jim robertson president, ceomindchild.com/assets/mirtle-investor-160715.pdfjim robertson president,...
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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