Epiminder (ASX:EPI): Less than 2 months since its IPO, this medtech made its first implant

Epiminder (ASX:EPI) only listed on the ASX at the end of November last year, but just announced to market that it completed the first implant of its Minder system in the USA.

The company’s Minder system is an epilepsy monitoring technology which is in a global clinical trial which will enrol over 200 patients. Shares only responded modestly today, but veteran investors would tell you there is potential for a re-rate if the company can bring it to market.

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Epiminder: Commercialising an EEG monitoring system

Epiminder was founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincents Hospital, the University of Melbourne and Cochlear. Professor Cook was (and is) a neurologist by trade interest in epilepsy-monitoring technology was influenced by personal experience with epilepsy in his own family and the clinical shortcomings of traditional short-term EEG approaches.

The company’s Minder device is an implantable continuous EEG monitoring system designed to record electrical brain activity sub-scalp over long periods.

Traditional EEG monitoring typically captures only brief snapshots during hospital visits, which can miss many seizures and lead to suboptimal treatment decisions.

Minder’s implant captures continuous, high-fidelity brain wave data that can be transmitted wirelessly to a wearable receiver and smartphone app, then uploaded securely to the cloud for clinician review. This design aims to give neurologists and patients accurate, long-term insights into seizure frequency, severity and patterns outside of clinical settings.

It comprises an implantable electrode array that sits beneath the scalp, a wearable receiver that collects brain activity data and sends it to a connected smartphone app, and cloud-based analytics that make this information available to clinicians for interpretation and treatment planning.

The idea behind all this is quicker and more optimal treatment decisions.

First the UMPIRE trial, enabling De Novo classification

The first trial of Minder was called UMPIRE (sUb-scalp Monitoring ePileptic seIzuREs). his prospective study compared Minder’s continuous EEG output against standard scalp EEG systems and was conducted in major Australian hospitals.

The results published in 2025 showed that the Minder system was safe and capable of capturing high-quality EEG data for extended periods — even achieving a remarkable five-year continuous recording in one participant — and provided clinically relevant insights in a large majority of participants.

A major regulatory breakthrough came in April 2025, when the U.S. Food and Drug Administration (FDA) granted De Novo authorisation and Breakthrough Device designation to Minder. The De Novo pathway created a new regulatory classification for the device, allowing Epiminder to market Minder in the United States as the first FDA-authorised implantable continuous EEG system for people with drug-resistant epilepsy.

The Breakthrough designation recognised the novel clinical potential of the technology and supported an expedited review process. De Novo is not the 510(k) pathway, but does enable use and is allowed in cases where there is no equivalent device. But, marketing authorisation is not the same as wide clinical uptake, reimbursement or established clinical utility, and so another trial was needed.

Next the DETECT trial

The company listed in November last year, raising $125m for the next trial. Cochlear, already a substantial shareholder with over a third of shares, chipped in further Proceeds from the IPO were earmarked for executing a U.S. phased commercial rollout under a demonstration initiative known as DETECT (Diagnosing Epilepsy To EffeCT Change), continued development of next-generation Minder products, and building out sales, marketing and reimbursement infrastructure.

Unlike the earlier UMPIRE trial (which showed that Minder is safe and produces high-quality continuous EEG data), DETECT is intended to show that routine use of the Minder system actually improves epilepsy monitoring outcomes versus standard of care — specifically in patients with drug-resistant epilepsy whose previous EEG tests have been inconclusive. This kind of evidence is exactly the sort of data U.S. clinicians and payers (insurers/Medicare) want to see to justify routine use and reimbursement of a new technology in clinical practice.

DETECT is a randomised controlled trial that will compare outcomes between two cohorts of patients implanted with the Minder device. One cohort’s clinicians receive continuous EEG data regularly (e.g., weekly) while the other cohort’s clinicians do not access the Minder data for an extended period (e.g., six months).

The comparison aims to show whether access to continuous EEG leads to better clinical decision-making. Around 210 patients are planned to be enrolled in this trial across up to 25 sites in the United States, including major epilepsy centres such as Mayo Clinic (multiple campuses) and Beth Israel Deaconess Medical Center.

So what next?

Well, sit back and wait for the trial. It may not be until the end of this year at the latest – more realistically next year. If the results are good, then there will be more widespread adoption of Minder. And given the US is the biggest healthcare market, success there will open plenty of doors in other countries too.