Epitel received FDA clearance for its first product, a wireless and wearable EEG (brain wave monitor) sensor, and remote access software known as REMI for use within hospital emergency rooms and critical care units. REMI first received clearance from the U.S. Food & Drug Administration in 2021.
Two-thirds of the U.S. population lack ready access to EEGs and most emergency departments lack the capability to adequately monitor EEG. REMI, Epitel’s first FDA-cleared product, has wearable, wireless sensors that can be rapidly and easily applied by a nurse or hospital technician. EEG data is then immediately connected to a cloud-based software platform available to neurologists to review and monitor for seizures at any time from any location. Because the Epitel System is wearable and wireless, it can continue to monitor the patient continuously for 48 hours during their hospital journey.
Mark Lehmkuhle, Ph.D., chief executive officer of Epitel, said: “Epitel’s first FDA-cleared product, REMI, has the potential to revolutionise the diagnosis, treatment, and management of seizures within the hospital. With Epitel, patients, no matter their geography, may have access to essential EEGs during the most critical times of need. We intend to further expand our product pipeline for use outside the hospital by people living with epilepsy and other seizure conditions. We are honoured to have the support of Catalyst Health Ventures, Genoa Ventures, and a strong investment syndicate in our first financing.”