ClearSolutions™ Family of Products

ClearECG™ for MRIENABLING MRI EXPANSION

by All Clear Diagnostics, Inc.

The MRI Magnet

Problem: Unmet Needs

ClearECG™ for MRI solves these unmet needs

Distorts ECG signals and

obstructs: Diagnostic Patient Safety Monitoring

Improved Workflow / Reduced Test Time

Market Expansion to multi-$B segments

MRIX-ray | CT Scan

CVD/CAD Diagnosis: MRI in Context

MRI: Best Soft-Tissue Resolution / No Ionizing Radiation

Echocardiogram

[ Widely used method

x Other diseases (i.e. lung) obstruct Echo views

x Limited cardiac diagnostic yield

[ Higher resolution vs. Echo

x Limited tissue resolution (vs. MRI)

x Ionizing Radiation Exposure

Superior soft tissue imaging

Zero Ionizing Radiation

x Magnet distorts ECG signals

Technical Problems

“MRI promises to revolutionize MIS, but is obstructed by the inability to provide diagnostic ECG monitoring during these procedures.”

— National Institutes of Health/National Heart Lung

Blood Institute

The MRI Promise

The Minimally Invasive Interventional Surgery (MIS) market growing to $0.00B by 2016, CAGR of 8.2%

— Frost & Sullivan, Kalorama,

Companys & Markets, Goliath

Industry Pressures

Reduced Profits: Reduced Reimbursements

Growing market demands: Industry Consolidations 5500 to 3500 hospitals/AI

facilities by 2018

— Ken Weixel, U.S. Managing Partner

Deloitte & Touche

MRI: The Promise, Problems & Pressures

ClearECG Value Proposition

Enabling an $0-00B MRI market potential

99.9%+Triggering/Adaptive

Gating Accuracy

Reduce test time up to 50%"Extend MRI useful life – delay new MRI installationExpand MRI MIS utilization ($00.0B by 2016)

Enable MRI to expanded markets: $0 – 00B Minimally Invasive Interventions $0 – 0B

Cardiac ischemia evaluations $0 – 0B

ER Chest Pain Referrals $0 – 0B

First-everDiagnostic ECG

during MRI

ClearECG™ for MRI

What is ClearECG for MRI?

What is it?

ClearECG Extraction Disease detection (CAD, CVD, CHF) Arrhythmia characterization

Unique Patented Software Algorithms SaaS-based Services

Real-time, online support Patient set up and fitting ECG calibration ECG alarm notify and

guidance

100% MRI-compatible

Integrated, interoperable Wearable-computing devices

Wearable/PortableHardware Components

P2

P1V

1V2

RA

LA

RL

V6

Easy to apply and wear

Provides: Ischemic detection Enhanced arrhythmia

characterization Improved Gating/Triggering

1st Dx ECG during MRI

Enables: Concurrent ECG/MRI Patient Safety Monitoring Ischemia & Arrhythmia 50% Reduced Test Times

ClearECG for MRI

Easy-to-Use | Faster | More Accurate & Robust

Direct to MRI Tube w/ECG

Continuous Monitoring

Facilitates: Patient transit from:

X-ray CT MRI Settable alarm thresholds Hemodynamic monitoring Protocol optimization

P2

P1

V1

V2

RA

LA

RL

V6

IP

IP Portfolio & Barriers

IP / Product / Business Partner Protection

StrategyTo continuously improve on this patent portfolio

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Patent Issued

On-body computer

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Action

Multi-Variate Signal Separation

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IP

OfficeActionIP

IP

Cine MRI 95% 90% 80% 70% 55% No No No

Echo 75% 75% 75% 75% 75% No No No

Invivo (Philips) 95% 92% 82% 73% 57% No No No

Vector ECG (VCG / VKG) 95% 90% 80% 70% 55% No No No

Competitive Advantage

Improved Triggering, Gating & Dx ECG monitoring

ClearECG™ for MRI 99%+ 99%+ 99%+ 99%+ 99%+ Yes Yes Yes

Capabilities 1T 1.5T 3T 7T 10T ARR ISC

Triggering/Gating Accuracy Adaptive

Gating

Dx Quality ECG

Regulatory Strategy

Fastest Path to Market

* CMS discussion re: combined ECG/MRI CPT code

Diagnostic ECG Predicate = 12L ECGGating/Triggering Predicate = Vector ECG

Defined FDA Predicates

Today: CV StressFuture: Combined coding

CMS Reimbursements*

CE Mark: Targeted EU countriesBRIC

Other Regulatory

Class II, 510K Equivalencies

Future: ECG/MRI Combined

CPT 93015 93115 93225

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

Achievements To-Date

Ready for Field Validation & Product Development

Advancing Medical Science

Multiple Revenue Streams

Business Model

Installation TrainingMaintenance

Service Contracts

Workflow/Protocol OptimizationPulse Sequence Optimization

Enhanced Services

Patient Set Up & CalibrationPatient MonitoringAlarm Notification & Clinical Guidance

Online Service Support

2 Sets of MRI-compatible leads (8 each)2 ClearWatch Platforms1 Server w/ClearECG Software Suite

ClearECGStarter Package

Direct &Channels

Sales & Services Revenues

Revenue Distribution over 5 years in Market

Install/MaintStandard $00K/yrEnhanced $00K/yr

$00M

SaaS ServicesFee/Test - $00-00

$00M

Services

DirectStarter Pack $000KDisposables $0-0KMaint/Consult $0-0K

$0.00M

Product Sales

ChannelsStart Pack $00K/unit

$00M

Strategy

Transit from Product sales to

Long-Term Service Contracts

$0M Series A Use of Funds

Building Value at Each Stage

$000K – (Tranche)

FVT #1 Component Validation

1

Procure equip, materials

Documentation / Hire personnel

Complete testable prototype

Partner/License/ CoDev

6 months

$0M

FVT #2 First Human

Subject Testing

2

QA product dev/test

Near-Market prototype

Interim Regulatory review

6 months

$0M

FVT #3 10 Human Subjects

3

Clinical data validation

Market-ready product

Submit regulatory approvals

4 months

$0.0M

Regulatory Approvals

4

FDA, CE mark, CMS

Pilot Program Training

Onboard Sales/Mktg personnel

8 months

Pilot Program

5

Engage 5-10 sites

Early Manufacture

Implement Pilots

ClearECG for MRI

A Disruptive, Game-Changing Solution

1st-ever Dx ECG patient monitorImproved Triggering and Gating1

THANK

YOU

Reduce test time by up to 50%2Extend MRI useful life Delay new MRI installation3Enable MRI ExpansionNew Revenues $0 - 00B4

ClearECG™ for MRIENABLING MRI EXPANSION

by All Clear Diagnostics, Inc.

Cover Image by Sony Sivanandan