Heartsciences Inc. · NASDAQ:HSCS
Heartsciences — Heart Test Laboratories — IPO Roadshow (June 2022)
25 slides from Heartsciences's IPO roadshow presentation, Jun 6, 2022
Slide 1: AI + Advanced Signal Processing - Designed to Revolutionize ECG Capability
AI + Advanced Signal Processing - Designed to Revolutionize ECG Capability Company Overview MyoVista® Wavelet ECG Game Changing AI Technology Designed for Point-of-Care Assessment of Heart Health. June 2022 Not FDA Cleared or Approved Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated J
Slide 2: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering to which this presentation relates. Because it is a summary, it does not contain all of the information that you should consider before investing in our securities. The Company has filed a Regi
Slide 3: Safe Harbor
SAFE HARBOR INVESTOR OVERVIEW This document contains forward-looking statements including statements that address activities, events or developments that Heart Test Laboratories, Inc., a Texas corporation (“HeartSciences” or the “Company”), expects, believes or anticipates will or may occur in the f
Slide 4: The Offering
The Offering Issuer Heart Test Laboratories, Inc. dba HeartSciences Transaction Type Initial Public Offering Securities Offered: 1,750,000 units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock (100% Primary) Anticipated NASDAQ Symbols: HSCS an
Slide 5: HeartSciences: An Innovation Leader in a New Era for ECG
HeartSciences: An Innovation Leader in a New Era for ECG INVESTOR OVERVIEW Designed to address the significant diagnostic gap in heart disease. New era for ECG - Disruptive technology. >$50 million investment in the Company to date and we aim to achieve FDA clearance with this offering. Significant
Slide 6: Heart Disease – The Diagnostic Gap is in Front-Line Healthcare
Heart Disease – The Diagnostic Gap is in Front-Line Healthcare Conventional ECG has low sensitivity for 2 out of the 3 categories of heart disease (ischemia (CAD) and structural) Inefficient referral process for #1 cause of death and #1 healthcare cost Possibly ECG Echo Stress Echo Risk Assessment E
Slide 7: Published Research on New Possibilities: AI Enables Much Greater Clinical Value
Published Research on New Possibilities: AI Enables Much Greater Clinical Value Beginning of a new era of expanded ECG capabilities “Application of AI to the ECG—a ubiquitous, low-cost test—permits the ECG to serve as a powerful screening tool in asymptomatic individuals to identify asymptomatic lef
Slide 8: Focused on New Clinical Indications to Address Conventional ECG’s Limitations
Focused on New Clinical Indications to Address Conventional ECG’s Limitations Traditional ECG: Significant Limitations Traditional ECG: Easier to Use AI using ECG: Research Now Validating the Possibilities AI + (Patented) Signal Processed ECG Designed to Add Detection of Cardiac Dysfunction Conventi
Slide 9: MyoVista: Patented wavECG Information + Standard ECG Information
MyoVista: Patented wavECG Information + Standard ECG Information Conventional ECG protocols – limited training required or barriers to use Standard 12-lead ECG protocols with no change in clinical workflow or training. Simple algorithm result output– easy to interpret. wavECG indication for LV relax
Slide 10: Intellectual Property
Intellectual Property 8 US granted or allowed patents covering more than a hundred of claims. Core signal processing patents protect use of key signal processed information – US and international protection. Proprietary patented electrode connector system. Proprietary wavECG patient database. Tradem
Slide 11: LV Diastolic Dysfunction (LVDD) an Early Biomarker for Heart Disease
LV Diastolic Dysfunction (LVDD) an Early Biomarker for Heart Disease “LV diastolic function [cardiac relaxation phase] is impaired by all of the common pathological processes that affect LV function or produce LV hypertrophy or fibrosis, including hypertension, diabetes mellitus, ischemia, myocardit
Slide 12: Prior Validation Study
Prior Validation Study: n= 343 Borderline patients generally sit around the threshold measures Impaired LV relaxation thresholds determined by ASE/EACVI 2016 GUIDELINES AND STANDARDS for Evaluation of Left Ventricular Diastolic Dysfunction (e’ lateral<10cm/s or e’ septal <7cm/s) MyoVista Algorithm O
Slide 13: MyoVista Technology Clinical Studies
Surface ECG-based Machine Learning Model For Predicting Patient Subgroup at a High Risk for Major Adverse Cardiac Events West Virginia, Mount Sinai, UCLA and Windsor Cardiac Center 1245 subjects (n=518). 84% sensitivity, 72% specificity with AUC 84% in prediction of MACE events over a 38-month perio
Slide 14: Key Milestones
Key Milestones Complete Validation Study Enrollment Validation Study Results FDA De Novo Resubmission Sales Launch FDA Clearance Build Sales Team and Undertake Early KOL Evaluations Publications and clinical studies. Research collaboration. International evaluations. Patents. Other On-going Activiti
Slide 15: MyoVista wavECG: Regulatory Status
MyoVista wavECG: Regulatory Status MyoVista a new type of ECG; FDA De Novo regulatory pathway; Class II non-significant risk device. Prior De Novo submission during 2020: Several rounds of interaction with FDA – greater clarity on resubmission requirements. Modifications have been made to MyoVista.
Slide 16: Big Market, Recurring Revenue, Fits Existing Care Pathways
Big Market, Recurring Revenue, Fits Existing Care Pathways RECURRING REVENUE Razor/razorblade business model Device revenue plus supplies revenue from every test LARGE GLOBAL OPPORTUNITY Conventional ECG market $5 billion (Capital equipment only) Est. 500 million - 1 billion ECG tests per year (Supp
Slide 17: Recurring Revenue: Razor/Razorblade Business Model
Recurring Revenue: Razor/Razorblade Business Model Full feature ECGs typically cost $5k - $10k. Expect to price MyoVista in or below this range. Business model not dependent on a high price for the MyoVista device. Patented electrode cable connection system. High quality, low impedance, stable signa
Slide 18: Scale of Market Opportunity is Enormous
Scale of Market Opportunity is Enormous ECG testing ubiquitous and growing despite general guidance against its use for screening: 27+ million tests in ambulatory care 7+ million cardiac stress tests in ambulatory care 28+ million tests in ER Estimated >100 million ECG tests in the USA alone. Echo t
Slide 19: ECG is Used Throughout Healthcare - MyoVista Could Have Wider Application
ECG is Used Throughout Healthcare - MyoVista Could Have Wider Application Cardiac dysfunction is critical in most use environments – Predominantly used outside cardiology Early Focus Areas Medium Term Opportunities PCP/ CONCIERGE Concierge Medicine Patient Management RETAIL CLINICS/ SCREENING Cardia
Slide 20: Adoption – Early Sales Focus on Early Adopters
Adoption – Early Sales Focus on Early Adopters Focus Rep Location Cardiology Regional PCP/ Concierge Regional Retail Clinics/ Screening HQ 209,000 PCPs in the USA Direct Sales Force in USA Distributors Internationally PCP/ Concierge Medicine High density of concentration in major states – even more
Slide 21: Adoption – Marketing, Validation and Reimbursement
Adoption – Marketing, Validation and Reimbursement Marketing Clinical Validation and Reimbursement Marketing Support Physician profit opportunity information Website and product literature Field clinical personnel to support evaluations and physician training Journal articles and PR Large number of
Slide 22: Senior Management Team
Senior Management Team HeartSciences Exec. Chairman 2013 – current. Peel Group CEO - $8 billion of assets. Speedy Hire Main Board Director and Division MD – Company became a FTSE 250 during that time. Rothschild. Investment Banker. PWC Chartered Accountant. HeartSciences CEO 2013 – current. INX CEO/
Slide 23: Clinical Study Institutions and Key Researchers
Clinical Study Institutions and Key Researchers HEART DISEASE CHALLENGES Mark Hilz COO Carol Krieger VP Clinical/Regulatory Partho Sengupta - Professor of Cardiology and Chief of Cardiology at Rutgers Robert Wood Johnson Medical School (RWJMS), and Chief of Cardiology at Robert Wood Johnson Universi
Slide 24: Cap Table Summary
Cap Table Summary Excludes Underwriter’s overallotment option. Assumes 1.75M Units Sold at $5.00 Per Unit. *Conversion price Anticipated Use of Net Proceeds $m To FDA submission 3.6 FDA clearance period 2.2 Interest payment 0.1 Post clearance period - market launch preparation, working capital and R
Slide 25: HeartSciences: An Innovation Leader in a New Era for ECG
HeartSciences: An Innovation Leader in a New Era for ECG INVESTOR OVERVIEW Designed to address the significant diagnostic gap in heart disease. New era for ECG - Disruptive technology. >$50 million investment in the Company to date and we aim to achieve FDA clearance with this offering. Significant