Highlights

  • The U.S. FDA cleared an age expansion for the Minder System to include patients aged 12 and older.
  • The original clearance covered adults aged 18 and older with drug-resistant epilepsy.
  • Minder is described as the world's first implantable sub-scalp continuous EEG monitoring device.
  • U.S. clinicians can now offer continuous EEG monitoring to adolescents with the device.

Epiminder Limited (ASX:EPI) has announced that the U.S. Food and Drug Administration has cleared an age expansion for its Minder System. The implantable continuous EEG monitoring device can now be used in patients aged 12 and older with drug-resistant epilepsy.

FDA Age Expansion

The Minder System was originally cleared for adults aged 18 and older. The expanded clearance, based on clinical and technical data showing safety and performance in adolescents, now covers patients aged 12 and older with drug-resistant epilepsy. The announcement headline refers to patients aged 12 to 75.

CEO Dr Rohan Hoare described the clearance as a meaningful step for patients and the epilepsy community, noting that adolescence is a vulnerable period for drug-resistant epilepsy.

Addressing an Unmet Need

About 3.4 million Americans have epilepsy, and roughly one-third of cases are drug resistant. Continuous EEG monitoring for adolescents has typically required hospital admission to an epilepsy monitoring unit, which provides short recordings that can miss seizures.

Dr R. Edward Hogan, Past President of the American Epilepsy Society, said the device allows objective, continuous capture of seizures while patients are at home, at school and in daily life.

How the Minder System Works

The system uses an implantable sub-scalp electrode array and a telemetry unit placed behind the ear, along with a wearable that charges the device and transmits data. Data is sent to a secure cloud platform for remote review, and the sub-scalp placement does not penetrate the skull.

Epiminder was founded in 2017 by Professor Mark Cook with the Bionics Institute, St Vincent's Hospital, the University of Melbourne and Cochlear Limited. The company is headquartered in Melbourne with offices in the United States.

Key Takeaways

  • The FDA clearance expands Minder's addressable patient population to adolescents.
  • Drug-resistant epilepsy affects about one-third of people with epilepsy in the U.S.
  • Minder offers long-term monitoring outside the hospital setting.
  • The clearance strengthens Epiminder's regulatory foundation for future indications.