My notes on the 30 min conversation with CEO Scott Kirkland this morning. As the communcation from EMV to the market on its journey have been clear and regular, nothing earth shatteringly new. It was a really good conversation to take a step backwards and look at how the various pieces tie together, the bigger picture of what is coming ahead and evolving management thinking on the revenue model - it does indeed look very positive and promising from all angles.

Discl: Held IRL and on SM

Progress of Trials

• Pre-Validation Trials going well - 150 suspected stroke patients presenting in 3 major stroke treatment hospitals - Liverpool Sydney, Royal Melbourne and Princess Alexandria, generating data for FDA Pre-Validation approval
• EMV scans are obtained immediately after the usual CT scans are done, before treatment commences, then get follow-up scans if patient is admitted - get data on suspect strokes, then data to monitor progress thereafter
• Targeting 150 stroke patients by Q2FY2023 - enrolment of patients into trial study has been relatively straightforward and has been accelerating - not invasive, dedicated nurses to do enrolling and scanning
• Validation trials commence in CY2024
• Engaging FDA in parallel with collected data
• Looking forward to presenting real data in Nov 2023 to the largest Imaging Conference RSNA - in 2019 only had brochures of the device, will now have production models of scanners and scanned data on-site

Path to Commercialisation

• Gen 1 Hospital Mobile Device market entry planned for FY25 - Gen 1 device is a mobile device and has no predicate, so need to prove its efficacy from the ground
• Once approved, Gen 1 will be the predicate device for Gen 2 Mobile Scanners as a lot of the patients that are scanning today are the same patients that will be seen in an ambulance or pre-hospital environment - data from Gen 1 will be applicable, the Gen 2 device will have a different form factor

Funding

• Pre-revenue, non-dilutive funding has been a key part of the EMV strategy - $20m in grants, about $4.4m left
• R&D funding requirement for ongoing trials is modest unlike a Phase 3 pharmaceutical trial - getting a quick scan, payment to access radiological files, not a huge cost
• National Reconstruction Fund, $1.5b earmarked for manufacturing of Australian medical products is positive in terms of funding opportunities, exploring other domestic funding for med tech, manufacturing, follow-on funding for next phases of funding from alliances eg. Australian Stroke Alliance - pursuing these funding opportunities aggressively

Radiation Dose of the Scanners

• The scanners operate on the Electro Magnetic Imaging on the microwave frequency - sending signals similar to what mobile phones transmit for voice and data - “non ionising”
• Passed all independent EMC testing required to get device into study, into hospital sites knowing that it is not going to cause any interference
• Can also have multiple scans as the signals are not in any way harmful to the patient and the operator - any healthcare professional can operate the device

Secret Sauce of the Data

• The EMV devices are a new modality - no data available to acquire to enhance or train the data - the only training sets that are available are the ones that EMV themselves generate
• Real patient scan data models are expensive and time consuming to acquire
• EMV creates a “simulation pipeline” - take an MRI file, segmented into the tissue types, use the model of EMV’s system in the simulation software which very closely matches the real world against a healthy MRI to see how the signals would response to to the healthy head. Then generate different synthetic strokes and see response in the system. Able to generate a lot of simulations in the time to get real data from 150 patients, speeding up verification, development etc.

Competitive Landscape

• Same or similar output of images with classification, localisation from a similar form factor and the ability to produce a quality image, is it a stroke, what type of stroke, where is it in the brain - no competitors for this
• Competitors in mobile brain imaging, sensing, smaller CT’s, new method of ultrasound for the brain - plenty of competitors, mostly to inform that a stroke has occurred and how big, but not much more than that
• R&D of big companies are mostly focused on incremental improvements to existing products - anything bigger and they usually have to go outside to partner/collaborate

Revenue Model

• Direct and Distributor models, likely to be different models for different regions - Aust likely to sell direct, US likely to be a Distributor model to leverage off brand name, established network and credentials of the Distributor, at least in the first 5 years
• US surveys indicate preference for a capital purchase model
• Consumable mix has changed: Gen 1 - $25 per patient per scan for the cap, gel, Gen 2 - $50 per patient per scan
• Service - 8-15% of asset cost per annum, labour and spare parts
• Survey suggests 5 scans per day per device for larger hospitals 
• Growth opportunities are to add use cases in the area of traumatic brain injury - 15m strokes per year worldwide but 27m cases of traumatic brain injury requiring treatment - these will add to consumable pool

Positioning of Use of EMV Scanners

• Longer term objective is to get use of the product in different workflows from early to post treatment monitoring, into guidelines, over time
• In Emergence Dept of a large tertiary hospital - have strict stroke protocols to get a CT scan quickly - not trying to replace or introduce an extra scan before a CT but rather for ICU/Stroke Wards, post treatment monitoring
• It is the rural settings where they might not have CT facilities and/or a radiographer to run the CT - definitely see a role for EMV Gen 1 in that ED scenario - speed up transfer decision making, triage, opening door to treatment
• Focus on environments where urgent brain imaging is required, not competing with a CT or MRI - not practical in that environment

Closing Thoughts

• Now in the studies face, recruiting trial patients at a great rate
• Encouraging insights and capability from the technology - will share further insights from the study as it progresses 
• Progress on partnership and strategic relationship fronts
• Gen 2 mobile helmet scanner - being fabricated at the moment, advanced prototype available, bench testing and healthy patient testing next quarter, ambulance and road trials next year
• 2 product pipelines running adjacent to each other