US Market News
4週前
Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical ProgressMay 12, 2026 8:05 AM
Business Wire Advancing Toward Submission for PMA Approval Following Late-Breaking FULCRUM-VT Data 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. Adagio Medical Holdings Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) March 31,
2026 December 31,
2025 (Unaudited) (Audited) Cash and cash equivalents $ 12,909 $ 17,105 Total assets 39,308 43,253 Total liabilities 33,583 30,851 Total stockholders’ equity 5,725 12,402 Adagio Medical Holdings Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (unaudited) Three Months Ended
March 31, 2026 2025 Revenue $ — $ — Cost of revenue and operating expenses: Cost of revenue — 253 Research and development 2,741 3,659 Selling, general, and administrative 2,459 3,485 Total cost of revenue and operating expenses 5,200 7,397 Loss from operations (5,200 ) (7,397 ) Other income (expense): Convertible notes fair value adjustment (1,063 ) 190 Warrant liabilities fair value adjustment (131 ) 38 Interest expense (778 ) (662 ) Interest income 107 164 Other income (expense), net 70 (46 ) Total other loss, net (1,795 ) (316 ) Net loss $ (6,995 ) $ (7,713 ) Other comprehensive loss: Foreign currency translation adjustment (44 ) (61 ) Comprehensive loss $ (7,039 ) $ (7,774 ) Basic net loss per share $ (0.31 ) $ (0.50 ) Diluted net loss per share $ (0.31 ) $ (0.51 ) Weighted-average shares outstanding – basic and diluted 22,210,459 15,375,521 View source version on businesswire.com: https://www.businesswire.com/news/home/20260512085398/en/ Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com Original: Adagio Medical Reports First Quarter 2026 Results and Meaningful Clinical Progress
US Market News
1月前
Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation SystemApril 26, 2026 9:32 AM
Business Wire
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
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.”
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1
ATP = anti-tachycardia pacing, or a painless, non-shock pacing therapy delivered by ICDs or pacemakers to terminate rapid heart rhythms. Monitor Zone is a programmed rate range where the device detects and records arrhythmias, but does not deliver active therapies like electric shocks or anti-tachycardia pacing
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/
Debbie Kaster
Chief Financial Officer and Chief Business Officer
dkaster@adagiomedical.com
Original: Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System