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 2
WHAT 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.0b013e31829734f2
TECHNOLOGY 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 5
PROMISING 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 6
PATIENT 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 7
PATIENT 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 8
CLINICAL 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 9
PRODUCT 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 10
ROAD 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 12
ATTRACTIVE 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 13
PARTNERS & 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 14
TEAM 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 15
CAPITAL 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 16
www.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 5337
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