Heartbeam, Inc. · NASDAQ:BEAT
Heartbeam — Q1 2024 Earnings Presentation
18 slides from Heartbeam's earnings presentation, May 9, 2024
Slide 1: The Power of a 12-Lead ECG
The Power of a 12-Lead ECG Always with the patient First Quarter 2024 Financial Results Conference Call NASDAQ: BEAT May 9, 2024
Slide 2: Disclaimers
First Quarter 2024 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 position
Slide 3: Agenda
First Quarter 2024 Financial Results Conference Call Agenda •Introduction and Company Overview 30 years of experience in 28 years of experience with a technology development and proven track record of developing •AIMIGo Regulatory and Clinical Study senior management positions. At Intel, he was the
Slide 4: No Heart Attack Solution Practical for Home Use on the Market
First Quarter 2024 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 use
Slide 5: HeartBeam AIMIGo: Easy-to-Use Credit Card-Sized 12-Lead ECG
First Quarter 2024 Financial Results Conference Call HeartBeam AIMIGo: Easy-to-Use Credit Card-Sized 12-Lead 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) • Prov
Slide 6: Patients Cannot Determine if They Are Having a Heart Attack
First Quarter 2024 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 an
Slide 7: 12-Lead ECG is the Standard of Care in Cardiology: Why AIMIGo Matters
First Quarter 2024 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-le
Slide 8: HeartBeam US Market Opportunity
First Quarter 2024 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 9: AIMIGo FDA Clearance Will be a Major Milestone
First Quarter 2024 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 excellent
Slide 10: Foundational Study Demonstrates Excellent Performance of VECG in Coronary Occlusion Detection
First Quarter 2024 Financial Results Conference Call Foundational Study Demonstrates Excellent Performance of VECG in Coronary Occlusion Detection HEARTBEAM MATCHED 12-LEAD BASELINE ENHANCES HEARTBEAM WITH BASELINE ECG PERFORMANCE DIAGNOSTIC PERFORMANCE OUTPERFORMS A SINGLE 12-LEAD ECG 95% >30% 68%
Slide 11: Regulatory Status for AIMIGo Product
First Quarter 2024 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, physicia
Slide 12: Regulatory Status for 12-Lead Synthesis Software
First Quarter 2024 Financial Results Conference Call Regulatory Status for 12-Lead 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 12-lead ECG and Z projections • Submission a
Slide 13: Enrollment Progressing in VALID-ECG Pivotal Study
First Quarter 2024 Financial Results Conference Call Enrollment Progressing 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 ~1
Slide 14: AI Program Update
First Quarter 2024 Financial Results Conference Call AI Program Update » PROGRAM OVERVIEW » ALGORITHM DEVELOPMENT » BENEFITS OF AI • Active AI Program underway • Initial algorithm, HeartBeam AI, • Automated classifications • Includes 5 PhDs developed focusing on ability to • Further enhance the user
Slide 15: EHRA Data: HeartBeam AI Improves Arrhythmia Detection Over Single-Lead ECGs
First Quarter 2024 Financial Results Conference Call EHRA Data: HeartBeam AI Improves Arrhythmia Detection Over Single- Lead ECGs Found in Leading Smartwatches and Other Wearables • Atrial flutter is a common arrhythmia and typically requires a 12-lead ECG to be taken in a medical setting which is c
Slide 16: Q1 2024 Financial Highlights
First Quarter 2024 Financial Results Conference Call Q1 2024 Financial Highlights $ in Thousands Quarter Ended March 31, 2024 2023 Operating Expenses: General & Administrative $2,356 $2,475 Research & Development 2,428 1,681 Total Operating Expenses 4,784 4,156 Loss from Operations (4,784) (4,156) I
Slide 17: Closing Summary
First Quarter 2024 Financial Results Conference Call Closing Summary SIGNIFICANT • AIMIGo clearance: Completed initial phase and working interactively with FDA. Guidance CLINICAL AND unchanged: Estimate clearance in Q2 REGULATORY • VALID-ECG study, the basis of 12-lead Synthesis clearance: enrollmen
Slide 18: 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