Epiminder Announces Publication of Landmark Clinical Trial Confirming Safety and Efficacy of the Minder® System

MELBOURNE, Australia & DALLAS--(BUSINESS WIRE)--Epiminder, a pioneer in implantable continuous EEG monitoring (iCEM™), today announced the publication of results from its landmark UMPIRE (sUb-scalp Monitoring ePileptic seIzuREs) clinical trial in Epilepsia validating the safety and efficacy of its iCEM. The study, conducted across leading Australian hospitals, demonstrated Minder’s ability to capture high-quality EEG data for extended periods that are comparable to current standard of care scalp-based EEG monitors.

The Minder system is a designated Breakthrough Device and has recently been granted clearance for marketing in the United States by the FDA. A world record five-year continuous EEG recording has recently been reported by Epiminder using the system.

“The UMPIRE results exceeded our expectations, proving that continuous EEG monitoring over years—not just days—is not only possible but transformative for epilepsy management,” said Professor Mark Cook, Epiminder’s Founder and Chief Medical Officer.

Key Highlights of UMPIRE Clinical Trial:

• The Minder system was found to be safe, with no device or procedure related Serious Adverse Events
• EEG signal clarity was comparable to standard of care 10-20 scalp-based recordings
• Clinically relevant findings were identified 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

Commercial Outlook:

Rohan Hoare, Epiminder’s CEO, said, “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.”

Please visit Epilepsia for open access to the UMPIRE publication.

Follow Epiminder on LinkedIn and explore Epiminder.com for more information.

About Minder

Minder is a minimally invasive device for continuous monitoring of electrographic activity of the brain, providing epilepsy patients and their doctors with detailed data on brain activity over an extended period. Patients can wear the device as they go about their normal daily activities.

Minder’s long-term monitoring of patients outside of a controlled clinical environment provides data needed for better understanding and more effective treatment of underlying conditions, including determining the effectiveness of drug therapies and other potential interventions.

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.