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HeartBeam Announces Positive Data From Two Studies at Prestigious American Heart Association Conference

HeartBeam Announces Positive Data From Two Studies at Prestigious American Heart Association Conference

HeartBeam在美國心臟協會會議上宣佈了兩項研究的積極數據
HeartBeam ·  11/19 21:31

HeartBeam Announces Positive Data from Two Studies at Prestigious American Heart Association Conference

HeartBeam在美國心臟協會大會上宣佈兩項研究的積極數據

November 19, 2024 8:31am EST Download as PDF
2024年11月19日 8:31am ESt 下載爲PDF
  • The studies further strengthen HeartBeam's body of clinical evidence for its portable, cable-free, credit card-sized device that is designed to be capable of synthesizing a 12-lead ECG
  • The first study is a pilot study demonstrating similar performance of HeartBeam's vector-based ambulatory technology to standard 12-lead ECGs for arrhythmia detection
  • The second study is a feasibility study highlighting the potential of HeartBeam's technology with a novel risk-score assessment algorithm to evaluate chest pain remotely and reduce delays in care for patients experiencing a heart attack
  • 這些研究進一步加強了HeartBeam的臨床證據庫,該公司設計的便攜式、無線電纜、信用卡大小的設備旨在能夠合成12導聯心電圖。
  • 第一項研究是一項試點研究,展示了HeartBeam基於矢量的運動技術與標準12導聯心電圖在心律失常檢測方面表現相似。
  • 第二項研究是一個可行性研究,突出了HeartBeam技術potential,通過一種新穎的風險評分評估算法,遠程評估胸痛症狀,縮短心臟病發作患者等待治療的時間。

SANTA CLARA, Calif.--(BUSINESS WIRE)--HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights wherever the patient is, announced the results from two studies evaluating HeartBeam's groundbreaking vector-based technology. The data add to the body of clinical evidence for the Company's key clinical indications, specifically arrhythmia and heart attack (myocardial infarction) detection, and showcase the technology's pivotal role in advancing patient care for these clinical indications. The studies were presented during the American Heart Association's annual Scientific Sessions in Chicago, November 16-18, 2024.

加利福尼亞州聖克拉拉--(業務資訊)--HeartBeam公司(納斯達克:BEAT)是一家醫療科技公司,致力於通過在患者所在的任何地方提供強大的心臟洞察來改變心臟護理。該公司宣佈了兩項評估HeartBeam突破性向量技術的研究結果。這些數據增添了公司關鍵醫療指徵的臨床證據,尤其是在心律失常和心臟病發作(心肌梗死)檢測方面,並展示了該技術在推進這些臨床指徵下患者護理中的關鍵作用。這些研究在2024年11月16日至18日舉行的美國心臟協會年會科學會議上進行介紹。

HeartBeam's vector-based technology captures the heart's electrical signals from three dimensions. The Company's first application of its groundbreaking technology is a cable-free, credit card-sized device that is designed to be capable of synthesizing a 12-lead electrocardiogram (ECG). The small size makes it convenient for patients to always have the device with them, ready to record an ECG whenever they feel symptoms to minimize delays in care. The HeartBeam system is currently under review with the FDA.

HeartBeam的基於矢量的技術可以從三個維度捕捉心臟的電信號。該公司的首次應用其開創性技術是一個無線電纜、信用卡大小的設備,旨在能夠合成12導心電圖。小巧的尺寸使患者可以隨身攜帶該設備,隨時準備記錄心電圖,以最大程度減少治療的延遲。HeartBeam系統目前正在接受FDA審查。

"The data presentations at AHA are a testament to HeartBeam's dedication to building a robust body of clinical evidence to support our groundbreaking technology as we strive to make it easier for patients and physicians to monitor cardiac symptoms and seek timely diagnosis outside of a healthcare facility," said Robert Eno, Chief Executive Officer, HeartBeam. "We thank our physician collaborators for their commitment to evaluating the value our technology can bring in different clinical situations and transform how cardiac conditions are managed in the future."

「在AHA的數據展示證明了HeartBeam致力於建立強大的臨床證據庫,以支持我們的開創性技術。我們努力使患者和醫生能夠在醫療機構之外監測心臟症狀,並及時尋求診斷。」HeartBeam首席執行官羅伯特·伊諾(Robert Eno)表示:「我們感謝我們的醫生合作伙伴們評估我們的技術在不同臨床情境中帶來的價值,並改變未來的心臟疾病管理方式。」

The first presentation by Thomas Deering, MD, FACC, FHRS, Chief of Arrhythmia Center, Piedmont Healthcare in Atlanta, GA, highlighted results from an 80-patient pilot study, which evaluated the performance of HeartBeam's synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The study found excellent agreement when physicians diagnosed various arrhythmias utilizing the HeartBeam synthesized 12-lead ECG compared to a standard 12-lead ECG (Sensitivity: 94%, Specificity: 100%). Arrhythmias evaluated include sinus rhythm, atrial fibrillation, atrial flutter, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC). This study is a precursor to the Company's pivotal study, VALID-ECG, which completed enrollment in June. VALID-ECG will support the clinical equivalence basis for the synthesized 12-lead ECG software in the Company's next FDA submission.

亞特蘭大皮德蒙特醫療中心心律失常中心主任、醫學博士、心臟病學會院士、心臟電生理會學會士Thomas Deering博士首次演示了一項80名患者試點研究的結果,該研究評估了HeartBeam合成的12導聯心電圖波形相對於同時收集的標準12導聯心電圖用於心律失常檢測的性能。該研究發現,與標準12導聯心電圖相比,醫生使用HeartBeam合成的12導聯心電圖診斷各種心律失常時存在極佳的一致性(敏感性:94%,特異性:100%)。評估的心律失常包括竇性心律、房顫、房撲動以及伴有室早或房早的竇性心律。該研究是該公司關鍵研究VALID-ECG的前期研究,VALID-ECG在6月已完成招募。VALID-ECG將支持該公司合成12導聯心電圖軟件在下一次FDA提交中的臨床等效性基礎。

"One of the main challenges with timely assessment of arrhythmias is that a single-lead ECG does not contain complete diagnostic information, and at the same time, obtaining a standard 12-lead ECG is highly impractical outside of a medical setting," commented Dr. Deering. "Our study showed that the synthesized 12-lead ECG obtained from the HeartBeam device is similar to a 12-lead ECG, allowing patients to easily obtain the highest fidelity ECG data wherever they are upon symptom onset and greatly reduce any potential delays in receiving care."

「及時評估心律失常的主要挑戰之一是,單導聯心電圖不包含完整的診斷信息,與此同時,在非醫療環境下獲取標準12導聯心電圖非常不切實際,」Deering博士評論道。「我們的研究表明,從HeartBeam設備獲得的合成12導聯心電圖類似於12導聯心電圖,使患者能夠輕鬆獲取最高保真度的心電圖數據,無論症狀發生在哪裏,並極大減少接受治療可能存在的任何延誤。」

A second study presented by Alexei Shvilkin, MD, PhD, Clinical Cardiac Electrophysiologist, Beth Israel Deaconess Medical Center in Boston, MA, evaluated the feasibility of calculating an acute coronary syndrome (ACS) risk score for assessment of chest pain using the Company's proprietary algorithm. This algorithm has the potential to shorten the time between when heart attack symptoms begin and when patients arrive at a medical facility, which is essential for improving outcomes. The study found HeartBeam's algorithm accurately detected ACS and matched the assessment of expert Emergency Department physicians who typically rely on standard 12-lead ECGs for ACS assessment. This data builds on the previously published JACC: Advances study, which demonstrated that HeartBeam's technology is comparable to 12-lead ECGs in identifying coronary occlusions. The latest findings reinforce the potential of the Company's technology to facilitate evaluation of patient's chest pain symptoms outside of a medical facility to reduce delays in care.

波士頓貝斯以色列骨科醫學中心臨床心臟電生理學博士、醫學博士Alexei Shvilkin博士介紹了第二項研究,評估了使用公司專有算法計算急性冠狀動脈綜合徵(ACS)風險評分,用於評估胸痛的可行性。該算法有潛力縮短心梗症狀開始和患者到醫療機構抵達之間的時間,這對改善治療結果至關重要。該研究發現,HeartBeam的算法準確檢測到ACS,並與緊急科專家醫生的評估相匹配,這些醫生通常依賴標準12導聯心電圖進行ACS評估。這些數據進一步證明了該公司技術的潛力,能夠在醫療設施之外評估患者胸痛症狀,以減少就醫延誤。

About HeartBeam, Inc.

關於HeartBeam, Inc.(心電波公司)

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The Company is creating the first ever cable-free 12-lead ECG capable of capturing the heart's electrical signals from three dimensions. This platform technology is designed to be used in 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. The Company holds 13 US and 4 international issued patents related to technology enablement.

HeartBeam公司(納斯達克代碼:BEAT)是一家醫療技術公司,致力於通過爲患者提供強大的心臟洞察力來改變心臟護理。該公司正在創建第一款能夠從三個維度捕獲心臟電信號的無線電纜自由12導聯心電圖。這一平台技術旨在用於可穿戴設備,可在患者所在的任何地方使用,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況,並將患者引導到適當的護理環境 - 所有這些都在醫療機構之外,從而重新定義了心臟健康管理的未來。該公司擁有13項美國和4項國際技術授權專利。

For additional information, visit HeartBeam.com.

如需更多信息,請訪問HeartBeam.com。

Forward-Looking Statements

前瞻性聲明

All statements in this release that are not based on historical fact are "forward-looking statements." 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.

本發佈中所有基於非歷史事實的陳述均爲「前瞻性陳述」。雖然管理層已經基於其目前的預期進行了任何包含在本發佈中的前瞻性陳述,但支撐這些預期的信息可能會改變。前瞻性陳述涉及固有的風險和不確定性,這些風險和不確定性可能會導致實際結果與前瞻性陳述中不同,這是各種因素的結果,包括那些在我們的10-k、10-q和其他提交給SEC的報告中的風險因素和管理討論和分析財務狀況和經營業績部分中描述的風險和不確定性,可在www.sec.gov上獲得。我們敦促您在評估我們的前瞻性陳述時考慮這些風險和不確定性。我們警告讀者不要對任何這樣的前瞻性陳述抱有過度依賴的期望,這些陳述僅當做出時有效。除聯邦證券法要求的其他情況外,我們否認任何更新或修改此處(或其他地方)的任何前瞻性陳述以反映我們對其基礎的任何期望上的任何變化或任何事件、情況或環境的變化的義務或承諾。

View source version on businesswire.com:

在businesswire.com上查看源版本:

Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us

Media Contact:
media@heartbeam.com

投資者關係聯繫人:
Chris Tyson
執行副總裁
MZ北美
直接撥打:949-491-8235
BEAT@mzgroup.us

媒體聯繫:
media@heartbeam.com

Source: HeartBeam, Inc.

來源:HeartBeam,Inc。

Released November 19, 2024

發佈於2024年11月19日

譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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