Only 27% of hospitals in the US are equipped to conduct EEGs. Epitel secured $26 million in funding.

      Epitel has successfully secured $26 million in a Series B funding round to enhance a wireless EEG system designed for use by patients at home. Catalyst Health Ventures and Genoa Ventures co-led this round. The company, based in Salt Lake City, indicates that the funds will primarily support sales, marketing, and distribution efforts instead of research.

      The target market

      One statistic presented is notably robust, as it originates from a peer-reviewed publication rather than a market estimation. A study published in 2023 in Neurology: Clinical Practice found that only 27% of hospitals in the US have EEG capabilities. According to Epitel, approximately 9.2 million Americans suffer from seizures annually, with 40% lacking access to EEG testing.

      A second related issue underpins the first. Conventional EEG monitoring can last for up to 72 hours. However, seizures may occur days or even weeks apart, and most do not exhibit any visible physical symptoms. Thus, a three-day test seeks an event that may not occur for a month, leading to lengthy diagnostic processes.

      What the device entails

      The REMI device utilizes four disposable wearable sensors and can record data for up to 30 days. The data is sent to Persyst Mobile, which Epitel claims is the most widely used EEG review platform, allowing neurologists to analyze it using familiar software.

      REMI is not merely a miniature version of a hospital EEG. The usage indications specify that the sensors transmit “a single channel of electrical activity of the brain.” Conventional clinical EEGs typically employ about 20 electrodes. A research article referenced on Epitel’s website describes this method as a “wearable reduced-channel EEG system.” This reflects a trade-off: fewer channels for extended recording periods in the comfort of the patient’s home.

      The description is more limited than the announcement

      While Epitel discusses diagnosis and the role of AI in expediting the diagnostic process, the regulatory language is more cautious. The indications specify that REMI “does not make any diagnostic conclusions about the subject’s condition and is intended as a physiological signal monitor.” Similarly, the AI functions with constraints; REMI Vigilenz identifies segments that may correspond to potential electrographic seizures lasting at least 10 seconds for clinical review, but it “does not mark REMI EEG records in real-time.”

      Such limitations are typical for cleared devices and indicate that the system provides evidence for neurologists rather than yielding autonomous conclusions.

      The age limitations in AI

      The portfolio includes five FDA 510(k) clearances. The latest clearance allows monitoring for patients as young as one year. However, the AI feature was not included in this clearance. While REMI monitoring is approved for ages one and above, Vigilenz event detection is only approved for use starting at age six. Young children exhibit distinct EEG patterns compared to adults, meaning the youngest patients receive the hardware without access to the automated review capabilities.

      The DexCom strategy

      CEO Steve Pacelli, who previously worked at DexCom, aims to implement a similar transformation in EEG monitoring that DexCom achieved with continuous glucose monitoring, replacing sporadic blood tests with ongoing wearable monitoring. This parallels Epitel's goal to extend EEG measurement beyond clinical settings and over longer time periods. DexCom has set a precedent for how the FDA manages this category of devices.

      A quieter commercial advantage

      A notable commercial detail is that REMI is reimbursable under current billing codes, which is advantageous since new medical devices often experience delays awaiting the establishment of specific codes.

      Clinician feedback

      Dr. Daniel Friedman, professor and director of the epilepsy division at NYU Langone Health, commented on the announcement. He pointed out that traditional tools have struggled with limitations in monitoring duration, as seen with ambulatory EEGs, or with the cost and artificial environments of inpatient video EEGs. He stated that REMI facilitates monitoring over clinically relevant timelines of days to weeks. Joshua Phillips from Catalyst Health Ventures was more straightforward about the potential, claiming, “The ambulatory EEG market has needed this kind of disruption for decades.” Phillips, who co-led the funding round and chairs Epitel’s board, has a vested interest in the company.

      Market positioning

      The realm of brain technology garners investment from both ends of the spectrum, evidenced by Paradromics' clinical brain chip for speech and warnings from researchers regarding the potential for neurotechnology to create new disparities in access. Smaller cleared devices continue to attract funding, with Tissium securing $60 million for sutureless nerve repair and 01Health raising funds to transform specialized care into infrastructural support.

      Epitel operates at the more modest end of the spectrum, which is intentional. A four-sensor patch for home use is a less ambitious concept than an implant yet has the potential to reach a significantly larger population.