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Highlights

 

Welcome to another episode of Category Visionaries — the show that explores GTM stories from tech’s most innovative B2B founders. In today’s episode, we’re speaking with Mark Lehmkuhle, CEO & Founder of Epitel, a brain health technology platform that has raised over $20 Million in funding.

Here are the most interesting points from our conversation:

  • Simplifying EEG Monitoring: Epitel has developed a wearable EEG sensor that makes brainwave monitoring easier for patients. Unlike traditional EEGs, which require extensive equipment and specialist interpretation, Epitel’s sensor offers a streamlined approach to detecting central nervous system disorders, especially seizures.
  • Seizures vs. Epilepsy: While seizures are common, with 1 in 10 people experiencing one in their lifetime, not all seizures indicate epilepsy. Epitel focuses on seizure detection, addressing a broader spectrum of neurological conditions, not just epilepsy.
  • Bootstrapping and Perseverance: Mark shared how the company started in 2008 with a small team and minimal resources, operating out of an artist colony with limited heating and air conditioning. The journey took years of grant funding and regulatory hurdles before reaching commercialization.
  • Regulatory Pathway: Despite being a medical device, Epitel’s technology sits on the lower end of the FDA’s regulatory spectrum, allowing them to move relatively quickly compared to more complex devices. They achieved FDA clearance with non-dilutive funding, a strategic milestone that paved the way for institutional investment.
  • Data Collection Challenges: To train their AI, Epitel had to develop their own clean EEG dataset because hospitals typically delete such data post-diagnosis. This created a significant technical hurdle but also underscored the uniqueness of their solution.
  • Future Vision: Mark envisions Epitel expanding beyond seizure monitoring into broader brain health applications. Long-term goals include creating a system for continuous brain health tracking, similar to continuous glucose monitors, potentially detecting early signs of conditions like Alzheimer’s or even alerting to stroke risks.

 

Actionable
Takeaways

Start Small, Think Big:

Epitel’s early focus was on a single use case—seizure detection—but they have a long-term vision for addressing broader brain health issues. Founders should focus on solving a specific problem first, then expand into adjacent areas.

Strategic Funding Decisions:

Instead of following traditional startup funding advice, Mark leveraged NIH grants to de-risk the development process. For founders in regulated industries, non-dilutive funding can be a critical bridge before taking on institutional investment.

Build Investor Relationships Early:

Mark emphasized the importance of finding investors who understand the long-term nature of medtech development. Founders should seek investors who have experience with similar time horizons and regulatory challenges.

Leverage AI for Efficiency, Not Replacement:

Epitel’s AI doesn’t replace neurologists but instead makes their work more efficient by flagging potential seizure events in long-term data. Founders working with AI should focus on how it enhances human expertise rather than positioning it as a replacement.

Stay Focused on the End User:

Mark highlighted how making the product easy for patients to use—no goopy gels or complicated equipment—is central to their success. Founders should prioritize user experience, especially in industries like healthcare where patient compliance can impact outcomes.

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