EMVision’s revolutionary brain scanning device for use in early diagnosis of stroke type is about to undergo a trial beginning in 2Q of CY22. The data will support EMV’s approval process with key regulatory bodies.
Delay in diagnosis and treatment of stroke is a huge problem for the second biggest cause of death worldwide. EMV has developed an affordable, portable scanner for use in ambulances (and hospitals) that could revolutionise the early diagnosis of stroke type (haemorrhagic or ischemic) and the subsequent critical care path for patients.
EMV has two scanners under development. The Gen 1 scanner is designed for use in hospitals where a CT or MRI is either not accessible or practical.
The Gen 1 trial will aim to provide data for regulatory approval with the US FDA, the Australian Therapeutic Goods Authority (TGA) and the Conformitè Europëenne (CE mark). The trial will enrol patients presenting with suspected stroke at Emergency Departments.
The choice of Emergency Departments is a strategic decision as it will allow the analysis of very early stage bleeds and clots, mimicking conditions closer to the ambulance setting. It is expected to yield valuable data for the Gen 2 product.
The US FDA has already deemed the scanner as ‘novel’ meaning that it can find its way to market much more quickly based on its intended use and risk profile. This could then also help get EMV’s Gen 2 scanner to market more expeditiously.
The Gen 2 scanner is a lightweight helmet scanner (<30kg) that can be carried in an ambulance. It is worth noting that neither scanner requires a specialist technician or radiographer to perform the scan.
The scan data can also be transmitted to stroke neurologists or radiologists in advance of the patient reaching hospital.
Investment view
The need for early diagnosis of stroke type is critical because it determines the correct form of treatment. A stroke occurs every 40 seconds in the USA so the demand for rapid diagnosis and treatment is obvious. Not all stroke victims die, but many suffer life changing circumstances and costs.
The estimated cost of EMV’s Gen 1 scanner at US$150k is substantially less than a modified CT scanner in an ambulance where the setup cost alone can be up to US$1 million. There are more than 10,000 hospitals across the US and Europe alone that would benefit from the scanner, and an estimated 100,000-plus ambulances in the US.
In these two markets alone, the potential market size could be approximately US$16 billion.
A pilot trial conducted in Brisbane demonstrated the scanner was 93-96% accurate in distinguishing between haemorrhagic (bleed) and embolic (clot) strokes. It was also very accurate in determining the locality within the brain.
Determining the type of stroke is critical. Applying the drug-based approach for the most common embolic (clot) stroke to dissolve a clot could be disastrous for a haemorrhagic stroke patient.
EMV’s scanners offer a low risk and low cost device to a very large market. If the device can gain regulatory approval, it could quickly become a high demand product.
Risks to investment view
The regulatory approval of the scanners may not be achieved, or the trial data may not be as successful as required.
Recommendation
We have retained our Buy recommendation.
