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COVANOS, INC.COMPUTATIONAL VASCULAR TECHNOLOGIES
WWW.COVANOS.COMOCTOBER 2019
NEXT-GENERATION COMPUTATIONAL SOLUTIONSFOR THE DIAGNOSIS AND TREATMENTOF CARDIAC AND VASCULAR DISEASE
IMPORTANT NOTICE TO PROSPECTIVE INVESTORS
THE INFORMATION CONTAINED HEREIN IS PROVIDED TO YOU ON A NON-CONFIDENTIAL BASISFOR INFORMATIONAL PURPOSES ONLY AND IS NOT, AND MAY NOT BE RELIED ON IN ANYMANNER AS, LEGAL, TAX OR INVESTMENT ADVICE OR AS AN OFFER TO SELL OR A SOLICITATIONOF AN OFFER TO BUY AN INTEREST IN COVANOS, INC. (the “Company”). This document does notpurport to contain all the information that may be required to evaluate an investment in the Company,and is subject to completion and amendment. Certain factual information has been obtained from third-party sources believed to be reliable but has not been independently verified. The information may notbe reproduced, redistributed or otherwise used outside your organization without the Company’sexpress written approval. Each recipient, by accepting these materials, is deemed to agree to theforegoing, and to agree to return these materials promptly upon request.
An investment in the Company will involve significant risks, including potential loss of the entireinvestment. Investors should also have the financial ability and willingness to accept the riskcharacteristics of the Company’s undertakings. No representation is being made that the Company willor is likely to achieve profits. None of the information presented herein is meant to be a historicaldescription or a prediction of the future performance of the Company.
Prospective investors should make their own investigations and evaluations of the information containedherein. Each prospective investor should consult its own attorney, business adviser and tax adviser as tolegal, business, tax and related matters concerning the information contained herein.
Except where otherwise indicated herein, the information provided herein is based on matters as theyexist as of the date of preparation and not as of any future date, and will not be updated or otherwiserevised to reflect information that subsequently becomes available, or circumstances existing orchanges occurring after the date hereof.
Certain information contained in this presentation constitutes “forward-looking statements,” which canbe identified by the use of forward-looking terminology such as “may,” “will,” “should,” “expect,”“anticipate,” “target,” “project,” “estimate,” “intend,” “continue” or “believe,” or the negativesthereof or other variations thereon or comparable terminology. Due to various uncertainties and risks,actual results and performance of the Company may differ materially from those reflected orcontemplated in such forward-looking statements.
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• A Transformational Technology• Proprietary physics-based computational platform• Non-invasive diagnosis and therapeutic decision making for cardiac and vascular disease
• C-HEART• Combined with CT angiography, C-HEART models the reduction in blood flow across coronary
blockages due to coronary artery disease (CAD)• Non-invasively identifies coronary artery blockages that should be re-vascularized by a
subsequent invasive procedure (stent placement or surgery).• Has the potential to eliminate over one million unnecessary invasive coronary angiograms
performed annually in the US and EU that do not demonstrate obstructive CAD
• The C-HEART Advantage• Clinically validated indices of coronary blood flow obstruction (FFR and iFR)• Local, Point-of-Care, client-controlled PC workstation solution• Rapid, near real time, integrated diagnostic report (<30 minutes)• Complete data integrity and IT security
• Series A $20M for the commercial development and launch of C-HEART
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Executive Summary
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Company History
• Founded by leaders at Emory University School of Medicine and Georgia Institute of Technology• $6 million invested in the technology platform• 10+ year multidisciplinary collaboration• Interventional Cardiology• Biomedical Engineering• Computational Fluid Dynamics• Mathematics
Covanos Addresses Two Critical Unmet Needs
Diagnosis of Stable AnginaDoctor’s Office or Clinic
Diagnosis of AnginaEmergency Department
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Chest Pain• Office evaluation• ED visit
Stress Test or CTA• Lack diagnostic accuracy•Drives unnecessary procedures
Invasive Procedures• Cardiac Catheterizations• Stents• Referral to surgery (CABG)
Current Medical Practice
*Computed Tomography Angiography 6
Non-Invasive Stress Tests or CT Angiography (CTA)* Overestimates the Severity of Coronary Artery Disease
The Consequence of Current Medical Practice
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Does the Patient have Obstructive Coronary
Disease Requiring Revascularization?
YES1,350,000 2
NO1,650,000 2
AbnormalTest
3 millionInvasive Coronary
AngiogramsNon-Invasive
55%
Stress or Imaging Tests
45%
1.6 Million+ Unnecessary Invasive Coronary Angiographies Annually1
$2.7B in US aloneProcedural Morbidity
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Either of two clinically-validated indices are used to measure the impact of a blockage on normal coronary blood flow• FFR: fractional flow reserve measures the ratio of distal to proximal pressures at
maximum flow• iFR: instantaneous wave-free ratio measures the ratio of distal to proximal pressures at
rest
Proximal pressuremeasurement
Distal pressuremeasurement
Flow
Blockage
Both FFR4,5 and iFR-guided therapies6,7 improve clinical outcomes and reduce costscompared to ICA guided therapy alone
Revascularization Decision is Made by Combining ICA with Functional Assessment of Coronary Blood Flow
To Stent or Not to Stent?
Outpatient CT Angiographic Diagnosis C-HEART Functional Diagnosis
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C-HEART uses proprietary computational algorithms to compute the decrease in blood flow due to specific coronary artery blockages identified by CTA
• Computed FFR and iFR are Clinically Validated 4,5,6,7
• Rapid integrated report (<30 minutes) • Point-of-Care• Complete Data integrity and IT security
FFR or iFR
CTA Plus C-HEART Provide the Answer Non-Invasively
2015Japan, Korea8
2017UK 9
2019European Union10
2020 (estimated)United States11
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CTA is Being Adopted Globally as a First Line Diagnostic To Assess the Severity of Coronary Artery Disease
Total Addressable Market for C-HEART – United States
Non-Invasive myocardial imaging tests
CT+SPECT+PET+MRI~11 million
US Present 11
US Future 12
Non-Invasive myocardial imaging tests
CT+SPECT+PET+MRI~11 million
Potential C-HEARTProcedures13
~1,600 K
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CT Angiography~550 K
Potential C-HEARTProcedures13
~300 K
CT Angiography~2,750 K
CT AngiographyPercent of Total Imaging
Tests Performed
5%
25%
CT Data 3D Geometry Generation
C-HEARTVessel
Segmentation
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ComputationalFluid Dynamics
Compatible with all major CT
manufacturers
Patient data, analysis and C-HEART reports remain LOCAL and do not leave the health-system firewall
How Does C-HEART Work?C-HEART Determines Whether there are Critical Obstructions to Blood
Flow due to Coronary Artery Blockages (Red)
FFR or iFR
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Dia
gno
stic
Acc
urac
y A
gai
nst
INVA
SIV
E FF
R (%
)
0
50
100
SPECTNuclear
Imaging14
StressEcho-
Cardiography15
CTAngiography16 C-HEART17
C-HEART Meets or Exceeds High Diagnostic Accuracy For Clinical Decision Making
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High Diagnostic Accuracy • Non-invasive• Compatible will all major CT manufacturers• Models blood flow across coronary blockages using well established physics
Clinically Validated• Improves patient outcomes• Reduces healthcare costs• Major medical societies diagnostic guideline recommendation
Rapid Integrated Report (<30 minutes)• Integrates seamlessly into CT imaging procedures• Improves physician workflow and clinical decision making• Enables time sensitive evaluations of chest pain (e.g., ED)
Point-of-Care, Complete Data Confidentiality and IT security• Superior algorithms utilize a single, locally-sited, client-controlled PC workstation • Patient data, analysis, reports reside WITHIN the local healthcare IT network• Facilitates adoption by IT security-restricted health provider systems (e.g., VA)
CT: CAT scan, ED: Emergency Department, VA: Veterans Administration, IT: Information Technology, PC: Personal Computer 14
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+ --
C-HEART Addresses the Needsof the Clinical Marketplace
Coronary Artery Disease
Cerebrovascular Disease
Carotid Artery Disease
Renal Disease
Peripheral Vascular Disease
Building a Diversified, Risk-Mitigated Product Portfolio with Multiple Horizontal and Vertical Market Opportunities
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Executive Team
Russell Medford MD, PhD, Chairman and Chief Executive OfficerPrior Experience: CEO AtheroGenics, Board Member Inhibitex, Board Chairman Oncospherix, Board Member Cesca Therapeutics (Nasdaq: KOOL)
Habib Samady, MD, Vice Chairman and Chief Medical OfficerProfessor of Medicine and Director of Interventional Cardiology for Emory University Healthcare Deputy Editor of the Journal of American College of Cardiology Cardiovascular Interventions
Don P. Giddens, PhD, Chief Operating OfficerMember of the National Academy of EngineeringPrior Experience: Dean, College of Engineering, Georgia Institute of Technology
Alessandro Veneziani, PhD, Chief Scientific OfficerProfessor of Mathematics and Computer Science at Emory University
Mark Colonnese, Chief Financial OfficerPrior Experience: CFO at: Aviragen Therapeutics, Stealth BioTherapeutics, AtheroGenics; VP Finance at Schering-Plough, Board Member: Bio-Path Holdings (Nasdaq: BPTH)
Brian Walsh, Senior Vice President, Commercial OperationsPrior Experience: President at Dornier MedTech America; General Manager at ADAC Laboratories and Senior Product Manager at Siemens
Laila Samady-Mustad, PhD, Vice President, Business DevelopmentPrior Experience: Global Trial Alliance Manager, Boehringer Ingelheim
COVANOS, INC.COMPUTATIONAL VASCULAR TECHNOLOGIES
WWW.COVANOS.COMOCTOBER 2019
NEXT-GENERATION COMPUTATIONAL SOLUTIONSFOR THE DIAGNOSIS AND TREATMENTOF CARDIAC AND VASCULAR DISEASE
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Appendix - Footnotes
1 Covanos internal data for US and major European market countries
2 Douglas PS et al (2011) “Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography”, Eur Heart J 36:3359-3367 – Obstructive coronary disease defined as >50% angiographic stenosis
3 Estimated 540,000 procedures in the US x $7000 cost per procedure4 Tonino P.A., De Bruyne B., Pijls N.H.,et al. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med 2009: 360:213–224.
5De Bruyne B, Fearon WF, Pijls NH, et al. Fractional Flow Reserve-Guided PCI for Stable Coronary Artery Disease. N Engl J Med 2014;371:1208-17.
6 Davies JE, et al., Use of the Instantaneous Wave-free Ratio or Fractional Flow Reserve in PCI. N Engl J Med. 2017 May 11;376(19):1824-1834.7Gotberg M, et al., iFR-SWEDEHEART Investigators. Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI. N Engl J Med. 2017 May 11;376(19):1813-1823
8Kim et al (2015) “Korean Guidelines for the Appropriate Use of Cardiac CT” Korean J Radiol 2015;16(2):251-285,
9Moss et al (2017) “The Updated NICE Guidelines: Cardiac CT as the First-Line Test for Coronary Artery Disease”, Curr Cardiovasc Imaging Rep 10: 15,
10 Knutti et al (2019) “2019 ESC Guidelines for the diagnosis and management of chronic coronary syndromes. The Task Force for the diagnosis and management of chronic coronary syndromes of the European Society of Cardiology (ESC)” European Heart Journal (2019) 00, 1-71 doi:10.1093/eurheartj/ehz425
11 Myocardial perfusion scans in the US, Berrington-Gonzalez, A et al Circulation. 2010;122:2403–2410, CT Angiography procedures US current – personal communication from Dr. Leslee Shaw, Cornell
12Assumes an adoption rate for CT angiography of 25% in 5 years post-launch
13Assumes 58% of CTAs will undergo C-HEART test – derived from Fairbairn et al, (2018) “Real-world clinical utility and impact on clinical decision-making of coronary computed tomography angiography-derived fractional flow reserve: lessons from the ADVANCE Registry”, European Heart Journal (2018) 39, 3701–3711
14Melikian N et al (2010) JACC:Cardiovascular Interventions 3:307-314
15Jung PH et al (2008) Eur Heart J 29:2536-2543
16Min J et al (2012) JAMA 308:1237-1245
17Covanos internal clinical data from 79 patient vessels