ASX healthcare stock EMvision Medical Devices Ltd (ASX: EMV) could be a growth stock about to take off, according to a new report from Bell Potter.
It soared 15% higher yesterday after the company released its quarterly report.
The company is developing portable brain imaging devices to enable faster stroke diagnosis.
It is commercialising technology developed from a decade of University of Queensland research. Its flagship emu™ device is designed for hospital use. Additionally, the First Responder device is a helmet-sized scanner for ambulances, aiming to improve stroke diagnosis before patients reach hospital.
Image source: Getty Images
What did the company announce?
Yesterday, EMvision released its quarterly activities report, which included:
- Strong balance sheet position maintained, with cash reserves of $17.1m as at 30 June 2026 and $4.6m in non-dilutive funding remaining under current grant programs
- Pivotal (Validation) Trial has surpassed key enrolment milestones, building momentum toward FDA De Novo clearance for EMVision's emu™ point-of-care brain scanner
- Successful First Responder aeromedical feasibility and usability study with Royal Flying Doctor Service (RFDS) completed, with flight nurses and patients rating the prototype device favourably in real-world operation
Following the results, the team at Bell Potter provided updated guidance on the ASX healthcare stock.
Forthcoming engagement with FDA on emu trial
In its market update, EMV advised that it is preparing for a pre-submission (Q-Sub) meeting with the FDA. This will cover the proposed claims and performance thresholds required for its De Novo clearance.
Bell Potter said the outcome of the meeting could be meaningful and set a tone for investor sentiment.
The primary objective of the pivotal trial is to demonstrate haemorrhage detection sensitivity & specificity at >80%. The inclusion of the ischaemic stroke cohort requires a minor adjustment to the required sample to ensure the sub-cohort meets statistical objectives. Including both types of strokes, is expected to reduce intervention delays and improve patient outcomes, expanding clinical utility from product launch.
The broker said this inclusion is expected to push out timelines on the result well into CY27.
However, the recent publication of the emu study provides independent peer-reviewed validation of the AI foundations underpinning the emu Brain Scanner / First Responder. Publication should serve to build audience awareness and credibility.
Big upside for ASX healthcare stock
Following the update, Bell Potter retained its speculative buy recommendation on this ASX healthcare stock.
It also retained its 12-month price target of $3.15.
From yesterday's closing price, this indicates a near 80% rise.
The first of three feasibility studies has concluded successfully, with the aeromedical study with the RFDS showing the First Responder is intuitive, practical and suited to the specific environment.
The Mobile Stroke Unit study is near completion and should be reported on in 1Q27, while the road ambulance study is in the planning stage. These studies are expected to lead to a 510(k) submission over the medium term.
