Australian medtech eyes IPO after securing regulatory milestone for epilepsy device

An Australian-based medtech company is setting its sights on an initial public offering following a major regulatory milestone in securing U.S. Food and Drug Administration (FDA) approval for its flagship minimally invasive epilepsy device.

Epiminder’s Minder, an implantable continuous electroencephalogram monitoring (iCEM) system, aims to transform the diagnosis and management of epilepsy, one of the world’s most common serious chronic neurological disorders. Approximately 52 million people globally, including 250,000 Australians, live with epilepsy, and current diagnosis and monitoring technologies present significant challenges.

Designed to address the limitations of existing EEG systems, Minder delivers reliable, actionable diagnostic data over extended periods, offering healthcare professionals and patients a new frontier in epilepsy care.

Cochlear-backed Epiminder CEO, Dr Rohan Hoare, said the device extends EEG monitoring from days to potentially months or even years, offering “unprecedented access” to continuous EEG data.

The safety and effectiveness of Minder were validated through Epiminder’s UMPIRE clinical study – a multi-centre, prospective, open design, case-controlled comparator trial conducted across leading Australian hospitals between 2019 and 2023.

Professor Mark Cook, Epiminder’s Founder and Chief Medical Officer, said “The results from UMPIRE exceeded our expectations and demonstrated Minder’s ability to capture high-quality EEG data continuously for extended periods, including a groundbreaking five-year continuous recording in one participant.

“Minder delivered actionable clinical insights for nearly 90% of study participants, highlighting the real-life benefits that Epiminder’s best-in-class iCEM can deliver relative to the current standard of care.”

Epiminder plans to formally launch the Minder system in the second half of 2025, beginning with a phased commercial rollout targeting leading epilepsy centres. The strategy is designed to demonstrate the system’s clinical utility in real-world settings.

Highlighting the broader significance of the FDA approval, Dr Hoare said “As the first and only implantable continuous EEG monitor approved in U.S., Minder can provide health care professionals and their patients with more accurate and timely diagnoses, enhanced therapeutic drug monitoring, and can better inform decisions on non-drug treatments like surgery.”

Looking ahead, the company’s ambitions extend beyond the device itself. “Epiminder plans to develop a suite of integrated software solutions that will extend the clinical impact of the Minder device, for example by providing patients with advance notice of seizures through AI-enabled forecasting,” Dr Hoare added.

Epiminder was founded in 2017 by Professor Mark Cook together with the Bionics Institute, St Vincent’s Hospital, the University of Melbourne and Cochlear.

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