DETECT Study reaches 25th enrolment as momentum builds

  • Epiminder announces the 25th patient enrolment in its strategic DETECT program – its prospective, randomised, controlled US clinical study evaluating the Minder® System.
  • 25th enrolment achieved in line with the forecast communicated at the February 2026 investor call and is an important milestone in Epiminder's commercialisation plan.
  • 19 leading clinical sites across the United States, including Mayo Clinic, Harvard, Stanford, Yale, Duke and the University of Pennsylvania, are now participating in DETECT, with enrolment accelerating as site activation continues.
  • Company remains focused on progressing toward its next enrolment target of 50 patients, expected in mid Q3 CY2026, with site activation continuing to support recruitment momentum.
  • The DETECT study is a key component of the Company's commercialisation plan and we remain on track to meet our stated target of enrolling 210 patients in the DETECT study by end of 1H CY2027.

Melbourne, Australia & Dallas, United States – June 1, 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 25th patient. 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. This milestone is a significant step in achieving the Company's commercialisation plan for its innovative medical device.

Rohan Hoare, CEO of Epiminder, said, "Reaching 25 enrolled patients in DETECT is an important milestone, and one we committed to delivering. With 19 sites now participating across the United States and enrolment continuing to build, we are focused on progressing toward our next target of 50 total enrolled patients, expected in mid Q3 CY2026. DETECT is central to our commercialisation strategy and is designed to generate the clinical evidence needed to support reimbursement and drive broader access to the Minder System for the many patients who remain without answers after inconclusive EEG monitoring."

The 25th enrolment was achieved in line with the timing communicated to shareholders at Epiminder's February 2026 investor call. The DETECT study is now supported by 19 participating clinical sites across the United States, including leading US epilepsy centres affiliated with Mayo Clinic, Harvard, Stanford, Yale, Duke and the University of Pennsylvania, with continued site activation expected to support progression toward the Company's target of 50 total enrolled patients expected in mid Q3 CY2026.

DETECT addresses a significant and widely recognised gap in epilepsy care. Between 30% and 50% of inpatient epilepsy monitoring unit stays are inconclusive, leaving many patients without a confirmed diagnosis or treatment pathway. For those patients, many of whom have drug-resistant epilepsy, the inability to capture and characterise seizure events during conventional monitoring can delay or prevent access to advanced therapies, including epilepsy surgery. The Minder System, authorised by the FDA via the de novo pathway, provides continuous bilateral subscalp EEG monitoring over extended periods, enabling neurologists to obtain objective electrographic data that may not be captured using conventional EEG monitoring techniques.

DETECT 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.

Professor Mark Cook, Founder of Epiminder and Professor of Medicine at the University of Melbourne, said, "The DETECT study is asking an important clinical question to patients with epilepsy who remain without a clear diagnosis or an effective treatment pathway. An inconclusive stay at an epilepsy monitoring unit should not mean patients are left without a path to diagnosis. Minder is designed to give clinicians a longer-term view of brain activity during daily life, helping to capture events that may not occur during a short inpatient stay. DETECT is an important step in demonstrating the clinical value of that approach."

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

In addition to the increasing momentum on DETECT there was also a recent research publication in Epilepsia supporting the feasibility of sub scalp EEG as a reliable long term monitoring tool. This publication can be accessed at doi.org/10.1002/epi.70290.

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.