<ul>
<li><em>旨在帮助检测缺血和复杂心律失常的可穿戴贴片设备</em></li>
<li><em>目标是一个 20 亿美元的市场，已有报销机制；缺血检测有潜力颠覆目前仅限于心房颤动检测的贴片市场</em></li>
</ul>
<p>加利福尼亚州圣克拉拉 --（商业资讯）-- <strong>HeartBeam, Inc.</strong>（纳斯达克：BEAT），一家专注于通过提供强大的心脏洞察来转变心脏护理的医疗科技公司，宣布启动一项针对疑似冠状动脉疾病患者的创新按需 12 导联心电图贴片的试点研究。该研究在塞尔维亚贝尔格莱德的两家领先医院进行。试点研究的启动标志着 HeartBeam 贴片开发的重要一步，该贴片有潜力颠覆长期连续监测和移动心脏遥测（MCT）市场。</p>
<p>基于贴片的可穿戴心脏监测市场约为 20 亿美元，并且已有报销途径。目前的可穿戴贴片心电图监测仪仅限于一到三导联，主要用于评估心律，而非缺血。因此，经历间歇性胸痛或心脏症状的患者在诊所外往往无法在症状发生时获得临床级心电图。</p>
<p>HeartBeam 的按需贴片目前仍在研究阶段，尚未获得 FDA 批准，旨在将这一能力扩展到医疗设施之外。该贴片设备是 HeartBeam 的信用卡大小设备的第二种形式，利用相同的专利 3D 心电图技术，从三个非共面的维度捕捉心脏的电信号。HeartBeam 贴片持续记录单导联心电图，并使患者能够通过将两个手指放在设备上按需启动完整的合成 12 导联心电图记录。这种方法旨在在传统护理环境之外的症状发生时为临床医生提供高质量的心脏洞察。</p>
<p><em>要了解 HeartBeam 贴片的工作原理，</em> <em>请观看此演示视频</em> _。</p>
<p>试点研究将招募约 50 名高风险冠状动脉疾病患者，他们的静息心电图未显示缺血证据。每位参与者将接受运动负荷测试，这是一种用于识别缺血性变化的标准诊断程序。运动后，患者将激活 HeartBeam 贴片生成合成的 12 导联心电图，并与同一时间记录的标准 12 导联心电图进行直接比较。结果将有助于指导公司对 HeartBeam 贴片的更广泛监管策略。</p>
<p>“在基于贴片的可穿戴监测仪上，缺血检测一直无法实现，并且它们在较长时间内无法提供临床级的洞察。HeartBeam 贴片旨在改变这一现状，” HeartBeam 首席执行官 Robert Eno 表示。“能够在症状发生时——无论患者身在何处——生成按需 12 导联心电图的设备，可能会从根本上扩展可穿戴心脏监测的角色，不仅限于心律评估。进入一个已有报销机制的 20 亿美元市场本身就很有吸引力。增加缺血检测作为一项能力使得机会显著扩大。”</p>
<p>这项研究还支持 12 导联心电图贴片作为 HeartBeam 的核心增长计划之一，此外还有针对心律失常评估的有限推出、未来心脏病检测的适应症扩展以及其人工智能程序的推进。这些计划共同反映了将临床级心脏评估扩展到传统护理环境之外的更广泛战略。</p>
<p><strong>关于 HeartBeam, Inc.</strong></p>
<p>HeartBeam, Inc.（纳斯达克：BEAT）是一家致力于转变关键心脏病状况检测和监测的医疗科技公司。该公司开发了首个能够从三个非共面方向收集 3D 心电图信号并将其合成到 12 导联心电图的无电缆设备。这一平台技术旨在用于便携式设备，可以在患者所在的任何地方提供可操作的心脏智能。医生将能够识别心脏健康趋势和急性病症，并将患者引导至适当的护理——所有这些都在医疗设施之外，从而重新定义心脏健康管理的未来。HeartBeam 的 3D 心电图技术于 2024 年 12 月获得 FDA 对心律失常评估的批准，12 导联心电图合成软件于 2025 年 12 月获得 FDA 对心律失常评估的批准。该公司拥有超过 20 项与技术赋能相关的已授予专利。有关更多信息，请访问 HeartBeam.com。</p>
<p><strong>前瞻性声明</strong></p>
<p>本公告中所有不基于历史事实的声明均为 “前瞻性声明”。尽管管理层已根据当前预期对本公告中包含的任何前瞻性声明进行了基础，但这些预期所依据的信息可能会发生变化。前瞻性声明涉及固有的风险和不确定性，这可能导致实际结果与前瞻性声明中的结果存在重大差异，原因包括在我们的 10-K、10-Q 表格及其他向 SEC 提交的报告中描述的风险因素，以及管理层对财务状况和运营结果的讨论与分析部分。我们敦促您在评估我们的前瞻性声明时考虑这些风险和不确定性。我们提醒读者不要对任何此类前瞻性声明过度依赖，这些声明仅在作出时有效。除非联邦证券法另有要求，否则我们不承担公开发布任何前瞻性声明（或其他地方）更新或修订的义务，以反映我们对此的预期变化或任何此类声明所依据的事件、条件或情况的变化。</p>
<p>1 <strong>已清除的使用指示</strong></p>
<p>HeartBeam 系统配备 12 导联 ECG 合成软件，已获得 FDA 批准用于心律失常评估。有关其技术的预期用途的详细信息，请参阅公司的已清除使用指示，网址为 https://www.heartbeam.com/indications。</p>
<p>MKT-144 v0</p>
<p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA1MTEyNjc5ODByMQ?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-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA1MTEyNjc5ODByMQ"/></p>
<p>在 businesswire.com 上查看源版本: https://www.businesswire.com/news/home/20260511267980/en/</p>
<p><strong>媒体联系：</strong></p>
<p>media@heartbeam.com</p>
<p><strong>投资者关系联系：</strong></p>
<p>Chris Tyson</p>
<p>执行副总裁</p>
<p>MZ 北美</p>
<p>直线电话：949-491-8235</p>
<p>BEAT@mzgroup.us</p>
<p>www.mzgroup.us</p>
<p>来源：HeartBeam, Inc.</p>

BEAT

美国医药设备 ETF - iShares

标普健康医疗设备 ETF - SPDR

<p>HeartBeam, Inc.（纳斯达克代码：BEAT）已启动一项针对其创新的按需 12 导联心电图贴片的试点研究，旨在检测疑似冠状动脉疾病患者的缺血情况。该研究在塞尔维亚进行，计划招募约 50 名患者，并将贴片合成的心电图与标准的 12 导联心电图进行比较。该设备利用专利的 3D 心电图技术，旨在扩展心脏监测能力，超越节律评估，目标市场为 20 亿美元，并已建立报销途径。HeartBeam 的首席执行官强调了这项技术在传统环境之外转变心脏护理的潜力</p>

<ul>
<li><em>Ambulatory patch device designed to aid in detecting ischemia and complex arrythmias</em></li>
<li><em>Targets a $2 billion market with established reimbursement; ischemia detection has potential to disrupt the patch market which is currently limited to atrial fibrillation detection</em></li>
</ul>
<div class="lb-trans"><ul>
<li><em>旨在帮助检测缺血和复杂心律失常的可穿戴贴片设备</em></li>
<li><em>目标是一个 20 亿美元的市场，已有报销机制；缺血检测有潜力颠覆目前仅限于心房颤动检测的贴片市场</em></li>
</ul>
</div><p>SANTA CLARA, Calif.--(BUSINESS WIRE)-- <strong>HeartBeam, Inc.</strong> (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, announced the initiation of a pilot study evaluating its novel on-demand 12-lead ECG patch in patients with suspected coronary artery disease. The study is being conducted at two leading hospitals in Belgrade, Serbia. The initiation of the pilot study represents a significant step in the development of the HeartBeam patch which has the potential to disrupt the long-term continuous monitor and mobile cardiac telemetry (MCT) markets.</p>
<div class="lb-trans"><p>加利福尼亚州圣克拉拉 --（商业资讯）-- <strong>HeartBeam, Inc.</strong>（纳斯达克：BEAT），一家专注于通过提供强大的心脏洞察来转变心脏护理的医疗科技公司，宣布启动一项针对疑似冠状动脉疾病患者的创新按需 12 导联心电图贴片的试点研究。该研究在塞尔维亚贝尔格莱德的两家领先医院进行。试点研究的启动标志着 HeartBeam 贴片开发的重要一步，该贴片有潜力颠覆长期连续监测和移动心脏遥测（MCT）市场。</p>
</div><p>Patch-based ambulatory cardiac monitoring represents an approximately $2 billion market with established reimbursement pathways. Today’s ambulatory patch ECG monitors are limited to one to three leads and are primarily designed to assess heart rhythms, not ischemia. As a result, patients experiencing intermittent chest pain or cardiac symptoms outside the clinic often cannot obtain a clinical-grade ECG at the moment symptoms occur.</p>
<div class="lb-trans"><p>基于贴片的可穿戴心脏监测市场约为 20 亿美元，并且已有报销途径。目前的可穿戴贴片心电图监测仪仅限于一到三导联，主要用于评估心律，而非缺血。因此，经历间歇性胸痛或心脏症状的患者在诊所外往往无法在症状发生时获得临床级心电图。</p>
</div><p>The HeartBeam on-demand patch, which is currently investigational and not yet FDA cleared, is designed to extend this capability beyond medical facilities. The patch device follows HeartBeam’s credit card-sized device as the second form factor and leverages the same patented 3D ECG technology that captures the heart’s electrical signals from 3 non-coplanar dimensions. The HeartBeam patch continuously records a single-lead ECG and enables patients to initiate a full synthesized 12-lead ECG recording on demand by placing two fingers on the device. This approach is intended to provide clinicians with high-quality cardiac insights when symptoms occur outside of traditional care settings.</p>
<div class="lb-trans"><p>HeartBeam 的按需贴片目前仍在研究阶段，尚未获得 FDA 批准，旨在将这一能力扩展到医疗设施之外。该贴片设备是 HeartBeam 的信用卡大小设备的第二种形式，利用相同的专利 3D 心电图技术，从三个非共面的维度捕捉心脏的电信号。HeartBeam 贴片持续记录单导联心电图，并使患者能够通过将两个手指放在设备上按需启动完整的合成 12 导联心电图记录。这种方法旨在在传统护理环境之外的症状发生时为临床医生提供高质量的心脏洞察。</p>
</div><p><em>To see how the HeartBeam patch works,</em> <em>watch this demo video</em> <em>.</em></p>
<div class="lb-trans"><p><em>要了解 HeartBeam 贴片的工作原理，</em> <em>请观看此演示视频</em> _。</p>
</div><p>The pilot study will enroll approximately 50 patients with a high risk of coronary artery disease whose resting ECGs show no evidence of ischemia. Each participant will undergo exercise stress testing, a standard diagnostic procedure used to identify ischemic changes. Immediately following exercise, patients will activate the HeartBeam patch to generate a synthesized 12-lead ECG, which will be compared directly with a standard 12-lead ECG recorded at the same time. The results will help inform the Company’s broader regulatory strategy for the HeartBeam patch.</p>
<div class="lb-trans"><p>试点研究将招募约 50 名高风险冠状动脉疾病患者，他们的静息心电图未显示缺血证据。每位参与者将接受运动负荷测试，这是一种用于识别缺血性变化的标准诊断程序。运动后，患者将激活 HeartBeam 贴片生成合成的 12 导联心电图，并与同一时间记录的标准 12 导联心电图进行直接比较。结果将有助于指导公司对 HeartBeam 贴片的更广泛监管策略。</p>
</div><p>&#34;Ischemia detection has not been possible on patch-based ambulatory monitors, and they do not provide clinical-grade insights over an extended period of time. The HeartBeam patch is designed to change that,&#34; said Robert Eno, Chief Executive Officer of HeartBeam. “A device capable of generating an on-demand 12-lead ECG at the moment symptoms occur — wherever the patient may be — could fundamentally expand the role of ambulatory cardiac monitoring beyond rhythm assessment alone. Entering a $2 billion market with established reimbursement is compelling on its own. Adding ischemia detection as a capability makes the opportunity significantly larger.”</p>
<div class="lb-trans"><p>“在基于贴片的可穿戴监测仪上，缺血检测一直无法实现，并且它们在较长时间内无法提供临床级的洞察。HeartBeam 贴片旨在改变这一现状，” HeartBeam 首席执行官 Robert Eno 表示。“能够在症状发生时——无论患者身在何处——生成按需 12 导联心电图的设备，可能会从根本上扩展可穿戴心脏监测的角色，不仅限于心律评估。进入一个已有报销机制的 20 亿美元市场本身就很有吸引力。增加缺血检测作为一项能力使得机会显著扩大。”</p>
</div><p>This study also supports the 12-lead ECG patch as one of HeartBeam’s core growth initiatives, along with the limited launch for arrhythmia assessment, future indication expansion for heart attack detection and advancement of its AI program. Together, the initiatives reflect a broader strategy to extend clinical-grade cardiac evaluation beyond traditional care settings.</p>
<div class="lb-trans"><p>这项研究还支持 12 导联心电图贴片作为 HeartBeam 的核心增长计划之一，此外还有针对心律失常评估的有限推出、未来心脏病检测的适应症扩展以及其人工智能程序的推进。这些计划共同反映了将临床级心脏评估扩展到传统护理环境之外的更广泛战略。</p>
</div><p><strong>About HeartBeam, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 HeartBeam, Inc.</strong></p>
</div><p>HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company has developed the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 20251. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.</p>
<div class="lb-trans"><p>HeartBeam, Inc.（纳斯达克：BEAT）是一家致力于转变关键心脏病状况检测和监测的医疗科技公司。该公司开发了首个能够从三个非共面方向收集 3D 心电图信号并将其合成到 12 导联心电图的无电缆设备。这一平台技术旨在用于便携式设备，可以在患者所在的任何地方提供可操作的心脏智能。医生将能够识别心脏健康趋势和急性病症，并将患者引导至适当的护理——所有这些都在医疗设施之外，从而重新定义心脏健康管理的未来。HeartBeam 的 3D 心电图技术于 2024 年 12 月获得 FDA 对心律失常评估的批准，12 导联心电图合成软件于 2025 年 12 月获得 FDA 对心律失常评估的批准。该公司拥有超过 20 项与技术赋能相关的已授予专利。有关更多信息，请访问 HeartBeam.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>All statements in this release that are not based on historical fact are &#34;forward-looking statements.&#34; While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.</p>
<div class="lb-trans"><p>本公告中所有不基于历史事实的声明均为 “前瞻性声明”。尽管管理层已根据当前预期对本公告中包含的任何前瞻性声明进行了基础，但这些预期所依据的信息可能会发生变化。前瞻性声明涉及固有的风险和不确定性，这可能导致实际结果与前瞻性声明中的结果存在重大差异，原因包括在我们的 10-K、10-Q 表格及其他向 SEC 提交的报告中描述的风险因素，以及管理层对财务状况和运营结果的讨论与分析部分。我们敦促您在评估我们的前瞻性声明时考虑这些风险和不确定性。我们提醒读者不要对任何此类前瞻性声明过度依赖，这些声明仅在作出时有效。除非联邦证券法另有要求，否则我们不承担公开发布任何前瞻性声明（或其他地方）更新或修订的义务，以反映我们对此的预期变化或任何此类声明所依据的事件、条件或情况的变化。</p>
</div><p>1 <strong>Cleared Indications for Use</strong></p>
<div class="lb-trans"><p>1 <strong>已清除的使用指示</strong></p>
</div><p>The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment. Refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.</p>
<div class="lb-trans"><p>HeartBeam 系统配备 12 导联 ECG 合成软件，已获得 FDA 批准用于心律失常评估。有关其技术的预期用途的详细信息，请参阅公司的已清除使用指示，网址为 https://www.heartbeam.com/indications。</p>
</div><p>MKT-144 v0</p>
<div class="lb-trans"><p>MKT-144 v0</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://cts.businesswire.com/ct/CT/query-ZGlzdHJvPW54JmlkPWJ3bmV3cyZsYW5nPWVuJnNpZD1hY3FyOCZzdHk9MjAyNjA1MTEyNjc5ODByMQ" alt="" original-src="https://cts.businesswire.com/ct/CT?id=bwnews&amp;sty=20260511267980r1&amp;sid=acqr8&amp;distro=nx&amp;lang=en"/></p>
<p>View source version on businesswire.com: https://www.businesswire.com/news/home/20260511267980/en/</p>
<div class="lb-trans"><p>在 businesswire.com 上查看源版本: https://www.businesswire.com/news/home/20260511267980/en/</p>
</div><p><strong>Media Contact:</strong></p>
<div class="lb-trans"><p><strong>媒体联系：</strong></p>
</div><p>media@heartbeam.com</p>
<div class="lb-trans"><p>media@heartbeam.com</p>
</div><p><strong>Investor Relations Contact:</strong></p>
<div class="lb-trans"><p><strong>投资者关系联系：</strong></p>
</div><p>Chris Tyson</p>
<div class="lb-trans"><p>Chris Tyson</p>
</div><p>Executive Vice President</p>
<div class="lb-trans"><p>执行副总裁</p>
</div><p>MZ North America</p>
<div class="lb-trans"><p>MZ 北美</p>
</div><p>Direct: 949-491-8235</p>
<div class="lb-trans"><p>直线电话：949-491-8235</p>
</div><p>BEAT@mzgroup.us</p>
<div class="lb-trans"><p>BEAT@mzgroup.us</p>
</div><p>www.mzgroup.us</p>
<div class="lb-trans"><p>www.mzgroup.us</p>
</div><p>Source: HeartBeam, Inc.</p>
<div class="lb-trans"><p>来源：HeartBeam, Inc.</p>
</div>

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