PARIS--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced the presentation of interim data supporting the role portable ultra-low-field MRI can play in acute stroke workup in a hospital emergency department setting..

巴黎--（商业新闻短讯）--Hyperfine，Inc.（纳斯达克：HYPR），一家开创性的健康技术公司，通过首个FDA批准的便携式磁共振（MR）脑成像系统重新定义了脑成像。Swoop®系统今天宣布提供临时数据，支持便携式超低场MRI在医院急诊科急性卒中检查中的作用。。

The findings from the study, titled Interim Analysis from Single Centre Observational Study of Ultra-Low Field Portable MRI in Acute Stroke Diagnostic Workup, were presented by Keith Muir, MD, of the University of Glasgow, during a scientific session at the 2024 European Society of Neuroradiology (ESNR) Annual Meeting..

格拉斯哥大学医学博士基思·缪尔（KeithMuir）在2024年欧洲神经放射学学会（ESNR）年会的一次科学会议上介绍了这项研究的结果，题为“超低场便携式MRI在急性卒中诊断检查中的单中心观察性研究的中期分析”。。

This study, which includes a subset of patients from phase one of the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) study, analyzed images from the ultra-low-field Swoop® MR brain imaging system to assess the system’s performance in acute care stroke workup as compared to the current standard of care.

这项研究包括前瞻性，国际性，多部位行动PMR（便携式MR急性缺血性卒中检测）研究第一阶段的一部分患者，分析了超低场Swoop®MR脑成像系统的图像，以评估与当前护理标准相比，该系统在急性护理卒中检查中的表现。

The analysis compared time-to-scan, diagnostic performance, specificity, and patient experience between ultra-low-field MRI, conventional MRI, and head CT..

该分析比较了超低场MRI，常规MRI和头部CT之间的扫描时间，诊断性能，特异性和患者体验。。

Key findings showed that the Swoop® system was dramatically faster than conventional MRI, with a median time-to-scan of 2.5 hours compared to 27.7 hours. The data also demonstrated reliability in acute stroke diagnosis with comparable diagnostic performance compared to head CT and good specificity when compared to routine clinical MRI (1.5T).

主要研究结果表明，Swoop®系统比传统MRI速度快得多，中位扫描时间为2.5小时，而27.7小时。与常规临床MRI（1.5T）相比，这些数据还证明了急性卒中诊断的可靠性，与头部CT相比具有相当的诊断性能，并且具有良好的特异性。

Further, nearly all patients reported a positive experience with the Swoop® system..

此外，几乎所有患者都报告了Swoop®系统的积极体验。。

The conclusion states, “This interim analysis demonstrates that the portable [ultra-low-field] MRI system is a promising tool for the acute stroke diagnostic workup in an emergency department setting. The improved time to imaging compared to routine MRI could facilitate quicker decision-making in acute stroke management.

结论指出：“这项中期分析表明，便携式[超低场]MRI系统是急诊科急性卒中诊断检查的一种有前途的工具。与常规MRI相比，成像时间的缩短可以促进急性卒中管理的更快决策。

Additionally, the high tolerance rate among patients underscores its potential usability in a clinical environment. The findings suggest that portable [ultra-low-field] MRI could enhance stroke diagnosis accessibility and efficiency, particularly in settings where conventional MRI availability is limited.”.

此外，患者的高耐受率强调了其在临床环境中的潜在可用性。研究结果表明，便携式[超低场]MRI可以提高中风诊断的可及性和效率，特别是在常规MRI可用性有限的环境中。”。

Dr. Edmond Knopp, Vice President of Medical Affairs at Hyperfine, commented, “Being at ESNR in Paris this year and showcasing our Swoop® system, we witnessed the growing interest and enthusiasm across the European neuroradiology community. This excitement was most notable when the attendees had the opportunity to see the system up close and personal.

Hyperfine医学事务副总裁Edmond Knopp博士评论道：“今年在巴黎的ESNR，我们展示了我们的Swoop®系统，我们见证了整个欧洲神经放射学界越来越大的兴趣和热情。当与会者有机会近距离亲眼看到该系统时，这种兴奋最为明显。

We were very pleased with Dr. Muir and his team’s participation in the ACTION PMR stroke study, and it was great to have Dr. Muir share exceptional data acquired during the study. Their findings highlight the potential of the Swoop® system’s clinical impact in improving stroke diagnosis and treatment.”.

我们对缪尔博士及其团队参与ACTION PMR中风研究感到非常高兴，很高兴缪尔博士分享了研究期间获得的异常数据。他们的研究结果突出了Swoop®系统在改善中风诊断和治疗方面的临床影响潜力。”。

For more information about the Swoop® Portable MR Imaging® system, please visit hyperfine.io.

有关Swoop®便携式MR Imaging®系统的更多信息，请访问hyperfine.io。

About the Swoop® Portable MR Imaging® System

关于Swoop®便携式MR成像®系统

The Swoop® Portable MR Imaging® system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical.

Swoop®便携式MR成像®系统已获得美国食品和药物管理局（FDA）的批准，可用于所有年龄段患者的脑部成像。。

When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets..

当由训练有素的医生解释时，这些图像提供的信息可用于确定诊断。Swoop®系统还拥有欧盟CE认证和英国UKCA认证。Swoop®系统可在多个国际市场上买到。。

About Hyperfine, Inc.

关于Hyperfine，Inc。

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc.

。Hyperfine公司的使命。

is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care.

是通过变革性的，可访问的，临床相关的诊断成像在全球范围内彻底改变患者护理。由Jonathan Rothberg博士在一个名为4Catalyzer的科技孵化器中创建，Hyperfine，Inc.的科学家、工程师和物理学家出于对重新定义大脑成像方法以及临床医生如何将可访问的诊断成像应用于患者护理的热情，开发了Swoop®系统。

For more information, visit hyperfine.io..

有关更多信息，请访问hyperfine.io。。

Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

Hyperfine、Swoop和便携式MR成像是Hyperfine，Inc.的注册商标。

Forward-Looking Statements

前瞻性声明

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events.

本新闻稿包括1995年《私人证券诉讼改革法案》中“安全港”条款所指的“前瞻性声明”。Hyperfine，Inc.（以下简称“公司”）的实际业绩可能与其预期、估计和预测不同，因此，您不应将这些前瞻性陈述视为对未来事件的预测。

Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements.

诸如“预期”、“估计”、“项目”、“预算”、“预测”、“预期”、“打算”、“计划”、“可能”、“会”、“可能”、“应该”、“相信”、“预测”、“潜在”、“继续”等词语以及类似表达（或此类词语或表达的负面版本）旨在识别此类前瞻性陈述。

These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results.

这些前瞻性陈述包括但不限于公司的目标和商业计划，公司产品和服务的益处，公司未来的业绩及其实施战略的能力。这些前瞻性陈述涉及重大风险和不确定性，可能导致实际结果与预期结果产生重大差异。

Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company’s business; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the .

这些因素大多不在公司控制范围内，难以预测。可能导致这种差异的因素包括但不限于：公司产品开发和商业化活动的成功、成本和时间安排，包括Swoop®系统被医疗保健专业人员接受和使用的程度；新型冠状病毒肺炎对公司业务的影响；；公司无法盈利增长和管理增长，无法留住关键员工；适用法律法规的变更；公司未来无法筹集资金；的。