The designation opens the door to an expedited regulatory pathway for a potential future indication expansion for the transcutaneous alternating current stimulator (tACS), complementing its prior FDA clearance for providing symptom relief for individuals with opioid addiction in May 2024.
NET Recovery’s tACS, dubbed NET Device, delivers transcutaneous stimulation via electrodes placed behind the ears. By targeting the brain’s reward pathway, the treatment is intended to reduce stimulant addicts’ cravings and desire to take drugs such as cocaine and methamphetamines.