The FDA granted Breakthrough Device Designation to the NET Device, made by Costa Mesa, Calif.-based NET Recovery, as an aid in reducing psychostimulant use in adults 18 and older diagnosed with stimulant use disorder.
The designation covers a proposed new indication for the device, including cocaine use disorder and amphetamine-type/methamphetamine use disorder, according to a Sept. 23 news release from the company. No drug is FDA-approved and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder.
Approximately 4.5 million Americans struggle with both opioid and stimulant use. Stimulant-involved overdose deaths also accounted for 59% of U.S. overdose deaths from January 2021 through June 2024, according to the CDC.
Here are three things to know:
1. The NET Device is a transcutaneous alternating current stimulator. It is currently cleared by the FDA for the management of opioid withdrawal symptoms in conjunction with standard symptomatic medications and other withdrawal therapies.
2. The Breakthrough Device 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.
3. NET Recovery is designing a pivotal randomized controlled trial to support FDA marketing authorization. The company expects to pursue authorization through the De Novo pathway. The NET Device is not currently authorized for the treatment of stimulant use disorder, and that use remains investigational.
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