8-K
Adagio Medical Holdings, Inc. (ADGM)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2025
ADAGIO MEDICAL HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-42199 | 99-1151466 |
|---|---|---|
| (State or other jurisdiction of incorporation) | (Commission File Number) | (I.R.S. Employer Identification No.) |
| 26051 Merit Circle , Suite 102<br>Laguna Hills , CA | 92653 |
|---|---|
| (Address of principal executive offices) | (Zip Code) |
( 949 ) 348-1188
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading<br>Symbol(s) | Name of each exchange<br>on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | ADGM | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On August 13, 2025, Adagio Medical Holdings, Inc. (the “Company”), issued a press release announcing the Company’s financial results for the quarter ended June 30, 2025, and providing a business update. A copy of this press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The information furnished with this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01 Regulation FD Disclosure.
On August 13, 2025, the Company updated its corporate presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K is being “furnished” and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act, and shall not be incorporated or deemed to be incorporated by reference into any filing by the Company under the Securities Act or the Exchange Act, regardless of any general incorporation language contained in such filing, unless otherwise expressly stated in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| | | |
|---|---|---|
| Exhibit No. | Description | |
| 99.1 | | Press Release, dated August 13, 2025 |
| 99.2 | | Corporate Presentation, dated August 13, 2025 |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: August 13, 2025
| | Adagio Medical Holdings, Inc. | ||
|---|---|---|---|
| | | ||
| | | By: | /s/ Todd Usen |
| | | Name: | Todd Usen |
| | | Title: | Chief Executive Officer |
3
Exhibit 99.1
Adagio Medical Reports Second Quarter 2025 Results
LAGUNA HILLS, CA, August 13, 2025 – 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.
Contact
Debbie Kaster
Chief Business Officer
dkaster@adagiomedical.com
Adagio Medical Holdings, **** Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | **** | Successor | Predecessor | **** | |||
| | | As of<br>6/30/2025 | | As of<br>12/31/2024 | | ||
| | | | | | | | |
| Cash and cash equivalents | | $ | 8,200 | | $ | 20,586 | |
| Total assets | | | 35,876 | | | 48,448 | |
| Total Liabilities | | | 27,210 | | | 28,536 | |
| Total stockholders’ equity | | | 8,666 | | | 19,912 | |
Condensed Statements of Operations
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | | | Three months ended June 30, | | |||
| | | | 2025 | | | 2024 | |
| | | | | | | | |
| Revenue | $ | — | $ | 254 | |||
| Cost of revenue | | | 342 | | | 682 | |
| Research and development | | | 1,971 | | | 2,865 | |
| Selling, general, and administrative | | | 2,404 | | | 3,366 | |
| Total cost of revenue and operating expenses | | | 4,717 | | | 6,913 | |
| Loss from operations | | | (4,717) | | | (6,659) | |
| Other (income) expenses: | | | | | | | |
| Convertible notes fair value adjustment | | | 1,427 | | | 1,584 | |
| Warrant liabilities fair value adjustment | | | (141) | | | 94 | |
| Interest expense | | | (720) | | | (760) | |
| Interest income | | | 102 | | | 2 | |
| Other income (expense), net | | | 102 | | | 5 | |
| Total other income, net | | | 770 | | | 925 | |
| Net loss | | $ | (3,947) | | $ | (5,734) | |
| | | | | | | | |
| Basic net loss per share | | $ | (0.26) | | $ | (7.35) | |
| Diluted net loss per share | | $ | (0.35) | | $ | (7.35) | |
| Weighted average shares outstanding, basic and diluted | | | 15,381,565 | | | 779,908 | |
Exhibit 99.2
| 1<br>Investor Presentation<br>August 2025 |
|---|
| 2<br>- CONFIDENTIAL -<br>Forward Looking Statements<br>This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding the potential<br>of our Proprietary Ultra Low Temperature Cryoablation technology, the durability and reproducibility of the clinical data from our FULCRUM-VT pivotal study, our research, development and regulatory plans, and our strategy, future<br>operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,”<br>“plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these<br>identifying words. These forward-looking statements speak only as of the date of this presentation and are subject to a number of known and unknown risks, assumptions, uncertainties, and other factors that may cause our actual<br>results, levels of activity, performance, or achievements to be materially different from those expressed or implied by any forward-looking statements and which may be beyond our control. We caution you that these statements are<br>based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited<br>to, the ability to implement business plans, forecasts and other expectations after the recently completed business combination, the outcome of any legal proceedings that may be instituted against us, the ability to recognize the<br>anticipated benefits of the recently completed business combination, which may be affected by, among other things, competition, our ability to grow and manage growth profitability, and our ability to meet Nasdaq’s listing standards,<br>risks that internal and external costs required for ongoing and planned activities may be higher than expected, which may cause us to use cash more quickly than we expect or change or curtail some of our plans, or both; risks that<br>our expectations as to expenses, cash usage, and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions, our ability to achieve future financial<br>targets, changes in our business or external market conditions, challenges inherent in developing, manufacturing, launching, marketing, and selling new products, interruptions or delays in the supply of components or materials for, or<br>manufacturing of, our products, unanticipated increases in costs or expenses, continued or sustained budgetary, inflationary, or recessionary pressures, uncertainties in contractual relationships, reductions in research and<br>development spending or changes in budget priorities by customers, uncertainties relating to our research and development activities, potential product performance and quality issues, and intellectual property risks. Risks regarding<br>our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended<br>March 31, 2025, and our other filings with the SEC, which are available on the SEC’s website at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you<br>should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking<br>statements contained in this presentation reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law.<br>Management's Estimates<br>We have based our estimates of the total addressable market and growth forecasts on a number of internal and third-party estimates and resources, including, without limitation, third party reports and the experience of the<br>management team across the industries. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting such assumptions<br>or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. In addition, the novelty of the markets for our products may make our assumptions and estimates more uncertain. As a result,<br>our estimates of the total addressable market and growth forecasts for our products are subject to significant uncertainty and may prove to be incorrect. If third-party or internally generated data prove to be inaccurate or we make<br>errors in our assumptions based on that data, the total addressable market for our products may be smaller than we have estimated, our future growth opportunities and sales growth may be impaired, any of which could have a<br>material adverse effect on our business, financial condition and results of operations.<br>Industry and Market Data; Trademarks<br>Certain information contained in the presentation relates to or is based on studies, publications, statistics and surveys from third-party sources, and on our own internal estimates and research. In addition, all of the market data<br>included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While we believe that the third-party sources and our internal<br>research are reliable, such sources and research have not been verified by any independent source. Any data on past performance or modeling contained herein is not an indication as to future performance. This information involves<br>many assumptions and limitations, and you are cautioned not to give undue weight to such industry and market data. The information contained in the third-party citations referenced in this presentation is not incorporated by reference<br>into this presentation. This presentation may include trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. The inclusion of particular trademarks, service marks,<br>trade names and copyrights of other companies is not intended to, and does not, imply a relationship with us or our endorsement or sponsorship. We own or have rights to various trademarks, service marks, trade names and<br>copyrights in connection with the operation of our business which are also included in this presentation. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this presentation may<br>be listed without the, ℠, ©, or ® symbols, but we will assert, to the fullest extent under applicable law, the right of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.<br>Disclaimer |
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| 3<br>- CONFIDENTIAL -<br>Leadership Team<br>Over 200 Combined Years of Med Tech Experience<br>Doug Kurschinski<br>VP Clinical Affairs<br>Daniel George<br>Interim Chief Financial Officer<br>Todd Usen<br>Chief Executive Officer<br>Debbie Kaster<br>Chief Business Officer<br>Nabil Jubran<br>Chief Compliance Officer<br>Alex Babkin<br>Chief Technology Officer<br>Select Prior Experiences<br>Ilya Grigorov<br>VP Global Marketing &<br>Product Management |
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| 4<br>- CONFIDENTIAL -<br>Adagio Medical Overview<br>Proprietary Ultra Low Temperature Cryoablation (ULTC): The Coolest Innovation in Ventricular Tachycardia (VT) Ablation<br>1) Based on management's analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations.<br>2) As of August 11, 2025<br>3) See slide 13 for references<br>Estimated $5.8B total addressable<br>market (TAM) for VT ablation1<br>Only 6% of TAM is served with existing<br>technologies, which were all designed<br>for Atrial Fibrillation (AF)1<br>VT ablation moving to first line<br>treatment option<br>Established reimbursement<br>Large Market with Significant<br>Unmet Need<br>2-year head start over other purpose-designed VT systems<br>Improved safety, effectiveness and<br>usability demonstrated through CE<br>mark study3<br>CE Mark April 2024<br>300+ patients treated2<br>2-Year Competitive Head Start<br>within VT<br>Granted FDA Breakthrough Designation<br>April 2025<br>Over 85% enrolled2<br>Enrollment completion expected<br>2H-2025<br>U.S. FULCRUM-VT Pivotal IDE<br>Swiftly Enrolling<br>Robust IP covering ULTC and Pulsed<br>Field Cryoablation (PFCA)<br>Product design optimization program<br>focused on enhanced next generation<br>devices<br>Strong IP and Pipeline |
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| 5<br>- CONFIDENTIAL -<br>Estimated $5.8B Global TAM for VT Ablation<br>Large, Underpenetrated Market with Established U.S. Reimbursement<br>Note: Market size, number of procedures and patients, and current market penetration are based on management's analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations.<br>~1.6M<br>Global Patients Eligible for<br>VT Ablation Annually<br>~200K<br>U.S. Patients Eligible for<br>VT Ablation Annually<br>Structural Heart Disease VTs<br>~730K Cases Unserved<br>Idiopathic VT and Premature<br>Ventricular Contractions<br>~780K Cases Unserved<br>~70K<br>~30K<br>~$5.8B Global TAM<br>~$1.6B U.S. TAM<br>(Assumes $8K ASP in U.S.)<br>~100K current VT ablation procedures represent<br>only 6% penetration of the global TAM<br>~1.6M<br>Global Patients<br>Eligible for VT<br>Ablation Annually |
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| 6<br>- CONFIDENTIAL -<br>Challenges of Current VT Ablation Catheters<br>Current Products Were Designed for Atrial Ablations<br>1) Ding WY, Pearman CM, Bonnett L, et al. Complication rates following ventricular tachycardia ablation in ischaemic and non-ischaemic cardiomyopathies: a systematic review. Journal of Interventional Cardiac Electrophysiology (2022) 63:59–67<br>2) Cheung JW, Yeo I, Ip JE, et al. Outcomes, Costs, and 30-Day Readmissions After Catheter Ablation of Myocardial Infarct–Associated Ventricular Tachycardia in the Real World. Circ Arrhythm Electrophysiol. 2018;11:e006754<br>Current catheters often lack depth for effective lesions in<br>the ventricle<br>Inadequate lesion durability leads to recurrence of VT<br>“Thermal Effect” leads to migrating microbubbles<br>Current catheters require irrigation in fluid compromised<br>heart failure patients<br>Most catheters are “repurposed” AF ablation catheters<br>Intensely contracting ventricular structures require catheter<br>stability not provided by current catheters<br>Existing Product Drawbacks Current Procedural Complication Rates1,2<br>The market is in need of a purpose-built treatment that can achieve lesion depth in the<br>ventricle with low complications and high efficacy in reducing VT episodes<br>2.7%<br>2.0%<br>5.6%<br>1.7%<br>0.4%<br>1.8%<br>11.5% |
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| 7<br>- CONFIDENTIAL -<br>Freedom From All-cause mortality,<br>VT storm, ICD shock, intervention for<br>sustained VT<br>Freedom from VT recurrence,<br>CV hospitalization or death<br>Cardiac ablation appears superior to AAD as both prophylaxis and response<br>to VT events in ICD population<br>Clinical Evidence Supporting VT Ablation as First Line<br>Therapy is Building<br>1) Sapp JL, Tang ASL, Parkash R, Stevenson WG, et al, Catheter Ablation or Antiarrhythmic Drugs or Ventricular Tachycardia. N Engl J Med 2024 Nov 16. doi: 10.1056/NEJMoa2409501<br>2) Tung R, Xue Y, Chen M, Jiang C, et al. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022;145:1839–1849<br>VANISH-21 PAUSE-SCD2<br>Ablation vs Antiarrhythmic Drugs (AAD) in post-myocardial infarction<br>implantable cardioverter-defibrillators (ICD) patients with prior VT events<br>Prophylactic ablation + ICD vs AAD + ICD in secondary prevention or<br>inducible primary prevention patients<br>Randomized trial with results published in November 2024<br>Trial compared VT ablation to AAD as first-line therapy<br>Study found ablation to be superior to AAD (p=.03)<br>Randomized trial published in May 2022 compared VT<br>ablation to AAD as first-line therapy at ICD implantation<br>Study found early catheter ablation reduced outcomes of<br>VT recurrence, cardiovascular hospitalization, or death |
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| 8<br>- CONFIDENTIAL -<br>0<br>200<br>400<br>600<br>800<br>1000<br>1200<br>1400<br>1600<br>2005 2010 2015 2020 2025 2030<br>Global Procedures1<br>VT Market Poised for AF-Like Acceleration<br>Fueled by Data Supporting Guidelines and Purpose-Built VT Solution<br>1) The current catheter market size, historical and future market growth are based on management's analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations.<br>2) Sapp JL, Tang ASL, Parkash R, Stevenson WG, et al, Catheter Ablation or Antiarrhythmic Drugs or Ventricular Tachycardia. N Engl J Med 2024 Nov 16. doi: 10.1056/NEJMoa2409501<br>3) Tung R, Xue Y, Chen M, Jiang C, et al. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022;145:1839–1849<br>4) Ding WY, Pearman CM, Bonnett L, et al. Complication rates following ventricular tachycardia ablation in ischaemic and non-ischaemic cardiomyopathies: a systematic review. Journal of Interventional Cardiac Electrophysiology (2022) 63:59–67<br>Large patient population<br>(~12M patients)<br>Significant investment in ablation<br>and mapping technology<br>Procedural standardization;<br>stable, predictable efficacy<br>Reduced complexity,<br>complications and<br>procedure time<br>Large, heterogeneous (and sick)<br>patient population (1.6M patients)<br>Market in need of purpose-built catheter addressing VT-specific requirements<br>− Lower rate of complications<br>− Safe ablation of large,<br>deep lesions<br>− Low-risk (endocardial)<br>approach<br>− Catheter stability<br>− Hemodynamic management<br>AF: Historic 10-13%<br>Growth1<br>VT: Historic 5-8%<br>Growth1<br>2012: Positive<br>guideline changes for<br>AF catheter ablation<br>2023: Pulsed field<br>ablation (PFA) widely<br>accepted as faster, safer,<br>and more efficacious<br>2024: Commercialization<br>of the first approved<br>PFA systems<br>Poised for<br>Acceleration<br>VANISH 2 and PAUSE-SCD<br>studies provide emerging<br>evidence for VT ablation as a<br>1st line therapy2,3<br>Studies starting in 2010 led to<br>guidelines now supporting AF<br>ablation as 1st line therapy4 |
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| 9<br>- CONFIDENTIAL -<br>9 Fr<br>115 mm working length<br>vCLAS Catheter Purpose Engineered for VT Ablations<br>Clinically Tested in Patients with Ischemic and Non-Ischemic Cardiomyopathy<br>Durable lesions of titratable depth and size<br>Endocardial ablations of mid-myocardial scar<br>Catheter stability during energy delivery<br>Time and effort: efficient procedures with few lesions<br>No irrigation simplifies hemodynamic management<br>Open platform works with current mapping technologies<br>Overview<br>CATHETER SPECIFICATIONS<br> 15 mm long cryoablation<br>element<br> 8 electrodes<br> Bidirectionally<br>deflectable<br>No need for irrigation |
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| 1 0<br>- CONFIDENTIAL -<br>Greater Than 2x Lesion Depth with ULTC<br>Note: Video courtesy Dr. Petr Neuzil, Nemecina Na Homolce, Prague, CZ. Preclinical images are adopted from Verma et al.<br>1) De Potter T, Balt, JC, Boersma L, et al. First-in-Human Experience With Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. J Am Coll Cardiol EP 2023; 9(5):686-691;<br>Verma A, Essebag V, Neuzil P, et al. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. EP Europace 2024; 26(4):euae076<br>0<br>2<br>4<br>6<br>8<br>10<br>12<br>14<br>16<br>18<br>Radiofrequency ULTC<br>Lesion Depth<br>Healthy Tissue Scar<br> Deep (as well as large area) ischemic scars<br> Mid-myocardial non-ischemic scars<br> All-cause sub-epicardial circuits from endocardium<br>2.1x<br>2.6x<br>Minimal<br>attenuation<br>in scar<br>tissue<br>Standard Deviation<br>Ventricle Depth from Different<br>Energy Sources1<br>ULTC Freeze and Lesions<br>(Pre-Clinical)<br>Wider Deeper |
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| 1 1<br>- CONFIDENTIAL -<br>ULTC vs. Traditional Cryo<br>Device Example Cryogen<br>Approx. Min.<br>Cryogen<br>Temp.<br>Approx.<br>Ablation<br>Element<br>Temp.<br>Cooling<br>Power Use Case Lesion Depth Limitations / Advantages<br>Traditional Cryo<br>(Nitrous Oxide-Based)<br>Nitrous<br>oxide -85°C -60°C<br>Low<br>Endocardial;<br>limited to atrial<br>applications Shallow; ineffective<br>for ventricular<br>ablation<br>X Requires occlusion<br>of flow; not suitable for thick<br>myocardial tissue<br>Joule-Thomson<br>Argon-Based<br>Cryo<br>Argon<br>(Joule-Thomson<br>expansion)<br>-180°C -140°C Low<br>Epicardial only;<br>typically in<br>surgical settings Moderate; limited<br>by surface cooling<br>X Not compatible with catheter-based endocardial use;<br>requires direct surgical access<br>ULTC Near-critical<br>nitrogen -195°C -145°C High<br>Endocardial<br>including<br>ventricular<br>ablation<br>Deep; effective<br>even in high-perfusion areas<br> Enables durable lesions in<br>thick myocardial tissue<br>Next Gen<br>ULTC<br>Critical<br>Nitrogen<br>with on-tip<br>expansion<br>cooling<br>-195°C -170°C<br>Very High<br>Endocardial and<br>ventricular<br>ablation<br>Deep; effective in<br>high perfusion<br>areas<br> Shorter ablation times due to<br>enhanced thermal gradient<br> Lower operating pressures<br>improve procedural safety<br> Optimized lesion control,<br>ability to titrate treatment, and<br>overall procedural efficiency<br>Comparison of Cryogens Used in Medical Devices for Cardiac Applications<br>Medtronic<br>Cryoballoon<br>Medtronic<br>Linear Ablation<br>AtriCure cryoFORM<br>Medtronic<br>Cardioblate CryoFlex<br>Adagio vCLAS<br>Adagio Next Gen |
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| 1 2<br>- CONFIDENTIAL -<br>CRYOCURE-VT Study Results<br>Note: vCLAS Catheter and Cryoablation Console are CE marked. VT Cryoablation System is an investigational device in the U.S., limited by Federal law to investigational use (IDE #G220229).<br>1) Verma A, Essebag V, Neuzil P, et al. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. Europace 2024;26:euae076<br>Clinical Results Supported CE Mark Approval1<br>Consistent results in both ischemic<br>and non-ischemic cardiomyopathy<br>60% chronic effectiveness<br>60% reduction in use of amiodarone<br>Significant reduction in VT Burden<br>81%<br>Freedom From ICD<br>Shock at 6 months<br>0 %<br>SAFETY<br>Material<br>Adverse<br>Effects<br>Procedural<br>Characteristics<br>Average # of lesions: 9<br>Average Procedure Time: 185 minutes<br>94% 97%<br>ACUTE<br>EFFECTIVENESS MORPHOLOGIES |
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| 1 3<br>- CONFIDENTIAL -<br>Favorable Safety and Effectiveness Profile<br>Adagio Results Address Challenges of Currently Approved and Investigational Devices for VT<br>Source: Adagio Medical CS-300, Data on File.<br>Note: Note that the comparisons in the table above are not based on data from head-to-head trials and are not direct comparisons. Differences in trial designs, patient groups, trial endpoints, study sizes and<br>other factors may impact the comparisons.<br>*For reference only: variability in end-points definition and lack of randomization<br>1) All complications reflect the rate of “serious adverse events” although the definitions vary between the studies<br>2) Acute effectiveness reflects non-inducibility of the targeted VTs, although definitions vary between the studies<br>3) Chronic effectiveness reflects primary endpoints of the study inclusive of the freedom from recurrence at 6 months, although definitions vary between the studies<br>4) Index procedure only. Higher values reported in limited number of staged procedures<br>Manufacturer / Device / Study<br>Energy<br>Source Indication Access<br>Procedure<br>Time, min<br># of<br>Lesions<br>Irrigation<br>Volume, L<br>Acute Complications1<br>Acute<br>Effectiveness2<br>Chronic All Death Stroke Effectiveness3<br>CRYOCURE-VT ICM+NICM Endocardial 188 9 0 6.3% 0% 0% 94% 60%<br>Thermocool PM ICM Endocardial 270 34 1.5 4.3% 1.3% 0% 76% 62%<br>Thermocool IDE ICM Endocardial 315 24 1.3 18.0% 3.4% 0% 49% 53%<br>LESS-VT IDE NICM<br>Endocardial<br>+<br>Epicardial<br>2324 NR 0.754 21.1% 1.2% 0.6% 93% 58%<br>SERF Needle ICM+NICM Endocardial 282 10 0.09 18.8% 6.3% 6.3% 97% 50%<br>BWH & JnJ SERF Needle ICM+NICM Endocardial 316 12 0.07 (est.) 19.5% 0% 0% 65% 40%<br>Approved by FDA for use in U.S.<br>Investigational Device in the U.S.<br>Radiofrequency Ablation<br>Non-Ischemic Cardiomyopathy<br>Ischemic Cardiomyopathy<br>NICM<br>ICM |
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| 1 4<br>- CONFIDENTIAL -<br>UCSF<br>LBMH<br>Banner<br>St. Davids<br>MUSC<br>VUMC<br>OSU<br>U M<br>JHU<br>Sentara<br>Brigham & Women<br>Beth - Israel<br>Cornell<br>Northwell<br>UPenn Mt. Sinai<br>McGill<br>MHI<br>Baptist Health<br>Vanderbilt<br>FULCRUM-VT* Pivotal Study<br>*FEASIBILITY OF ULTRA-LOW TEMPERATURE CRYOABLATION FOR RECURRING MONOMORPHIC VT, NCT #05675865<br>Source: Adagio Medical CS-300. Data on File.<br>1) As of August 11, 2025<br>Overview FULCRUM-VT Centers<br>Proposed Indication: treatment of drug-refractory, recurrent, sustained monomorphic<br>ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease<br>Study Design<br>Single arm; 206 patients across ~20 sites<br>Ischemic cardiomyopathy<br>Non-ischemic cardiomyopathy<br>FDA Performance Goals<br>Status<br>Over 85% Enrolled1<br>Breakthrough Device Designation by FDA<br>Expected enrollment completion: 2H-2025<br>Metrics Value Cryocure-VT<br>Reference<br>Primary<br>Safety<br>Major Adverse Events @<br>7 days ≤ 20% 0%<br>Primary<br>Effectiveness<br>Freedom from VT<br>recurrence @ 6 month ≥ 50% 60% |
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| 1 5<br>- CONFIDENTIAL -<br>Pipeline: Next Generation ULTC – Single Freeze<br>Initial Pre-clinical Evaluation of the<br>Augmented Ultra-Low Temperature<br>Cryoablation Catheter for<br>Ventricular Ablations<br>Katia Dyrda, Atul Verma, Borislav Dinov, Thomas Fink,<br>Santi Raffa, Tom De Potter, Vidal Essebag<br>Presented at:<br>Images courtesy Dr. Katia Dyrda<br>8.5 Fr sheath provides improved compatibility<br>Enabled by “new physics” – expansion of the cryogen within the distal<br>cryoablation element<br>Lower ablation temperatures allow for faster ablation without<br>bonus freeze<br>More flexible and deflectable shaft design enabled by lower internal<br>pressure<br>Significant COGS reduction compared to vCLAS<br>Overview<br>Smaller • Colder • Deeper • Faster |
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| 1 6<br>- CONFIDENTIAL -<br>Improved Usability with Next Gen ULTC<br>1) Including LVOT, peri-valvular areas, apical septum<br>2) Target characteristics based on the commonly used curve definitions. Final specifications TBD.<br>Catheter Specifications User Benefits<br>vCLAS Next Gen<br>Lower<br>Commercial<br>Barriers<br>Improved In-Sheath<br>Torqueability<br>Challenging<br>Locations<br>Navigation1<br>Smaller<br>Hearts<br>Navigation<br>Improved<br>Tissue<br>Opposition<br>Improved<br>Retrograde<br>Access<br>Perceived<br>Overall<br>Safety<br>Sheath<br>compatibility > 9 Fr 8.5 Fr <br>Bi-directional<br>deflection2 F/F D/F <br>Ablation element<br>length 15 mm 12 mm <br>Number of<br>electrodes 8 6<br>Shaft design Uniform<br>Stiffness<br>Variable<br>Stiffness <br>D-curve F-curve<br>Agilis 8.5 Fr sheath<br>Stiffer<br>Softer<br>The Softest<br>Deflection Curves Variable Stiffness Shaft Design |
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| 1 7<br>- CONFIDENTIAL -<br>Pulsed Field Cryoablation<br>Desired Depth with Less Energy than PFA Alone<br>Increased impedance of frozen tissue dramatically reduces PFA current<br>Consistent tissue contact<br>No phrenic nerve capture<br>No or minimal skeletal muscle<br>activation<br>No or minimized microbubbles<br>No or minimized coronary<br>spasm vs PFA<br>Demonstrated in AF through the PARALLEL study – but even more applicable to VT<br>Pulsed Current ~ 25 amp2 Zero < 1 amp<br>Ablation Time <10s of seconds1 ~60-120 seconds3,4 ~30 seconds5,6<br>PFA ULTC PFCA<br>Catheter Pulsed<br>E-field<br>Target<br>Tissue<br>-30°C<br>-145°C -145°C<br><0°C<br>-30°C<br>1Shapira-Daniels A, et al. Circ Arrhythm Electrophysiol 2019;<br>2Verma A, et al. J Cardiovasc Electrophysiol 2022.<br>3De Potter T, et al. JACC EP 2022;<br>4De Potter T, et al. JACC EP 2023;<br>5Essebag V et al. J. Cardiovasc Electrophysiol 2025<br>6Dewland T, et al. HRS 2023, submitted to JACC EP |
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| 1 8<br>- CONFIDENTIAL -<br>Established U.S. Reimbursement<br>VT Ablation Covered by Existing Codes<br>1) The incremental payment gets added to the standard payment for the intervention<br>2) Payment amount varies and depends on hospital specific charges and metrics Existing U.S. Reimbursement<br>$22-27k<br>Inpatient (DRG) Payment Amount<br>~40%<br>% of VT Ablation Procedures<br>$24.5k<br>Outpatient (APC) Payment Amount<br>~60%<br>% of VT Ablation Procedures<br>Breakthrough Designation Increases Likelihood of Additional Payment Through NTAP1<br>New Technology Add-On Payment (NTAP) for Inpatient Procedures<br>Goal of NTAP is to cover the majority (up to 65%) of costs in excess of DRG2<br>Breakthrough Designation reduces the criterion for NTAP<br> Cost – higher charge per case<br> Substantial clinical improvement – waived by CMS for devices with Breakthrough Designation<br> Newness – waived by CMS for devices with Breakthrough Designation |
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| 1 9<br>- CONFIDENTIAL -<br>Select Financials and Capitalization<br>($ in millions) At 6/30/25<br>Cash and Cash Equivalents $8.2M<br>Convertible Notes Payable (including accrued interest) $22.49M<br>Shares Outstanding 15.38M<br>Total Base Warrants ($10 ex. price) 7.53M<br>Total Convert Warrants ($25 ex. price) 1.50M |
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| 2 0<br>- CONFIDENTIAL -<br>Business Highlights<br>1) Market size and current market penetration are based on management's analysis and calculations using internal and third-party estimates and resources, subject to<br>certain assumptions and limitations.<br>Two-Year Lead with Purpose Built Catheter for VT Ablation<br>Addressing Underserved, 6% Penetrated, $5.8 Billion VT Ablation Market1<br>Promising Results from CE Mark Study for VT<br>Breakthrough Device Designation from FDA<br>Surpassed 85% Enrollment of FULCRUM-VT IDE Study to Support Potential FDA Approval<br>Next Gen Device Addresses Evolving Needs of Market<br>Established Reimbursement with VT Ablation Covered by Existing Codes |
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