The next step when antidepressants fail

FDA-approved, physician-directed, home-based therapy for patients who haven't adequetly responded to antidepresant medications, without added clinical or operational burden.
FDA-approved
Clinician-directed
Home-based
For patients who haven’t responded to standard depression treatments
Whitout added clinical or operational burden.

The Proliv™Rx System provides focal external Combined Occipital and Trigeminal Afferent Stimulation (eCOT-AS) treatment.
It is intended as an adjunctive treatment for Major Depressive Disorder (MDD) in adults who failed to achieve satisfactory improvement from at least one previous antidepressant medication, for use at home or in clinic. It is a prescription-only device.

Where depression care falls apart

After first line of treatments fall short, the gap in next-step care turns early failure into chronic depression

The Pressure Builds Across Every Step Of The Care Pathway:

  • Medication cycling continues with low chances of remission.
  • Clinic-based neuromodulation is limited by geography, staffing, and long waitlists.
  • Escalation takes too long, especially for patients without access to specialists.
  • Overhead and clinical burden grow, requiring new rooms, technicians, scheduling capacity, and coordination
  • Crisis utilization rises, driving Emergency Room visits and admissions.

Most patients never reach an effective next-step intervention and it is this that drives more than half the cost or economic burden of depression.

A physician-directed next-step therapy, delivered at home

Proliv™Rx is an FDA-approved neuromodulation therapy designed specifically for the gap after first-line depression treatments fall short.

Proliv™Rx is an FDA-approved neuromodulation therapy designed specifically for the gap after first-line depression treatments fall short.

It combines an at-home treatment experience with continuous physician direction and visibility throughout the program.
Adults who haven’t improved on antidepressants complete a guided 8-week treatment at home, while clinicians track symptoms, compliance and progress throughout the program.

  • FDA-approved, prescription-directed therapy
  • Structured 8-week treatment program with optional prescription extension.
  • Home-based delivery with physician oversight
  • Continuous adherence and symptom tracking
  • No additional clinic equipment, staffing, or geographic limitations

Measurable impact at the next critical step in care

Outcomes observed in patients with prior inadequate response to antidepressants - a population historically harder to treat
87%
Demonstrated improvement in depression severity
  • Depression severity levels:
    Very Severe, Severe, Moderate, Mild, No Depression.
  • After completion of a 16-week therapy program.
Improved by one or more depression severity levels in a population with prior inadequate response to antidepressants.
Depression severity levels: Very Severe, Severe, Moderate, Mild, No Depression.
After completion of a 16-week therapy program.
96%
Fully adhered to the treatment protocol
Most patients completed the structured therapy program with full adherence to the treatment protocol, despite prior antidepressant treatments failure.
$35K
Estimated annual savings per patient
Based on actuarial analyses, driven by reduced escalation to in-clinic neuromodulation treatments, emergency room visits, and inpatient utilization.
0
Facility or staffing burden
Delivered at home without facilities, workflow changes, or clinician overhead.

Who Proliv™Rx is for

Proliv™Rx is intended for delivery after standard antidepressant medications failed to provide adequate improvement
Health systems
Deliver a scalable next-step therapy for patients who haven’t responded to standard care, without adding clinics, staff, or operational burden.
VA VISNs & veterans
Extend evidence-based next-step depression care to veterans at home, while preserving clinical oversight and fitting into existing VA workflows.
Clinicians
Offer patients who aren’t improving on medication a structured, FDA-approved next-step therapy that fits naturally into specialist-led care.
Patients & families
A guided, at-home treatment program delivered under clinician direction, designed to support meaningful improvement when standard treatments fall short.

How Proliv™Rx compares

An effective, more scalable path forward once medications fail

Proliv™Rx was well tolerated in clinical studies, with no device-related unanticipated serious adverse events reported.
Observed adverse events were generally mild to moderate in severity and transient in nature.

The most commonly reported adverse events included scalp numbness, localized skin reactions at the electrode sites, and headache.

What leading psychiatrists are saying

This effective and highly accessible therapy with a favorable safety profile, addresses a significant unmet need in this underserved patient population and expands how we can deliver care.
Professor of Psychiatry, Radiology, and Neuroscience.
Director, Center for Advanced Imaging Research & Brain Stimulation Laboratory, MUSC
Mark George, MD
Proliv™Rx offers an accessible and effective solution for patients whose depression is unresponsive to medications, many of whom have endured years of persistent symptoms. This therapy has the potential to become an essential tool in the mental health treatment landscape.
Professor of Psychiatry, Warren Alpert Medical School at Brown University Chief, Mood Disorders Program, Butler Hospital
Linda Carpenter, MD

Get the information you need

See how Proliv™Rx fits your behavioral-health workflows, coverage pathways, and TRD population.