<ul>
<li><em>旨在幫助檢測缺血和複雜心律失常的可穿戴貼片設備</em></li>
<li><em>目標是一個 20 億美元的市場，已有報銷機制；缺血檢測有潛力顛覆目前僅限於心房顫動檢測的貼片市場</em></li>
</ul>
<p>加利福尼亞州聖克拉拉 --（商業資訊）-- <strong>HeartBeam, Inc.</strong>（納斯達克：BEAT），一家專注於通過提供強大的心臟洞察來轉變心臟護理的醫療科技公司，宣佈啓動一項針對疑似冠狀動脈疾病患者的創新按需 12 導聯心電圖貼片的試點研究。該研究在塞爾維亞貝爾格萊德的兩家領先醫院進行。試點研究的啓動標誌着 HeartBeam 貼片開發的重要一步，該貼片有潛力顛覆長期連續監測和移動心臟遙測（MCT）市場。</p>
<p>基於貼片的可穿戴心臟監測市場約為 20 億美元，並且已有報銷途徑。目前的可穿戴貼片心電圖監測儀僅限於一到三導聯，主要用於評估心律，而非缺血。因此，經歷間歇性胸痛或心臟症狀的患者在診所外往往無法在症狀發生時獲得臨牀級心電圖。</p>
<p>HeartBeam 的按需貼片目前仍在研究階段，尚未獲得 FDA 批准，旨在將這一能力擴展到醫療設施之外。該貼片設備是 HeartBeam 的信用卡大小設備的第二種形式，利用相同的專利 3D 心電圖技術，從三個非共面的維度捕捉心臟的電信號。HeartBeam 貼片持續記錄單導聯心電圖，並使患者能夠通過將兩個手指放在設備上按需啓動完整的合成 12 導聯心電圖記錄。這種方法旨在在傳統護理環境之外的症狀發生時為臨牀醫生提供高質量的心臟洞察。</p>
<p><em>要了解 HeartBeam 貼片的工作原理，</em> <em>請觀看此演示視頻</em> _。</p>
<p>試點研究將招募約 50 名高風險冠狀動脈疾病患者，他們的靜息心電圖未顯示缺血證據。每位參與者將接受運動負荷測試，這是一種用於識別缺血性變化的標準診斷程序。運動後，患者將激活 HeartBeam 貼片生成合成的 12 導聯心電圖，並與同一時間記錄的標準 12 導聯心電圖進行直接比較。結果將有助於指導公司對 HeartBeam 貼片的更廣泛監管策略。</p>
<p>“在基於貼片的可穿戴監測儀上，缺血檢測一直無法實現，並且它們在較長時間內無法提供臨牀級的洞察。HeartBeam 貼片旨在改變這一現狀，” HeartBeam 首席執行官 Robert Eno 表示。“能夠在症狀發生時——無論患者身在何處——生成按需 12 導聯心電圖的設備，可能會從根本上擴展可穿戴心臟監測的角色，不僅限於心律評估。進入一個已有報銷機制的 20 億美元市場本身就很有吸引力。增加缺血檢測作為一項能力使得機會顯著擴大。”</p>
<p>這項研究還支持 12 導聯心電圖貼片作為 HeartBeam 的核心增長計劃之一，此外還有針對心律失常評估的有限推出、未來心臟病檢測的適應症擴展以及其人工智能程序的推進。這些計劃共同反映了將臨牀級心臟評估擴展到傳統護理環境之外的更廣泛戰略。</p>
<p><strong>關於 HeartBeam, Inc.</strong></p>
<p>HeartBeam, Inc.（納斯達克：BEAT）是一家致力於轉變關鍵心臟病狀況檢測和監測的醫療科技公司。該公司開發了首個能夠從三個非共面方向收集 3D 心電圖信號並將其合成到 12 導聯心電圖的無電纜設備。這一平台技術旨在用於便攜式設備，可以在患者所在的任何地方提供可操作的心臟智能。醫生將能夠識別心臟健康趨勢和急性病症，並將患者引導至適當的護理——所有這些都在醫療設施之外，從而重新定義心臟健康管理的未來。HeartBeam 的 3D 心電圖技術於 2024 年 12 月獲得 FDA 對心律失常評估的批准，12 導聯心電圖合成軟件於 2025 年 12 月獲得 FDA 對心律失常評估的批准。該公司擁有超過 20 項與技術賦能相關的已授予專利。有關更多信息，請訪問 HeartBeam.com。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本公告中所有不基於歷史事實的聲明均為 “前瞻性聲明”。儘管管理層已根據當前預期對本公告中包含的任何前瞻性聲明進行了基礎，但這些預期所依據的信息可能會發生變化。前瞻性聲明涉及固有的風險和不確定性，這可能導致實際結果與前瞻性聲明中的結果存在重大差異，原因包括在我們的 10-K、10-Q 表格及其他向 SEC 提交的報告中描述的風險因素，以及管理層對財務狀況和運營結果的討論與分析部分。我們敦促您在評估我們的前瞻性聲明時考慮這些風險和不確定性。我們提醒讀者不要對任何此類前瞻性聲明過度依賴，這些聲明僅在作出時有效。除非聯邦證券法另有要求，否則我們不承擔公開發布任何前瞻性聲明（或其他地方）更新或修訂的義務，以反映我們對此的預期變化或任何此類聲明所依據的事件、條件或情況的變化。</p>
<p>1 <strong>已清除的使用指示</strong></p>
<p>HeartBeam 系統配備 12 導聯 ECG 合成軟件，已獲得 FDA 批准用於心律失常評估。有關其技術的預期用途的詳細信息，請參閲公司的已清除使用指示，網址為 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>媒體聯繫：</strong></p>
<p>media@heartbeam.com</p>
<p><strong>投資者關係聯繫：</strong></p>
<p>Chris Tyson</p>
<p>執行副總裁</p>
<p>MZ 北美</p>
<p>直線電話：949-491-8235</p>
<p>BEAT@mzgroup.us</p>
<p>www.mzgroup.us</p>
<p>來源：HeartBeam, Inc.</p>

BEAT

美國醫藥設備 ETF - iShares

標普健康醫療設備 ETF - SPDR

<p>HeartBeam, Inc.（納斯達克代碼：BEAT）已啓動一項針對其創新的按需 12 導聯心電圖貼片的試點研究，旨在檢測疑似冠狀動脈疾病患者的缺血情況。該研究在塞爾維亞進行，計劃招募約 50 名患者，並將貼片合成的心電圖與標準的 12 導聯心電圖進行比較。該設備利用專利的 3D 心電圖技術，旨在擴展心臟監測能力，超越節律評估，目標市場為 20 億美元，並已建立報銷途徑。HeartBeam 的首席執行官強調了這項技術在傳統環境之外轉變心臟護理的潛力</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>旨在幫助檢測缺血和複雜心律失常的可穿戴貼片設備</em></li>
<li><em>目標是一個 20 億美元的市場，已有報銷機制；缺血檢測有潛力顛覆目前僅限於心房顫動檢測的貼片市場</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>加利福尼亞州聖克拉拉 --（商業資訊）-- <strong>HeartBeam, Inc.</strong>（納斯達克：BEAT），一家專注於通過提供強大的心臟洞察來轉變心臟護理的醫療科技公司，宣佈啓動一項針對疑似冠狀動脈疾病患者的創新按需 12 導聯心電圖貼片的試點研究。該研究在塞爾維亞貝爾格萊德的兩家領先醫院進行。試點研究的啓動標誌着 HeartBeam 貼片開發的重要一步，該貼片有潛力顛覆長期連續監測和移動心臟遙測（MCT）市場。</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>基於貼片的可穿戴心臟監測市場約為 20 億美元，並且已有報銷途徑。目前的可穿戴貼片心電圖監測儀僅限於一到三導聯，主要用於評估心律，而非缺血。因此，經歷間歇性胸痛或心臟症狀的患者在診所外往往無法在症狀發生時獲得臨牀級心電圖。</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 的按需貼片目前仍在研究階段，尚未獲得 FDA 批准，旨在將這一能力擴展到醫療設施之外。該貼片設備是 HeartBeam 的信用卡大小設備的第二種形式，利用相同的專利 3D 心電圖技術，從三個非共面的維度捕捉心臟的電信號。HeartBeam 貼片持續記錄單導聯心電圖，並使患者能夠通過將兩個手指放在設備上按需啓動完整的合成 12 導聯心電圖記錄。這種方法旨在在傳統護理環境之外的症狀發生時為臨牀醫生提供高質量的心臟洞察。</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 貼片的工作原理，</em> <em>請觀看此演示視頻</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>試點研究將招募約 50 名高風險冠狀動脈疾病患者，他們的靜息心電圖未顯示缺血證據。每位參與者將接受運動負荷測試，這是一種用於識別缺血性變化的標準診斷程序。運動後，患者將激活 HeartBeam 貼片生成合成的 12 導聯心電圖，並與同一時間記錄的標準 12 導聯心電圖進行直接比較。結果將有助於指導公司對 HeartBeam 貼片的更廣泛監管策略。</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>“在基於貼片的可穿戴監測儀上，缺血檢測一直無法實現，並且它們在較長時間內無法提供臨牀級的洞察。HeartBeam 貼片旨在改變這一現狀，” HeartBeam 首席執行官 Robert Eno 表示。“能夠在症狀發生時——無論患者身在何處——生成按需 12 導聯心電圖的設備，可能會從根本上擴展可穿戴心臟監測的角色，不僅限於心律評估。進入一個已有報銷機制的 20 億美元市場本身就很有吸引力。增加缺血檢測作為一項能力使得機會顯著擴大。”</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>這項研究還支持 12 導聯心電圖貼片作為 HeartBeam 的核心增長計劃之一，此外還有針對心律失常評估的有限推出、未來心臟病檢測的適應症擴展以及其人工智能程序的推進。這些計劃共同反映了將臨牀級心臟評估擴展到傳統護理環境之外的更廣泛戰略。</p>
</div><p><strong>About HeartBeam, Inc.</strong></p>
<div class="lb-trans"><p><strong>關於 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.（納斯達克：BEAT）是一家致力於轉變關鍵心臟病狀況檢測和監測的醫療科技公司。該公司開發了首個能夠從三個非共面方向收集 3D 心電圖信號並將其合成到 12 導聯心電圖的無電纜設備。這一平台技術旨在用於便攜式設備，可以在患者所在的任何地方提供可操作的心臟智能。醫生將能夠識別心臟健康趨勢和急性病症，並將患者引導至適當的護理——所有這些都在醫療設施之外，從而重新定義心臟健康管理的未來。HeartBeam 的 3D 心電圖技術於 2024 年 12 月獲得 FDA 對心律失常評估的批准，12 導聯心電圖合成軟件於 2025 年 12 月獲得 FDA 對心律失常評估的批准。該公司擁有超過 20 項與技術賦能相關的已授予專利。有關更多信息，請訪問 HeartBeam.com。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</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>本公告中所有不基於歷史事實的聲明均為 “前瞻性聲明”。儘管管理層已根據當前預期對本公告中包含的任何前瞻性聲明進行了基礎，但這些預期所依據的信息可能會發生變化。前瞻性聲明涉及固有的風險和不確定性，這可能導致實際結果與前瞻性聲明中的結果存在重大差異，原因包括在我們的 10-K、10-Q 表格及其他向 SEC 提交的報告中描述的風險因素，以及管理層對財務狀況和運營結果的討論與分析部分。我們敦促您在評估我們的前瞻性聲明時考慮這些風險和不確定性。我們提醒讀者不要對任何此類前瞻性聲明過度依賴，這些聲明僅在作出時有效。除非聯邦證券法另有要求，否則我們不承擔公開發布任何前瞻性聲明（或其他地方）更新或修訂的義務，以反映我們對此的預期變化或任何此類聲明所依據的事件、條件或情況的變化。</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 系統配備 12 導聯 ECG 合成軟件，已獲得 FDA 批准用於心律失常評估。有關其技術的預期用途的詳細信息，請參閲公司的已清除使用指示，網址為 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>媒體聯繫：</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>投資者關係聯繫：</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>執行副總裁</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>直線電話：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>來源：HeartBeam, Inc.</p>
</div>

HeartBeam 啓動首個按需 12 導聯心電圖貼片的試點研究，以檢測診所外的缺血 | BEAT 股票新聞