NET Recovery Granted FDA Breakthrough Device Designation for Stimulant Use Disorder, Where No Drug is FDA-Approved or Medical Device FDA-Cleared

COSTA MESA, Calif., Sept. 23, 2026 /PRNewswire/ -- NET Recovery, the company pioneering non-pharmacological technology to address the nation's addiction crisis, announced today that the U.S. Food and Drug Administration (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 breakthrough designation addresses a critical gap: Approximately 4.5 million Americans struggle with both opioid and stimulant use, and stimulant-involved overdose deaths account for 59% of U.S. overdose deaths from January 2021 through June 2024, according to the CDC. Despite this crisis and FDA-approved and cleared treatments for opioid use disorder, no medication is FDA-approved, and no medical device is FDA-cleared to treat cocaine or methamphetamine use disorder.

"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, 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 non-pharmacological approach can deliver real change for people struggling with stimulant 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.

About NET Recovery

NET Recovery is a company pioneering non-pharmacological technology to address the nation's addiction crisis. Our mission is to transform addiction treatment through safe, effective, and accessible technology, restoring choice and giving hope. For more information, visit www.netrecovery.net.

NET Recovery Media Contact

Supreme Communications, on behalf of NET Recovery
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SOURCE NET Recovery