Clinical Endpoints Successfully Met in Study for Groundbreaking 12-Lead ECG Synthesis Technology Allowing Software Application to FDA: HeartBeam, Inc

SANTA CLARA, Calif. - PrZen -- 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.

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.

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.

HeartBeam, Inc. (Stock Symbol: 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.

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

On April 29^th 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 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 24^th 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™, available on BEAT devices. For more information on AccurKardia visit www.accurkardia.com.

The BEAT groundbreaking credit card-sized, cable-free 3D ECG device 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. BEAT plans to initiate commercialization upon receiving FDA clearance for the 12-lead ECG synthesis software.

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.

"We believe combining AccurKardia's device‑agnostic, FDA‑cleared automated ECG analytics with HeartBeam's novel credit card‑sized device will be a true game‑changer that empowers patients to take charge of their cardiac health, wherever they are. By uniting our strengths, we're creating a best‑in‑class platform that transforms how cardiac arrhythmia conditions are monitored and detected," said Juan C. Jimenez, Co-Founder and Chief Executive Officer of AccurKardia. Putting clinical-grade ECG insights directly into a patient's pocket aims to meaningfully address the increasing lack of access to cardiology specialists in the United States."

Fourth Quarter and Full Year 2024 Results

On March 13^th 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:  www.HeartBeam.com

Media Contact:
Company Name: HeartBeam, Inc. (Stock Symbol: BEAT)
Contact: Robert Eno, Chief Executive Officer
Email: media@heartbeam.com
Phone: 408-899-4443
Country: United States
Website:  www.HeartBeam.com

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