- First clinical trial published demonstrating safety and efficacy of a bilateral continuous EEG monitoring system
- Clinically relevant findings were identified in 88% of patients
- High-quality, durable EEG signals comparable to standard of care scalp monitor
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."
