Epiminder today announced results from a clinical trial of its implantable continuous electroencephalogram monitoring (iCEM) system.
Results from the landmark UMPIRE trial — published in Epilepsia — validated the safety and efficacy of the Minder iCEM system. The study, conducted across Australia, demonstrated Minder’s ability to capture high-quality EEG data for extended periods. According to a news release, it proved comparable to current standard of care, scalp-based EEG monitors.
Minder could provide more effective diagnosis and management for people living with epilepsy. The technology also received FDA breakthrough device designation, according to a news release. Australia-based Epiminder designed Minder to address the shortcomings in current EEG technologies. It aims to provide reliable, actionable diagnostic data for more patients to enhance epilepsy treatment and management.
The system won FDA de novo clearance in April.
According to Mark Cook, Epiminder founder and chief medical officer, the UMPIRE results exceeded company expectations. Outcomes proved the potential of continuous EEG monitoring over years, not just days, he said. This could prove “transformative” for epilepsy management, according to Cook.
Key outcomes included safety, with no device- or procedure-related serious adverse events. EEG signal clarity proved comparable to standard of care scalp recordings as well.
Epiminder reported clinically relevant findings in 88% of drug-resistant epilepsy patients, including patients with frequent unreported seizures. Minder’s unique bilateral recording capability revealed clinically relevant findings not possible with unilateral recordings in 23% of patients.
“We are very pleased with the positive impact that Minder can have on the lives of people with epilepsy. Following the FDA authorization in April 2025, Epiminder will initiate a phased U.S. launch in Q3 2025, targeting major epilepsy centers,” said Rohan Hoare, Epiminder CEO.
