Oct 2020 BioWorld Online

epi minderThe Minder system, a long-term ambulatory electroencephalography monitoring device for epilepsy

Epi-Minder Pty. Ltd. has completed an oversubscribed series A round of AU$18 million (US$12.89 million) that will see its Minder epilepsy monitoring device enter a pivotal trial to support marketing applications in Europe and the U.S. The funds will support ongoing clinical trials for Minder, long-term ambulatory electroencephalography (EEG) monitoring device. The smartphone-enabled device promises to improve on wearables and other tools – such as patient diaries – that have proven to be unreliable. “It’s a brand-new concept that is designed to be able to measure continuously via an EEG, or brain signals, in patients in a relatively non-invasive way,” Robert Klupacs, Epi-Minder non-executive director, told BioWorld.

About one-third of patients with epilepsy are refractive epileptics, and the way they’re currently treated doesn’t work, he said, noting that many either don’t recall having seizures or don’t report on them accurately. Epi-Minder founder Mark Cook, whose father had epilepsy, was determined to invent a better method for recording seizures in epileptics by implanting a device in the brain. He was the first to show that patients’ own records were distorted, Klupacs said. What was needed was an ongoing continuous recording that was quantitative and not biased by the patient. The challenge was that an invasive device would require brain surgery. Cook sought a less invasive way, and so he linked up with Cochlear Ltd. They developed a device that could be implanted sub-scalp that was built on top of a Cochlear implant. The device has been tested in six patients so far.

“Results so far have been outstanding, and the company has raised enough money to take the product to clinical trials,” Klupacs said. “We are extremely pleased by the results obtained to date, especially the quality of the brain signals obtained and the very positive feedback from patients on ease of use and comfort,” said Cook, who is a neurologist at St. Vincent’s Hospital and chair of medicine at the University of Melbourne.

How it works

The Minder is a minimally invasive device for long-term monitoring of brain seizures, providing patients and their doctors with detailed data on seizure activity and frequency over an extended period. Patients can wear the device as they go about their normal daily activities. An electrode is placed under the scalp and above the skull, where it records neural events. An implant captures EEG from the electrode and transmits signals to a wearable processor that provides power to the implant and a Bluetooth connection to a smartphone. The Minder companion app collects EEG data using the Bluetooth connection to the wearable and uploads to the cloud for processing.

Minder’s long-term monitoring of patients outside a controlled clinical environment is expected to lead to more effective treatment of underlying conditions, including determining the effectiveness of drug therapies.

The Melbourne, Australia-based startup plans to launch a pivotal study, to be carried out in its home country and the U.S. The results will support submissions to the FDA and the EU officials. Subject to clinical results, later generations of the device could include advanced detection and warning of impending seizures. “That could really change the lives for a lot of people, because even if they only have seizures, say 1% of the time, they never know when they’re going to get them,” Klupacs said.

Epilepsy affects 65 million people globally, with current medications only effective in two-thirds of cases. More than 250,000 Australians and 3.4 million Americans are living with epilepsy, the most common brain disorder worldwide.

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