The team at Bell Potter have been covering ASX small-cap EMvision Medical Devices Ltd (ASX: EMV) for some time.
Over that period, it has drawn positive ratings from the broker.
Like many ASX small-cap healthcare stocks, a large part of its valuation and future success depends on whether its clinical trials produce strong results.
Image source: Getty Images
Company overview
EMvision was established in 2017 and listed on the ASX in 2018. It aims to change the Stroke Care paradigm to positively impact the lives of millions globally.
The lead product in development is a portable, cost-effective, non-ionising and safe brain scanner. The scanner is capable of rapidly determining the presence of suspected stroke and stroke type to provide game-changing insights for clinicians.
The lead product is a hospital and cart-based device that can be wheeled around and used by Stroke Centres, Intensive Care Units and Emergency Departments, called emu™.
A new report from Bell Potter has updated its view following a key clinical trial update for the ASX small-cap.
Fresh clinical trial update
According to the report, EMvision is expanding its main clinical trial so its brain scanner can detect:
- bleeding strokes (haemorrhagic), and now also
- blocked-vessel strokes (ischaemic).
That matters because only about 13% of strokes are bleeding strokes, while about 87% are ischaemic strokes.
In short, EMvision is trying to make its device useful for almost all stroke patients, not just a small subset.
While correctly identifying c.13% of strokes is valuable, having a further indication that covers detecting ischaemic strokes (c.87%), would enhance clinical utility and commercial value.
Adding the additional indication is expected to add a relatively modest amount of time to the Pivotal trial's timelines, with enrolment now expected to be completed in late CY26 / early CY27.
The broker said at present 125 patients have been enrolled across multiple sites with a target of 300 patients.
Including the ischaemia detection endpoint in the current Pivotal Trial leverages the same patient cohorts, infrastructure, and regulatory pathway to generate expanded indications, potentially saves up to two years and several million dollars in trial costs compared to funding and enrolling a standalone trial later.
Steady progress
Following the update, Bell Potter has retained its buy recommendation on this ASX small-cap.
It also has retained its price target of $3.15.
From yesterday's closing price of $1.89, this indicates an upside potential of approximately 67%.
EMV continues to make steady progress in its Pivotal Trial and other studies. Despite extending the trial timeline, adding in ischaemia as a primary endpoint, seems wise from a cost, timeline and commercial value perspective.
One can infer a timeline for the readout at 3QFY27, followed by an FDA decision on the De Novo application in 1H28.
