HeartBeam, Inc. a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced its regulatory strategy following receipt of a Not Substantially Equivalent (NSE) decision on the Company’s 510(k) submission for its 12-lead Electrocardiogram (ECG) Synthesis Software..

HeartBeam, Inc.是一家专注于通过提供强大的个性化洞察来变革心脏护理的医疗技术公司，近日宣布了其在收到美国食品药品监督管理局（FDA）对其12导联心电图（ECG）合成软件的510(k)提交作出的“非实质等效”（NSE）决定后的监管策略。

Immediately following the receipt of the NSE letter and through today, HeartBeam has been engaging with the Food and Drug Administration (FDA) review staff to better understand the concerns and determine the best path forward.

在收到NSE信函后直至今日，HeartBeam一直在与食品药品监督管理局（FDA）的审查人员沟通，以更好地了解相关问题并确定最佳的后续方案。

The FDA has signaled a willingness to work with the Company towards a constructive resolution.

美国食品药品监督管理局（FDA）已表示愿意与公司合作，寻求建设性的解决方案。

The Company stands behind the clinical study (VALID-ECG) submitted in support of the application. The study met its clinical endpoints and the Company believes it has a viable argument to address outstanding concerns of the agency.

公司支持为申请而提交的临床研究（VALID-ECG）。该研究达到了其临床终点，公司相信它有一个可行的论点来解决机构的未决问题。

The Company believes these concerns can be addressed through modifications to the proposed labeling of the device.

公司认为，通过对设备的拟议标签进行修改，可以解决这些问题。

HeartBeam has determined that the best course of action to reach a favorable resolution with the FDA is to pursue multiple parallel paths, which are designed for this type of situation.

HeartBeam 已确定，为与 FDA 达成有利的解决方案，最佳行动方案是追求多种并行路径，这些路径专为此类情况而设计。

The range of options include, but are not limited to, an appeal process or a resubmission of a 510(k) application.

可选方案的范围包括但不限于上诉程序或重新提交510(k)申请。

Based on the recent discussions with the FDA and the information available at present, the Company believes there is a path forward under an appeal process.

基于最近与FDA的讨论以及目前可获得的信息，公司认为在上诉程序下有一条可行的路径。

The official appeal process has a timeline of approximately 60 days from submission of an appeal to resolution.

官方上诉程序的时间表大约为从提交上诉到解决问题的60天。

The Company looks forward to working with the agency to resolve the unexpected NSE letter. While this regulatory process moves forward, the Company will continue to provide shareholders with updates on the commercial launch and funding plans.

公司期待与该机构合作解决意外收到的NSE函件。在这一监管程序进行的同时，公司将持续向股东提供有关商业发布和融资计划的最新信息。

“HeartBeam appreciates the extensive interactions with the FDA on the HeartBeam 12-lead Synthesis Software,” said Robert Eno, Chief Executive Officer of HeartBeam. “We have engaged in good faith with the agency over a period of two years and have had extremely positive interactions. Together with the agency, we resolved the vast majority of open questions..

“HeartBeam非常感谢与FDA就HeartBeam 12导联合成软件进行的广泛互动，” HeartBeam首席执行官罗伯特·恩诺表示。“我们本着诚意与该机构进行了为期两年的合作，并且互动非常积极。在与该机构的共同努力下，我们解决了绝大多数未决问题。”

“After assessing our options, we believe that the best way to resolve the open questions and to get this technology into the hands of patients is to engage in the multiple paths available for constructive resolution. Since the remaining concerns from the FDA are well defined and can be readily addressed by our team, we believe these paths can lead to a favorable resolution.”.

“在评估了我们的选择后，我们认为解决悬而未决的问题并将这项技术交到患者手中的最佳方法，是利用所有可用的建设性解决方案。由于FDA剩余的关注点定义明确，并且我们的团队可以轻松解决，我们相信这些途径能够带来有利的结果。”

About HeartBeam, Inc.

关于HeartBeam公司

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar dimensions, and synthesizing the signals into a 12-lead ECG.

HeartBeam, Inc.（纳斯达克股票代码：BEAT）是一家致力于改变关键心脏疾病检测和监测的医疗技术公司。该公司正在开发首款无需电缆的设备，能够从三个非共面维度收集三维心电图信号，并将信号合成为12导联心电图。

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.

该平台技术专为便携式设备设计，可以在患者所在的任何地方使用，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状况，并指导患者获得适当的护理——所有这些都在医疗机构之外完成，从而重新定义心脏健康管理的未来。

HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com..

HeartBeam的3D ECG技术在2024年12月获得了FDA关于心律失常评估的许可。该公司拥有超过20项与技术赋能相关的已授权专利。欲了解更多信息，请访问HeartBeam.com。

Forward-Looking Statements

前瞻性声明

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.

本发布中所有非基于历史事实的陈述均为“前瞻性陈述”。尽管管理层已将本发布中包含的任何前瞻性陈述基于其当前预期，但这些预期所依据的信息可能会发生变化。前瞻性陈述涉及固有的风险和不确定性，这些风险和不确定性可能导致实际结果与前瞻性陈述中的结果存在重大差异，原因包括我们向美国证券交易委员会（SEC）提交并在www.sec.gov上可查阅的10-K、10-Q及其他报告中的风险因素以及管理层对财务状况和经营结果的讨论与分析部分中描述的各种因素。

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..

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。我们提醒读者不要过分依赖任何此类前瞻性声明，这些声明仅在其作出之日有效。除非联邦证券法另有要求，我们不承担任何义务或承诺公开发布对本文（或其他地方）包含的任何前瞻性声明的更新或修订，以反映我们对此的期望的任何变化或任何此类声明所依据的事件、条件或情况的任何变化。

Cleared Indications for Use

已批准的使用适应症

The HeartBeam System is a portable non-invasive recorder intended to record, store, and transfer a patient’s 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

HeartBeam系统是一种便携式无创记录仪，旨在记录、存储和传输从5个电极获取的患者3导联（三个方向）心电图（ECG）。该设备可供成年患者在临床环境或家中使用。设备不进行心脏分析，但可以与ECG查看器软件系统配合使用，供医生或医疗专业人员手动解读非危及生命的心律失常。

For full safety information, see the full Instructions for Use or Clinician Portal Manual..

有关完整的安全信息，请参阅完整的使用说明书或临床医生门户手册。

Contacts

联系人

Investor Relations Contact:

投资者关系联系人：

Chris Tyson

克里斯·泰森

Executive Vice President

执行副总裁

MZ North America

MZ北美

Direct: 949-491-8235

直线电话：949-491-8235

[email protected]

电子邮件地址

www.mzgroup.us

www.mzgroup.us

Media Contact:

媒体联系人：

[email protected]

电子邮件地址

Source: businesswire.com

来源：businesswire.com