STOCK TITAN

[424B3] Adagio Medical Holdings, Inc. Prospectus Filed Pursuant to Rule 424(b)(3)

Filing Impact
(Low)
Filing Sentiment
(Neutral)
Form Type
424B3

Adagio Medical Holdings filed a prospectus supplement for the resale of up to 67,963,695 shares of common stock by selling stockholders. The registration covers 12,146,988 issued shares, up to 9,098,727 shares issuable upon exercise of warrants, and up to 46,717,980 shares issuable upon conversion of notes, along with other previously issued or issuable shares detailed in the underlying agreements.

The supplement attaches a Current Report on Form 8‑K noting the company announced the closing of a private placement with $19 million upfront, with stated priorities including support for FULCRUM‑VT PMA submission activities, next‑generation ULTC catheter development, manufacturing scale‑up, and corporate operations. Adagio’s common stock trades on Nasdaq as “ADGM”; the last reported sales price was $1.375 per share on October 17, 2025.

Adagio Medical Holdings ha depositato un supplemento al prospetto per la rivendita di fino a 67.963.695 azioni ordinarie da parte degli azionisti venditori. La registrazione copre 12.146.988 azioni emesse, fino a 9.098.727 azioni da esercitare con warrant, e fino a 46.717.980 azioni da conversione di note, insieme ad altre azioni già emesse o da emettere dettagliate negli accordi sottostanti.

Il supplemento allega un Current Report on Form 8-K che segnala che la società ha annunciato la chiusura di un private placement con 19 milioni di dollari iniziali, con priorità dichiarate tra cui supporto per le attività di sottomissione FULCRUM‑VT PMA, sviluppo di un catetere ULTC di prossima generazione, aumento della capacità produttiva e operazioni societarie. Le azioni ordinarie di Adagio sono negoziate su Nasdaq come “ADGM”; l'ultimo prezzo di vendita riportato è stato 1,375 dollari per azione il 17 ottobre 2025.

Adagio Medical Holdings presentó un suplemento del prospecto para la reventa de hasta 67,963,695 acciones ordinarias por parte de accionistas vendedores. La registración cubre 12,146,988 acciones emitidas, hasta 9,098,727 acciones susceptibles de ser ejercidas mediante warrants y hasta 46,717,980 acciones susceptibles de conversión de notas, junto con otras acciones ya emitidas o susceptibles de emitir según los acuerdos subyacentes.

El suplemento adjunta un Current Report on Form 8‑K que señala que la empresa anunció el cierre de una colocación privada con 19 millones de dólares iniciales, con prioridades declaradas que incluyen apoyo para las actividades de presentación de PMA FULCRUM‑VT, desarrollo del catéter ULTC de próxima generación, escalado de la fabricación y operaciones corporativas. Las acciones ordinarias de Adagio cotizan en Nasdaq como “ADGM”; el último precio de venta reportado fue 1,375 dólares por acción el 17 de octubre de 2025.

Adagio Medical Holdings은 매도 주주들에 의한 일반주 67,963,695주 재판매를 위한 증권신고서 보충서를 제출했습니다. 등록은 발행 주식 12,146,988주, 워런트를 행사함으로써 발행 가능한 9,098,727주, 채권의 전환으로 발행 가능 46,717,980주를 포함하고, 기초 계약에 상세히 기재된 기타 이미 발행되었거나발행 가능주를 포함합니다.

보충서는 회사가 초기 1,900만 달러의 프라이빗 배치를 마쳤다고 공시하는 현행 Form 8-K 보고서를 첨부하고 있으며, 우선순위로 FULCRUM‑VT PMA 제출 활동 지원, 차세대 ULTC 카테터 개발, 제조 규모 확장 및 기업 운영을 포함하고 있습니다. Adagio의 일반주식은 나스닥에서 “ADGM”로 거래되며, 마지막으로 보고된 매매가는 2025년 10월 17일 주당 1.375달러였습니다.

Adagio Medical Holdings a déposé un supplément de prospectus en vue de la revente de jusqu'à 67 963 695 actions ordinaires par des actionnaires vendeurs. L'inscription couvre 12 146 988 actions émis, jusqu'à 9 098 727 actions susceptibles d'être émises lors de l'exercice de bons de souscription et jusqu'à 46 717 980 actions pouvant être émises lors de la conversion de notes, ainsi que d'autres actions déjà émise ou susceptibles d'être émises détaillées dans les accords sous-jacents.

Le supplément joint un Current Report on Form 8‑K indiquant que la société a annoncé la clôture d'une placement privé avec 19 millions de dollars initiaux, avec des priorités déclarées comprenant le soutien aux activités de soumission PMA FULCRUM‑VT, le développement d'un cathéter ULTC de nouvelle génération, l'augmentation de l'échelle de fabrication et les opérations corporatives. Les actions ordinaires d'Adagio se négocient sur le Nasdaq sous le symbole « ADGM » ; le dernier prix de vente signalé était 1,375 dollars par action le 17 octobre 2025.

Adagio Medical Holdings hat einen Prospekt-Supplement für den Weiterverkauf von bis zu 67.963.695 Aktien der Stammaktien eingereicht von verkaufswilligen Aktionären. Die Registrierung umfasst 12.146.988 ausgegebene Aktien, bis zu 9.098.727 Aktien, die durch Ausübung von Optionsscheinen ausgestellt werden können, und bis zu 46.717.980 Aktien, die durch Umwandlung von Anleihen ausgestellt werden können, zusammen mit anderen bereits ausgegebenen oder auszugebenden Aktien, die in den zugrunde liegenden Vereinbarungen detailliert aufgeführt sind.

Der Supplement fügt einen Current Report on Form 8‑K bei, in dem bekannt gegeben wird, dass das Unternehmen den Abschluss einer privaten Platzierung mit 19 Millionen USD im Voraus angekündigt hat, mit festgelegten Prioritäten, darunter Unterstützung für die FULCRUM‑VT PMA‑Einreichungsaktivitäten, die Entwicklung einer nächsten Generation des ULTC‑Katheters, die Skalierung der Fertigung und den Unternehmenseinsatz. Adagios Stammaktien werden an der Nasdaq als „ADGM“ gehandelt; der zuletzt gemeldete Verkaufspreis betrug 1,375 USD pro Aktie am 17. Oktober 2025.

قدمت Adagio Medical Holdings نشرة اكتتاب معدلة لإعادة بيع حتى 67,963,695 سهماً عائداً عاديًا من قبل مساهمين بائعين. يغطي التسجيل 12,146,988 سهماً مُصدرًا، وحتى 9,098,727 سهماً يمكن إصدارها عند ممارسة المزايا، وحتى 46,717,980 سهماً يمكن إصدارها عند تحويل السندات، بالإضافة إلى أسهم أخرى مُصدرة سابقًا أو قابلة للإصدار كما هو موضح في الاتفاقيات الأساسية.

تُرفق النشرة تقريرًا حاليًا على النموذج 8‑K يشير إلى إعلان الشركة إغلاق صفقة خاصة مع 19 مليون دولار مقدماً، مع أولويات محددة بما في ذلك دعم أنشطة تقديم طلب PMA لـ FULCRUM‑VT، وتطوير مُسبار ULTC من الجيل التالي، وتكبير التصنيع وعمليات الشركات. تتداول أسهم Adagio العادية في ناسداك تحت الرمز “ADGM”؛ وكانت آخر سعر بيع مُبلغ عنه هو 1.375 دولار للسهم في 17 أكتوبر 2025.

Adagio Medical Holdings 已为由销售股东转售至多67,963,695股普通股提交了招股说明书补充文件。注册涵盖已发行的12,146,988股、可在行使认股权证时发出的最多9,098,727股,以及在转换票据时可发出的最多46,717,980股,以及在基础协议中详细说明的其他已发行或可发出的股票。

该补充文件附有一份当前报表(Form 8-K),说明公司宣布完成一次私募配售,预初金额为1900万美元,明确的优先事项包括支持 FULCRUM‑VT PMA 的提交工作、第二代 ULTC 导管的开发、制造规模扩大以及公司运营。Adagio 的普通股在纳斯达克交易,代码为“ADGM”;最近的成交价格为 每股1.375美元,日期为2025年10月17日

Positive
  • None.
Negative
  • None.

Insights

Resale shelf updated; $19M private financing closed.

Adagio Medical updated its resale registration for up to 67,963,695 shares, including 12,146,988 issued shares, warrants for up to 9,098,727 shares, and notes convertible into up to 46,717,980 shares. This permits selling stockholders to sell over time, with actual activity depending on holder decisions.

Separately, the company announced closing a private placement with $19 million upfront. Management lists uses tied to FULCRUM‑VT submission activities and next‑generation ULTC catheter work, plus manufacturing and operations. This represents cash in from financing; resale transactions, if any, would be by holders.

Key items to track from disclosures include progress on FULCRUM‑VT and PMA submission milestones and any subsequent updates in future filings. Timing beyond the stated October 20, 2025 closing for the financing is not detailed in the excerpt.

Adagio Medical Holdings ha depositato un supplemento al prospetto per la rivendita di fino a 67.963.695 azioni ordinarie da parte degli azionisti venditori. La registrazione copre 12.146.988 azioni emesse, fino a 9.098.727 azioni da esercitare con warrant, e fino a 46.717.980 azioni da conversione di note, insieme ad altre azioni già emesse o da emettere dettagliate negli accordi sottostanti.

Il supplemento allega un Current Report on Form 8-K che segnala che la società ha annunciato la chiusura di un private placement con 19 milioni di dollari iniziali, con priorità dichiarate tra cui supporto per le attività di sottomissione FULCRUM‑VT PMA, sviluppo di un catetere ULTC di prossima generazione, aumento della capacità produttiva e operazioni societarie. Le azioni ordinarie di Adagio sono negoziate su Nasdaq come “ADGM”; l'ultimo prezzo di vendita riportato è stato 1,375 dollari per azione il 17 ottobre 2025.

Adagio Medical Holdings presentó un suplemento del prospecto para la reventa de hasta 67,963,695 acciones ordinarias por parte de accionistas vendedores. La registración cubre 12,146,988 acciones emitidas, hasta 9,098,727 acciones susceptibles de ser ejercidas mediante warrants y hasta 46,717,980 acciones susceptibles de conversión de notas, junto con otras acciones ya emitidas o susceptibles de emitir según los acuerdos subyacentes.

El suplemento adjunta un Current Report on Form 8‑K que señala que la empresa anunció el cierre de una colocación privada con 19 millones de dólares iniciales, con prioridades declaradas que incluyen apoyo para las actividades de presentación de PMA FULCRUM‑VT, desarrollo del catéter ULTC de próxima generación, escalado de la fabricación y operaciones corporativas. Las acciones ordinarias de Adagio cotizan en Nasdaq como “ADGM”; el último precio de venta reportado fue 1,375 dólares por acción el 17 de octubre de 2025.

Adagio Medical Holdings은 매도 주주들에 의한 일반주 67,963,695주 재판매를 위한 증권신고서 보충서를 제출했습니다. 등록은 발행 주식 12,146,988주, 워런트를 행사함으로써 발행 가능한 9,098,727주, 채권의 전환으로 발행 가능 46,717,980주를 포함하고, 기초 계약에 상세히 기재된 기타 이미 발행되었거나발행 가능주를 포함합니다.

보충서는 회사가 초기 1,900만 달러의 프라이빗 배치를 마쳤다고 공시하는 현행 Form 8-K 보고서를 첨부하고 있으며, 우선순위로 FULCRUM‑VT PMA 제출 활동 지원, 차세대 ULTC 카테터 개발, 제조 규모 확장 및 기업 운영을 포함하고 있습니다. Adagio의 일반주식은 나스닥에서 “ADGM”로 거래되며, 마지막으로 보고된 매매가는 2025년 10월 17일 주당 1.375달러였습니다.

Adagio Medical Holdings a déposé un supplément de prospectus en vue de la revente de jusqu'à 67 963 695 actions ordinaires par des actionnaires vendeurs. L'inscription couvre 12 146 988 actions émis, jusqu'à 9 098 727 actions susceptibles d'être émises lors de l'exercice de bons de souscription et jusqu'à 46 717 980 actions pouvant être émises lors de la conversion de notes, ainsi que d'autres actions déjà émise ou susceptibles d'être émises détaillées dans les accords sous-jacents.

Le supplément joint un Current Report on Form 8‑K indiquant que la société a annoncé la clôture d'une placement privé avec 19 millions de dollars initiaux, avec des priorités déclarées comprenant le soutien aux activités de soumission PMA FULCRUM‑VT, le développement d'un cathéter ULTC de nouvelle génération, l'augmentation de l'échelle de fabrication et les opérations corporatives. Les actions ordinaires d'Adagio se négocient sur le Nasdaq sous le symbole « ADGM » ; le dernier prix de vente signalé était 1,375 dollars par action le 17 octobre 2025.

Adagio Medical Holdings hat einen Prospekt-Supplement für den Weiterverkauf von bis zu 67.963.695 Aktien der Stammaktien eingereicht von verkaufswilligen Aktionären. Die Registrierung umfasst 12.146.988 ausgegebene Aktien, bis zu 9.098.727 Aktien, die durch Ausübung von Optionsscheinen ausgestellt werden können, und bis zu 46.717.980 Aktien, die durch Umwandlung von Anleihen ausgestellt werden können, zusammen mit anderen bereits ausgegebenen oder auszugebenden Aktien, die in den zugrunde liegenden Vereinbarungen detailliert aufgeführt sind.

Der Supplement fügt einen Current Report on Form 8‑K bei, in dem bekannt gegeben wird, dass das Unternehmen den Abschluss einer privaten Platzierung mit 19 Millionen USD im Voraus angekündigt hat, mit festgelegten Prioritäten, darunter Unterstützung für die FULCRUM‑VT PMA‑Einreichungsaktivitäten, die Entwicklung einer nächsten Generation des ULTC‑Katheters, die Skalierung der Fertigung und den Unternehmenseinsatz. Adagios Stammaktien werden an der Nasdaq als „ADGM“ gehandelt; der zuletzt gemeldete Verkaufspreis betrug 1,375 USD pro Aktie am 17. Oktober 2025.

 

Filed Pursuant to Rule 424(b)(3)

Registration No. 333-284266

PROSPECTUS SUPPLEMENT

To Prospectus dated February 7, 2025

 

Up to 12,146,988 Shares of Common Stock

Up to 9,098,727 Shares of Common Stock Issuable Upon Exercise of Warrants

Up to 46,717,980 Shares of Common Stock Issuable Upon Conversion of Notes

 

Adagio Medical Holdings, Inc.

 

This prospectus supplement updates and supplements the information contained in the prospectus dated February 7, 2025 (as may be supplemented or amended from time to time, the “Prospectus”), which forms part of our registration statement on Form S-1 (File No. 333-284266) with the information contained in our Current Report on Form 8-K that was filed with the Securities and Exchange Commission on October 20, 2025 (the “Current Report”). Accordingly, we have attached the Current Report to this prospectus supplement.

 

The Prospectus and this prospectus supplement relate to the offer, sale or other disposition from time to time of up to 67,963,695 shares of our common stock, $0.0001 par value per share (the “Common Stock”), by the selling stockholders named in the Prospectus or their permitted transferees (collectively, the “selling stockholders”), consisting of (i) up to 7,951,913 shares of Common Stock (excluding the shares of Common Stock underlying the PIPE Warrants (as defined below)) (the “PIPE Shares”) and 110,000 shares of Common Stock (the “Registration Delay Shares”) issued pursuant to the terms of the Convert Waivers (as defined below), (ii) up to 670,000 shares of Common Stock issuable upon exercise of pre-funded warrants to purchase shares (the “Pre-Funded Warrant Shares”) of Common Stock, with an exercise price of $0.01 per share (the “Pre-Funded Warrants”), (iii) up to 7,528,727 shares of Common Stock (the “PIPE Warrant Shares”) issuable upon exercise of warrants to purchase shares of Common Stock, with an exercise price of $10.00 per share (the “PIPE Warrants”), in each of cases (i) through (iii), issued pursuant to those certain amended and restated subscription agreements, dated July 31, 2024 (the “Subscription Agreements”), by and among us, ARYA Sciences Acquisition Corp IV, a Cayman Islands exempted company (“ARYA”), and certain selling stockholders named therein (the “PIPE Investors”) at an effective price of approximately $7.10 per PIPE Share and/or Pre-Funded Warrant, (iv) up to 46,717,980 shares of Common Stock (excluding the shares of Common Stock underlying the Convert Warrants (as defined below)) (the “Convertible Note Shares”) issuable upon the conversion of those certain 13% senior secured convertible notes, with a conversion price of $10.00 per share, subject to adjustment as provided in the Convertible Security Subscription Agreement (as defined below), (the “Convert Notes”), (v) up to 900,000 shares of Common Stock (the “Convert Warrant Shares”) issuable upon exercise of warrants to purchase shares of Common Stock, with an exercise price of $24.00 per share, subject to adjustment as provided in such warrants (the “Convert Warrants” and, together with the PIPE Warrants, the “Warrants”), in each of cases (iv) and (v), issued pursuant to that certain securities purchase agreement, dated February 13, 2024, by and among us and certain investors named therein (the “Convert Investors”), and any assignment thereunder (the “Convertible Security Subscription Agreement”), and that certain note purchase agreement, dated February 13, 2024, by and among us, Adagio Medical, Inc., a Delaware corporation, and Perceptive Life Sciences Master Fund, Ltd, a Cayman Islands exempted company (the “2024 Bridge Financing Note Subscription Agreement”), (vi) up to 2,354,100 shares issued to ARYA Sciences Holdings IV, a Cayman Islands exempted company (the “Sponsor”), consisting of 499,000 shares of Common Stock that were initially issued to Sponsor in a private placement as Class A ordinary shares of ARYA at a price of $10.00 per share and exchanged for shares of Common Stock at Closing (as defined below) (the “Sponsor Class A Conversion Shares”), 1,500,000 shares of Common Stock that were initially issued to Sponsor as Class B ordinary shares of ARYA at an effective price of approximately $0.007 per share and exchanged for shares of Common Stock at Closing (the “Sponsor Class B Conversion Shares”), and 355,100 shares of Common Stock that were originally issued to Sponsor as Class A ordinary shares of ARYA upon the conversion of certain convertible promissory notes issued by ARYA at an effective price of $10.00 per share and exchanged for shares of Common Stock at Closing (the “Sponsor Working Capital Shares”), (vii) up to 582,475 shares of Common Stock, consisting of 492,475 shares of Common Stock issued to certain of our affiliates as consideration in connection with the Business Combination (as defined below) at an equity consideration value of approximately $9.23 per share and 30,000 shares of Common Stock issued to each of Michael Henderson, Todd Wider and Leslie Trigg (collectively, the “Independent ARYA Directors”), which were originally issued as Class B ordinary shares of ARYA, valued at approximately $0.007 per share, (viii) up to 1,147,500 shares of Common Stock issuable to the Sponsor that are subject to share trigger price vesting and will vest if, prior to the tenth anniversary of the Closing, the post-Closing share price of Common Stock equals or exceeds $24.00 per share for any 20 trading days within any 30 trading day period (the “Share Trigger Price Vesting”), which were originally issued as Class B ordinary shares of ARYA, valued at approximately $0.007 per share and exchanged for shares of Common Stock at Closing; and (ix) 1,000 shares of Common Stock issuable upon exercise of certain stock options assumed by us in connection with the consummation of the Business Combination held by our Chief Operating Officer with an exercise price of $1.67 per share.

 

 

 

 

You should read this prospectus supplement in conjunction with the Prospectus. This prospectus supplement is qualified by reference to the Prospectus except to the extent that the information in this prospectus supplement supersedes the information contained in the Prospectus. This prospectus supplement is not complete without, and may not be delivered or utilized except in connection with, the Prospectus. If there is any inconsistency between the information in the Prospectus and this prospectus supplement, you should rely on the information in this prospectus supplement. Terms used in this prospectus supplement but not defined herein shall have the meanings given to such terms in the Prospectus.

 

Our Common Stock is listed on The Nasdaq Capital Market under the symbol “ADGM”. On October 17, 2025, the last reported sales price of our Common Stock was $1.375 per share.

 

We are an “emerging growth company” as defined under U.S. federal securities laws and, as such, have elected to comply with reduced public company reporting requirements. This prospectus complies with the requirements that apply to an issuer that is an emerging growth company.

 

Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described in the section titled “Risk Factors” beginning on page 15 of the prospectus, and under similar headings in any amendments or supplements to the prospectus.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy or adequacy of the prospectus. Any representation to the contrary is a criminal offense.

 

The date of this prospectus supplement is October 20, 2025.

 

 

 

 

 

 

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): October 20, 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

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

Symbol(s)

Name of each exchange

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 x

 

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 8.01 Other Events

 

On October 20, 2025, Adagio Medical Holdings, Inc. (the “Company”) issued a press release announcing the closing (the “Closing”) of its previously announced private placement, which was the subject of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission ("SEC") on October 14, 2025, reporting entry into a Securities Purchase Agreement with certain accredited investors. A copy of the press release announcing the Closing is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated October 20, 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: October 20, 2025

 

  Adagio Medical Holdings, Inc.
   
  By: /s/ Todd Usen
  Name: Todd Usen
  Title: Chief Executive Officer

 

3

 

 

Exhibit 99.1

 

Adagio Medical Closes Financing of $19 Million Upfront; Positions Company to Advance Purpose-Built Technology for Treatment of Ventricular Tachycardia

 

Proceeds Expected to Fund Ongoing Development and Submission Activities to Support FDA Evaluation of Company’s First and Next Generation Proprietary Ultralow Cryoablation Technologies

 

LAGUNA HILLS, CA, October 20, 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 the closing of its previously announced private placement (https://investors.adagiomedical.com/news-releases/news-release-details/adagio-medical-announces-pricing-50-million-private-placement), led by existing investors and new healthcare-dedicated institutional investors.

 

Adagio intends to deploy the net proceeds to:

 

·Support submission activities for its FULCRUM-VT pivotal clinical study for Premarket (PMA) approval of the vCLASTM ULTC System by the U.S. Food and Drug Administration (“FDA”)
·Advance clinical experience and FDA submission activities for the Company’s faster, smaller, more flexible next generation ULTC catheter
·Build awareness of ULTC and its many advantages as a purpose-built solution for VT patients and the ventricular anatomy
·Expand manufacturing and scale commercial-readiness
·Strengthen overall corporate operations

 

The Company anticipates that this infusion of capital will de-risk execution and extend the Company’s cash runway into key inflection points.

 

“Closing this financing on the heels of sharing the acute results from our FULCRUM-VT clinical study at the recent VT Symposium is further validation of the positive feedback we received both from the podium and the electrophysiologists in attendance. We have treated over 350 patients, including those from our two regulatory studies, combined with commercial and compassionate use cases, which supports the potential of our Ultra Low ablation technology for VT to improve clinical outcomes and safety. I want to thank our investors for their support and partnership.” said Todd Usen, CEO of Adagio Medical. “We believe we now have the financial flexibility to unlock the full potential of our portfolio of ULTC therapies to transform treatment for the large, underserved population of patients with ventricular tachycardia.”

 

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, which completed enrollment on October 1, 2025, of 208 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.

 

The Offering

 

The securities issued in connection with the private placement described above were offered in a private placement and have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdictions’ securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

 

This news release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

 

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 if the accompanying warrants are exercised in full; the Company’s intended use of the proceeds from the private placement; the period over which the Company estimates its cash runway will be sufficient to fund its future operating expenses and capital expenditure requirements; 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.

 

Contact

Debbie Kaster

Chief Financial Officer and Chief Business Officer

dkaster@adagiomedical.com

 

 

 

Adagio Medical

NASDAQ:ADGM

ADGM Rankings

ADGM Latest News

ADGM Latest SEC Filings

ADGM Stock Data

22.30M
5.46M
0.29%
87.46%
0.94%
Medical Devices
Surgical & Medical Instruments & Apparatus
Link
United States
LAGUNA HILLS