Press Release
FDA Accepts NET Device Into Total Product Life Cycle Advisory Program Pilot
Acceptance follows Breakthrough Device Designation granted Sept. 15 and covers the same proposed indication in stimulant use disorder
COSTA MESA, Calif., Oct. 8, 2026 – NET Recovery today announced that the U.S. Food and Drug Administration (FDA) accepted the NET Device into the Center for Devices and Radiological Health’s Total Product Life Cycle Advisory Program (TAP) pilot on Oct. 1. The acceptance covers the same proposed indications as the Breakthrough Device Designation the company received in September. Those proposed indications are for use 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.
FDA designed TAP to support early, frequent and strategic communication between the agency and developers of innovative devices of public health importance, including those with Breakthrough Device Designation. The program can also help companies engage payers, clinicians and patient groups during development. TAP does not change FDA’s review standards or the requirements for marketing authorization, and enrollment does not guarantee authorization.
“Our team now has two FDA milestones in a matter of weeks, and both point to the same goal: building the strongest possible evidence for people with stimulant use disorder, who have no FDA-authorized medication today,” said Joe Winston, CEO and co-founder of NET Recovery. “TAP gives us a structured way to work with FDA as we prepare our pivotal trial. The program can also help us hear from clinicians and payers early, while their input can still shape our work.”
No medication is FDA-approved, and no medical device is FDA-authorized to treat stimulant use disorder. The CDC reports that stimulant-involved deaths accounted for 59% of U.S. overdose deaths from January 2021 through June 2024.
The NET Device is a transcutaneous alternating current stimulator (tACS) cleared by FDA under 510(k) K233166 for use in patients experiencing opioid withdrawal, in conjunction with standard symptomatic medications and other therapies for opioid withdrawal symptoms, under the supervision of trained clinical personnel. NET Recovery is preparing a pivotal randomized controlled trial to support a De Novo request to expand the device’s indications for use to include the stimulant use indication. The NET Device is not authorized for any stimulant use indication and this use is investigational.
Read the Sept. 23 Breakthrough Device Designation announcement
About NET Recovery
NET Recovery is a company pioneering non-pharmacological technology to address the nation’s addiction crisis. The company’s mission is to transform addiction treatment through safe, effective and accessible technology, restoring choice and giving hope. For more information, visit www.netrecovery.net.
Media contact
Supreme Communications, on behalf of NET Recovery
netrecovery@supremegroup.ai