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HeartBeam to Attend JP Morgan 2026 Annual Healthcare Conference

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us food and drug administration regulatory
The U.S. Food and Drug Administration (FDA) is the federal agency that reviews and approves medicines, vaccines, medical devices, and certain food-related products and labeling for sale in the United States. Its decisions act like a gatekeeper or traffic light for companies: approval clears the way for products to reach large markets and generate revenue, while rejection or delays can halt sales and materially change a company’s value, so investors watch FDA actions closely.
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A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.
12-lead electrocardiogram medical
A 12-lead electrocardiogram is a medical test that records the heart’s electrical activity from 12 viewpoints using sensors placed on the chest and limbs, producing a set of tracings that show heart rhythm and signs of damage or stress. For investors, results matter because they are a standard measure used to evaluate cardiac health in clinical trials, product approvals, or workforce health disclosures—think of it as a multi-angle snapshot that helps assess safety and risk.
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An ECG (electrocardiogram) records the heart’s electrical activity through small sensors on the skin and produces a waveform that shows heart rate, rhythm and signs of stress or damage—think of it as a seismograph for the heart’s electrical signals. Investors care because ECGs are central to diagnosing and monitoring cardiac safety in clinical trials, required for regulatory approval of many drugs and devices, and drive demand for related medical equipment and services.
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Arrhythmias are disturbances in the heart’s normal rhythm, where the heartbeat may be too fast, too slow, or irregular—think of the heart like a metronome that is skipping or racing. For investors, they matter because treatments, devices, or tests that diagnose or control arrhythmias can drive drug approvals, device sales, litigation risk, and patient outcomes, all of which affect revenue, regulatory timelines, and market value.
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A cardiologist is a medical doctor who specializes in diagnosing and treating diseases and conditions of the heart and blood vessels. Investors pay attention to cardiologists because their clinical judgments, participation in trials, and endorsements can shape whether new drugs, devices or procedures gain regulatory approval, clinical adoption and insurance coverage — much like a trusted mechanic whose sign-off determines whether a new car part reaches the market and sells well.
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  • HeartBeam Recently Received US Food and Drug Administration (FDA) Clearance for First-Ever Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment
  • Pivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy

SANTA CLARA, Calif.--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, today announced that it will attend the JP Morgan 2026 Annual Healthcare Conference taking place January 12-15, 2026 at the Westin St. Francis Hotel in San Francisco, CA.

HeartBeam Chief Executive Officer, Robert Eno, and Chief Financial Officer, Timothy Cruickshank, will be available January 12-14 for off-site meetings with investors and potential commercialization and co-development partners to discuss the recently announced US Food and Drug Administration (FDA) 510(k) clearance for the Company’s groundbreaking 12-lead electrocardiogram (ECG) synthesis software for the assessment of arrhythmias. Unlike any single-lead or 6-lead consumer device, HeartBeam’s patented cable-free technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a 12-lead ECG representation. This allows patients to obtain an ECG reading for their arrhythmia from the comfort of home, or wherever they happen to be, representing a new level of convenience and peace of mind. The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist.

HeartBeam plans to initiate a limited U.S. commercial launch in Q1 2026 with select concierge and preventive cardiology practices that have already signaled strong adoption interest. Additional details on broader geographic rollout, wearable integration, AI-enabled automated insights, and the Company’s heart attack detection program will be announced in the near future.

To schedule an off-site one-on-one meeting with HeartBeam management during the event, please contact MZ Group at BEAT@mzgroup.us.

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 device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. 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. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software in December 20251. The Company holds over 20 issued patents related to technology enablement. For additional information, visit HeartBeam.com.

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.

1Cleared Indications for Use

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.

The HeartBeam 12-Lead ECG Synthesis Software synthesizes a 12-Lead ECG from the HeartBeam System 3-Leads (in three-directions) recording device, producing a visual 12-Lead ECG representation that is similar, but not identical, to the same leads of a standard diagnostic 12-Lead ECG. The synthesized 12-Lead ECG output is solely intended for manual assessment of normal sinus rhythm and the following non-life-threatening arrhythmias: sinus arrhythmia, sinus tachycardia, sinus bradycardia, atrial premature complexes, atrial fibrillation, and ventricular premature complex. The synthesized 12-Lead ECG output is not intended for the assessment of any other arrhythmia or conditions (including but not limited to: other atrial arrhythmias, ventricular arrhythmias, hypertrophy, conduction disorders, myocardial infarction or ischemia, pacemaker functions, localization of arrhythmia foci, ECG wave abnormalities, and/or any other disorder). The software does not conduct cardiac analysis and is not intended to replace a standard 12-Lead ECG. The 12-Lead ECG Synthesis Software is intended for adult use only.

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

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

Source: HeartBeam, Inc.

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