ACDx Investor Presentation
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PPT Presentation for All Clear Diagnostics, Inc. to prospective investors that demonstrates how their product, ClearECG for MRI, fulfills unmet needs in what represents a very lucrative investment opportunity.
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ACDx Investor Presentation
- 1. ClearSolutions™ Family of Products
- 2. ClearECG™ for MRI ENABLING MRI EXPANSION by All Clear Diagnostics, Inc.
- 3. Problem: Unmet Needs The MRI Magnet Distorts ECG signals and obstructs: Diagnostic Patient Safety Monitoring Improved Workflow / Reduced Test Time Market Expansion to multi-$B segments ClearECG™ for MRI solves these unmet needs
- 4. MRI: Best Soft-Tissue Resolution / No Ionizing Radiation CVD/CAD Diagnosis: MRI in Context Echocardiogram X-ray | CT Scan MRI [ Widely used method [ Higher resolution vs. Echo Superior soft tissue imaging Zero Ionizing Radiation x Other diseases (i.e. lung) x Limited tissue resolution x Magnet distorts ECG signals obstruct Echo views (vs. MRI) x Limited cardiac diagnostic x Ionizing Radiation yield Exposure
- 5. MRI: The Promise, Problems & Pressures The MRI Promise Technical Problems Industry Pressures The Minimally Invasive “MRI promises to Reduced Profits: Interventional Surgery (MIS) revolutionize MIS, but is Reduced Reimbursements market growing to $0.00B obstructed by the inability by 2016, CAGR of 8.2% to provide diagnostic Growing market demands: ECG monitoring during Industry Consolidations — Frost & Sullivan, these procedures.” 5500 to 3500 hospitals/AI Kalorama, Companys & Markets, — National Institutes of facilities by 2018 Goliath Health/National Heart Lung — Ken Weixel, Blood Institute U.S. Managing Partner Deloitte & Touche
- 6. Enabling an $0-00B MRI market potential ClearECG Value Proposition Enable MRI to expanded markets: $0 – 00B First-ever Minimally Invasive Interventions $0 – 0B Diagnostic ECG Cardiac ischemia evaluations $0 – 0B during MRI ER Chest Pain Referrals $0 – 0B 99.9%+ Reduce test time up to 50%" Triggering/Adaptive Extend MRI useful life – delay new MRI installation Gating Accuracy Expand MRI MIS utilization ($00.0B by 2016)
- 7. What is ClearECG for MRI? ClearECG™ for MRI R L A P A 1 V V 1 2 P 2 V 6 R L What is it? Unique Patented Wearable/Portable Software Algorithms Hardware Components SaaS-based Services ClearECG Extraction 100% MRI- Real-time, online support Disease detection (CAD, CVD, CHF) compatible Patient set up and fitting Arrhythmia characterization Integrated, interoperable ECG calibration Wearable-computing devices ECG alarm notify and guidance
- 8. Easy-to-Use | Faster | More Accurate & Robust ClearECG for MRI Direct to MRI Tube w/ECG Easy to apply and wear 1st Dx ECG during MRI Continuous Monitoring R L A P A 1 V V 1 2 P 2 V 6 R L Provides: Enables: Facilitates: Ischemic detection Concurrent ECG/MRI Patient transit from: Enhanced arrhythmia Patient Safety Monitoring X-ray CT MRI characterization Ischemia & Arrhythmia Settable alarm thresholds Improved Gating/Triggering 50% Reduced Test Times Hemodynamic monitoring Protocol optimization
- 9. IP / Product / Business Partner Protection IP Portfolio & Barriers Vest Strategy Multi-Variate Signal Lorem ipsum dolor To continuously Separation sit amet, On-body improve on this Lorem ipsum dolor sit amet, consectetur computer patent portfolio consectetur adipiscing elit. adipiscing elit. Nam dictum ipsum sed Lorem ipsum dolor Nam dictum ipsum sed sit amet, consectetur tellus mattis viverra. adipiscing elit. Nam Aenean vitae dui mi. dictum ipsum sed Integer mi risus, Office tellus mattis viverra. Patent posuere vel tristique sed, Action Issued ornare vitae purus. Integer dolor mi Office Action IP
- 10. Improved Triggering, Gating & Dx ECG monitoring Competitive Advantage Triggering/Gating Dx Quality ECG Accuracy Adaptive Capabilities 1T 1.5T 3T 7T 10T Gating ARR ISC ClearECG™ for MRI 99%+ 99%+ 99%+ 99%+ 99%+ Yes Yes Yes Vector ECG (VCG / VKG) 95% 90% 80% 70% 55% No No No Invivo (Philips) 95% 92% 82% 73% 57% No No No Echo 75% 75% 75% 75% 75% No No No Cine MRI 95% 90% 80% 70% 55% No No No
- 11. Fastest Path to Market Regulatory Strategy Class II, 510K Equivalencies Defined FDA Diagnostic ECG Predicate = 12L ECG Predicates Gating/Triggering Predicate = Vector ECG CPT 93015 93115 CMS Today: CV Stress 93225 Reimbursements* Future: Combined coding Future: ECG/MRI CE Mark: Targeted EU countries Combined Other Regulatory BRIC * CMS discussion re: combined ECG/MRI CPT code
- 12. Ready for Field Validation & Product Development Achievements To-Date Validated Core IP – Dartmouth-Hitchcock Ability to extract Dx ECG during MRI 36 human double-blind tests ClearECG selected 85% time vs. pre-MRI ECG Coded algorithms and simulation tests Hardware IP – Designs and early prototypes Team – Medical & Technology expertise Boot-strapped R&D, Founder/F&F funding Advancing Medical Science
- 13. Business Model Multiple Revenue Streams 2 Sets of MRI-compatible leads (8 each) Direct & ClearECG 2 ClearWatch Platforms Starter Package Channels 1 Server w/ClearECG Software Suite Installation Service Training Contracts Maintenance Enhanced Workflow/Protocol Optimization Services Pulse Sequence Optimization Patient Set Up & Calibration Online Service Patient Monitoring Support Alarm Notification & Clinical Guidance
- 14. Sales & Services Revenues Revenue Distribution over 5 years in Market Product Sales Services $00M $00M $00M Strategy Transit from $0.00M Product sales to Long-Term Service Contracts Direct Channels Install/Maint SaaS Services Starter Pack $000K Start Pack $00K/unit Standard $00K/yr Fee/Test - $00-00 Disposables $0-0K Enhanced $00K/yr Maint/Consult $0-0K
- 15. Building Value at Each Stage $0M Series A Use of Funds $000K – (Tranche) $0M $0M $0.0M FVT #1 FVT #2 FVT #3 Regulatory Pilot Program Component First Human 10 Human Approvals Validation Subject Testing Subjects Procure QA product Clinical data FDA, CE Engage 5-10 equip, materials dev/test validation mark, CMS sites Documentation / Near-Market Market-ready Pilot Program Early Hire personnel prototype product Training Manufacture Complete Interim Submit regulatory Onboard Implement Pilots testable prototype Regulatory approvals Sales/Mktg Partner/License/ review personnel CoDev 6 months 1 6 months 2 4 months 3 8 months 4 5
- 16. A Disruptive, Game-Changing Solution 1st-ever Dx ECG patient monitor 1 Improved Triggering and Gating ClearECG for MRI 2 Reduce test time by up to 50% Extend MRI useful life THANK 3 Delay new MRI installation YOU Enable MRI Expansion 4 New Revenues $0 - 00B
- 17. ClearECG™ for MRI ENABLING MRI EXPANSION by All Clear Diagnostics, Inc. Cover Image by Sony Sivanandan
Editor's Notes
- Title: ACDxInvestor PresentationDescription: PPT Presentation for ClearSolutions to prospective investors that demonstrates how their product, ClearECG for MRI, fulfills unmet needs in what represents a greenfield, multi-billion dollar market investment opportunity. Category: Investor Relations (SlideShare)Tags: venture capital, investors, MRI, ECG, funding for business, medical devices, cardiac, capital fund raising, MRI magnet, diagnostic, diagnostic ECG, Cardiovascular, tranche, ClearSolutions
- Based on a definition by Applied Radiology, there are two primary modalities in nuclear imaging : Anatomical and Functional - CTA and CMR angiography provide anatomical data, allowing for the assessment of coronary stenosis (for example build up of arterial plaque). Alternatively, functional imaging modalities such as Cardiac MRI, SPECT, PET, and stress ECHO provide measures of ischemia.Echocardiogram is one of the most widely used diagnostic imaging methods, but has difficulty measuring ischemic conditions, particularly when other diseases are present, such as lung cancer. It also has limited data yield for cardiac conditions.X-ray, PET and CT provide higher resolution compared to Echo, but are still limited in their soft-tissue data yield compared to MRI. They also present the risk of ionizing radiation exposure.MRI has the highest soft tissue resolution of all other imaging modalities, with no ionizing radiation exposure. However, due to the magnet’s electro-magnetic field, ECG and other electrical signals within its field are distorted, obstructing patient safety diagnostic monitoring and improvements to gating and triggering extremely challenging. And, as MRI magnet’s or T-levels become stronger, the challenge increases.With ClearECG for MRI, we remove these barriers with a robust diagnostic and accurate triggering/gating solution at any T-level.
- Extract clear ECG trace during MRI: 1st-ever Dx ECG during MRI99.9%+ Triggering/Gating Accuracy
- ClearECG for MRI is a set of software algorithms that can extract a clean ECG during MRI procedures. To-date, we have tested at 99.9% accuracy at 1.5T and during our planned Field Validation Tests will provide clinical proof of our ability to do the same at 3 and 7T.As a result of our accurate triggering and gating proficiencies, we conservatively estimate a reduction in overall MRI testing time of 20-30%, extending the useful life and revenue generating capability of existing MRI machines.This opens the doors to “Safe ischemia evaluations” and “MRI guided interventions”, both multi-billion dollar market opportunities.
- ClearECG for MRI is 100% MRI-compliant, is easy to fit and wear and provides both clinical and financial benefits.As the 1st-ever diagnostic ECG during MRI solution, we can support concurrent ECG/MRI testing, with ischemic and arrhythmic detection, while improving MRI throughput by reducing overall testing time.Given our wired and wireless capability, we can monitor the patient while en route between diagnostic imaging labs and provide real-time support to medical technicians during procedures.
- Software algorithms improve:Data acquisitionIschemic captureCompared to 12-lead (50% to 95% sensitivity)First-ever ECG to be Validated by MRIHeart Orientation and Lead placementHardware designs:Ease of use VestWearable computer/communicationsService InfrastructureGlobal telecommunicationsSupport continuous monitoring and real-time reportingSaaS environment Plug-n-PlayDisplay on any computing platform (smartphone, ipad, workstation, etc.)
- The current primary methods for gating & triggering during MRI include: Invivo, VectorEKG, Echo and Cine MRI. None are diagnostic. Regarding gating, if a patient has had a previous heart attack or experiences arrhythmia during testing, none of these methods adapt well to these conditions. As a result, more images are required during testing, as well as more extensive post-imaging measurement resests – prolonging overall test times. This condition is exacerbated as magnet’s grow stronger. From a triggering perspective, the magnet’s electro-magnetic field distorts the electrical signals within its influence. Filtering methods (variable or adaptive) are limited at higher T-levels or magnet strengths.Only ClearECG for MRI provides both ischemic and arrhythmic diagnostic quality during MRI, with adaptive gating. With our Field Validation testing we intend to prove that ClearECG for MRI is consistently accurate at 3 and 7 T-levels.
- Although our product ventures into new unmet territories, based on our pre-IDE FDA conversations, we have confirmed our ability to obtain approval as a Class II, 510K equivalency. During Field Validation Testing we will provide human subject clinical data showing equivalent or better vs. 12-lead EKG for diagnostic quality (including ischemic detection) and vs. Vector ECG for equivalent or better gating/triggering capability.CMS approvals will be based on predicate 12-lead EKG/Treadmill stress test reimbursements and we, based on preliminary discussions with CMS, apply for a new combined MRI/ECG code at higher reimbursement rates.We also intend to obtain CE Mark for participating countries.
- ClearECG for MRI is a set of software algorithms that can extract a clean ECG during MRI procedures. To-date, we have tested at 99.9% accuracy at 1.5T and during our planned Field Validation Tests will provide clinical proof of our ability to do the same at 3 and 7T.As a result of our accurate triggering and gating proficiencies, we conservatively estimate a reduction in overall MRI testing time of 20-30%, extending the useful life and revenue generating capability of existing MRI machines.This opens the doors to “Safe ischemia evaluations” and “MRI guided interventions”, both multi-billion dollar market opportunities.
- Although our product ventures into new unmet territories, based on our pre-IDE FDA conversations, we have confirmed our ability to obtain approval as a Class II, 510K equivalency. During Field Validation Testing we will provide human subject clinical data showing equivalent or better vs. 12-lead EKG for diagnostic quality (including ischemic detection) and vs. Vector ECG for equivalent or better gating/triggering capability.CMS approvals will be based on predicate 12-lead EKG/Treadmill stress test reimbursements and we, based on preliminary discussions with CMS, apply for a new combined MRI/ECG code at higher reimbursement rates.We also intend to obtain CE Mark for participating countries.
- Our business model strategizes multiple revenue paths:Initially targeting the top 500 MRI centers, we will offer a ClearECG for MRI starter package at $100K, which will include our software server, a portable ClearWatch ECG platform and a selection of MRI-compatible, radio-translucent lead sets.As we introduce our embedded-lead vest as a disposable, this will generate an additional revenue stream.Our service contracts will range from initial set up, training and basic maintenance to full system assessment and optimization of protocols and pulse sequences.We will also offer advanced online monitoring services supporting ECG life-cycle calibration, monitoring and alerting during test and interventional procedures.Secondary revenue streams will come from Core IP and product licensing to business partners, as well as channel sales.
- We have designated 5 major milestones during the commercialization phase of ClearECG for MRI. Milestone #1 will target Field Validation Testing of our product components, while building our infrastructure and developing early partner/licensing agreements. This will require a tranche funding of $800K during a 6 month period.Milestone #2 will begin first human subject testing in the MRI. We will contract with UCSF for the use of their equipment and personnel resources.Milestone #3 will expand human subject testing providing clinical data equivalency vs. 12-lead and VKG predicates.Milestone #4 will target regulatory approvals, onboarding of marketing/sales personnel and preparations for our pilot programMilestone #5 somewhat concurrent with #4, will engage 5-10 pilot sites in the U.S., Canada and 1-2 select international sites.Our goal is to continue building market value, product efficacy and partnerships during each milestone stage.