The next step when antidepressants fail

FDA-approved, physician-directed, home-based therapy for patients who haven't adequately responded to antidepressant medications, without added clinical or operational burden.
FDA-approved
Clinician-directed
Home-based
For patients who haven't adequately responded to antidepressant medication
Without 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.

Once antidepressants fail
the care pathway breaks

A gap in next‑step care turns early treatment 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 out of reach due to geography, staffing, and long waitlists.
  • Escalation takes too long, especially for patients without access to specialists.
  • Operational burden keeps growing, requiring more space, trained staff, expanded scheduling capacity, and additional coordination.
  • Crisis-related utilization rises, driving higher rates of Emergency Room visits and hospital admissions.

Most patients never reach an effective next-step intervention and this 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.

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 8-16 week treatment at home, while clinicians track symptoms, compliance and progress throughout the program.

  • FDA-approved, prescription therapy.
  • Structured 8-16 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 level:
    Very Severe, Severe, Moderate, Mild, No Depression.
  • After completion of a 16-week therapy program.
Improved by one or more depression severity level 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 treatment 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 is Proliv®Rx for

Proliv®Rx is intended for delivery after standard antidepressant medication 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

Unlike clinic or hospital-dependent alternatives that require intensive infrastructure, staffing, or invasive procedures, Proliv®Rx delivers clinically meaningful improvement through home-based, clinician-directed care for adults with MDD who have not responded adequately to antidepressants.

As the only at-home brain neuromodulation therapy available for this patient population, it offers high access, no added workforce burden, system-wide scalability, and an estimated high cost avoidance per patient – positioning it as a high-impact advancement in depression care.

More meds antidepressants or antipsychotics TMS Transcranial Magnetic Stimulation Spravato Esketamine ECT Electroconvulsive Therapy VNS/DBS Vagus Nerve Stimulation or Deep Brain Stimulation Other prescription at-home neuromodulation
Efficacy
Effective - even in this severe patient population
Limited benefit

Even with augmentation

Effective
Effective

But short lasting

Effective

Limited to severe cases & has major side effects

Effective

But invasive and reserved for very severe cases

N/A
Not approved for patients who failed medication
Flexible Care Setting
Home, physician directed
Home
Clinic Only
Clinic Only
Hospital only
Hospital only
Accessibility
High accessibility
High
Limited
Limited
Limited
Very limited
Workforce Burden
Low- No added staff
Moderate
High
High
Very High
Very High
Infrastructure Required
No infrastructure required
None
Extensive

Clinic, Machine and Staff

Extensive

Infusion and monitoring center

Extensive

Procedure suite

Extensive

QR and implant

Scalability
High scalability
High
Limited
Limited
Limited
Limited
Adherence
96% adherence + Treatment monitoring
Unknown
High Dropout
High dropout
Limited
N/A
Total Cost Impact
$35K annual cost avoidance per member
Moderate-High

Rising cost - especially with augmentation

High
High
Very high
Very high
Meds
TMS
Spravato
ECT
VNS/DBS
Other At-Home Neuromodulation
Efficacy
Effective - even in this severe patient population
Limited benefit

Even with augmentation

Flexible care setting
Home, physician directed
Home
Accessibility
High accessibility
High
Workforce burden
Low- NO added staff
Moderate
Infrastructure required
No infrastructure required
None
Scalability
High scalability
High
Adherence
96% adherence + Treatment monitoring
Unknown
Total Cost Impact
$35K annual cost avoidance per member
Moderate-High

Rising cost especially with augmentation

Efficacy
Effective - even in this severe patient population
Effective
Flexible care setting
Home, physician directed
Clinic Only
Accessibility
High accessibility
Limited
Workforce burden
Low- NO added staff
High
Infrastructure required
No infrastructure required
Extensive

Clinic, Machine and Staff

Scalability
High scalability
Limited
Adherence
96% adherence + Treatment monitoring
High Dropout
Total Cost Impact
$35K annual cost avoidance per member
High
Efficacy
Effective - even in this severe patient population
Effective

But short lasting

Flexible care setting
Home, physician directed
Clinic Only
Accessibility
High accessibility
Limited
Workforce burden
Low- NO added staff
High
Infrastructure required
No infrastructure required
Extensive

Clinic, Machine and Staff

Scalability
High scalability
Limited
Adherence
96% adherence + Treatment monitoring
Total Cost Impact
$35K annual cost avoidance per member
High
Efficacy
Effective - even in this severe patient population
Effective

But reserved for severe cases and with substantial side-effects

Flexible care setting
Home, physician directed
Hospital only
Accessibility
High accessibility
Limited
Workforce burden
Low- NO added staff
Very High
Infrastructure required
No infrastructure required
Extensive

Procedure suite

Scalability
High scalability
Limited
Adherence
96% adherence + Treatment monitoring
Limited
Total Cost Impact
$35K annual cost avoidance per member
Very high
Efficacy
Effective - even in this severe patient population
Effective

But invasive and reserved for very severe cases side-effects

Flexible care setting
Home, physician directed
Hospital only
Accessibility
High accessibility
Very limited
Workforce burden
Low- NO added staff
Very High
Infrastructure required
No infrastructure required
Extensive

QR and implant

Scalability
High scalability
Limited
Adherence
96% adherence + Treatment monitoring
N/A
Total Cost Impact
$35K annual cost avoidance per member
Very high
Efficacy
Effective - even in this severe patient population
N/A Not approved for patients who failed medication
Flexible care setting
Home, physician directed
N/A Not approved for patients who failed medication
Accessibility
High accessibility
N/A Not approved for patients who failed medication
Workforce burden
Low- NO added staff
N/A Not approved for patients who failed medication
Infrastructure required
No infrastructure required
N/A Not approved for patients who failed medication
Scalability
High scalability
N/A Not approved for patients who failed medication
Adherence
96% adherence + Treatment monitoring
N/A Not approved for patients who failed medication
Total Cost Impact
$35K annual cost avoidance per member
N/A Not approved for patients who failed medication

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 Neurosciences and Director of the Brain Stimulation Division at the Medical University of South Carolina (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 at Brown University and Chief of the Mood Disorder Program at Buttler Hospital
Linda Carpenter, MD

Get the information you need

See how Proliv®Rx fits your mental-health workflows, coverage pathways, and TRD population.
More Information
  • Depression severity levels:
    Very Severe, Severe, Moderate, Mild, No Depression.
    After completion of a 16-week therapy program.
  • Placebo:
    Explained