRUM-VT not only included patients with ischemic myopathy, but also a large number with nonischemic disease, whose VT is often more difficult to treat due to deep substrate. Despite this, the acute effectiveness across the study population was excellent. This, along with the favorable safety profile of the ULTC System, is encouraging. VT is a largely undertreated condition, partially because the available treatment tools make ablation procedures challenging, and I have hope that ULTC will help to change that. We look forward to the six-month primary efficacy endpoint results of the FULCRUM-VT trial, which the company currently plans to share at the Heart Rhythm 2026 conference." The FULCRUM-VT Study is a prospective, multi-center investigation of ULTC evaluating acute safety and effectiveness in patients with scar-related VT refractory to antiarrhythmic drug therapy and a left ventricular ejection fraction greater than 20%. Long-term outcomes as well as analysis of the effectiveness in different myocardial substrates will be reported in the future. "We are pleased with the preliminary FULCRUM-VT acute data, which highlight the potential of Adagio’s proprietary ULTC technology to transform treatment for patients with ventricular tachycardia," said Todd Usen, Chief Executive Officer of Adagio Medical. "On behalf of the entire Adagio Medical team, I want to thank all of the investigators, research coordinators and patients who have supported this study and whose commitment to serving this underserved population of patients will bring us one step closer to a purpose-built solution for VT. We thank the VT Symposium for this opportunity to share our results as part of a Late Breaking Session in Philadelphia." 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 Cryoablation (ULTC) technology. ULTC 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 tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. IDE Pivotal Study. 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 study, enrolling 206 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the reproducibility of any favorable results initially seen in Adagio’s preliminary FULCRUM-VT acute data; the ability of Adagio’s proprietary ULTC system to become a tool for a broad patient population; Adagio’s research, development and regulatory plans for its product candidates; and the ability of Adagio’s proprietary ULTC technology to transform treatment for patients with VT. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251010655037/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2025-09-18Adagio Medical FULCRUM-VT U.S. Pivotal Study Acute Results to be Presented in Late-Breaking Session at VT Symposium
Business Wire
Adagio Medical FULCRUM-VT U.S. Pivotal Study Acute Results to be Presented in Late-Breaking Session at VT Symposium
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 study, enrolling 206 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: Adagio’s research, development and regulatory plans for its product candidates and Adagio’s ability to bring its proprietary ULTC solutions to patients. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these…Read full documentShow less
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 study, enrolling 206 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: Adagio’s research, development and regulatory plans for its product candidates and Adagio’s ability to bring its proprietary ULTC solutions to patients. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250918083876/en/ Contacts Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]
Investor releaseQuarter not tagged2025-08-14Adagio Medical Reports Second Quarter 2025 Results
Business Wire
Adagio Medical Reports Second Quarter 2025 Results
LAGUNA HILLS, Calif., August 13, 2025--(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 financial results for the second quarter ended June 30, 2025. Recent Business Highlights: Surpassed 85% enrollment in the FULCRUM-VT pivotal study of the Company’s vCLAS™ Cryoablation System. The study, which seeks to enroll 206 patients with either ischemic or non-ischemic drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025 First-in-human results from the PARALELL study, which evaluated the safety and effectiveness of Adagio’s Pulsed Field Cryoablation ("PFCA"), a novel, dual-energy cardiac ablation modality combining Pulsed Field Ablation (PFA) with Adagio’s proprietary Ultra-Low Temperature Cryoablation ("ULTC"), were published in the Journal of Cardiovascular Electrophysiology Reduced cash burn quarter-over-quarter as a result of the Company’s corporate prioritization initiative, which streamlined operations and focused resources on highest-value programs "In the second quarter we saw continued strong momentum in the enrollment of our FULCRUM-VT study, which we believe validates the market need for our purpose-built technology and brings us one step closer to offering our proprietary ULTC solutions to patients in the United States who suffer from ventricular tachycardia," said Todd Usen, Chief Executive Officer of Adagio. "The team also made meaningful progress in advancing our pipeline through the continued development of our next-generation product, which is designed to improve usability for physicians while further enhancing the capabilities of our differentiated ULTC platform." Second Quarter 2025 Financial Results Cost of revenue was $0.3 million for the three months ended June 30, 2025, compared to $0.7 million for the three months ended June 30, 2024. Research and development expenses were $2.0 million for the three months ended June 30, 2025 compared to $2.9 million for the three months ended June 30, 2024 Selling, general and administrative expenses were $2.4 million for the three months ended June 30, 2025, compared to $3.4 million for the three months ended June 30, 2024…Read full documentShow less
LAGUNA HILLS, Calif., August 13, 2025--(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 financial results for the second quarter ended June 30, 2025. Recent Business Highlights: Surpassed 85% enrollment in the FULCRUM-VT pivotal study of the Company’s vCLAS™ Cryoablation System. The study, which seeks to enroll 206 patients with either ischemic or non-ischemic drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025 First-in-human results from the PARALELL study, which evaluated the safety and effectiveness of Adagio’s Pulsed Field Cryoablation ("PFCA"), a novel, dual-energy cardiac ablation modality combining Pulsed Field Ablation (PFA) with Adagio’s proprietary Ultra-Low Temperature Cryoablation ("ULTC"), were published in the Journal of Cardiovascular Electrophysiology Reduced cash burn quarter-over-quarter as a result of the Company’s corporate prioritization initiative, which streamlined operations and focused resources on highest-value programs "In the second quarter we saw continued strong momentum in the enrollment of our FULCRUM-VT study, which we believe validates the market need for our purpose-built technology and brings us one step closer to offering our proprietary ULTC solutions to patients in the United States who suffer from ventricular tachycardia," said Todd Usen, Chief Executive Officer of Adagio. "The team also made meaningful progress in advancing our pipeline through the continued development of our next-generation product, which is designed to improve usability for physicians while further enhancing the capabilities of our differentiated ULTC platform." Second Quarter 2025 Financial Results Cost of revenue was $0.3 million for the three months ended June 30, 2025, compared to $0.7 million for the three months ended June 30, 2024. Research and development expenses were $2.0 million for the three months ended June 30, 2025 compared to $2.9 million for the three months ended June 30, 2024 Selling, general and administrative expenses were $2.4 million for the three months ended June 30, 2025, compared to $3.4 million for the three months ended June 30, 2024. Net loss for the three months ended June 30, 2025, was $3.9 million, or $(0.26) per share (Basic), compared to a net loss of $5.7 million, or $(7.35) per share (Basic), for the three months ended June 30, 2024. Reported cash and cash equivalents of $8.2 million as of June 30, 2025. 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 Cryoablation (ULTC) technology. ULTC 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 tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. IDE Pivotal Study. 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 study, enrolling 206 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of Adagio’s vCLAS™ Cryoablation System; Adagio’s research, development and regulatory plans for its product candidates, including the timing of initiating additional trials and reporting data from its trials; the ability of Adagio to bring its proprietary ULTC solutions to patients in the United States who suffer from VT and their ability to improve usability for physicians; the potential for its product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies; and its current cash resources and the impacts of its corporate prioritization initiative and realignment of resources. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described in detail in Adagio’s Securities and Exchange Commission ("SEC") filings, including in its Annual Report on Form 10-K for the full-year ended December 31, 2024, which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250813301975/en/ Contacts Debbie Kaster Chief Business Officer [email protected]
Investor releaseQuarter not tagged2025-05-16Adagio Medical Reports First Quarter 2025 Results
Business Wire
Adagio Medical Reports First Quarter 2025 Results
LAGUNA HILLS, Calif., May 15, 2025--(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 financial results for the first quarter ended March 31, 2025. Recent Business Highlights: Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the "FDA") for the vCLAS™ Cryoablation System ("vCLAS"), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease. The vCLASTM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ("IDE") study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLASTM review phase. Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025. Adagio’s Ultra-Low Temperature Cryoablation ("ULTC") and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings. Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer. Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company’s new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands. "This has been a defining quarter for Adagio Medical and for our progress across the company. The FDA’s Breakthrough Device Designation, multiple impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology," said Todd Usen…Read full documentShow less
LAGUNA HILLS, Calif., May 15, 2025--(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 financial results for the first quarter ended March 31, 2025. Recent Business Highlights: Received Breakthrough Device Designation from the U.S. Food and Drug Administration (the "FDA") for the vCLAS™ Cryoablation System ("vCLAS"), for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease. The vCLASTM Cryoablation System is currently the subject of the FULCRUM-VT Investigational Device Exemption ("IDE") study designed to support FDA approval. The Breakthrough Device program allows for the FDA to potentially provide Adagio with priority review and interactive communication during the vCLASTM review phase. Surpassed 50% enrollment in the FULCRUM-VT pivotal study. The study, which seeks to enroll 206 patients with ischemic and non-ischemic disease at 20 U.S. and Canadian centers, is on track for completion of patient enrollment in the second half of 2025. Adagio’s Ultra-Low Temperature Cryoablation ("ULTC") and vCLAS technologies were showcased by leading electrophysiologists during multiple scientific sessions at the recent European Heart Rhythm Association (EHRA) and Heart Rhythm Society (HRS) industry meetings. Hired industry veteran Deborah Kaster, who has more than 25 years of leadership experience in the medical technology sector, as Chief Business Officer. Implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and the Company’s new product design optimization program, which has been designed to advance faster innovation and iteration to meet market demands. "This has been a defining quarter for Adagio Medical and for our progress across the company. The FDA’s Breakthrough Device Designation, multiple impactful presentations at leading industry conferences, the introduction of our optimized smaller, faster next generation ULTC technology in development and the continued momentum in enrolling patients in our FULCRUM-VT trial all underscore the clinical promise and growing validation of our proprietary ULTC platform technology," said Todd Usen, Chief Executive Officer of Adagio. "I am so proud of the Adagio team’s accomplishments as we remain resolute in our mission to transform patient treatment and outcomes with our purpose-built solution for the large, underserved population of patients suffering from ventricular tachycardia." First Quarter 2025 Financial Results Cost of revenue was $0.3 million for the three months ended March 31, 2025, compared to $0.5 million for the three months ended March 31, 2024. Research and development expenses were $3.7 million for the three months ended March 31, 2025, compared to $3.5 million for the three months ended March 31, 2024. Selling, general and administrative expenses were $3.5 million for the three months ended March 31, 2025, compared to $4.8 million for the three months ended March 31, 2024. Net loss for the three months ended, March 31, 2025 was $7.7 million, or $(0.50) per share, compared to a net loss of $8.0 million, or $(10.28) per share, for the three months ended, March 31, 2024. Reported cash and cash equivalents of $13.0 million as of March 31, 2025. 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 Cryoablation (ULTC) technology. ULTC 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 tachycardia (VT) with its purpose-built vCLAS™ Cryoablation System which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT U.S. IDE Pivotal Study. 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 study, enrolling 206 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 ventricular tachycardia in Europe and select other geographies but is limited to investigational use in the United States. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipates," "believes," "expects," "intends," "projects," "plans," and "future" or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of our vCLAS™ Cryoablation System; our research, development and regulatory plans for our product candidates, including the timing of initiating additional trials and reporting data from our trials; the regulatory pathway for our vCLAS™ Cryoablation System and the potential impacts of the Breakthrough Device Designation; the potential for our product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies; and our current cash resources and the impacts of our corporate prioritization initiative and realignment of resources. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission ("SEC") filings, including in our Annual Report on Form 10-K for the full-year ended December 31, 2024, which is available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250515296787/en/ Contacts Debbie KasterChief Business [email protected] Caroline Corner, PhDICR [email protected]

