Free Report • ASX med-tech small cap
One of the Most Exciting ASX MedTech Stocks to Watch in 2026
Our analysts believe this emerging ASX MedTech company offers more than 300% potential upside, with multiple high-impact FDA catalysts approaching. Download the full research report free.
Analyst target price
200%+ potential upside*
Key FDA catalyst timeline
Full valuation model
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The Upside
Current Share Price
Analyst Target Price
Potential Upside
The opportunity
Why We're Watching This Company Closely
World-first technology
Major FDA catalyst approaching
Potential 200%+ upside
Large addressable market
the software-as-a-medical-device market, 2024 to 2028, growing 25.3% a year
estimated US market for the company’s two lead tests
The pathway
A dated route to an FDA decision
Most speculative med-techs ask investors to wait indefinitely. This one has published its schedule. The catalyst window is ahead, and it has dates on it.
2025 · Done
FDA agrees the pivotal study design
The clearance bar is set: 65% sensitivity and 65% specificity.
Late 2025 · Done
The pilot clears that bar with room to spare
~84% sensitivity and ~85% specificity across several hundred children, most of them testing at home.
Now · Underway
Pivotal study enrolling
First patient enrolled. Run by a top global CRO across ten leading US autism centres.
Targeted year-end 2026
FDA submission
Pivotal read-out, then the 510(k) filing.
Expected ~Q1 2027
FDA decision
A European CE-Mark track runs in parallel.
Dates are company targets and may move. Regulatory outcomes are never guaranteed.
THE PRODUCT
A test that measures reflexes, not opinions
Autism still lacks an objective medical test. This company’s app turns an ordinary smartphone into an at-home neurobehavioural instrument — no verbal or social interaction required.
01
Test on a smartphone
Two 15-minute phone sessions use gentle cues while the camera and microphone capture reflex responses — no clinic visit or extra hardware.
02
Reflexes become biomarkers
Eye-blink, startle and attention responses become digital biomarkers — objective nervous-system measurements, not questionnaire scores.
03
AI sharpens with every test
A patented self-improving model reads the biomarkers, getting more accurate as test volume scales.
How accurate is it?
This test, real-world pilot
~84% / ~85%
Expert clinician agreement
85–90%
Existing FDA-cleared digital tools
52–71%
FDA’s agreed clearance bar
65% / 65%
Sensitivity / specificity from a pilot of several hundred children, most testing at home. Clinicians agree with each other only 85–90% of the time, the practical ceiling for any test. Pilot results are not a like-for-like comparison with cleared devices; one cleared tool returns no usable result in two-thirds of cases. Clearance is not guaranteed.
Why believe it
Evidence from outside the building
Peer-reviewed
Published open-access in a peer-reviewed Wiley neuroscience journal.
Externally run
Pivotal study run by a top global CRO across ten US autism centres.
Government-selected
Selected for a government-funded nationwide screening rollout overseas.
Proven leadership
Chaired by a founder who sold an ASX digital-health company to global pharma.
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Important information
General advice only. This page contains general information and is not personal financial advice. It does not take into account your objectives, financial situation or needs. Consider seeking advice from a licensed professional before making any investment decision.
Paid research coverage. The research figures cited on this page were produced by a research house that was engaged and paid by the featured company for ongoing research coverage. Directors or associates of that research house may hold or trade the company’s securities. Valuation figures are a third party’s opinion, may change without notice, and are not a guarantee of future performance.
Forward-looking statements. This page contains forward-looking statements, including anticipated regulatory milestones and market estimates. Such statements are predictions, subject to risks and uncertainties, and actual results may differ materially. All securities involve risk, including adverse or unanticipated market, financial or political developments.
Regulatory status. The featured company is pre-revenue and its lead product is not yet FDA-cleared. Regulatory clearance is not guaranteed. Past performance and forecasts are not reliable indicators of future results.
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