NET Recovery said the FDA has granted Breakthrough Device Designation for its NET Device as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder, including cocaine use disorder and amphetamine-type/ methamphetamine use disorder.
The NET Device is a transcutaneous alternating current stimulator (tACS) currently cleared by FDA for the management of opioid withdrawal symptoms in conjunction with standard symptomatic medications and other withdrawal therapies.
The breakthrough device designation applies to a proposed new indication: as an aid in reducing psychostimulant use in adults 18 and older with stimulant use disorder. The designation provides NET Recovery expedited FDA review and priority status for future submissions related to the stimulant use indication, though it does not change FDA clearance or approval requirements. NET Recovery is designing a pivotal randomized controlled trial designed to support FDA marketing authorization through what the company believes will be the De Novo review pathway. The NET Device is not currently authorized for the treatment of stimulant use disorder, and that use remains investigational.
