The Story of Epitel: Building the Wireless Halter Monitor for the Brain

The Story of Epitel: Building the Wireless Halter Monitor for the Brain

Four engineers working in an artist colony where the heating barely functioned. No venture capital. No proven ability to commercialize anything. Just a conviction that neurology was decades behind cardiology, and someone needed to fix it.

In a recent episode of Category Visionaries, Mark Lehmkuhle, CEO and Founder of Epitel, a brain health technology platform that’s raised over $20 million, shared the unlikely story of building a medical device company on patience, government grants, and an insight about brain monitoring that would take 15 years to bring to market.

The Parallel That Started Everything

Mark’s founding insight emerged during grad school at the University of Utah in 2008, where he developed a deep background in central nervous system disorders and epilepsy. The University of Utah had a unique advantage—for over 35 years, it hosted the NIH’s anticonvulsant screening program, giving Mark direct exposure to how pharmaceutical companies tested novel anti-seizure compounds.

But the insight that sparked Epitel came from looking at a different field entirely. “Right now, you could walk into your neighborhood clinic and walk out with a wireless halter monitor for your heart,” Mark explains. “But your chances of getting a long term EEG anywhere, even if you go to your neighborhood hospital, is slim to none.”

This wasn’t just a product gap—it was an infrastructure gap that affected millions. The gold standard for detecting seizures was a three-day wired EEG where patients “got a wrap of gauze around your head. It’s coming down to an old school recorder that looks like a vhs tape deck, and you got to wear that for three days. And you can’t shower or anything like that.”

Even worse, for rare events like seizures, three days often isn’t enough. “Your chances of actually capturing an event, like in your case, is very low,” Mark notes. “But recording just a little bit longer drastically improves your probability of capturing these events.”

The market size was staggering. “One in ten people are going to have a seizure in their lifetime,” Mark explains, and epilepsy alone affects “3.4 million in the US. And to put that into perspective, the number of people with epilepsy is twice the number of people living with type one diabetes.”

The solution seemed obvious: make the wireless halter monitor for the brain. The execution would prove anything but.

The Artist Colony Years

Starting with a team of four engineers, none of whom had ever commercialized anything, Epitel faced a fundamental credibility problem with investors. Mark’s solution was unconventional—fund development through the NIH’s Small Business Innovative Research (SBIR) program rather than venture capital.

“We successfully did it on ninds grants and a few grants from the epilepsy foundation that allowed us to develop this technology and take it through the FDA. And it was all non dilutive,” Mark recalls.

The grants came with severe constraints. “These grants aren’t very big, and they take a long time to develop anything on them,” Mark acknowledges. For years, he split time between the university and the company, which was housed “literally in an artist colony because that’s the only thing that we could afford. So we’re building medical devices in an art studio in the heat of—the heat doesn’t work very well. The air conditioning didn’t work at all.”

This bootstrap approach forced Mark to really think through fundamentals. “It really, as a Founder, allows you to dig in and really think about what you’re developing. You know, who are you developing it for? Why are you developing it? What’s the value proposition? The whole package.”

Mark finally left the university in 2017, “once we started demonstrating this traction.” By then, Epitel had spent nearly a decade proving they could build something regulators would approve.

The Dataset Nobody Would Sell

Development hit an unexpected roadblock when Epitel needed training data for their AI algorithm. Mark looked to cardiology companies for guidance on their approach: “We just purchased 30,000 EKG records that were well annotated.”

But when Epitel approached hospitals with epilepsy monitoring units, they discovered a fundamental infrastructure problem. “We go and we look and talking to many of these hospitals that have an epilepsy monitoring unit and things like that, and said, hey, do you have records that we could purchase?” The response was crushing: “No, we don’t have the storage for that. You know, after we record it, we enter the report into the electronic health record, and then we just delete the data because we don’t have the storage for it.”

This revelation reshaped Epitel’s entire development timeline. “So now we’re going to have to develop our own data set,” Mark realized. The company spent years collecting data where “we used the wired EEG as kind of the ground truth and then trained our machine learning on our sensor data.”

The AI component wasn’t optional—it was essential to making long-term monitoring viable. “Beyond the three days, no neurologist has the time to review that EEG data, because they’re literally reviewing it beat by beat, going from the very beginning to the very end, looking for these patterns that they’ve been trained to recognize as seizures,” Mark explains.

The solution: “It’s meant to take these weeks and weeks of EEG, where in most cases, nothing’s going on that’s interesting and flag interesting bits of information for a neurologist to then go through. So now they can quickly go from event to event and say, is my patient experiencing seizures at home? Yes or no?”

The Technology Today

The final product is elegantly simple: four sensors that attach to the forehead and behind the ear with stickers—no goopy gels, no trained technician required. The sensors wirelessly transmit to a smart device, which sends data to the cloud where neurologists review AI-flagged events.

Epitel is currently FDA cleared for up to 30 days of continuous use, with a submission pending for chronic use beyond 30 days. The product serves two distinct markets: hospital emergency departments for rapid diagnosis, and outpatient monitoring for capturing rare seizure events.

Four Weeks In

Fifteen years after founding, Epitel launched commercially just four weeks before this conversation. For Mark, who spent his career in R&D, the transition represents an entirely new challenge. “It’s something I’ve never done before is sell anything,” he admits candidly. “But it’s super exciting and also really scary because I’ve never commercialized anything before.”

The company is deliberately focusing on two geographic markets to prove the commercial model before scaling. “Here’s what we can do in two geographical locations with these very limited resources. Now we’re fundraising again for our series B, what we’re calling our series B, to really then scale this nationally.”

The Future: Beyond Seizures

Mark’s vision extends far beyond seizure detection into comprehensive brain health monitoring. The long-term roadmap is ambitious and transformative.

First, the product evolution: “What I want to do next with this is for people who have been diagnosed with a seizure disorder,” Mark explains, describing a future where the device “really fits behind the ear and looks like a hearing aid. It’s rechargeable, reusable, you can use it whenever you want, and it would count the number of seizures that you’re having.”

This would enable objective medication management—”how do we know that this anti seizure medication is working?”—and real-time alerting to prevent sudden unexpected death in epilepsy. It could even enable forecasting: “What’s my probability of having a seizure in the next hour? I want to go to the grocery store. I have a high probability of having a seizure. Maybe I’ll go tomorrow.”

But the biggest vision involves preventive brain health monitoring. Mark sees a future where “you go into your primary care physician’s office for your annual physical, and you’re recording eeg with our system for ten minutes while you do a task. And that becomes kind of like the baseline for your brain health year after year.”

The potential applications are staggering: “Could we detect the symptoms of Alzheimer’s through eeg years before you have any physical symptoms? And in that way, we could have an intervention early on that either slows the progression or even prevents the disease altogether.”

Mark’s roadmap extends to stroke differentiation in ambulances and other central nervous system disorders. “I’ve got this, like, roadmap that is huge of all the different spaces that we want to go with this technology,” he notes with the enthusiasm of someone who’s already proven he can execute on decade-long timelines.

The ultimate goal: “Long term brain health monitoring” that transforms neurology the way continuous glucose monitors transformed diabetes management and wireless halter monitors transformed cardiology.

For a company that spent 15 years building in an artist colony with broken heating, the vision is remarkably ambitious. But Mark’s already proven that with patience, government grants, and a clear insight about market gaps, the impossible just takes a little longer.