FDA Grants Breakthrough Device Designation to NET Recovery's Device for Stimulant Use Disorder

The US Food and Drug Administration has granted Breakthrough Device Designation to NET Recovery 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.¹

The NET Device is a transcutaneous alternating current stimulator (tACS) that is cleared for the management of opioid withdrawal symptoms in conjunction with standard symptomatic medications and other withdrawal therapies. The designation provides NET Recovery expedited FDA review and priority status for future submissions related to the stimulant use indication.

“There are millions of people suffering without any approved treatment options for stimulant use disorder, and this Breakthrough Device Designation brings us one step closer to helping change that with a device that does not require the use of drugs," said Joe Winston, the CEO and co-founder of NET Recovery. “Our goal is to fundamentally transform what treatment looks like with the urgency it deserves—because waiting is not an option for those who are seeking help. We're focused on proving that a nonpharmacological approach can deliver real change for people struggling with stimulant use disorder.”

Addressing a Care Gap

According to the Centers for Disease Control and Prevention, approximately 4.5 million Americans struggle with both opioid and stimulant use,² and stimulant-involved overdose deaths account for 59% of US overdose deaths from January 2021 through June 2024.³ Despite this crisis, there are no FDA-approved medications or FDA-cleared medical devices to treat cocaine or methamphetamine use disorder.

Next Steps

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.

References

1. NET Recovery granted FDA Breakthrough Device Designation for stimulant use disorder, where no drug is FDA-approved or medical device FDA-cleared. News release. September 23, 2026. Accessed September 23, 2026.

2. Release of the 2025 National Survey on Drug Use and Health: Using Data to Drive the Great American Recovery. SAMHSA. July 27, 2026. Accessed September 23, 2026. https://www.samhsa.gov/blog/release-2025-nsduh-using-data-to-drive-great-american-recovery

3. Tanz LJ, Miller KD, Dinwiddie AT, et al. Drug Overdose Deaths Involving Stimulants ― United States, January 2018–June 2024. MMWR Morb Mortal Wkly Rep. 2025;74(32):491-499.