Continuing momentum as US DETECT study reaches 75th enrolment

Epiminder announces the 75th patient enrolment in DETECT, the Company's prospective, randomised, controlled US clinical study evaluating the Minder® System, in line with the September 2026 target previously announced.
75th enrolment milestone reflects continuing strong recruitment pace across the DETECT site network, underscoring the increasing appetite for the Minder System among US clinicians and their patients.
The pace of enrolment reflects the engagement of a world-class US site network now encompassing 21 sites and spanning Mayo Clinic, Harvard, Stanford, Yale, Duke and the University of Pennsylvania, with clinicians at these centres actively identifying patients for whom long-term continuous monitoring represents a meaningful diagnostic step forward.
The Company anticipates reaching 100th enrolment milestone in November and remains on track to meet its stated target of enrolling 210 patients in the DETECT study by end of 1H CY2027.

Melbourne, Australia & Dallas, United States – September 17, 2026 – Epiminder Limited (ASX: EPI), a pioneer medical device company developing breakthrough epilepsy monitoring technology, today announced that the DETECT (Diagnosing Epilepsy To EffeCT change) study has enrolled its 75th patient, reaching this milestone in line with September 2026 target previously announced. The pace of enrolment across the DETECT site network reflects a strong appetite for the Minder System among US neurologists and the patients they serve. DETECT is a prospective, randomised, controlled, blinded, multi-centre US clinical study evaluating the Minder System as a tool to improve clinical decision-making for patients with epilepsy following an inconclusive prolonged electroencephalographic (EEG) monitoring assessment.

Rohan Hoare, CEO of Epiminder, said, "The rate at which we are enrolling patients in DETECT speaks for itself. Reaching 75 patients early in September, and during summer holiday period, in line with our expectations signals to us that US neurologists are actively seeking solutions for their most complex epilepsy patients, and that the Minder System is resonating as that solution. We anticipate we will reach the 100th enrolment milestone in November. With every milestone we attain it gives us greater confidence in the path to 210 patients. We remain on track to enrol 210 patients by end of 1H CY2027, and the programme's trajectory gives us real confidence in getting there."

The DETECT study is now supported by 21 clinical sites across the United States, spanning institutions including Mayo Clinic, Harvard, Stanford, Yale, Duke and the University of Pennsylvania. The depth of engagement at these sites, and the rate at which they are identifying eligible patients, reflects a clinical community that sees real and immediate value in what the Minder System offers.

The enrolment pace in DETECT also reflects a shift in how leading US epilepsy centres are thinking about the diagnostic pathway for their most complex patients. Drug-resistant epilepsy presents a particular challenge: patients may go years without a confirmed seizure characterisation or treatment pathway because conventional inpatient EEG monitoring is too short to capture the events that define their condition. The Minder System addresses this directly, providing continuous bilateral subscalp EEG monitoring across patients' daily lives over months or years. For neurologists at DETECT sites, the ability to capture real-world electrographic data outside the constraints of an inpatient stay is not a marginal improvement. It is a fundamentally different diagnostic tool.

The scale of the problem DETECT is designed to address helps explain why enrolment is accelerating. Between 30% and 50% (25,000 to 45,000) of inpatient epilepsy monitoring unit stays in the United States are inconclusive. For patients in that group, the consequences are significant: without a confirmed diagnosis or characterised seizure type, access to definitive therapies including epilepsy surgery is frequently delayed or denied entirely. Many of these patients have drug-resistant epilepsy, meaning medication alone is unlikely to deliver adequate seizure control. The Minder System, authorised by the FDA via the De Novo pathway, was developed precisely for this population. Its ability to provide objective, continuous electrographic data over extended real-world periods gives neurologists what short inpatient stays cannot.

Professor Mark Cook, Founder of Epiminder and Professor of Medicine at the University of Melbourne, said, "The speed at which DETECT is enrolling patients is a direct reflection of how unmet this need is. These are not patients who have simply not yet been seen by the right specialist. Many of them have spent years being monitored by some of the best neurologists in the world, without getting the answers they need. Minder exists for exactly that patient. The fact that clinicians at institutions like Mayo Clinic, Harvard and Stanford are enrolling their most diagnostically challenging patients into DETECT tells us something important: the epilepsy community understands what this technology can offer, and they want to see the evidence that will allow them to use it at scale. Reaching 75 patients on schedule puts us in a strong position to build a definitive evidence base. The sites, the patient numbers, and the rigour of the study design are all in place. That is exactly what the field needs."

To learn more about the DETECT study, please visit www.clinicaltrials.gov and search for NCT07110337.

This announcement has been authorised for lodgement to the ASX by Epiminder's Board of Directors.

Investor & Media Enquiries

Gabriella Hold, The Capital Network P: +61 2 7257 7338 E: gaby@thecapitalnetwork.com.au

Julia Maguire, The Capital Network P: +61 2 7257 7338 E: julia@thecapitalnetwork.com.au

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About Minder®

Minder® is a minimally invasive implantable continuous EEG Monitoring (iCEM®) device that provides clinicians and patients with long-term, objective data on brain electrical activity. The system continuously records bilateral subscalp EEG and transmits data via an external wearable and smartphone application to a secure cloud platform. Patients wear the device during their normal daily activities, enabling real-world monitoring over months or years.

The Minder System was authorised by the FDA via the de novo pathway and is being used in DETECT as a marketed device in a post-market study. The UMPIRE first-in-human multicentre trial, published in Epilepsia (2025), demonstrated Minder's safety and high-quality signal acquisition across extended monitoring periods.

About Epiminder

Founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited, Epiminder is a medical device and information solutions company focused on developing diagnostic and treatment tools for epilepsy and other seizure disorders where continuous monitoring is required. Epiminder is headquartered in Melbourne, Australia and has offices in the United States.

About DETECT

DETECT (Diagnosing Epilepsy To EffeCT change) is designed to enrol up to 210 participants across up to 25 US sites, with a six-month primary follow-up period. The primary endpoint is the proportion of subjects who achieve an actionable clinical event, including a confirmed diagnosis, seizure characterisation, surgery evaluation, event classification, or psychogenic nonepileptic seizure (PNES) determination. The study is registered on ClinicalTrials.gov (NCT07110337).