HeartBeam Achieves Major Milestone with FDA Submission for its Groundbreaking 12-Lead ECG Synthesis Software

$BEAT
Medical/Dental Instruments
Health Care
Get the next $BEAT alert in real time by email

HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the Company's groundbreaking 12-lead electrocardiogram (ECG) synthesis software designed for the assessment of rhythms and arrhythmias, including sinus rhythm, atrial fibrillation, atrial flutter, bradycardia, tachycardia, and sinus with premature ventricular contraction (PVC) or premature atrial contraction (PAC).

The FDA submission is backed by robust data from the VALID-ECG pivotal study, which enrolled 198 patients across five clinical sites. The Company believes the study's findings support the clinical equivalence of HeartBeam's synthesized 12-lead ECG where the leads are similar to standard 12-lead ECGs for rhythm and arrhythmia assessment.

The submission builds on HeartBeam's recent FDA clearance for its patented technology which captures the heart's electrical signals from three distinct directions. The software synthesizes these signals into a familiar 12-lead ECG using a personalized transformation matrix.

Upon FDA clearance for the software, the Company plans to initiate commercial launch leveraging the learnings and feedback gained from its Early Access Program. Hundreds of physicians and patients have already joined the waitlist underscoring the widespread interest in a powerful and convenient cardiac monitoring option that can be used outside of a medical facility.

Robert Eno, Chief Executive Officer of HeartBeam, commented, "The FDA submission for the 12-lead synthesis software is a significant step as we work towards fulfilling HeartBeam's vision to offer patients and physicians an easy-to-use portable device and transform how cardiac conditions are monitored and detected."

Additional future planned advances include the integration of AI-based classification algorithms and detection of heart attacks to aid in reducing "symptom to door" times – an area of major focus for the American Heart Association (AHA) to shorten the time from heart attack symptom onset and treatment. HeartBeam believes its groundbreaking technology presents a transformative opportunity to bring about a paradigm shift in cardiovascular care for millions of patients globally.

Additional Details About Data Supporting FDA Submission

The FDA submission was supported by data from the VALID-ECG pivotal study, which completed enrollment in June 2024. VALID-ECG used the same protocol as an 80-person pilot study which was presented at the AHA 2024 Scientific Sessions. The Company plans to present the results from VALID-ECG at a scientific conference in 2025.

Data from the pilot study presented at the AHA Scientific Sessions, which also supported the FDA submission, found similar performance of HeartBeam's synthesized 12-lead ECG waveforms compared to simultaneously collected standard 12-lead ECGs for arrhythmia detection. The pilot 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).

About HeartBeam, Inc.

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 synthesized 12-lead ECG capable of capturing the heart's electrical signals from three distinct directions. 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. The Company holds 13 US and 4 international issued patents related to technology enablement. For additional information, visit HeartBeam.com.

About the HeartBeam System

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

Forward-Looking Statements

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.

Investor Relations Contact:

Chris Tyson

Executive Vice President

MZ North America

Direct: 949-491-8235

BEAT@mzgroup.us

www.mzgroup.us

Media Contact:

media@heartbeam.com

Get the next $BEAT alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$BEAT

DatePrice TargetRatingAnalyst
12/20/2021$9.00Speculative Buy
Benchmark
More analyst ratings

$BEAT
Press Releases

Fastest customizable press release news feed in the world

See more
  • HeartBeam Reports Fourth Quarter and Full Year 2024 Results

    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 Management to Host Webcast and Conference Call Today at 4:30 p.m. ET HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, has reported its financial and operation

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam to Participate at Upcoming Conferences in Dana Point, California, March 16-21, 2025

    HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced that CEO Robert Eno and CFO Timothy Cruickshank will be participating in the following upcoming conferences in Dana Point, CA. 37th Annual Roth Conference being held at The Laguna Cliffs Marriott Resort & Spa, March 16-18, 2025 LSI USA '25 Conference being held at the Waldorf Astoria, Monarch Beach, March 17-21, 2025 To schedule a one-on-one meeting with HeartBeam management, please contact your conference representative or email your request to BEAT@mzgroup.us or call Chris Tyson at (949) 491-8235. About HeartBeam, Inc. HeartB

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam to Host Fourth Quarter Full Year 2024 Results Conference Call on Thursday, March 13, 2025 at 4:30 p.m. Eastern Time

    HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, will hold a conference call on Thursday, March 13, 2025 at 4:30 p.m. Eastern time to discuss its results for the fourth quarter and full year ended December 31, 2024, and will be providing updates on regulatory initiatives, commercial-readiness activities and anticipated milestones. A press release detailing these results will be issued prior to the call. HeartBeam CEO Robert Eno and CFO Timothy Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be

    $BEAT
    Medical/Dental Instruments
    Health Care

$BEAT
Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

See more

$BEAT
Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

See more

$BEAT
Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

See more

$BEAT
SEC Filings

See more

$BEAT
Leadership Updates

Live Leadership Updates

See more
  • HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology

    First cable-free, ambulatory ECG that captures the heart's electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in preparation for commercial launch HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that the US Food and Drug Administration (FDA) has granted 510(k) cl

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam Appoints Robert Eno as Chief Executive Officer in Preparation for US Commercialization

    Industry leader brings extensive experience in developing go-to-market strategies for breakthrough products and delivering growth Founder and current CEO Branislav Vajdic named President to focus on advancing the Company's groundbreaking vector-based technology for heart health, including AI applications HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful insights wherever the patient is, announced that Robert Eno has been appointed Chief Executive Officer (CEO), effective Monday, October 21, 2024. The seasoned MedTech executive joined HeartBeam as President in January 2023 and will lead as the Company continues to work

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam Appoints Dr. Lance Myers as Chief AI Scientist

    Industry Leader, Former Head of Data Science at Verily (Google Life Sciences) and Globally Respected Authority on Artificial Intelligence (AI) Applications in Biosensor Technologies Dr. Myers to Drive Innovation and Strategic Growth as HeartBeam Advances and Expands its AI Capabilities HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights wherever the patient is, announced the appointment of Lance Myers, PhD, a pioneer in digital health data analytics and body-worn biosensor technologies, as Chief Artificial Intelligence (AI) Scientist. In this newly created position, Dr. Myers will play a pivotal role in gu

    $BEAT
    Medical/Dental Instruments
    Health Care

$BEAT
Financials

Live finance-specific insights

See more
  • HeartBeam to Host Fourth Quarter Full Year 2024 Results Conference Call on Thursday, March 13, 2025 at 4:30 p.m. Eastern Time

    HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, will hold a conference call on Thursday, March 13, 2025 at 4:30 p.m. Eastern time to discuss its results for the fourth quarter and full year ended December 31, 2024, and will be providing updates on regulatory initiatives, commercial-readiness activities and anticipated milestones. A press release detailing these results will be issued prior to the call. HeartBeam CEO Robert Eno and CFO Timothy Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam Reports Third Quarter 2024 Results

    Continued Clinical and Regulatory Progress on the HeartBeam System Key Appointments to Management Team Completed as Part of Planned Evolution in Preparation for US Commercialization Strengthening Clinical Evidence Base, with Two Additional Studies to be Presented at the American Heart Association Conference in November 2024 Management to Host Webcast and Conference Call Today at 4:30 p.m. ET HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has reported its financial and operational results for the third quarter ended September 30, 2024. Third Quarter & Subsequent 2024 Operational Highlights

    $BEAT
    Medical/Dental Instruments
    Health Care
  • HeartBeam to Host Third Quarter 2024 Results Conference Call on Thursday, November 7, 2024 at 4:30 p.m. Eastern Time

    HeartBeam, Inc. (NASDAQ:BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights wherever the patient is, will hold a conference call on Thursday, November 7, 2024 at 4:30 p.m. Eastern time to discuss its results for the third quarter ended September 30, 2024, and will be providing regulatory updates, reviewing ongoing initiatives, and anticipated milestones. A press release detailing these results will be issued prior to the call. HeartBeam CEO Robert Eno, Founder and President Branislav Vajdic, PhD, and CFO Timothy Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompa

    $BEAT
    Medical/Dental Instruments
    Health Care

$BEAT
Large Ownership Changes

This live feed shows all institutional transactions in real time.

See more