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Melbourne-based medical device company Epiminder (ASX: EPI) has reported accelerating momentum in its pivotal US reimbursement study for the Minder implantable EEG monitoring system, with 18 medical centres now contracted and 15 patients enrolled as the Cochlear-backed firm maintains a cash war chest of $83.8 million with no debt.
The Q3 FY26 quarterly update marks a sharp step-up in enrolment for the DETECT study, which had just three patients at the end of February.
Epiminder is targeting 210 patients across up to 25 US centres by the end of the first half of calendar year 2027, with a G1 submission to the US Food and Drug Administration planned for the second half of CY2027 and full commercial launch in early 2028.
The Minder system is a sub-scalp implant designed to continuously monitor brain activity in epilepsy patients, with data transmitted wirelessly to clinicians.
“Epiminder has made strong progress, with continued momentum across DETECT site contracting, patient enrolment and G1 development," says Epiminder CEO Rohan Hoare.
"The level of interest from leading US medical institutions supports our confidence in enrolling the required 210 patients in the DETECT reimbursement study and reinforces the clinical and commercial potential of the Minder device.
"With DETECT and G1 progressing well, we remain on track with our commercialisation plans, with full market rollout planned for early 2028.”
Net operating cash outflow for the quarter was $5.7 million, down sharply from $25.2 million in Q2, which had been inflated by a $15.8 million Australian Taxation Office R&D settlement and elevated costs associated with the company's December 2025 initial public offering.
Epiminder now expects second-half FY26 cash burn of about $17 million, lower than the $20 million previously guided at its half-year result.
The company attributes the reduction primarily to slower invoicing by US medical institutions during the DETECT study start-up phase, and cautions that the timing difference will unwind in FY27.
The $83.8 million cash balance at quarter-end, down from $89.5 million at the end of Q2, provides funding well into calendar year 2028, giving Epiminder a long runway through its anticipated FDA submission and into commercialisation.
During the quarter, Epiminder paid $2.16 million to largest shareholder Cochlear (ASX: COH) for research and development services, and $90,000 in director fees.
Epiminder listed on the ASX in December 2025 after raising $125 million at $1.50 per share. The shares last closed at 55c each.
The company posted a $34.5 million net loss in FY25 and has not yet generated revenue from the Minder device.
Epiminder was founded by Professor Mark Cook, who serves as the company's chief medical officer.
Cook, a neurologist, developed the Minder technology to address the limitations of short-term in-hospital EEG monitoring, which captures only a brief snapshot of brain activity and often fails to detect seizure patterns in epilepsy patients.
The company's immediate focus remains filling out its network of contracted US medical centres and accelerating patient enrolment toward the 210-patient target ahead of its planned FDA submission in the second half of CY2027.
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