Adagio Medical Provides Business Updates
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), a leader in catheter ablation technologies for cardiac arrhythmias, has provided a business update highlighting significant milestones. The company has obtained CE Mark approval and initiated the commercial launch of its vCLAS™ catheter and ultra-low temperature cryoablation (ULTC) system for ventricular tachycardia (VT) treatment in Europe. Additionally, Adagio has received FDA approval for the FULCRUM-VT Pivotal IDE study in the US, with patient enrollment expected to begin in September.
The company recently closed a business combination with ARYA Sciences Acquisition Corp IV, resulting in its listing on the Nasdaq Capital Market under the ticker symbol 'ADGM'. This transaction, along with concurrent financings, raised approximately $84.2 million, leaving the company with a proforma cash-on-hand of about $35 million after closing.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), un leader nelle tecnologie di ablazione con catetere per le aritmie cardiache, ha fornito un aggiornamento aziendale evidenziando importanti traguardi. L'azienda ha ottenuto l'approvazione CE e ha avviato il lancio commerciale del suo catetere vCLAS™ e del sistema di crioablazione a bassa temperatura (ULTC) per il trattamento della tachicardia ventricolare (VT) in Europa. Inoltre, Adagio ha ricevuto l'approvazione della FDA per lo studio FULCRUM-VT Pivotal IDE negli Stati Uniti, con l'iscrizione dei pazienti prevista per settembre.
L'azienda ha recentemente concluso una combinazione aziendale con ARYA Sciences Acquisition Corp IV, risultando nella sua quotazione sul Nasdaq Capital Market con il simbolo 'ADGM'. Questa transazione, insieme ai finanziamenti concomitanti, ha raccolto circa $84,2 milioni, lasciando all'azienda un cash-on-hand proforma di circa $35 milioni dopo la chiusura.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), un líder en tecnologías de ablación con catéter para arritmias cardíacas, ha proporcionado una actualización comercial destacando hitos significativos. La compañía ha conseguido la aprobación CE e iniciado el lanzamiento comercial de su catéter vCLAS™ y del sistema de crioablación a temperaturas ultra-bajas (ULTC) para el tratamiento de la taquicardia ventricular (VT) en Europa. Además, Adagio ha recibido la aprobación de la FDA para el estudio FULCRUM-VT Pivotal IDE en Estados Unidos, con la inscripción de pacientes programada para comenzar en septiembre.
La compañía recientemente cerró una combinación de negocios con ARYA Sciences Acquisition Corp IV, resultando en su cotización en el Nasdaq Capital Market bajo el símbolo 'ADGM'. Esta transacción, junto con financiamientos concomitantes, recaudó aproximadamente $84.2 millones, dejando a la empresa con un efectivo proforma de alrededor de $35 millones después del cierre.
아다지오 메디컬 홀딩스, 주식 코드(Nasdaq: ADGM)는 심장 부정맥을 위한 카테터 절제술 기술의 선두 기업으로, 중요한 이정표를 강조하는 사업 업데이트를 제공했습니다. 회사는 CE 마크 승인을 획득하고 유럽에서 심실 빈맥(VT) 치료를 위한 vCLAS™ 카테터 및 초저온 냉동 절제(ULTC) 시스템의 상업적 출시를 시작했습니다. 또한, 아다지오는 미국의 FULCRUM-VT 피보탈 IDE 연구에 대한 FDA 승인을 받았습니다며, 환자 등록은 9월에 시작될 예정입니다.
회사는 최근 ARYA Sciences Acquisition Corp IV와의 사업 결합을 마무리하고 'ADGM'이라는 기호 아래 Nasdaq 자본 시장에 상장되었습니다. 이 거래는 동시에 진행된 자금 조달과 함께 약 $84.2백만을 모금했으며, 거래 종료 후 약 $35백만의 현금을 보유하고 있습니다.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), un leader dans les technologies d'ablation par cathéter pour les arythmies cardiaques, a fourni une mise à jour commerciale mettant en évidence des étapes importantes. L'entreprise a obtenu l'approbation CE et a lancé commercialement son cathéter vCLAS™ et son système de cryo-ablation à très basse température (ULTC) pour le traitement de la tachycardie ventriculaire (VT) en Europe. De plus, Adagio a reçu l'approbation de la FDA pour l'étude FULCRUM-VT Pivotal IDE aux États-Unis, avec un début d'inscription des patients prévu pour septembre.
L'entreprise a récemment conclu une combinaison d'affaires avec ARYA Sciences Acquisition Corp IV, ce qui a conduit à sa cotation sur le Nasdaq Capital Market sous le symbole 'ADGM'. Cette transaction, avec des financements concomitants, a rapporté environ 84,2 millions USD, laissant l'entreprise avec un cash-on-hand pro forma d'environ 35 millions USD après la clôture.
Adagio Medical Holdings, Inc. (Nasdaq: ADGM), ein führendes Unternehmen im Bereich der Katheterablationstechnologien für Herzrhythmusstörungen, hat ein Geschäftswachstum präsentiert, das bedeutende Meilensteine hervorhebt. Das Unternehmen hat die CE-Kennzeichnung erhalten und den kommerziellen Start seines vCLAS™ Katheters und des Ultra-Low-Temperature Cryoablation (ULTC) Systems zur Behandlung von ventrikulärer Tachykardie (VT) in Europa eingeleitet. Darüber hinaus hat Adagio die FDA-Zulassung für die FULCRUM-VT Pivotal IDE-Studie in den USA erhalten, wobei die Patienteneinschreibung im September beginnen soll.
Das Unternehmen hat kürzlich eine Geschäftskombination mit ARYA Sciences Acquisition Corp IV abgeschlossen, was zu seiner Listung im Nasdaq Capital Market unter dem Tickersymbol 'ADGM' geführt hat. Diese Transaktion, zusammen mit parallelen Finanzierungen, brachte etwa 84,2 Millionen USD ein, was dem Unternehmen nach dem Abschluss einen pro forma Bargeldbestand von etwa 35 Millionen USD lässt.
- Obtained CE Mark approval for vCLAS™ catheter and ULTC system for VT treatment in Europe
- Received FDA approval for FULCRUM-VT Pivotal IDE study in the US
- Closed business combination and listed on Nasdaq Capital Market under ticker 'ADGM'
- Raised approximately $84.2 million through business combination and concurrent financings
- Proforma cash-on-hand of $35 million after closing
- Approximately $13.1 million in transaction costs related to the business combination closing
Insights
The business update from Adagio Medical Holdings presents a mixed financial picture. While the company has achieved significant milestones, including CE Mark approval and FDA approval for a pivotal study, the financial implications are not entirely clear. The
Adagio Medical's ultra-low temperature cryoablation (ULTC) technology for ventricular tachycardia (VT) treatment shows promising potential. The CE Mark approval and initiation of commercial launch in Europe are significant milestones. The positive feedback from physicians and the publication of clinical data in EP Europace lend credibility to the technology. The upcoming FULCRUM-VT Pivotal IDE Study, with its large sample size of 206 patients across 20 centers, will be important in determining the safety and effectiveness of the VT Cryoablation System. The involvement of renowned investigators like Dr. Roderick Tung and Dr. Atul Verma adds weight to the study. However, investors should note that the full results and potential FDA approval are still some time away, with patient enrollment expected to start in September.
Adagio Medical is positioning itself in a niche market with significant unmet needs. The company's focus on innovation in VT ablation addresses the "underinvestment" and "pent-up demand" in this area, as mentioned by CEO Olav Bergheim. The positive reception from physicians and initial commercial cases in Europe suggest potential market acceptance. However, the true market potential remains uncertain without specific sales figures or market size estimates. The company's success will depend on its ability to demonstrate superior clinical outcomes and cost-effectiveness compared to existing treatments. The upcoming FULCRUM-VT study will be critical in this regard. Investors should also consider potential competitors and the overall growth trajectory of the VT treatment market when evaluating Adagio's long-term prospects.
Recent Business Highlights:
- Obtained CE Mark approval and initiated commercial launch of the vCLAS™ catheter and ultra-low temperature cryoablation (ULTC) system for treatment of ventricular tachycardia (VT) into select European markets
- Presented CRYOCURE-VT trial data at European Heart Rhythm Association and Heart Rhythm Society annual meetings with results published in EP Europace journal
-
Obtained the
U.S. Food and Drug Administration (“FDA”) approval for the FULCRUM-VT Pivotal IDE study - Closed business combination and PIPE financing and listed the Company’s common stock on The Nasdaq Capital Market
“For years there has been underinvestment in and pent-up demand for innovation in ablation catheter technology for patients with VT,” said Olav Bergheim, Chief Executive Officer of Adagio Medical. “Adagio’s proprietary ULTC platform holds the promise to solve a number of unique technical and clinical challenges which make VT ablations complex and time-consuming, resulting in underutilization of this potentially life-altering therapeutic procedure. We’ve received consistent, positive feedback from physicians regarding our published clinical data, and we are seeing a similar reception in the initial commercial cases in
FULCRUM-VT Pivotal IDE Study is a prospective, multi-center, open label, single-arm study which will evaluate safety and effectiveness of Adagio Medical VT Cryoablation System in patients with sustained monomorphic VT due to structural heart disease of both ischemic and non-ischemic origin. The study will enroll 206 patients at twenty US and Canadian centers, with Roderick Tung (Banner University Medical Center Phoenix,
Business Combination
As previously announced, on July 31, the Company closed its business combination with ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD; or “ARYA”), a special purpose acquisition company sponsored by an affiliate of Perceptive Advisors, LLC. The shares of common stock of the Company commenced trading under the ticker symbol “ADGM” on the Nasdaq Capital Market on August 1, 2024.
In conjunction with the consummation of the Business Combination with ARYA, the combined company raised approximately
About Adagio Medical
Adagio Medical is an early commercial stage medical device company located in
Forward-Looking Statements
Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of the Company. For example, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of the Company and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by the Company and its management, are inherently uncertain. The Company cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the Business Combination, which was filed by the Company with the SEC, and described in other documents filed by the Company from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. The Company cannot assure you that the forward-looking statements in this communication will prove to be accurate.
Nothing in this Press Release should be regarded as a representation or warranty by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved, in any specified time frame, or at all. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made in this Press Release. Subsequent events and developments may cause those views to change. The Company does not undertake any duty to update these forward-looking statements.
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Media
Ilya Grigorov
Vice President, Global Marketing and Product Management
Adagio Medical, Inc.
igrigorov@adagiomedical.com
Investor
IR@adagiomedical.com
Source: Adagio Medical Holdings, Inc.
FAQ
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