MiRTLE Medical, LLC.Jim RobertsonPresident, CEO

Investor Presentation

V1629

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MRI as a platform for medical advancement

Magnetic resonance (MR) is a non-invasive three-dimensional imaging technique. Its primary field of application includes the display of morphology, that is, tissue structures in a series of slice images through the body.

MRI Advantages• Excellent soft tissue contrast with high resolution• Display of several images and oblique views• No ionizing radiation to the patient• Immediate image creation

Cusp of AdvancementMR’s high capital cost restricted rapid adoption of the technology. However in the last 5 years, MR installed base and availability has finally exceeded patient demand. MR “free” time is now used by researchers to discover new procedures using real time MR imaging to precisely position catheters for surgical intervention.

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Product Overview • Diagnostic-grade 12-lead electrocardiogram (ECG) during MRI

• Why?– Safety and technical problems restrict ECG monitoring inside MRI, putting

patient’s wellbeing at risk by “flying blind”– Existing MR compatible ECG monitors are poor fidelity, not diagnostic-grade,

primarily used to monitor heart beat for imaging a stationary heart– Currently, diagnostic-grade 12-lead ECG is used before/after MRI scanning, but

must be removed during

• Who benefits?– High risk patients: ischemic disease, anesthetized/sedated (pediatric, stroke),

or during trauma– Atrial or ventricular arrhythmia patients, since unsteady rhythm leads to

blurred cardiac MRI and prolonged time in the MRI– MRI-guided intervention (surgery) on the heart, brain, abdomen

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The Problem

The ECG signal with the subject inside the MRI is distorted due to moving blood interacting with the MRI’s magnetic field, known as the Magneto-hydrodynamic effect (MHD)

When the MRI is scanning, the ECG signal is obliterated by the MRI’s energy

The MRI’s energy is picked up by ECG cables and burns the skin from heating electrodes. Therefore, existing devices restrict cable length by dictating a tight electrode placement pattern, which cannot produce a diagnostic grade ECG

SSFP is an MRI imaging mode (Steady State Free Precession)

Not a single patient can be monitored for the onset of a heart attack while in an MRI

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The Solution• Custom designed and

manufactured cable eliminates absorbed energy, thereby eliminating any heating of electrodes

• A combination of analog and digital filters remove MR interference

• Digital signal processing removes MHD effect

MiRTLE Device PerformancePerfect diagnostic grade ECG even with MR operational

ECG signal prior to filtering & processing.Superimposed to illustrate significant

MR interference when scanning.

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MRI Compatible 12-Lead ECG Market• US MRI installed base of 20,000 units, 3-5% CAGR (Frost & Sullivan, 2016 est.)

• Application 1: MRI guided ablation– Arrhythmia treatment– Serviceable market: 10% or 2,000 units at ~$75K per unit

• Application 2: MRI guided intervention– Surgical procedures on the heart, brain, abdomen– Serviceable market: 3% or 600 Units at ~$200K per unit

• Application 3: Physiological monitoring during MRI imaging– Anesthetized patients, pediatric, trauma, ischemic histories (~30% of people needing an MRI)– Serviceable market: 30% or 6,000 units at ~$100K per unit

• Total Serviceable Market for devices:– US: 2,000 x $75k + 600 x $200k + 6,000 x $100k = $870,000,000– Global market is 2.5x US or $2.2b

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MiRTLE Product – Current Prototype

Features• ECG 12-Lead, diagnostic grade• Patient safety• Beat detection at 3T scanner gating• Diagnostic quality ECG during scan• SSFP, GRE, TSE sequences cleansed• Zero Radio Frequency noise in MRI• Defibrillation protection

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MiRTLE Product – Current Prototype

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MiRTLE Product – Current Prototype12-Lead ECG Patient Cable

• Carbon fiber clips for transparency• Chokes for patient safety,

improved signal quality, reduced emissions

• Tuned to 1.5T & 3T MRIs• Anatomically optimized

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MiRTLE Equivalent to Gold StandardAnalytical comparison to GE CardioLab (>99% accurate)

“Congratulations on these promising findings. I would be eager to test your system.”

Dr. Robert LedermanInterventional CardiologistNIH/NHLBI

Bland-Altman plot of deviation to CardioLab• 8 human subjects, n = 45,000• Std Dev = 0.15mV, overall correlation of 0.994

ECG Plots by Lead

GE’s CardioLab & Siemens’ Sensis ECG devices are the gold standard of diagnostic grade ECG monitors and the primary tool used in cardiac procedures.

MiRTLE exhibits the same signal resolution, accuracy, and noise performance as CardioLabs.

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Current Performance – Imaging Results

No visual signs of interference• No loss of contrast• No vertical banding

Demonstrates that MiRTLE emits zero electrical signals from the device – a critical requirement

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First Customer – Johns Hopkins Hospital

• Purchased MiRTLE device for pioneering research into MRI-based arrhythmia procedures• Research to demonstrate improvement in outcome from 30% success rate to 80%• Payed $40,000 for prototype• Device installed June 2016

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First Customer – Johns Hopkins Hospital• SSFP performance of

Johns Hopkins’ device on 1.5T Siemens MRI

• Real time SSFP sequence needed for arrhythmia procedures

• Provides precise catheter positioning images inside heart for ablation of tissue (arrhythmia treatment)

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Multiple Requests for Devices• Other researches have requested product

Houston Methodist Hospital Johns Hopkins (a second team) King’s College London NIH, NHLBI University of Toronto University of Utah

• Research on MRI guided procedures Arrhythmia outcome improvement Ventricular fibrillation treatment Cancer tumor removal Cancer chemotherapy delivery directly into tumor

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Success Drives Opportunity• Based on the recent Johns Hopkins success, the ability to sell several

prototypes for IRB research, in their current form, is a strategic opportunity

• New ablation product envisioned to expedite adoption rate into hospitals that conduct arrhythmia procedures today

Core Feature Status IRB Research Ablation ECG

DiagnosticECG

Interventional

Patient Safety Cable 100%

MRI Interference Removal 2 of 4 Accept-

able 4 Req’d 4 Req’d

MHD Removal 0% Accept-able Not Req’d Req’d Req’d

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Success Drives OpportunityFD

A Ap

prov

ed D

evic

esIR

B U

se

Diagnostic ECGV3b

+Toronto Univ +JHU+Houston Hosp +Utah+Kings College +NIH

NEW Revenue Opportunity

AblationV1

Subset of ECG V3a

+JHU validation test

NEW Product Opportunity

AblationV2

>FDANEW Product Opportunity

Interventional ECGV4

>FDA

Diagnostic ECGV4

>FDA

Q1 2016 Q3 & Q4 2016 2017 2018

Diagnostic ECGV3a

@BWH@JHU

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New Revenue Opportunity – IRB Device• Leverage performance success at Johns Hopkins

• At 50% functionality, researchers will pay for device

• Existing MiRTLE V3a device with minor improvements• Finished cable• Improved battery life• New package

• Target six interested institutions

• Estimate up to $300k in revenue in the next 3-6 months

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New Product Opportunity - AblationCurrent Market &

Approach

• More than 100,000 ablation procedures annually in US in over 800 hospitals with 2-3 operational suites per hospital

• GE CardioLabs or Siemens Sensis is required for simultaneous 12-lead ECG and intracardiac monitoring, a $150k device

• Fluoroscopy (x-ray imaging device) positioning of the catheter is inaccurate and yields a 20-40% success rate

MiRTLE Product

• MRI-based catheter positioning promises significant improvement in outcomes, estimated at 80%, based on superior image resolution

• However CardioLabs and Sensis cannot be used with MRI

• A subset of the existing MiRTLE V3a device, analog filter only, with minor improvements: finished cable, battery, package

• Fastest path to commercialization

• Expedites adoption rate by enabling existing equipment (CardioLabs / Sensis) to work in the MR environment

ArrhythmiaSpecial cells in the heart createelectrical signals that travelalong pathways to thechambers of your heart. Thesesignals make the heart’s upperand lower chambers beat in theproper sequence. Abnormalcells may create disorganizedelectrical signals that causeirregular or rapid heartbeatscalled arrhythmias.

AblationCatheter ablation is a procedurethat uses radiofrequencyenergy (similar to microwaveheat) to destroy a small area ofheart tissue that is causingrapid and irregular heartbeats.Destroying this tissue helpsrestore a heart’s regularrhythm.

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Device Road MapCommercial Product

Feature Device VersionIRBUse

AblationDiagnostic

DeviceInterventional

Device

Now 2017 2018 2018

ECG 12-Lead, diagnostic grade

Patient safety system including cable

Beat detection at 3T scanner gating

Defibrillation protection

Diagnostic quality ECG during scan

SSFP, GRE, TSE, EPI sequences cleansed 2 of 4 2 of 4

CardioLab, Sensis Interfaces

MHD real-time removal

Dual imaging modalities with uninterrupted monitoring – Wireless

Stroke volume estimation

Continuous comparison with baseline ECG morphology

SPO2, Dual Invasive Blood Pressure

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IP Portfolio• Licensed IP

– Brigham & Women’s Hospital• “System and method for acquiring patient physiological information during an mri

scan”• US Application: PCT/US2012/033883; dated 4-20-2011

– E-TROLZ, Inc.• “Real-time data interface”• USP: 8,244,941, Issued: 8/14/12

• New – Filed– MiRTLE: MRI-Compatible ECG Cable Design

• US Application: US 62/213,896; dated September 3, 2015

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Projected Sales

Year 1 2 3 4 5

Acquisition - annual 0.6% 1.2% 3.0% 6.6% 9.6%

Estimated Annual Monitor Volume (Units) 42 84 210 462 672

Estimated Annual Monitor Revenue ($K) 4,200 8,652 22,680 53,130 84,000

Estimated Annual Service Revenue ($K) 420 1,260 3,360 7,980 14,700

Estimated Annual Total Revenue ($K) 4,620 9,912 26,040 61,110 98,700

Estimated Gross Profit ($K) 3,696 8,029 21,352 50,721 82,908

Direct sales force leveraging partnerships with all major MRI manufacturers

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Supplier Interest• Letters of Support from major MRI suppliers

– GE Healthcare– Siemens Healthcare– St. Jude Medical– IMRIS

Letters included in Business Plan

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Financial ForecastFinancial Plan Phase 2 Development Dev. & Clinical Testing Clinical Trial & FDA Phase

($k) Quarter Q4'15 Q1'16 Q2'16 Q3'16 Q4'16 Q1'17 Q2'17 Q3'17 Q4'17 Q1'18 Q2'18 Q3'18 Q4'18

REVENUE 16 16 100 100 100 150 150 225 225Mfg. COGS 16 0 40 40 40 30 30 45 45GROSS MARGIN 0 16 60 60 60 0 0 120 120 180 180

Product Development 131 139 165 150 150 150 120 120 120 120 120 120 120Hospital Integrated MRI Testing 67 67 35Electrical & Safety Testing 30 30 30 30Clinical Testing 30 30 30 30 30FDA Consultants 10 10 10 10Sales & ServiceLegal 1 6 6 5 5 5 5 5 5 5 5 5 5License/Patent 7 22 30 60Insurance 0 0 1 1 1 1 1 1 1 1 1Other (T&E, Taxes, Misc.) 0 4 1 1 1 1 1 1 1 1 1 1 1

TOTAL EXPENSES 139 216 194 223 192 217 187 167 167 217 187 167 137OPERATING INC/(LOSS) (139) (216) (194) (207) (132) (157) (127) (167) (167) (97) (67) 13 43

CUM CASH BURN (2,052) (2,268) (2,462) (2,669) (2,801) (2,958) (3,085) (3,252) (3,419) (3,516) (3,583) (3,570) (3,527)Cash from financing 170 160 70

Cum Cash from Financing 2,023 2,193 2,353 2,423 2,423 2,423 2,423 2,423 2,423 2,423 2,423 2,423 2,423

GRANTSCASH ON HAND start of period 302 163 117 83 (54) (186) (343) (470) (637) (804) (901) (968) (955)

CASH ON HAND end of period 163 117 83 (54) (186) (343) (470) (637) (804) (901) (968) (955) (912)

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Capitalization Summary • Financing History – Total Cash In: $2,363k as of 7/2016

– $250k Convertible Note (2012)• Converted to Series A at 10% discount

– $575k Series A (2013)– $635k Series A (2014)– $563k Series A1 (2015)– $340k Series A2 (2016)

Class Shares Options Fully Diluted

Founders 3,500,000 3,500,000 56.3%

Investors 2,245,543 2,245,543 36.1%

Outstanding Holders 475,000 475,000 7.6%

5,745,543 475,000 6,220,543 100.0%

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Supplemental Content

• Current device performance

• Opportunity for improvement

• MiRTLE’s advanced technology

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Induced Gradient Removal StatusLEGEND

A Axial / HorizontalS Sagittal / VerticalC Coronal / XY PlaneO ObliqueDO Double Oblique

0% Removal Partial Removal 100% Removal

Not Tested – predicted 0% Not Tested – predicted partial Not Tested – predicted 100%

DIAGNOSTIC IMAGING USES

SSFP CardiacGRE All – old & slow, TSE replacingTSE Neuro, muscular, skeletal, cardiacEPI Neuro, spinal, joints, abdominal

NOTESTSE Requires Dark Blood on & TR>250

Slices Angle SSFP GRE TSE EPI

A

S

C

O

DO

A

S

C

O

DO

A

S

C

O

DO

Actual 5 / 5 5 / 7 3 / 12 3 / 14Predicted 15 / 15 12 / 15 3 / 15 3 / 15

1

10

20

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Induced Gradient Removal Approaches

Approach SSFP GRE EPI TSE

Analog Blanking 100% 80% 20% 20%

Digital Blanking 100% 100% 40% 40%

Predictive Gradient Interference Subtraction 100% 100% ~95% ~95%

Insufficient performance

Predictive Gradient Interference SubtractionCalculates the expected interference from the MRI’s gradient

amplifiers and subtracts the prediction to leave clean ECG plots

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Predictive Gradient Interference SubtractionA 19-parameter analytical equation based on Maxwell’s

equations and the concomitant fields equation

Gx

Gy

Gz

MRI’s Gradient Amplifier Signals Predicted vs Measured GIV

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Predictive Gradient Interference SubtractionTSE Sequence showing both gradient interference (grey block) and resultant

cleansed ECG (blue) which matches no interference with MRI off (white background)

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VCG GatingConverts 12-lead ECG into 3D vectors

ECG’s R-wave in unique plane from MHD and induced gradient interference

Algorithm learns patient specific R-wave plane before entering MRI

Runs on dedicated DSP module in 16 milliseconds triggered by spherical threshold

MRI Noise

Heartbeat

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MiRTLE at BWH & Siemens 3T MRITesting device & custom cable on patient