INVESTOR PRESENTATION - www.emvision.com.au - Open Briefing
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BREAKTHROUGH
TECHNOLOGY
Commercialising novel electromagnetic
imaging technology as a result of 10
TRANSFORMATIVE years development at University of
Queensland
POINT-OF-CARE
IMAGING SOLVING UNMET
CLINICAL NEEDS
Rapidly Diagnose & Monitor Stroke Immense commercial
opportunity in solving clinical
Portable problems for which there are
currently no solutions
Safe & Non-Ionizing
30 Second scan time
PROMISING
Cost Effective APPLICATIONS
Technology has potential for diagnostic
applications across the whole body,
with time sensitive neurological
disorders being the first target
Artistic impression of first-generation commercial device. The Clinical Prototype is currently undergoing trials at Princess Alexandria Hospital, Brisbane www.emvision.com.au 2WHAT PROBLEMS
ARE WE SOLVING?
HEALTH & ECONOMIC BURDEN EFFECTIVE TREATMENTS UNDER DEPLOYED LACK OF PORTABLE IMAGING
Recent years have seen ground-breaking stroke Imaging is a prerequisite to determine the type
therapies implemented – including innovative of stroke, the appropriate treatment protocol
Stroke is a leading cause of death and blood clot retrieval, intravenous thrombolysis to and to evaluate the patient’s response to
disability worldwide with 1 in 6 people dissolve clots and drugs designed to halt bleeding reperfusion therapies and interventions.
having a stroke in their lifetime 1 into the brain.
Today there are no practical, truly portable
Annual Stroke Related
Unfortunately, innovation in portable imaging and easy to use, bedside or pre-hospital
Medical Costs in the US 2
has not kept pace with the innovation in stroke imaging solutions available, to allow clinicians
treatment, meaning many patients are not and paramedics to intervene earlier, and make
$184 bn diagnosed in time and so may not receive the critical decisions earlier, when time matters.
$71 bn 2030 most effective treatment.
2012
Source: 1 – World Stroke Organisation | 2 - : Forecasting the future of stroke in the United States: a policy statement from the American Heart www.emvision.com.au 3
Association and American Stroke Association. Stroke J. Cereb. Circ. 44(8), 2361–2375 (2013). https://doi. org/10.1161/STR.0b013e31829734f2TECHNOLOGY OVERVIEW
SHARED UNDERLYING
PRINCIPLES
NON-DESTRUCTIVE TESTING
Array of antennas send pulses of low-power
1 electromagnetic waves into the head
Microwave frequency
2 – 18 GHz
SECURITY
Millimeter frequency
Waves penetrate tissue in a non-ionizing and 10 - 80 GHz
2 harmless manner and get scattered based on
the electrical properties of tissue
ELECTROMAGNETIC IMAGING
Microwave frequency
500 MHz – 5 GHz+
Sensors in the helmet detect these interactions
3 to identify and locate abnormal tissue
PROPRIETARY ALGORITHMS
& AI USED FOR IMAGING
&
4 Multiple novel algorithms reconstruct the image
5 AI driven stroke classification to assist in decision making
Artistic impression of first-generation commercial device. Device under development and subject to clinical validation. The Clinical Prototype is currently undergoing trials at Princess Alexandra Hospital, Brisbane www.emvision.com.au 5PROMISING
PRELIMINARY CLINICAL PROTOTYPE
IMAGES Detected Abnormal Tissue
Commenced 30 patient pilot-clinical trial at the Princess
Alexandra Hospital in Brisbane in late January 2020 to: Provided a good guide to the
extent of brain tissue
damaged or under threat
1 Collect data from stroke patients,
both ischaemic and haemorrhagic
Accurate Localization
2 Compare EMVision scans with
ground truth CT and MRI images
EMV scans show the effects
of stroke in the same region
3 Refine and select optimal imaging
algorithms including fusion combination as the gold standard imaging
methods MRI and CT
This approximately 6-month trial informs commercial
product development as well as regulatory strategy and Clear Contrast
pivotal trial design
Abnormal brain tissue clearly
The following preliminary images represent the first set of distinguished from surrounding tissue
two ischaemic datasets processed and have been reviewed
extensively by EMVision’s clinical advisors. These results
reflect an initial two datasets of the patients enrolled to date
and the final results of the clinical study, when completed,
will undergo a detailed review by the Company’s clinical
advisors.
www.emvision.com.au 6PATIENT A
Right M2 Occlusion
GROUND TRUTH EMVISION SCANS OVERLAID
EMVISION SCANS (MULTIPLE ALGORITHMS)
GROUND TRUTH MRI
L R
L R L R
Beamforming Direct Mapping Beamforming Direct Mapping
L R
Perfusion CT / MRI
L R L R
Statistical Tomography Statistical Fusion
with Fusion www.emvision.com.au 7PATIENT B
Left frontal small stroke, difficult to see clot and probably small M3 occlusion. Posterior CTP change probably fragmented clot
GROUND TRUTH EMVISION SCANS OVERLAID
EMVISION SCANS (MULTIPLE ALGORITHMS)
GROUND TRUTH MRI
L R L R L R
Beamforming Direct Mapping
Beamforming Direct Mapping
L R
Perfusion CT / MRI
L R L R
Statistical Fusion
Statistical Tomography
with Fusion www.emvision.com.au 8CLINICAL FEEDBACK
PROF MICHAEL O’SULLIVAN A/PROF DAVID COOK
Neurologist specializing in Stroke Lead Investigator, Snr Critical Care Specialist
EMV Clinical Advisor EMV Clinical Advisor
“Although obviously preliminary, these early “The last two years has seen EMVision technology
results are highly promising. In both cases, the advancing us towards the realisation of a novel
EMVision scans were clearly positive and imaging technology that will assist medical
provided a good guide to the extent of brain practitioners in making critical decisions, and
tissue damaged or under threat.” critical interventions earlier, when time matters.”
PROF GEOFF DONNAN PROF STEPHEN DAVIS
Stroke Neurologist Stroke Neurologist
Past President of the World Stroke Organization Past President of the World Stroke Organization
Co-chair of the Australian Stroke Alliance Co-chair of the Australian Stroke Alliance
“The lightweight portability of the device “These early images are clinically
makes it a potential candidate for emergency promising, clearly showing the effects of
stroke imaging in the pre-hospital setting.” ischaemic stroke in the same region as the
gold standard imaging methods.”
www.emvision.com.au 9PRODUCT DEVELOPMENT ROADMAP
2019 2020-21
CLINICAL PROTOTYPE 1 st GEN FOR COMMERCIALISATION FIRST RESPONDER
Clinical prototype to gather data For use in ICUs, stroke and neurology Next generation device that
from stroke patients to enable wards. This device intends to offer a intends to speed up pre-hospital
refinement and selection of optimal bedside decision support and triage and create opportunity for
imaging algorithms as well as data on monitoring capability for the response earlier treatment choices
correlation with CT and MRI imaging to treatments, complications and pre-hospital
progress of strokes
CURRENTLY UNDER DEVELOPMENT
www.emvision.com.au 10ROAD TO COMMERCIALISATION
CY Q3 2020 Q4 2020 2021
Pilot-Clinical Trial Results from Pivotal Clinical Pivotal Clinical Trial Pivotal Clinical
CLINICAL TRIALS Completion Pilot Clinical Trial Trial Site Selection Ethics Approval Trial Enrolment
1 st GEN DEVICE DEVELOPMENT Refinement and selection of the optimal imaging Device Build V&V, EMC, Safety & Transfer to
algorithms for 1st gen device for commercialisation Progress Healthy Volunteer Testing Manufacturing
FOR COMMERCIALISATION
Feedback From Initial Regulatory Approval Plan First Regulatory
REGULATORY FDA Pre-submission & Pivotal Trial Design Submission Preparation
Strategic MRFF Stage 2 Building of In-house Establishment of
CORPORATE Employee Hires ASA Outcome Engineering Team Manufacturing Capability
V&V: Verification and Validation, EMC: Electromagnetic Compatibility Testing. MRFF: Medical Research Future Fund. ASA: Australian Stroke Alliance. The indicative timetable is a guide of EMVision’s intentions at the date of this presentation only.
EMVision reserves the right to vary this timetable at its discretion, and further notes the above timings are subject to change due to circumstances outside of its control. It is EMVision’s intention to apply for the relevant regulatory clearances as 11
part of its commercialization strategy at the appropriate point in the development cycle of the brain scanner, however EMVision notes there is no guarantee that the requisite clearances will be acquired in a timely matter, or at all.KEY ADDRESSABLE MARKETS
US. GERMANY FRANCE UK. JAPAN AU.
CAPITAL E QUIPME N T
PRICIN G TARGE T
ULTRASOUND STROKE
LOW RANGE ~$20,000 USD 2,200 450 140 150 625 105
/ NEUROLOGY WARDS
TARGETING MID RANGE CRITICAL CARE UNITS 2,800 1,700 600 210 650 150
ULTRASOUND PRICING
ULTRASOUND
~$250,000 USD EMERGENCY DEPTS 5,200 1,860 630 220 1,600 290
HIGH RANGE
TOTAL 10,200 4,010 1,370 580 2,875 545
ROAD & AIR AMBULANCES SECONDARY MARKETS
US. EUROPE AU. AGED CARE CRUISE SHIPS
MILITARY
MEDICAL NGOS SPORT
CENTRES
60,000 58,000 5,200
EMV cautions investors that there are regulatory barriers and unique access challenges to each market and can be subject to varying rates of penetration.
Ultrasound device images for illustrative purposes only. Addressable market sources: Estimates based on ABS, U.S. Census Bureau, WHO, AHA, EMS data and other publicly available data. www.emvision.com.au 12ATTRACTIVE REVENUE MODEL
SALES MODEL: DISTRIBUTION OR DIRECT MULTIPLE RECURRING REVENUE STREAMS OVER LIFE OF EACH DEVICE
Distribution Partners
EMVision’s sales model will be flexible on a FREQUENCY:HIGH
geography by geography basis. Future distribution
$10
partners would purchase equipment, consumables, Consumables
accessories and spare parts from EMVision and on-
Disposable Caps purchased for infection control and PRICE EACH
sell to their network
signal quality. Depending upon the number of stroke CAP $USD
patients being admitted to the hospital and those
recovering, one device could generate 5-10+ cap $30
FLEXIBLE PURCHASING MODELS usages per day
Capital Sales
Equipment is sold upfront with customer
FREQUENCY:VARIABLE FREQUENCY:ROUTINE
purchasing consumables as required
Accessories Maintenance & Service
Managed Equipment Model
Cables, Head-Neck support Preventative Maintenance,
Equipment provided to customers with Service Contracts, Software
and power supply units,
consumables bundled in upgrades over life span of
purchased with initial
device or over time device
Rental
Customer rents equipment from EMVision and
purchases consumables as required
Revenue generation is subject to many factors, including the successful product development, completion of clinical trials and regulatory approvals. For further information, see slide 11. www.emvision.com.au 13PARTNERS & COLLABORATORS
GE Healthcare is the $19 billion healthcare
Awarded EMVision a $2.6M CRC-P non-dilutive Developer of EMVision’s IP, CRC-P partner, and
business of GE (NYSE:GE) and a leading global
cash grant, over three years, in Dec’17. Australia's most successful commercialisation
manufacturer and distributor of imaging
university with more than US$15.5 billion in gross
modalities.
Secured key academic, clinical and industry product sales from UQ licenced technologies.
partners, who contribute a further $910,000
GE Healthcare have partnered with EMVision in a
non-dilutive cash and ~$3.5M of in-kind Over 20 researchers at UQ across software,
CRC-P program providing cash and in-kind
contributions and resources to the brain mechanical and electrical engineering advancing
expertise commitment towards EMvision’s brain
scanner program. EMVision’s imaging modality.
scanner program.
EMVision is a key commercial collaborator with the Strategic collaboration with Keysight Technologies Inc. Highly regarded hospital with world leading
Australian Stroke Alliance (ASA) who are looking to (NYSE:KEYS) via MOU to collaborate on the neurology, radiology and critical care experts.
deploy portable imaging technologies for pre- development of personalized Vector Network Analyser
hospital stroke triage and treatment. (VNA) units for the healthcare market. EMVision’s CRC-P partner and pilot-clinical trial site
where data is being collected from patients with
Working towards a Medical Research Future Fund VNA’s are a key component in EMVision’s brain scanner diagnosed ischaemic and haemorrhagic stroke, with
(MRFF) Stage 2 competitive grant pledged at $50 and allow for accurate measurement confirmatory CT and/or MRI images.
million or more per successful consortium. of the signals transmitted and received.
www.emvision.com.au 14TEAM
Significant experience developing and commercialising medical devices
Dr Ron Weinberger John Keep Scott Kirkland Prof Stuart Crozier Robert Tiller
CEO & Managing Director Chairman Executive Director Co-Inventor & Clinical Advisory Chair Product Design & Development
Former Exec Director / CEO of Former CEO of Queensland Co-founder of EMvision Co-inventor of underlying
Executive
Nanosonics (ASX: NAN), $2BN market Diagnostic Imaging ($109M Trade Medical Devices Ltd technology CEO and Founder of Tiller Design (product
cap company sale to Mayne Pharma) developer for ResMed and Nanosonics)
Experienced corporate affairs, Globally renowned for MRI
20 yrs experience developing and Over 30 yrs senior executive capital markets and technology advancements (70% installed hold 25 yrs experience in medical device design,
commercialising medical devices leadership and M&A experience sales executive Stuart’s patents) development and commercialisation
Geoff Pocock Tony Keane Ryan Laws Emma Waldon Dr. Konstanty Bialkowski Ruth Cremin
Non-Executive Director Non-Executive Director Non-Executive Director Company Secretary Head of Tech Development Head of Quality & Regulatory
Over 30 years finance experience in Co-founder of EMvision Chartered Accountant Co-inventor of underlying Affairs
Executive Director of Osteopore
business, corporate and Medical Devices Ltd technology
(ASX:OSX) and Former MD / Co-Founder Former Head of Quality and
of Hazer Group (ASX:HZR) institutional banking Diverse capital markets &
Expert in near-field biomedical Regulatory at Nanosonics (ASX:NAN)
Experienced corporate advisor corporate governance
radar, microwave imaging and and Snr Regulatory Specialist at
20 yrs experience commercialising Advisory Board and NED roles & investor experience
signal processing techniques. Cochlear (ASX:COH)
emerging technologies and capital including ASX 200 company
markets National Storage REIT (ASX:NSR)
Multiple successful FDA, TGA and CE
mark clearances.
www.emvision.com.au 15CAPITAL
STRUCTURE
Shares on issue 63.7m
$4.5M PLACE ME N T
Total Options on issue 1 8.9m PROMISIN G STROKE IMAGE S
Performance Rights2 6m CLIN ICAL PROTOTYPE BUILT
Market Cap @ $1.26c* $80m
POSITIVE HHT JOIN STROKE ALLIAN CE
EV @ $1.26c* $74m
TRIAL STARTS
IPO
Current Cash Balance 3 $6.06m
KE YSIGHT COLLABORA T IO N
Top Shareholders
MANAGEMENT
& DIRECTORS
UNIQUEST (UQ)
17.7% 9.4%
1 – 8.9m Options: 6,000,000 strike price $0.35 expiring 31st December 2021, 400,000 Options strike price $0.57 expiring 1st July 2022, 115,000 Options strike price $1.11 expiring 13th November 2022 and
1,000,00 Options strike price $1.25 expiring 6th May 2023, vesting over time, granted to Dr Ron Weinberger subject to shareholder approval. Option incentives held by executive management, directors, advisors
& key contractors | 2 – All performance rights are held by UniQuest and will vest on particular milestones over time – further details in IPO prospectus | 3 – As of 31 March 2020. The Company anticipates
having access to additional sources of undrawn non-dilutive cash funding of approximately $1,224,854 from its ongoing CRC Project |* Closing price 23rd June 2020 www.emvision.com.au 16www.emvision.com.au
GET IN TOUCH
Dr Ron Weinberger Scott Kirkland
CEO and MD, EMVision Executive Director, EMVision
E: rweinberger@emvision.com.au E: skirkland@emvision.com.au
P: 02 8667 5337 P: 02 8667 5337You can also read