Only 27% of hospitals in the US are capable of performing an EEG. Epitel has secured $26 million in funding.

      Epitel has secured $26 million in a Series B funding round to enhance its wireless EEG system designed for patients to use at home. Catalyst Health Ventures and Genoa Ventures co-led this round. The Salt Lake City-based company plans to allocate the funds towards sales, marketing, and distribution rather than research.

      The gap it intends to address is significant. A noteworthy statistic comes from a peer-reviewed paper, showing that only 27% of hospitals in the U.S. have EEG capabilities, according to a 2023 study published in Neurology: Clinical Practice. Epitel notes that 9.2 million Americans experience seizures annually, with 40% lacking access to EEG services.

      There is another disparity beneath this first statistic. Traditional EEG monitoring can last up to 72 hours, but seizures often occur days or weeks apart and are usually not visibly apparent. Therefore, a three-day test is searching for an event that may not happen for a month, leading to delays in diagnosis that can take several months.

      REMI, Epitel's device, employs four disposable wearable sensors and can record data for up to 30 days. The data is transmitted to Persyst Mobile, described by Epitel as the most commonly used EEG review platform, allowing neurologists to analyze it using familiar software. This device is not simply a reduced version of a hospital EEG; the usage indications specify that the sensors transmit “a single channel of electrical activity of the brain.” Typically, clinical EEG uses around 20 electrodes. The research paper cited by Epitel refers to their approach as a “wearable reduced-channel EEG system,” which trades fewer channels for the ability to record continuously in the patient’s home for weeks.

      While Epitel discusses diagnosis and AI aiding clinicians, the regulatory language is more cautious. The REMI device “does not make any diagnostic conclusions about the subject’s condition and is intended as a physiological signal monitor,” as stated in the usage indications. The AI has similar limitations; REMI Vigilenz highlights sections that may indicate potential electrographic seizures lasting at least 10 seconds for physician review, but it “does not mark REMI EEG records in real time.” This is typical for cleared devices, meaning the system provides evidence for neurologists rather than delivering conclusions independently.

      Regarding age limitations in AI, the portfolio includes five FDA 510(k) clearances, with the most recent extending monitoring capabilities to patients as young as one year old. However, the AI component is not included for this age group; while REMI monitoring is cleared from age one, the Vigilenz event detection is only approved for those aged six and older. Since young children exhibit different EEG patterns compared to adults, the youngest patients receive the hardware without the automated review feature.

      CEO Steve Pacelli, who previously worked at DexCom, aims to replicate their success in transforming blood glucose monitoring from occasional testing to continuous wearable monitoring in the EEG space. Epitel seeks to achieve what continuous glucose monitors have done for finger pricking by moving measurement capabilities outside clinical settings and extending them over time. DexCom serves as a case study for how the FDA navigates this category.

      On a more practical note, REMI is reimbursable under existing billing codes, a significant advantage as new medical devices often face long delays while waiting for the establishment of billing codes.

      Dr. Daniel Friedman, a professor and director of the epilepsy division at NYU Langone Health, commented on the announcement, stating that conventional monitoring tools have been limited by their duration, as seen with ambulatory EEG, or by costs and unnatural settings associated with inpatient video EEG monitoring. He praised REMI for enabling tracking “on clinically relevant timescales of days to weeks.” Joshua Phillips from Catalyst Health Ventures noted the long-standing need for disruption in the ambulatory EEG market, expressing candid enthusiasm for the opportunity. Phillips co-led the funding round and chairs Epitel’s board, indicating a vested interest.

      In the broader landscape, brain technology is attracting investments at both ends of the spectrum. Paradromics has implanted a clinical brain chip for speech, while some researchers caution that unequal access to neurotechnology could lead to a new digital divide. Smaller cleared devices are also attracting funding; Tissium raised $60 million for sutureless nerve repair, and 01Health secured funding to transform specialized care into infrastructure.

      Epitel operates at a less glamorous point in this spectrum, but that is precisely the objective. A four-sensor patch worn at home is a simpler idea compared to an implant and has the potential to reach a far larger audience.