In The Spotlight: Epiminder

In The Spotlight: Epiminder

Doctor Rohan Hoare will forever remember Easter 2025 for the celebrations that took place at 9.39am on the morning of Friday, April 18.

“It was actually Good Friday, and it turned out to be a very good Friday for Epiminder,” he quips of the Melbourne medtech that he has run since late 2020.

That morning Hoare and his team received an email from the United States Food and Drug Administration granting approval for Epiminder’s flagship “Minder” device to be sold in North America.

The device also picked up a “breakthrough” designation, which gives it priority processing with the regulatory body.

“The agency has given 700 breakthrough designations in recent years, of which only about 70 of actually got commercialised. So we are one of those 70, a very, very small cohort that actually makes it through to commercialising a breakthrough designation,” Hoare says.

“We feel that is a pretty special achievement.”

Founded in 2018 by University of Melbourne researchers Professor Mark Cook and Associate Professor Chris Williams, Epiminder’s implantable device monitors the brain’s electrical activity to detect epileptic seizures.

Australian hearing implant device manufacturer and global trail-blazer, Cochlear, is a significant investor and technology partner.

Taking inspiration from the Cochlear implant, the “Minder” - a tiny device with a string of electrodes - is implanted under the scalp and gives patients a “weather forecast” of their brain activity, alerting them that they may soon suffer a seizure.

It has been called a “Fitbit for the brain”.

“So having the FDA approval means that we can distribute and sell the product in the United States for its indicated population, and we are very pleased with the labelling that we got from the agency so we can go and start selling in the second half of calendar 2025,” Hoare says.

“We will also be conducting a post market demonstration trial for reimbursement purposes to really show the clinical utility of the minder system in terms of aiding clinicians in the diagnosis and management of patients with epilepsy.”

Born in Australia and a science graduate of Monash University, Hoare moved to America over 35 years ago where he completed a PhD in atomic physics from Harvard University. There he was a Fulbright Scholar, one of the most prestigious international scholarship programs in the United States.

His subsequent 10 years at McKinsey, where he served clients in high tech and med tech, led him to be an executive, president, and CEO of eight companies in the US health care industry, two of which were publicly listed.

It means he is well prepared to pilot Epiminder through the likely next stage of its evolution in the public markets.

In February the company completed a $10 million pre-IPO convertible note bridging round, in which Cochlear was an investor.

The doctor-led US venture capital group Netra Health also backed the raising, alongside a range of high-net-worth individuals and sophisticated investors.

Epiminder was set up as a partnership between Cochlear, Melbourne’s St Vincent’s Hospital, the University of Melbourne and the Bionics Institute in 2017. Cochlear helped with designing the implant and is a significant investor in the company.

“Cochlear has been a development partner for a long period of time. They provided a lot of capital and then a lot of technology to help get us where we are in seven years,” Hoare says.

“Then we had terrific support from angels and high net worth and a couple of institutions along the way. But at this stage, as our capital needs grow, we've really got to move to that next level and that will come from accessing the public market.”

He says private market investors in the US and Europe tend to stick to their home markets, so are less likely to look at Australian investment opportunities.

“We think we have a world changing opportunity, but we need the capital to be able to drive the business to that next level of performance. So the public markets seem to be the most appropriate way for us to be able to raise the substantial amount that we need to on a going forward basis,” he says.

The Australian sharemarket is also a focus because unlike the US markets, the Australian Securities Exchange has actively encouraged pre revenue companies like Epiminder to pursue Initial Public Offerings.

“I also think that because this is a homegrown technology, the market will be supportive of what will hopefully be the next big Australian med tech,” he says.

“This says Australia can punch above its weight in terms of technology development and coming up with the ideas. We've known that for quite a while. But I think what Epiminder is showing is that you can actually take this thing along the entire road to approval and to commercialisation, and that really then sets up the opportunity.”

An expected IPO will fund Epiminder for the next 2-3 years, allowing the company to generate the clinical evidence to convince so-called payers in the US - health plan providers that set service rates, collect payments, process claims, and pay provider claims - that they should be covering its products as a standard of care in the US market.

The raising will also allow Epiminder to take all the learnings gleaned from its clinical work to continue the development of its next generation device to come to market.

“That is well and truly in design development,” Hoare says.

“The next gen device will be better in just about every dimension that you can imagine, in terms of the ease of implantation, in terms of its performance, in terms of its power consumption, durability, and its communication approach.”

Hoare is now visiting the country of his birth - he was born at Mentone in Melbourne’s Bayside - from his home in Dallas up to eight times a year, double the number of annual trips he made in the first few years of running Epiminder.

One of his adult sons, who was born in America, has even taken out Australian citizenship.

But despite the gruelling travel schedule, Hoare is energised by the opportunity to commercialise a technology he believes will truly change the world.

“This has probably been the best fun I've had in a long, long time. It has been a joy. I

took on this role to give back to Australia, to develop and grow a remarkable piece of medtech. I have loved doing it, especially bringing along and mentoring so many folks here. It's just been a fabulous opportunity,” he says.

“Now, that is not to say that there are not days and weeks when things don’t go your way, but that is what happens in a startup. I had one of my mates say it only takes 10 years to become an overnight success. Everybody remembers success, but you've got to do the hard yards prior to get there.”

Morgans has been appointed as a Joint Lead Manager and Joint Bookrunner to the proposed IPO

About Epiminder

Epiminder was founded in 2017 by Professor Mark Cook as a research collaboration between the Bionics Institute, the University of Melbourne, St Vincent's Hospital Melbourne and Cochlear.

The partnership combined the technological expertise in epilepsy seizure monitoring of the three research institutions with Cochlear's proficiency in implant design, development and manufacturing.

Board and Management

• Rohan Hoare, Chief Executive Officer & Director
• Professor Mark Cook, AO, Chief Medical Officer
• Dr John Heasman, Chief Operating Officer
• Toby McSweeney, Chief Technology Officer
• Dr Tracy Cameron, VP, Clinical & Regulatory
• Chip Moebus, VP, Market Access
• Steven Ringo, VP, IT & Security

‍