Transcription of The Stock Network Interview with Epiminder (ASX:EPI), CEO Rohan Hoare
Lel Smits: Epiminder is a medical device company developing next-generation technology for continuous brain monitoring in epilepsy patients. The company is advancing its STATEC study in the United States, a large-scale clinical trial designed to support future reimbursement for its Minder device. Momentum is building with 18 leading U.S. medical centers now contracted and patient enrollment ramping up quickly, positioning the study for significant expansion this year.
I’m joined today by Epiminder CEO Rohan Hoare to discuss what this progress means, also how the study is tracking against key milestones and Epiminder’s plans as it scales. Rohan, welcome to the Stock Network.
Rohan Hoare: Thanks, Lel. It’s nice to be with you.
Lel Smits: Now, we’ve seen a strong ramp up in the DETECT study with 18 U.S. medical centers now contracted and also patient enrollment increasing. Can you outline for us what’s really driving this acceleration and also when it comes to investors, how do you think they should interpret this progress?
Rohan Hoare: Sure. Clinical trial success is built from having a product that meets a significant unmet clinical need, having engaged clinicians and building a pipeline. We have all three ingredients for success. The Minder implantable continuous EEG monitoring system is the first of its kind in the U.S. It is breakthrough designated and is approved by the FDA.
Clinicians are excited by the potential of Minder’s long-term EEG recording to make informed clinical decisions for their patients. And third, clinical sites have expanded rapidly this year due to dedicated principal investigators and coordinators at the sites. With an increasing number of clinical sites, we should expect to see further acceleration of patient enrollment.
Lel Smits: Fantastic. And you are targeting 210 patients across up to 25 leading U.S. sites. How important really are the next few months in terms of hitting enrollment milestones?
Rohan Hoare: I’d have to say every month is an important month in terms of generating and maintaining clinical trial momentum.
We got out of the gate quickly at the beginning of this year and kicked into high gear and the focus in the first few months was really sort of getting centers stood up. Now that we have 18 out of a maximum 25 centers contracted, which I think has been terrific progress, we will continue to contract with those sites, but we will also be then placing a greater emphasis on throughput at each site to drive enrollment. As of now, we have 15 enrollees in the program and anticipate that we’ll have 25 in May as previously forecast.
Lel Smits: Excellent. And Rohan, you have an exceptionally strong cash balance of $83.8 million also funding through to 2028. How does this position, Epiminder, really to execute on detect complete G1 development and also move towards that very important commercial rollout?
Rohan Hoare: You’re right, Lel. We’re in a good strong cash position and we forecast that the cash will take us well into calendar 2028 to be able to complete our major programs, which are detect the post-market, i.e. post FDA approval study designed to generate evidence to support reimbursement in the U.S. market. Detect will enroll and will be enrolled in the first half of calendar 2027. Next generation minder device design should also be complete in the first half of calendar 2027 and we anticipate FDA approval in the second half of calendar 2027.
These milestones, along with progress on early commercialization proof points, sets us up for a commercial launch in calendar 2028.
Lel Smits: Fantastic. Well, Rohan, I appreciate the update from Epiminder today and look forward to hearing more as those developments come through.
Rohan Hoare: Thank you very much and we look forward to coming back and talking about it.
Ends