<p>该前瞻性研究旨在评估增强对比超低场便携式 MRI 的可行性和可视化益处，以支持 FDA 510(k) 申请。</p>
<p>康涅狄格州吉尔福德 --（商业资讯）--Hyperfine, Inc.（纳斯达克：HYPR），这家开创性的健康科技公司通过首个获得 FDA 批准的 AI 驱动便携式脑部 MRI 系统——Swoop®系统，重新定义了脑部成像，今天宣布在对比 PMR 研究中招募了首位患者。这是一项前瞻性的多中心临床研究，旨在评估增强对比超低场便携式 MRI 的可行性和可视化益处。该研究旨在支持未来向 FDA 提交申请，以扩展 Swoop®系统的预期用途，包括钆基对比剂，可能会在多个护理环境中解锁新的应用。</p>
<p>该研究的主要目标是评估使用对比剂与超低场便携式 MRI 对脑部病变的可视化，包括与血脑屏障破坏相关的病变。可视化益处将通过与病变外观相关的三个终点进行评估。该研究将在美国多个地点招募约 70 名患者。</p>
<p>“便携式 MRI 已经改变了我们中心成像脑部的方式和地点，结合使用对比剂是一个自然的下一步，” 基督母弗朗西斯医院研究中心的首席医疗官 Mark Anderson 博士表示。“增强对比的 MRI 对于评估许多神经疾病非常重要，我们期待参与这项研究，以评估使用 Swoop®系统进行的增强对比成像。这可能进一步扩展 Swoop®系统的实用性，并改变我们诊断和监测脑部疾病的方式。”</p>
<p>“在超低场强度下看到对比剂是 Swoop®系统实用性的一个令人兴奋的扩展机会。使用钆基对比剂的能力可能增强其临床实用性，特别是在常用对比剂的情况下，例如脑肿瘤、疑似脓肿和多发性硬化等炎症性疾病。随着对比 PMR 研究的招募，我们预计将在 2026 年底向 FDA 提交指示扩展申请，” Hyperfine 的首席运营官 Tom Teisseyre 博士表示。</p>
<p>有关该研究的更多详细信息，请访问 ClinicalTrials.gov（NCT07296263）。</p>
<p>有关 Swoop®系统的更多信息，请访问 HyperfineMRI.com。</p>
<p><strong>关于 Swoop®便携式 MRI 系统</strong></p>
<p>Swoop®便携式 MR 成像系统已获得美国食品和药物管理局（FDA）批准，用于各年龄段患者的脑部成像。它们是便携式的超低场磁共振成像设备，用于生成显示头部内部结构的图像，在临床上无法进行全面诊断检查时使用。当经过训练的医生解读这些图像时，它们提供的信息可能对确定诊断有用。</p>
<p><strong>关于 Hyperfine, Inc.</strong></p>
<p>Hyperfine, Inc.（纳斯达克：HYPR）是一家开创性的健康科技公司，通过 Swoop®系统重新定义了脑部成像——这是首个获得 FDA 批准的便携式超低场磁共振脑成像系统，能够在多个专业护理点提供成像。Hyperfine, Inc.的使命是通过变革性的、可及的、临床相关的诊断成像在全球范围内彻底改变患者护理。Hyperfine, Inc.由 Jonathan Rothberg 博士在一个名为 4Catalyzer 的技术孵化器中创立，Hyperfine, Inc.的科学家、工程师和物理学家出于重新定义脑成像方法及临床医生如何将可及的诊断成像应用于患者护理的热情，开发了 Swoop®系统。有关更多信息，请访问 HyperfineMRI.com。</p>
<p>Hyperfine 标志、Swoop 和便携式 MR 成像是 Hyperfine, Inc.的注册商标。Swoop 标志、Optive AI 标志和 Optive AI 是 Hyperfine, Inc.的商标。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含根据 1995 年《私人证券诉讼改革法案》的 “安全港” 条款定义的 “前瞻性声明”。Hyperfine, Inc.（“公司”）的实际结果可能与其预期、估计和预测有所不同，因此，您不应将这些前瞻性声明视为未来事件的预测。诸如 “期望”、“估计”、“项目”、“预算”、“预测”、“预期”、“打算”、“计划”、“可能”、“将”、“能够”、“应该”、“相信”、“预测”、“潜在”、“继续” 等词汇（或这些词汇或表达的否定形式）旨在识别此类前瞻性声明。这些前瞻性声明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，以及公司的未来表现及其实施战略的能力。这些前瞻性声明涉及重大风险和不确定性，可能导致实际结果与预期结果存在重大差异。这些因素大多数超出公司的控制范围，且难以预测。可能导致此类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®_系统被医疗专业人士接受和使用的程度；COVID-19 对公司业务的影响；无法维持公司 A 类普通股在纳斯达克的上市；公司无法盈利地增长和管理增长并留住关键员工；适用法律或法规的变化；公司未来无法筹集资金；公司无法获得和维持其产品的监管许可或批准，以及任何已获批准产品的相关限制和条件；公司无法识别、许可或收购额外技术；公司无法维持现有或未来的许可、制造、供应和分销协议，并获得其产品的充足供应；公司无法与其他目前正在营销或开发公司当前营销或开发的产品和服务的公司竞争；公司产品和服务市场的规模和增长潜力，以及其单独或与他人合作服务这些市场的能力；公司产品和服务的定价及使用公司产品和服务进行的医疗程序的报销；公司对费用、收入、资本需求和额外融资需求的估计；公司的财务表现；以及公司在向证券交易委员会提交的文件中不时指出的其他风险和不确定性，包括 “风险因素” 下的内容。公司提醒读者，以上因素列表并不详尽，读者不应对任何前瞻性声明过度依赖，这些声明仅在发布之日有效。公司不承担或接受任何义务或承诺，公开发布任何前瞻性声明的更新或修订，以反映其预期的任何变化或任何此类声明所基于的事件、条件或情况的变化。</p>
<p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjAxMTUyMDc5NTZyMQ?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjAxMTUyMDc5NTZyMQ"/></p>
<p>在 businesswire.com 查看源版本：https://www.businesswire.com/news/home/20260115207956/en/</p>
<p><strong>媒体联系人</strong></p>
<p>德文·泽尔</p>
<p>Hyperfine</p>
<p>dzell@hyperfine.io</p>
<p><strong>投资者联系人</strong></p>
<p>韦布·坎贝尔</p>
<p>Gilmartin Group LLC</p>
<p>webb@gilmartinir.com</p>
<p>来源：Hyperfine, Inc.</p>

HYPR

<p>Hyperfine, Inc.（纳斯达克代码：HYPR）宣布其对比 PMR 研究的首位患者已入组，该研究旨在评估对比增强超低场便携式 MRI 的可行性。该研究旨在支持向 FDA 提交申请，以扩大 Swoop®系统的使用范围，包括钆基对比剂，从而增强其在神经疾病诊断中的实用性。预计将在美国多个地点招募约 70 名患者，研究结果预计将在 2026 年底之前为未来的临床应用提供信息</p>

<p><em>The prospective study is designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI to support an FDA 510(k) submission.</em></p>
<div class="lb-trans"><p>该前瞻性研究旨在评估增强对比超低场便携式 MRI 的可行性和可视化益处，以支持 FDA 510(k) 申请。</p>
</div><p>GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the enrollment of the first patient in the Contrast PMR study, a prospective, multi-center clinical study designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI. The study is intended to support a future FDA submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents, potentially unlocking new applications across multiple care settings.</p>
<div class="lb-trans"><p>康涅狄格州吉尔福德 --（商业资讯）--Hyperfine, Inc.（纳斯达克：HYPR），这家开创性的健康科技公司通过首个获得 FDA 批准的 AI 驱动便携式脑部 MRI 系统——Swoop®系统，重新定义了脑部成像，今天宣布在对比 PMR 研究中招募了首位患者。这是一项前瞻性的多中心临床研究，旨在评估增强对比超低场便携式 MRI 的可行性和可视化益处。该研究旨在支持未来向 FDA 提交申请，以扩展 Swoop®系统的预期用途，包括钆基对比剂，可能会在多个护理环境中解锁新的应用。</p>
</div><p>The primary objective of the study is to evaluate the visualization of brain lesions, including lesions associated with blood-brain barrier disruption, using contrast agents with ultra-low-field portable MRI. Visualization benefits will be assessed using three endpoints related to lesion appearance. The study will enroll approximately 70 patients across multiple sites in the United States.</p>
<div class="lb-trans"><p>该研究的主要目标是评估使用对比剂与超低场便携式 MRI 对脑部病变的可视化，包括与血脑屏障破坏相关的病变。可视化益处将通过与病变外观相关的三个终点进行评估。该研究将在美国多个地点招募约 70 名患者。</p>
</div><p>“Portable MRI has already changed how and where we image the brain at our center, and incorporating the use of contrast is a natural next step,” said Mark Anderson, MD, Chief Medical Officer at the CHRISTUS Mother Frances Hospital study site. “Contrast-enhanced MRI is important for evaluating many neurological conditions, and we are looking forward to participating in this study to assess contrast-enhanced imaging with the Swoop® system. This could further expand Swoop® system utility and transform how we diagnose and monitor brain conditions.”</p>
<div class="lb-trans"><p>“便携式 MRI 已经改变了我们中心成像脑部的方式和地点，结合使用对比剂是一个自然的下一步，” 基督母弗朗西斯医院研究中心的首席医疗官 Mark Anderson 博士表示。“增强对比的 MRI 对于评估许多神经疾病非常重要，我们期待参与这项研究，以评估使用 Swoop®系统进行的增强对比成像。这可能进一步扩展 Swoop®系统的实用性，并改变我们诊断和监测脑部疾病的方式。”</p>
</div><p>“Seeing contrast at ultra-low field strengths is an exciting expansion opportunity for the utility of the Swoop® system. The ability to use gadolinium-based contrast agents could enhance its clinical utility, particularly in cases where contrast is commonly used, such as brain tumors, suspected abscesses, and inflammatory conditions like multiple sclerosis. With the Contrast PMR study enrolling, we anticipate submission to the FDA for indication expansion towards the end of 2026,” said Tom Teisseyre, PhD, Chief Operating Officer at Hyperfine.</p>
<div class="lb-trans"><p>“在超低场强度下看到对比剂是 Swoop®系统实用性的一个令人兴奋的扩展机会。使用钆基对比剂的能力可能增强其临床实用性，特别是在常用对比剂的情况下，例如脑肿瘤、疑似脓肿和多发性硬化等炎症性疾病。随着对比 PMR 研究的招募，我们预计将在 2026 年底向 FDA 提交指示扩展申请，” Hyperfine 的首席运营官 Tom Teisseyre 博士表示。</p>
</div><p>Additional details about the study are available at ClinicalTrials.gov (NCT07296263).</p>
<div class="lb-trans"><p>有关该研究的更多详细信息，请访问 ClinicalTrials.gov（NCT07296263）。</p>
</div><p>For more information about the Swoop® system, please visit HyperfineMRI.com.</p>
<div class="lb-trans"><p>有关 Swoop®系统的更多信息，请访问 HyperfineMRI.com。</p>
</div><p><strong>About the Swoop® Portable MRI Systems</strong></p>
<div class="lb-trans"><p><strong>关于 Swoop®便携式 MRI 系统</strong></p>
</div><p>The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.</p>
<div class="lb-trans"><p>Swoop®便携式 MR 成像系统已获得美国食品和药物管理局（FDA）批准，用于各年龄段患者的脑部成像。它们是便携式的超低场磁共振成像设备，用于生成显示头部内部结构的图像，在临床上无法进行全面诊断检查时使用。当经过训练的医生解读这些图像时，它们提供的信息可能对确定诊断有用。</p>
</div><p><strong>About Hyperfine, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Hyperfine, Inc.</strong></p>
</div><p>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. 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. For more information, visit HyperfineMRI.com.</p>
<div class="lb-trans"><p>Hyperfine, Inc.（纳斯达克：HYPR）是一家开创性的健康科技公司，通过 Swoop®系统重新定义了脑部成像——这是首个获得 FDA 批准的便携式超低场磁共振脑成像系统，能够在多个专业护理点提供成像。Hyperfine, Inc.的使命是通过变革性的、可及的、临床相关的诊断成像在全球范围内彻底改变患者护理。Hyperfine, Inc.由 Jonathan Rothberg 博士在一个名为 4Catalyzer 的技术孵化器中创立，Hyperfine, Inc.的科学家、工程师和物理学家出于重新定义脑成像方法及临床医生如何将可及的诊断成像应用于患者护理的热情，开发了 Swoop®系统。有关更多信息，请访问 HyperfineMRI.com。</p>
</div><p>The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc.</p>
<div class="lb-trans"><p>Hyperfine 标志、Swoop 和便携式 MR 成像是 Hyperfine, Inc.的注册商标。Swoop 标志、Optive AI 标志和 Optive AI 是 Hyperfine, Inc.的商标。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>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. 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. 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. 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 <em>Swoop®</em> 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 inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.</p>
<div class="lb-trans"><p>本新闻稿包含根据 1995 年《私人证券诉讼改革法案》的 “安全港” 条款定义的 “前瞻性声明”。Hyperfine, Inc.（“公司”）的实际结果可能与其预期、估计和预测有所不同，因此，您不应将这些前瞻性声明视为未来事件的预测。诸如 “期望”、“估计”、“项目”、“预算”、“预测”、“预期”、“打算”、“计划”、“可能”、“将”、“能够”、“应该”、“相信”、“预测”、“潜在”、“继续” 等词汇（或这些词汇或表达的否定形式）旨在识别此类前瞻性声明。这些前瞻性声明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，以及公司的未来表现及其实施战略的能力。这些前瞻性声明涉及重大风险和不确定性，可能导致实际结果与预期结果存在重大差异。这些因素大多数超出公司的控制范围，且难以预测。可能导致此类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®_系统被医疗专业人士接受和使用的程度；COVID-19 对公司业务的影响；无法维持公司 A 类普通股在纳斯达克的上市；公司无法盈利地增长和管理增长并留住关键员工；适用法律或法规的变化；公司未来无法筹集资金；公司无法获得和维持其产品的监管许可或批准，以及任何已获批准产品的相关限制和条件；公司无法识别、许可或收购额外技术；公司无法维持现有或未来的许可、制造、供应和分销协议，并获得其产品的充足供应；公司无法与其他目前正在营销或开发公司当前营销或开发的产品和服务的公司竞争；公司产品和服务市场的规模和增长潜力，以及其单独或与他人合作服务这些市场的能力；公司产品和服务的定价及使用公司产品和服务进行的医疗程序的报销；公司对费用、收入、资本需求和额外融资需求的估计；公司的财务表现；以及公司在向证券交易委员会提交的文件中不时指出的其他风险和不确定性，包括 “风险因素” 下的内容。公司提醒读者，以上因素列表并不详尽，读者不应对任何前瞻性声明过度依赖，这些声明仅在发布之日有效。公司不承担或接受任何义务或承诺，公开发布任何前瞻性声明的更新或修订，以反映其预期的任何变化或任何此类声明所基于的事件、条件或情况的变化。</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjAxMTUyMDc5NTZyMQ" alt="" original-src="https://cts.businesswire.com/ct/CT?id=bwnews&amp;sty=20260115207956r1&amp;sid=acqr8&amp;distro=nx&amp;lang=en"/></p>
<p>View source version on businesswire.com: https://www.businesswire.com/news/home/20260115207956/en/</p>
<div class="lb-trans"><p>在 businesswire.com 查看源版本：https://www.businesswire.com/news/home/20260115207956/en/</p>
</div><p><strong>Media Contact</strong></p>
<div class="lb-trans"><p><strong>媒体联系人</strong></p>
</div><p>Devin Zell</p>
<div class="lb-trans"><p>德文·泽尔</p>
</div><p>Hyperfine</p>
<div class="lb-trans"><p>Hyperfine</p>
</div><p>dzell@hyperfine.io</p>
<div class="lb-trans"><p>dzell@hyperfine.io</p>
</div><p><strong>Investor Contact</strong></p>
<div class="lb-trans"><p><strong>投资者联系人</strong></p>
</div><p>Webb Campbell</p>
<div class="lb-trans"><p>韦布·坎贝尔</p>
</div><p>Gilmartin Group LLC</p>
<div class="lb-trans"><p>Gilmartin Group LLC</p>
</div><p>webb@gilmartinir.com</p>
<div class="lb-trans"><p>webb@gilmartinir.com</p>
</div><p>Source: Hyperfine, Inc.</p>
<div class="lb-trans"><p>来源：Hyperfine, Inc.</p>
</div>

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