Heartbeam, Inc. · NASDAQ:BEAT
Heartbeam — Q4 2023 Earnings Presentation
26 slides from Heartbeam's earnings presentation, Mar 20, 2024
Slide 1: The Power of a 12-Lead ECG
The Power of a 12-Lead ECG Always with the patient Fourth Quarter & Full Year 2023 Financial Results Conference Call NASDAQ: BEAT March 20, 2024
Slide 2: Disclaimers
Fourth Quarter 2023 Financial Results Conference Call DISCLAIMERS 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 positio
Slide 3: Agenda
Fourth Quarter 2023 Financial Results Conference Call Agenda 30 years of experience in 28 years of experience with a •Introduction and Company Overview technology development and proven track record of developing senior management positions. markets and commercializing •AIMIGo Update At Intel, he wa
Slide 4: Company Overview
Fourth Quarter 2023 Financial Results Conference Call Company Overview Branislav Vajdic, PhD Chief Executive Officer 4
Slide 5: No Heart Attack Solution Practical for Home Use on the Market
Fourth Quarter 2023 Financial Results Conference Call No Heart Attack Solution Practical for Home Use on the Market IMPRACTICAL DO NOT DETECT FOR HOME USE HEART ATTACKS TRADITIONAL 12-LEAD ECG PATIENT-FRIENDLY Standard 12-lead ECGs require a health care professional and are not practical for home us
Slide 6: HeartBeam AIMIGo: Easy-to-Use Credit Card-Sized 12L ECG
Fourth Quarter 2023 Financial Results Conference Call HeartBeam AIMIGo: Easy-to-Use Credit Card-Sized 12L ECG HEARTBEAM AIMIGo: • First and only credit card-sized 12-lead ECG device • Handheld device with no external electrodes or wires • Captures heart’s signals in 3 projections (X, Y, Z) • Provide
Slide 7: Patients Cannot Determine if They Are Having a Heart Attack
Fourth Quarter 2023 Financial Results Conference Call Patients Cannot Determine if They Are Having a Heart Attack Ignore symptoms Go to Emergency Department Lost lives Wasted healthcare dollars » Patients delay an average of 3 hours » Chest pain is second most before seeking care common reason for a
Slide 8: 12-Lead ECG is the Standard of Care in Cardiology
Fourth Quarter 2023 Financial Results Conference Call 12-Lead ECG is the Standard of Care in Cardiology: WHY AIMIGo MATTERS IMPACT: TRANSFORMATIONAL: • Ability to take frequent 12-lead ECG recordings over time in various real-life situations is potentially of major diagnostic value AIMIGo makes 12-l
Slide 9: HeartBeam US Market Opportunity
Fourth Quarter 2023 Financial Results Conference Call HeartBeam US Market Opportunity Potential to address Total CAD Patients ~20M Atrial Fibrillation market AFib Patients ~3M and 6x larger Coronary MARKET OPPORTUNITY Artery Disease (CAD) • AFib: $2 Billion $14B+ market • CAD: $12+ Billion HeartBeam
Slide 10: AIMIGo Update
Fourth Quarter 2023 Financial Results Conference Call AIMIGo Update Rob Eno President 10
Slide 11: AIMIGo FDA Clearance Will be a Major Milestone
Fourth Quarter 2023 Financial Results Conference Call AIMIGo FDA Clearance Will be a Major Milestone FOUNDATION FOR FUTURE SUBMISSIONS AND PRODUCT PIPELINE • Expect to be first patient-held 3D VECG device cleared by the FDA • Basis for further HeartBeam FDA submissions • 3D VECG approach is excellen
Slide 12: Foundational Study Demonstrates Excellent Performance of VECG in Coronary Occlusion Detection
Fourth Quarter 2023 Financial Results Conference Call Foundational Study Demonstrates Excellent Performance of VECG in Coronary Occlusion Detection HEARTBEAM MATCHED BASELINE ENHANCES HEARTBEAM WITH BASELINE 12L ECG PERFORMANCE DIAGNOSTIC PERFORMANCE OUTPERFORMS A SINGLE 12L ECG 95% >30% 68% Standar
Slide 13: Regulatory Updates
Fourth Quarter 2023 Financial Results Conference Call Regulatory Updates Deborah Castillo, PhD VP, Regulatory Affairs 13
Slide 14: Regulatory Status for AIMIGo Product
Fourth Quarter 2023 Financial Results Conference Call Regulatory Status for AIMIGo Product • HeartBeam AIMIGo 510(k) application submitted STATUS • Cornerstone submission for HeartBeam • Clearance as a 3D VECG recording device PRODUCT • Includes credit card-sized device, patient application, physici
Slide 15: Regulatory Status for 12L Synthesis Software
Fourth Quarter 2023 Financial Results Conference Call Regulatory Status for 12L Synthesis Software Algorithm to • 510(k) pathway synthesize a 12- • Pivotal study underway to show similarity to a lead ECG from X, Y simultaneously recorded hospital-based 12L ECG and Z projections • Submission anticipa
Slide 16: VALID-ECG Study
Fourth Quarter 2023 Financial Results Conference Call VALID-ECG Study Rob Eno President 16
Slide 17: First Patients Enrolled in VALID-ECG Pivotal Study
Fourth Quarter 2023 Financial Results Conference Call First Patients Enrolled in VALID-ECG Pivotal Study STUDY • VALID-ECG (Clinical Validation of the AIMIGo 12-Lead OVERVIEW ECG Synthesis Software for Arrhythmia Detection) Pivotal Study • Prospective, single-arm, multicenter trial • Plan to enroll
Slide 18: AI Program Update
Fourth Quarter 2023 Financial Results Conference Call AI Program Update Branislav Vajdic, PhD Chief Executive Officer 18
Slide 19: AI Program Update
Fourth Quarter 2023 Financial Results Conference Call AI Program Update » PROGRAM OVERVIEW » ALGORITHM DEVELOPMENT » BENEFITS OF AI • Active AI Program underway • Initial algorithm developed • Automated classifications • Includes 5 PhDs focusing on ability to detect • Further enhance the user variou
Slide 20: IP Update
Fourth Quarter 2023 Financial Results Conference Call IP Update Branislav Vajdic, PhD Chief Executive Officer 20
Slide 21: Leadership in Portable VECG Space
Fourth Quarter 2023 Financial Results Conference Call Leadership in Portable VECG Space INTELLECTUAL PROPERTY & PRODUCT PIPELINE AIMIGo EXTENDED WEAR INTEGRATED HEARTBEAM 12L VECG SYSTEM PATCH SYSTEM SMART WATCH Multiple granted patents, including Foundational patents granted: Multiple patents grant
Slide 22: Financial Results
Fourth Quarter 2023 Financial Results Conference Call Financial Results Rick Brounstein Consulting CFO 22
Slide 23: Q4 & Full Year 2023 Financial Highlights
Fourth Quarter 2023 Financial Results Conference Call Q4 & Full Year 2023 Financial Highlights $ in Thousands Quarter Ended December 31, Year Ended December 31, 2023 2022 2023 2022 Operating Expenses: General & Administrative $2,099 $2,098 $8,516 $7,354 Research & Development 2,010 1,641 6,798 5,677
Slide 24: Closing Summary
Fourth Quarter 2023 Financial Results Conference Call Closing Summary Branislav Vajdic, PhD Chief Executive Officer 24
Slide 25: Closing Summary
Fourth Quarter 2023 Financial Results Conference Call Closing Summary • AIMIGo clearance: Completed initial phase and working interactively with FDA. Estimate SIGNIFICANT clearance in Q2 CLINICAL AND • Initiated VALID-ECG study, which will be the basis of 12L Synthesis clearance REGULATORY PROGRESS
Slide 26: Q&A
Q&A Company Investor Relations Rick Brounstein Chris Tyson Consulting CFO Executive Vice President HeartBeam, Inc. MZ North America ir@heartbeam.com Direct: 949-491-8235 BEAT@mzgroup.us www.mzgroup.us www.heartbeam.com 2118 Walsh Avenue, Suite 210 Santa Clara, CA 95050