Two New U.S. Patents Bring Total to 20 Issued Worldwide, Cementing Company Leadership in Cardiac Monitoring Innovation for 12-Lead ECG Synthesis Technology: HeartBeam, Inc. (Nasdaq: BEAT)

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$BEAT Clinical Endpoints Successfully Met in Pivotal Study, Plus FDA Clearance for At-Home, High-Fidelity Heart Monitoring System.

* Creating First Ever Cable-Free 12-Lead ECG Capable of Capturing Cardiac Electrical Signals from Three Dimensions.

* Technology Designed for Portable Devices to Deliver Actionable Heart Intelligence Anywhere.

* Two New U.S. Patents Issued, Reinforcing Core Intellectual Property Position and Enabling Future Product Extensions.

* Clinical Endpoints Successfully Met in Pivotal Study for Groundbreaking 12-Lead ECG Synthesis Technology.

* Milestone Study Results Form the Basis of 12-Lead ECG Synthesis Software Application Submitted to FDA in January, 2025.

* Strategic Collaboration with AccurKardia Brings Together Two Leaders in Ambulatory ECG Recording and Analysis to Advance Cardiac Monitoring.

* Received FDA Clearance for the HeartBeam System - an At-Home, High-Fidelity Heart Monitoring Technology.

* Commenced Early Access Program to Attain Key Insights and Establish Sales Funnel in Preparation for Commercialization.

* Submitted 510(k) Application to FDA for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software.

* Gross Proceeds of ~$11.5 Million from Public Offering and Over-Allotment Option to Fund Near-Term Milestones.

* Awarded Diamond Pinnacle Healthcare Award in Medical Device Innovation.

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. BEAT is creating the first ever cable-free 12-lead ECG capable of capturing the heart's electrical signals from three dimensions. This BEAT 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. BEAT holds 14 US and 4 international issued patents related to technology enablement.

Two New U.S. Patents Bring Total to 20 Issued Worldwide, Cementing Company's Leadership in Cardiac Monitoring Innovation

On May 6th BEAT announced the addition of two new U.S. patents, reinforcing its core intellectual property position and enabling future product extensions. The patents reinforce BEAT groundbreaking innovations and further solidify the Company's intellectual property (IP) footprint in cardiac monitoring technology that bring advanced cardiac insights to patients and clinicians.

The first patent protects IP around the BEAT credit card-sized, cable-free 3D ECG device. Designed for ease of use, the device features chest and finger electrodes to capture high-fidelity electrical signals in 3D (by capturing 3 non-coplanar directions) - enabling patients to record their symptoms the moment they occur, wherever they are. The signals are then synthesized into a familiar 12-lead ECG using a personalized transformational matrix. The 12-lead ECG synthesis software is currently under review with the FDA.

The second patent protects the BEAT rhythm analysis algorithm, which distinguishes between sinus rhythm, atrial fibrillation, and other arrhythmias using continuous signal input. Designed to operate on any cardiac monitoring system including wearables, the algorithm enables risk-based escalation by detecting anomalies during passive monitoring and prompting the user to collect high-fidelity 3D ECG signals with the BEAT credit card-sized device, enabling synthesis of a 12-lead ECG.

BEAT now holds 20 issued US and international patents, as well as 2 allowed patents and 32 pending patents, adding to an already robust IP portfolio.

Clinical Endpoints Successfully Met in Pivotal Study for Groundbreaking 12-Lead ECG Synthesis Technology

On April 29th BEAT announced that its groundbreaking synthesized 12-lead electrocardiogram (ECG) successfully met the clinical endpoints in the VALID-ECG pivotal study. Thomas Deering, M.D., of Piedmont Heart Institute, presented the data during the just concluded Heart Rhythm Society's annual conference in San Diego.

The study evaluated the mean difference in ECG intervals and amplitudes between the BEAT HeartBeam synthesized 12-lead ECG and simultaneously collected standard 12-lead ECG that are important in assessing non-life-threatening arrhythmias. Data showed a 93.4% overall diagnostic agreement, indicating that BEAT HeartBeam synthesized 12-lead ECG can support diagnosis of arrhythmias in a manner consistent with standard 12-lead ECGs.

BEAT patented 3D ECG technology captures the heart's electrical signals in 3 non-coplanar directions and then synthesizes these signals into a 12-lead ECG using a personalized transformation matrix. Data from the VALID-ECG study formed the basis of the FDA application for the 12-lead ECG synthesis software [https://ir.heartbeam.com/news-events/press-releases/detail/85/heartbeam-achieves-major-milestone-with-fda-submission-for] submitted by HeartBeam in January 2025.

BEAT plans to initiate commercialization upon receiving FDA clearance for the 12-lead ECG synthesis software. In advance of that, BEAT recently commenced an Early Access Program to obtain important feedback on the end-to-end clinical workflow, ensure operational readiness and establish an early adopter funnel in anticipation of US commercialization.

Strategic Collaboration with AccurKardia to Advance Cardiac Monitoring Innovation

On April 24th BEAT announced a strategic collaboration with AccurKardia, an innovator in ECG-based diagnostics technology, bringing together two innovation leaders in ambulatory electrocardiogram (ECG) recording and analysis. The initial collaboration aims to enhance the accessibility of cardiac monitoring solutions and will focus on making AccurKardia's FDA-cleared ECG analysis software, AccurECG Trademark , available on BEAT devices. For more information on AccurKardia visit www.accurkardia.com [https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.accurkardia.com&esheet=54242849&newsitemid=20250424671250&lan=en-US&anchor=www.accurkardia.com&index=3&md5=f0a80e72c783651f72d2e7cb4f815c22].

Adding AccurKardia's FDA-cleared, device-agnostic automated ECG interpretation platform to the BEAT device will enhance the Company's subsequent commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite BEAT product development efforts, reducing both costs and timelines.

Fourth Quarter and Full Year 2024 Results

On March 13th BEAT reported its financial and operational results for the fourth quarter and year ended December 31, 2024.

BEAT Operational Highlights

FDA 510(k) Clearance & Early Access Program:

Received US Food and Drug Administration (FDA) 510(k) clearance of the BEAT HeartBeam System for comprehensive arrhythmia assessment in December 2024.

Commenced an Early Access Program to obtain important feedback on the end-to-end clinical workflow, ensure operational readiness and establish an early adopter funnel in anticipation of US commercialization.

12-Lead Synthesis Software FDA Submission:

Submitted FDA 510(k) application focused on the BEAT HeartBeam software that converts the heart's electrical signals captured from 3 distinct directions into a synthesized 12-lead ECG, utilizing the company's patented technology.

Plan to present VALID-ECG pivotal study results on 12-lead ECG synthesis software at the Heart Rhythm Society (HRS) meeting in April 2025. This study is the basis of the FDA 510(k) submission.

BEAT anticipates initiating commercialization upon receiving 510(k) clearance for the 12-lead ECG synthesis software.

Other Highlights:

Closed a Public Offering of common stock with gross proceeds of approximately $11.5 million, including the exercise of the underwriter's over-allotment option, to fund key growth milestones and preparation for US commercialization.

Continued to build significant clinical evidence on BEAT HeartBeam technology: At the American Heart Association (AHA) conference in November 2024, presented results from a pilot study demonstrating similar performance between BEAT HeartBeam synthesized 12-lead ECG and a standard 12-lead ECG for arrhythmia detection. The pilot study used the same protocol as the VALID-ECG pivotal study. Also, at AHA, presented data from a feasibility study on a novel algorithm, used in conjunction with the BEAT HeartBeam ECG technology, to detect acute coronary conditions like heart attacks.

BEAT awarded Diamond Pinnacle Healthcare Award in Medical Device Innovation, adding to the growing body of industry recognition in March 2025.

Cash and cash equivalents totaled $2.4 million as of December 31, 2024, with net cash used in operating activities of $14.5 million during 2024.

For more information on $BEAT visit: http://www.HeartBeam.com

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Media Contact
Company Name: HeartBeam, Inc.
Contact Person: Robert Eno, Chief Executive Officer
Email: Send Email [http://www.universalpressrelease.com/?pr=two-new-us-patents-bring-total-to-20-issued-worldwide-cementing-company-leadership-in-cardiac-monitoring-innovation-for-12lead-ecg-synthesis-technology-heartbeam-inc-nasdaq-beat]
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