LAGUNA HILLS, Calif., March 25, 2024 /PRNewswire/ -- Adagio Medical, Inc., a leading innovator in catheter ablation technologies for ventricular tachycardia ('VT') and atrial fibrillation ('AF'), today announced CE Mark approval of its ultra-low temperature cryoablation ('ULTC') system for the treatment of monomorphic ventricular tachycardia.

加利福尼亚州拉古纳山（LAGUNA HILLS），2024年3月25日/PRNewswire/--Adagio Medical，Inc.，室性心动过速（VT）和心房颤动（AF）导管消融技术的领先创新者，今天宣布CE Mark批准其用于治疗单形性室性心动过速的超低温冷冻消融（ULTC）系统。

The system consists of the upgraded cryoablation console, also capable of supporting atrial ablation procedures using commercially available iCLAS™ catheters, and the vCLAS™ ventricular cryoablation catheter ('vCLAS'). The system will be featured at the upcoming conference of the European Heart Rhythm Association ('EHRA') in Berlin on April 7-9, 2024 and will become immediately available for clinical use in select European centers..

该系统由升级的冷冻消融控制台（也能够使用市售的iCLAS™导管支持心房消融程序）和vCLAS™心室冷冻消融导管（“vCLAS”）组成。该系统将于2024年4月7日至9日在柏林举行的欧洲心律协会（EHRA）会议上展出，并将立即在选定的欧洲中心用于临床。。

Unlike conventional radiofrequency ('RF') catheters commonly used for both ventricular and atrial procedures, the 9Fr, bi-directional deflectable vCLAS catheter was designed specifically to address the challenges of VT ablations. It features a 15-millimeter long ULTC ablation element, capable of creating lesions with titratable width and depth exceeding 10 millimeters, making it time- and effort-efficient across the range of purely endocardial ablation strategies in patients with both ischemic and non-ischemic cardiomyopathies,1 including those with otherwise challenging mid-myocardial scarring.2 The use of cryogenic energy and associated cryoadhesion ensures catheter stability during ablation while the absence of catheter irrigation simplifies the hemodynamic management of patients who often present with symptoms of clinical heart failure..

与通常用于心室和心房手术的常规射频（“RF”）导管不同，9Fr双向可偏转vCLAS导管专门设计用于解决VT消融的挑战。它具有一个15毫米长的ULTC消融元件，能够产生可滴定宽度和深度超过10毫米的病变，使其在缺血性和非缺血性心肌病患者的纯心内膜消融策略范围内具有时间和精力效率，1包括那些在其他方面具有挑战性的心肌瘢痕形成的患者。2使用低温能量和相关的低温粘附可以确保消融过程中导管的稳定性，而没有导管冲洗可以简化经常出现临床心力衰竭症状的患者的血流动力学管理。。

'We are encouraged by the commercial availability of the dedicated VT ablation system in our European centers, as it shows promise for patients with ventricular arrhythmias,' said Professor Dr. KR Julian Chun of Cardiovascular Center Bethanien ('CCB') in Frankfurt, Germany. 'The current VT ablation practice has evolved around generic catheter tools available to the clinicians, with all associated trade-offs, limiting, to an extent, how broadly we offer ablations to a rather sick patient population with structural heart disease,' added Professor Dr.

德国法兰克福Bethanien心血管中心（CCB）的KR Julian Chun教授说：“我们对欧洲中心专用VT消融系统的商业可用性感到鼓舞，因为它为室性心律失常患者带来了希望。”目前的VT消融实践已经围绕临床医生可用的通用导管工具发展，并进行了所有相关的权衡，在一定程度上限制了我们为患有结构性心脏病的相当患病的患者群体提供消融的范围。

Boris Schmidt, an Electrophysiologist at CCB. 'We now have the opportunity to thoroughly evaluate Adagio's ULTC technology in both routine clinical practice and post-market studies to see the impact it will have on our patient selection, procedural approaches and outcomes.'.

中国建设银行的电生理学家鲍里斯·施密特说我们现在有机会在常规临床实践和上市后研究中彻底评估Adagio的ULTC技术，以了解它对我们的患者选择，程序方法和结果的影响。”。

CE Mark approval for the vCLAS catheter has been granted based on the results of the Cryocure-VT trial, which enrolled patients with monomorphic VT of both ischemic and non-ischemic origin at nine European and Canadian centers. The early acute results of the trial were published in the Journal of American College of Cardiology: Clinical Electrophysiology in 20231, and the full results inclusive of six months follow-up will be presented on April 8, 2024 at EHRA's Late-Breaking Clinical Science session by Dr.

根据Cryocure VT试验的结果，已经批准了vCLAS导管的CE标志批准，该试验在九个欧洲和加拿大中心招募了缺血性和非缺血性起源的单形性VT患者。该试验的早期急性结果于20231年发表在《美国心脏病学会杂志：临床电生理学》上，包括六个月随访在内的全部结果将于2024年4月8日在EHRA最新的临床科学会议上由Dr。

Atul Verma, MD, the Director of the Division of Cardiology at McGill University Health Centre..

麦吉尔大学健康中心心脏病学系主任Atul Verma医学博士。。

'We believe that the unique features and performance of ULTC will advance the field of VT ablations with outcomes warranting expansion of patient eligibility and earlier intervention,' said Olav Bergheim, President and CEO of Adagio Medical, Inc. 'Adagio is highly committed to the VT space, with the Cryocure-VT trial and CE Mark approval of vCLAS catheter being the first steps of the journey.

Adagio Medical，Inc.总裁兼首席执行官Olav Bergheim说：“我们相信，ULTC的独特功能和性能将推动VT消融领域的发展，其结果有助于扩大患者资格和早期干预。”Adagio高度致力于VT领域，Cryocure VT试验和vCLAS导管的CE标志批准是旅程的第一步。

Additional US studies are either ongoing or in planning. We are grateful to the Cryocure-VT investigators and are looking forward to engaging the European Electrophysiology community to maximize the potential of ULTC technology and patient benefit in VT ablations'. .

美国的其他研究正在进行中或正在计划中。我们感谢Cryocure VT研究人员，并期待着欧洲电生理学界的参与，以最大限度地发挥ULTC技术的潜力和患者在VT消融中的益处。。

1De Potter T, Balt J, Boersma L, Sacher F, et al. First-In-Human Experience with Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. J Am Coll Cardiol EP 2023;9:686-61

1De Potter T，Balt J，Boersma L，Sacher F等。首次在人体内使用超低温冷冻消融治疗单形性室性心动过速。J Am Coll Cardiol EP 2023；9： 686-61年

2 Dilk P, Darma A, Hindricks G, Dinov B. Ultra-low-temperature cryoablation for ventricular tachycardia in nonischemic cardiomyopathy – a case report. Heart Rhythm Case Reports 2023;9:469-472

2 Dilk P，Darma A，Hindricks G，Dinov B.超低温冷冻消融治疗非缺血性心肌病室性心动过速-病例报告。心律病例报告2023；9： 469-472

About Adagio Medical, Inc.

关于Adagio Medical，Inc。

Adagio Medical, Inc. is a privately held company located in Laguna Hills, California developing innovative cryoablation technologies that create contiguous, transmural lesions to treat cardiac arrhythmias, including paroxysmal and persistent atrial fibrillation, atrial flutter, and ventricular tachycardia. .

Adagio Medical，Inc.是一家位于加利福尼亚州拉古纳山（Laguna Hills）的私营公司，开发创新的冷冻消融技术，可产生连续的透壁病变，以治疗心律失常，包括阵发性和持续性心房颤动，心房扑动和室性心动过速。。

Forward-Looking Statements

前瞻性声明

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 ARYA, Adagio Medical, Inc.

根据1995年《美国私人证券诉讼改革法案》的“安全港”规定，本新闻稿（“本新闻稿”）中的某些声明可能被视为“前瞻性声明”。前瞻性陈述通常与ARYA，Adagio Medical，Inc.的未来事件或未来财务或经营业绩有关。

('Adagio Medical') or Aja Holdco, Inc. (the 'Combined Company'). For example, any statements that refer to expectations, projections or other characterizations of future events or circumstances, including the commercialization of new products, the timing and scope thereof, the fully diluted equity value following the proposed business combination (the 'transaction'), the anticipated enterprise value of the Combined Company, expected ownership in the Combined Company, projections of market opportunity and market share, the capability of Adagio Medical's or the Combined Company's business plans including its plans to expand, the sources and uses of cash from the proposed transaction, any benefits of Adagio Medical's partnerships, strategies or plans as they relate to the proposed transaction, anticipated benefits of the proposed transaction and expectations related to the terms and timing of the proposed transaction, Adagio Medical's expected pro forma cash, Adagio Medical's or the Combined Company's expected cash runway through 2025 or statements related to Adagio Medical's or the Combined Company's funding gap, funded business plan or use of proceeds, or other metrics or statements derived therefrom, are forward-looking statements.

（“Adagio Medical”）或Aja Holdco，Inc.（“合并公司”）。例如，任何涉及未来事件或情况的预期、预测或其他特征的报表，包括新产品的商业化、时间和范围、拟议企业合并（“交易”）后完全稀释的股权价值、合并公司的预期企业价值、合并公司的预期所有权、市场机会和市场份额的预测、Adagio Medical或合并公司的业务计划（包括其扩张计划）的能力、拟议交易的现金来源和使用、Adagio Medical合伙企业的任何收益、与拟议交易相关的战略或计划、拟议交易的预期收益以及与拟议交易的条款和时间相关的预期。Adagio Medical预计的形式现金，Adagio Medical或合并公司到2025年的预期现金跑道或与Adagio Medical或合并公司的资金缺口、资助商业计划或收益使用相关的报表，或由此产生的其他指标或报表，均为前瞻性报表。

In some cases, you can identify forward-looking statements by terminology such as 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'future,' 'intend.

在某些情况下，您可以通过“预期”、“相信”、“继续”、“可能”、“估计”、“预期”、“预测”、“未来”、“打算”等术语来识别前瞻性陈述。

No Offer or Solicitation

无要约或招揽

This press release does not constitute (i) a solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction or (ii) an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any securities of ARYA, Adagio Medical or the Combined Company, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

本新闻稿不构成（i）就任何证券或潜在交易征求代理、同意或授权，或（ii）出售要约、购买要约或购买ARYA、Adagio Medical或合并公司任何证券的建议，也不构成在根据该州或司法管辖区的证券法注册或取得资格之前，在任何州或司法管辖区内出售任何此类证券的行为，在该州或司法管辖区内，此类要约、征求或出售将是非法的。

No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act, or an exemption therefrom..

除非通过符合《证券法》第10节要求的招股说明书或豁免的方式，否则不得进行证券要约。。

Important Additional Information Regarding the Transaction Will Be Filed With the SEC

有关交易的重要附加信息将提交给SEC

In connection with the proposed transaction, the Combined Company intends to file with the SEC a Registration Statement on Form S-4 (the 'Registration Statement') containing a preliminary proxy statement of ARYA and a preliminary prospectus of the Combined Company, and after the Registration Statement is declared effective, ARYA expects to mail a definitive proxy statement/prospectus related to the proposed transaction to its shareholders.

就拟议交易而言，合并公司打算向美国证券交易委员会提交一份S-4表格的登记声明（“登记声明”），其中包含ARYA的初步代理声明和合并公司的初步招股说明书，在登记声明宣布生效后，ARYA预计将向其股东邮寄一份与拟议交易相关的最终代理声明/招股说明书。

The proxy statement/prospectus will contain important information about the proposed transaction and the other matters to be voted upon at ARYA's shareholder meeting to be held to approve the proposed transaction. ARYA and the Combined Company may also file other documents with the SEC regarding the proposed transaction. This Press Release does not contain all the information that should be considered concerning the proposed transaction and is not intended to form the basis of any investment decision or any other decision in respect of the proposed transaction. Before making any voting or other investment decisions, shareholders of ARYA and other interested persons are advised to read, when available, the preliminary proxy statement/prospectus and any amendments thereto, the definitive proxy statement/prospectus and other documents filed in connection with the proposed transaction, as these materials will contain important information about ARYA, Adagio Medical and the proposed transaction. After the Registration Statement becomes effective, the definitive proxy statement/prospectus and other relevant materials for the proposed transaction will be mailed to shareholders of ARYA as of a record date to be established for voting on the proposed transaction.

委托书/招股说明书将包含有关拟议交易的重要信息以及将在雅利雅股东大会上投票批准拟议交易的其他事项。ARYA和合并公司也可以向SEC提交有关拟议交易的其他文件。本新闻稿不包含应考虑的与拟议交易有关的所有信息，也不打算构成任何投资决策或与拟议交易有关的任何其他决策的基础。在做出任何投票或其他投资决定之前，建议雅利雅股东和其他利益相关者阅读初步委托书/招股说明书及其任何修正案、最终委托书/招股说明书以及与拟议交易相关的其他文件，因为这些材料将包含有关雅利雅、Adagio Medical和拟议交易的重要信息。登记声明生效后，拟议交易的最终委托书/招股说明书和其他相关材料将在拟议交易投票的记录日期邮寄给雅利雅股东。

Shareholders will also be able to obtain copies of the definitive proxy statement.

股东还可以获得最终委托书的副本。

INVESTMENT IN ANY SECURITIES DESCRIBED HEREIN HAS NOT BEEN APPROVED OR DISAPPROVED BY THE SEC OR ANY OTHER REGULATORY AUTHORITY NOR HAS ANY AUTHORITY PASSED UPON OR ENDORSED THE MERITS OF THE OFFERING OR THE ACCURACY OR ADEQUACY OF THE INFORMATION CONTAINED HEREIN. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE..

证券交易委员会（SEC）或任何其他监管机构均未批准或不批准对本文所述任何证券的投资，也未通过或认可本次发行的优点或本文所含信息的准确性或充分性。任何相反的陈述都是刑事犯罪。。

Participants in the Solicitation

征集参与者

ARYA and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from ARYA's shareholders with respect to the proposed transaction. A list of the names of ARYA's directors and executive officers and a description of their interests in ARYA is contained in ARYA's Annual Report on Form 10-K, which was filed with the SEC and is available free of charge at the SEC's web site at www.sec.gov, or by directing a request to ARYA Sciences Acquisition Corp IV, 51 Astor Place, 10th Floor, New York, New York, Attention: Secretary.

雅利雅及其各自的董事和执行官可能被视为雅利雅股东就拟议交易征集代理人的参与者。雅利雅董事和执行官的名单及其在雅利雅的利益描述载于雅利雅年度报告中的表格10-K，该表格已提交给美国证券交易委员会，可在美国证券交易委员会的网站www.SEC.gov上免费获得，也可向雅利雅科学收购公司IV提出请求，地址：纽约州纽约市阿斯特广场51号10楼，收件人：秘书。

Additional information regarding the interests of such participants will be contained in the proxy statement/prospectus for the proposed transaction when available. Investors, security holders and other interested persons of ARYA, Adagio Medical and the Combined Company are urged to carefully read in their entirety the proxy statement/prospectus and other relevant documents that will be filed with the SEC, when they become available, because they will contain important information about the proposed transaction. Also see above under the heading 'Important Additional Information Regarding the Transaction Will Be Filed With the SEC.'.

有关此类参与者利益的其他信息将包含在拟议交易的委托书/招股说明书中（如果可用）。敦促ARYA、Adagio Medical和合并公司的投资者、证券持有人和其他利益相关者仔细阅读委托书/招股说明书和其他相关文件，这些文件将在可用时提交给SEC，因为它们将包含有关拟议交易的重要信息。另见上文标题“有关交易的重要附加信息将提交给SEC”。

Adagio Medical and the Combined Company, and their directors and executive officers may also be deemed to be participants in the solicitation of proxies from the shareholders of ARYA in connection with the proposed transaction. A list of the names of such directors and executive officers and information regarding their interests in the proposed transaction will be included in the proxy statement/prospectus for the proposed transaction when available..

Adagio Medical和合并公司及其董事和执行官也可能被视为与拟议交易有关的雅利雅股东委托书征集的参与者。该等董事和执行官的名单以及有关其在拟议交易中的权益的信息将包含在拟议交易的委托书/招股说明书中（如有）。。

Please note that Adagio Medical's website and social media accounts, including but not limited on X(formerly known as Twitter) or LinkedIn, as well as any other information contained on, or that can be accessed through, its website or social media channels described below, are not deemed to be incorporated by reference in, and are not considered part of, this Press Release..

请注意，Adagio Medical的网站和社交媒体账户，包括但不限于X（以前称为Twitter）或LinkedIn，以及包含在其网站或社交媒体渠道上或可以通过其网站或社交媒体渠道访问的任何其他信息，不被视为通过引用纳入本新闻稿，也不被视为本新闻稿的一部分。。

Follow Adagio Medical, Inc. on:

关注Adagio Medical，Inc.：

X: @AdagioMedical

十： @慢板医学

LinkedIn: www.linkedin.com/company/adagio-medical-inc-/

LinkedIn：www.LinkedIn.com/company/adagio-medical-inc-/

Related Links

相关链接

https://adagiomedical.com

https://adagiomedical.com

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