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    SEC Form FWP filed by Heartbeam Inc.

    1/8/25 4:24:43 PM ET
    $BEAT
    Medical/Dental Instruments
    Health Care
    Get the next $BEAT alert in real time by email
    FWP 1 ea0227186-fwp_heartbeam.htm FREE WRITING PROSPECTUS

    Filed Pursuant to Rule 433

    Issuer Free Writing Prospectus

    Dated January 8, 2025

    Relating to Preliminary Prospectus

    dated December 23, 2024

    Registration Statement No. 333-269520

     

    Total Heart Intelligence… Wherever You Are NASDAQ: BEAT January 2025

     

     

    2 This presentation contains forward - looking statements . All statements other than statements of historical fact contained in this presentation, including statements as to the Company’s future results of operations and financial position, planned products and services, business strategy and plans and objectives of management for future operations, are forward - looking statements . These statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward - looking statements . In some cases, you can identify forward - looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “aims,” “predicts,” ”potential,” “seeks,” attempts,” “poised“ or “continues” or the negative of these terms or other similar words . These statements are only predictions . The Company has based these forward - looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its business, financial condition and results of operations . Also, these forward - looking statements represent the Company’s estimates and assumptions only as of the date of this presentation . The Company assumes no obligation to update any forward - looking statements after the date of this presentation . This presentation also contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other industry data . This data involves several assumptions and limitations, and you are cautioned not to give undue weight to such estimates . The Company has not independently verified the statistical and other industry data generated by independent parties and contained in this presentation and, accordingly, it cannot guarantee their accuracy or completeness . In addition, projections, assumptions and estimates of its future performance and the future performance of the industries in which it operates are necessarily subject to a high degree of uncertainty and risk due to a variety of factors . These and other factors could cause results to differ materially from those expressed in the estimates made by independent parties and by the Company . For additional risks and uncertainties that could impact the Company's forward - looking statements, please see disclosures contained in HeartBeam’s public filings with the SEC, including the "Risk Factors" in HeartBeam’s Annual Report on Form 10 - K, and which may be viewed at www . sec . gov . DISCLAIMERS

     

     

    3 Introductions Tim Cruickshank Chief Financial Officer Rob Eno President Rob Eno Chief Executive Officer Richa Gujarati SVP, Product

     

     

    4 HeartBeam: Total Heart Intelligence…Wherever You Are De - risked through recent FDA clearance and near - term milestones Strong commercial plan: Initial target markets validated First ever cable - free 12L ECG for use by patients synthesized from a novel approach that captures heart signals in three directions Positioned to disrupt markets worth a combined $100B+ in areas of large healthcare spend Symptom - driven diagnosis Monitoring and Screening Replace traditional 12L ECGs Unique IP - enabled disruptive technology Roadmap with 3 Clear Focus Areas Massive Market Opportunity Clear Go To Market Strategy Artificial Intelligence applied to rich, longitudinal data can deliver personalized cardiac insights Highest resolution cardiac data 12 - lead synthesis software not cleared by the FDA and n ot available for sale in the United States and other geographies.

     

     

    5 CONSUMER - GRADE ECGs • Generally 1 Lead • Not accurate enough • Produce noisy data • Inundate physicians with data • Limited to arrhythmia detection STANDARD 12 Lead ECGs • Current gold standard for data quality and ability to diagnose • Limited to the hospital • Not practical for at - home use • Rarely capture data over time AT HOME USE Today’s ECG Technology is Not Adequate MEDICAL FACILITY

     

     

    6 HeartBeam Overcomes these Limitations, Creating a New Paradigm # OF LEADS 1 LEAD 12 LEADS DESIGN CABLE - FREE, EASY TO USE CABLES/EXTERNAL LEADS 6 LEADS * For Healthcare professional use only 12L ECG with cables Kardia 6L Patch Technology Kardia 1L Kardia 12L* Only Cable - Free 12L ECG 12 - lead synthesis software not cleared by the FDA and n ot available for sale in the United States and other geographies.

     

     

    7 Fundamental, IP Protected Advances Enable HeartBeam’s 12L Technology IP Breakthrough Credit card - sized device with a novel resistive network captures the “front to back” direction, providing actionable heart intelligence 3 Directions Collects signals in 3 directions , capturing the totality of the heart’s electrical signals Personalized Signals from 3 directions train HeartBeam’s AI algorithms and are synthesized into 12L ECGs using a personalized transformation matrix 12 - lead synthesis software not cleared by the FDA and n ot available for sale in the United States and other geographies.

     

     

    8 HeartBeam Demo

     

     

    9 Strong intellectual property position on core technology and product pipeline HEARTBEAM 12L SMART WATCH INTEGRATED SYSTEM EXTENDED WEAR PATCH HEARTBEAM 12L ECG SYSTEM Foundational patents granted: synthesis to 12 - lead upon placing band electrodes on chest Multiple patents granted on HeartBeam and LIVMOR watch Foundational patents granted: synthesis to 12 - lead upon pressing electrodes with fingers Multiple granted patents, including foundational resistive network enabling “front to back” axis 17 issued patents worldwide Leadership in Cable - Free 12L ECG Space 12 - lead synthesis software not cleared by the FDA and n ot available for sale in the United States and other geographies.

     

     

    10 HeartBeam will allow patients with symptoms to get treatment sooner, saving lives and reducing healthcare costs Patients Delay Seeking Care Symptom Onset Arrival at Emergency Room Treatment (stenting) Symptom - to - Door Time Door - to - Balloon Time 3 - 4 hours Variable, Patient denial <90 minutes Optimized, in guidelines Delays Greatly Impact Patient Outcomes Every 30 minutes increases 1 year mortality rate by 7.5% 1 and risk of heart failure by 8.7% 1 Heart Failure is Deadly and Extremely Expensive to the Healthcare System Annual Cost 2 $30,000 Average life expectancy 3 5 years 1. De Luca G. Circulation. 2004 Mar 16;109(10):1223 - 5 2. Heidenreich PA, J Card Fail. 2022 Mar;28(3):453 - 466. 3. Heart Failure S ociety of American, Heart Failure Facts & Information Ischemia product not cleared by FDA and n ot available for sale in the United States or other geographies .

     

     

    11 PATIENTS IN CLINICAL STUDIES 500+ USERS 250+ RECORDINGS 15,000+ Significant Body of Evidence on HeartBeam’s Groundbreaking Technology Equivalence to 12L for Coronary Occlusions HeartBeam AI + Vector ECG for Complex Arrhythmias Fundamentals of HeartBeam technology HeartBeam algorithm for Heart Attack vs Standard of Care PAPERS AND PRESENTATIONS 9 Equivalence to 12L ECG for Arrhythmia Strengthening evidence base per indication for use 12 - lead synthesis software and ischemia product not cleared by the FDA. Not available for sale in the United States and other ge ographies.

     

     

    12 Large and Rapidly Expanding Body of Evidence on HeartBeam’s Groundbreaking Technology 12 - lead synthesis software and ischemia product not cleared by the FDA. Not available for sale in the United States and other ge ographies. 1, 5. AHA 2024. 2. Shvilkin, et al, Coronary Artery Occlusion Detection Using 3 - Lead ECG System Suitable for Credit Card - Size Pe rsonal Device Integration. JACC Adv. 2023 Aug, 2 (6). 3 EHRA 2024. 4. HRS 2024 Comparable with Standard 12L ECG for Arrhythmias 1 Interval & amplitude differences: 1/10 of margin of ECG reading error EP Rhythm classification: 100% Specificity, 95% Sensitivity Arrhythmia Heart Attack Equivalence Algorithms Able to Detect Coronary Occlusions 4 Equivalent To 12L ECG performance >40% better with baseline (HB with baseline vs. single 12L) Deep Learning on Vector ECG Improves Performance 28% Improvement In detecting atrial flutter vs 1L ECG 2 Outperformed Panel of EPs Reading 12L ECG in detecting atrial flutter 3 Algorithm with ECG + Symptoms + Patient History 5 Equivalent To MD panel with 12L ECG in classifying ACS >33% better with baseline More negative ACS patients classified as low risk

     

     

    13 HeartBeam Roadmap: Groundbreaking Form Factor and AI Drive Significant Expansion 12 - lead synthesis software and ischemia product not cleared by the FDA. Not available for sale in the United States and other ge ographies. 31 MILLION US PATIENTS 186 MILLION US PATIENTS 300 MILLION ANNUAL ECGS 1 2 3 SYMPTOM - DRIVEN DIAGNOSIS MONITOR AND PREDICT CUT THE CORDS • Earlier diagnosis of cardiac conditions upon symptom onset: • Heart attack • Complex arrhythmia • Track 12L ECG to see changes in cardiac health in response to interventions (therapeutic, lifestyle) • Predictive algorithms for onset of heart failure, heart valve disease, etc. • Become the new standard of care • Replace 12L ECG with enterprise version of HeartBeam device in h ospitals and beyond

     

     

    14 HeartBeam AI: Driving Earlier Insights into Cardiac Conditions Transforming data into life - saving insights, predicting cardiac events before they happen 12 - lead synthesis software and ischemia product not cleared by the FDA. Not available for sale in the United States and other ge ographies. AI: PREDICTIVE INSIGHTS HEARTBEAM’S UNIQUE VALUE • Proven ability of AI algorithms applied to 12L ECG to predict/identify cardiac conditions : • Heart Failure • Coronary Artery Disease • Hypertension • Arrhythmias • Sudden Cardiac D eath prediction • Aortic Stenosis • Amyloidosis • Mitral regurgitation • Stroke prediction • Hyperkalemia • Diastolic dysfunction • + many more • HeartBeam brings these directly to the patient • Potential to further improve accuracy through Longitudinal 12L ECG readings For patients : • Early detection of cardiac conditions before symptoms appear • Routine use updates cardiac risk score prompting follow - up on additional testing or treatment For pharma/health insurance companies : • Targeted drug development and clinical trial optimization • Better identification of patients at high - risk driving improved outcomes Compelling reasons for patients to pay for HeartBeam Data HeartBeam generates provide valuable insights

     

     

    15 Near - term milestones creating significant momentum HeartBeam System Foundational Clearance MI Detection AI Classifications Clinical Commercial Regulatory Initial FDA interactions RAISE - ECG Enrollment Complete FDA Submission Start of Early Access Program FDA Clearance 12L Synthesis Software FDA Clearance Beta and Commercial Launch Initial Commercial Launch Innovation Paving Way for Commercialization Launch 2024 2025 RAISE - ECG Enrollment Start FDA 510(k) Submission Clinical Evidence AHA: Ischemia VALID - ECG Pilot Potential data releases: AI for Arrhythmia/VECG for STEMI/VALID - ECG VALID - ECG Enrollment Complete

     

     

    16 Focus of Initial Commercial Launch: Direct Patient Pay • Establish HeartBeam as first personal, cable - free 12L ECG • Create a focused direct sales and marketing operation in US • Prove concept in select geographic markets, then expand • Establish premium pricing and subscription model • Focus on customer experience and retention OVERALL STRATEGY • Known cardiac issue/higher risk/family history • Proactive/concerned with cardiac health • Willingness and ability to pay without reimbursement • Preventive cardiology + concierge practices • Individuals through targeted digital marketing • Cardiologists recommend to patients INITIAL MARKETS TARGET PATIENT PROFILE 1.5 million concierge patients in US 1/3 with elevated cardiac risk: 500,000 people $250 - $500 million annual revenue* Concierge Market 160 million people ages 35 - 74 1/3 with elevated cardiac risk, top 5% income: 2.6 million people** $1.3 - $2.6 billion annual revenue* Direct Patient Pay Market * Based on $500 - $1,000 per year per unit ** >2.5 million Oura rings and >3 million AliveCor Kardia devices have been sold 12 - lead synthesis software not cleared by the FDA. Not available for sale in the United States and other geographies.

     

     

    17 Start direct, create playbook, prove concept Concierge Additive to revenue; drive downstream treatments (stents, valves, pacemakers) Synergy with CAD Diagnostics companies: same customer and patient Broader Patient Pay Wearable identifies heart issue and prompts patient to use 12L ECG HeartBeam 12L watchband Wearables On demand 12L patch has best - in - class performance Patch Transition legacy business, expand to new locations Traditional 12L ECG Early insights into patients with disease Data GTM Options in Multiple Verticals Positioned to disrupt multiple large markets VERTICAL COMMENTS POTENTIAL PARTNERS

     

     

    18 Financial Discipline Cash Burn Aligned with Key Milestones Strong foundation for execution Corporate Overview i. Approximate, as of January 3, 2025 ii. As of September 30, 2024; refer to the Form 10 - Q unaudited financial statements for the quarterly period ended September 30, 202 4 $5.8 Million Cash on Hand ii Debt: N/A No Bank Borrowings ii $60 Million Market Capitalization i High Margin Business Recurring Revenue with Reader Service NASDAQ: BEAT Since November 2021

     

     

    19 Operating cash burn of $3.3M in prior quarter i , aligned with key milestones Cash Burn Focused on financial discipline to deliver on goals while minimizing cash burn Financials Strong support from existing shareholders , committed to groundbreaking technologies Shareholder Support i. Calculated as Net loss, less non - cash items such as stock - based compensation and timing differences. ii. Refer to the Form 10 - Q unaudited financial statements for the quarterly period ended September 30, 2024 Quarter Ended September 30, $ in Thousands 2023 2024 ii Operating Expenses: $2,114 $2,176 General & Administrative 1,623 2,893 Research & Development 3,737 5,069 Total Operating Expenses (3,737) (5,069) Loss from Operations 267 90 Interest and Other (expense) $(3,470) $(4,979) Net loss 1,372 1,570 Less non - cash items and timing differences $(2,098) $(3,306) Net cash used in operating activities i December 31, 2023 September 30, 2024 $ in Thousands $16,189 $5,768 Cash & Cash Equivalents

     

     

    20 Investment aligned with milestones Funding Next Wave of Milestones i. Refer to Slide 15 for HeartBeam 2025 Milestones. Commercial - readiness • Business development and partnerships • Initial build out of commercial team • Onboarding and customer service • Health economic studies and market access • Marketing for Phase 1 Go - To - Market plans R&D (Clin/Reg, AI, Software) • Continued clinical data for commercialization • RAISE ECG Pivotal Study • AI for Arrhythmia / Ischemia indication • Regulatory filings and certifications Inventory/Manufacturing • Build out of HeartBeam Systems • Contracts with manufacturing partners • Establishment of physician reader service G&A • Minimize incremental G&A spend over coming period • Invest in critical IT and ERP Systems for growth • Focused on maintaining and adding value - add investors • Plan to strategically finance the company to manage dilution • Upcoming milestones i are clear catalysts for investment • Continue to align our cash burn to the achievement of our key milestones, in advance of commercialization • Investing in commercial - readiness, key R&D activities, initial inventory build outs and other key initiatives

     

     

    21 BRANISLAV VAJDIC, PHD Founder & President KEN PERSEN Chief Technology Officer PETER FITZGERALD, MD, PHD Chief Medical Officer DEBORAH CASTILLO, PHD VP, Regulatory POOJA CHATERJEE VP, Clinical RICHA GUJARATI SVP, Product TIM CRUICKSHANK Chief Financial Officer HeartBeam Leadership Team LANCE MYERS Chief AI Scientist Depth of experience across healthcare and technology ROB ENO Chief Executive Officer

     

     

    22 PETER FITZGERALD, MD, PHD Chief Medical Officer C. MICHAEL GIBSON, MD SAB Chair CHARLES L. BROWN III, MD SAB Member TONY DAS, MD SAB Member CAMPBELL ROGERS, MD SAB Member NIRAJ VARMA, MD, PHD SAB Member ROBERT HARRINGTON, MD SAB Member HeartBeam Scientific Advisory Board Worldwide experts in cardiology

     

     

    23 Closing Summary BREAKTHROUGH IN CARDIAC TECHNOLOGY • IP protected design: smallest, easiest - to - use and first cable - free 12 - lead ECG device • Potential for major advances over existing ambulatory ECG technology • Heart attack detection with patient • AI algorithms for early disease detection and personalized cardiac insights SIGNIFICANTLY DERISKED OPPORTUNITY GO - TO - MARKET OPTIONS IN MULTIPLE VERTICALS • $1 billion+ opportunity in initial markets: Concierge and Direct Patient Pay • Positioned to disrupt numerous large markets and clinical applications worth a combined $100 billion+ • High margin, recurring revenue model • Range of strategic partnership opportunities to accelerate growth • Foundational FDA clearance achieved • Second FDA submission to be submitted imminently • Significant clinical data on equivalence/superiority to 12L ECG • Continued derisking through near - term milestones

     

     

    24 Enables sufficient runway to reach next value - inflection milestones The Offering Price Per Share To Be Determined Offer Type Registered Public Offering* Security Straight Common Stock Offering Amount $10 MILLION * A copy of the registration statement can be found here: https://www.sec.gov/Archives/edgar/data/1779372/000121390024111343/ea0225279 - 424b5_heartbeam.htm Additional Information • Allocation preference given to existing shareholders (MDBH and BEAT) • Account with MDB Direct or a selected dealer required to participate • Management believes the Offering qualifies for Section 1202/QSBS exclusion** ** We believe that upon the close of this offering ( i ) we will be an “eligible corporation” as defined in Section 1202 (e)( 4 ) of the Internal Revenue Code of 1986 , as amended, or Code, (ii) we will not have made any purchases of our own stock during the one - year period preceding the closing having an aggregate value exceeding 5 % of the aggregate value of all our stock as of the beginning of such period and (iii) our aggregate gross assets, as defined by Code Section 1202 (d)( 2 ), at no time and through the closing will have exceeded or will exceed $ 50 million, taking into account the assets of any corporations required to be aggregated with us in accordance with Code Section 1202 (d)( 3 ) . As such, we believe that the common stock offered hereby may be “qualified small business stock” pursuant to Code Section 1202 (c) . Certain prospective purchasers may be eligible for an exemption from federal income tax on capital gains with respect to “qualified small business stock” held for more than five years . For such exemption to apply to such purchaser, we will have to meet certain active business tests during substantially all of the purchaser’s holding period, which tests may be impacted by our future operations and our utilization of the proceeds of this offering . We cannot assure that we will meet all or any of such tests during substantially all of a purchaser’s holding period . Purchasers must consult their own tax advisors with regard to the applicability or interpretation of Section 1202 of the Code .

     

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    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

    10/17/24 8:31:00 AM ET
    $BEAT
    Medical/Dental Instruments
    Health Care