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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 responded to standard depression treatments.
Without added clinical or operational burden.
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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.

Comparison to Existing Solutions

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.
How the Treatment Works

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.
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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.
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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
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
Effective - even in this severe patient population
Flexible Care Setting
Home
Clinic Only
Clinic Only
Hospital only
Hospital only
Home, physician directed
Accessibility
High
Limited
Limited
Limited
Very limited
High accessibility
Workforce Burden
Moderate
High
High
Very High
Very High
Low- No added staff
Infrastructure Required
None
Extensive

Clinic, Machine and Staff
Extensive

Infusion and monitoring center
Extensive

Procedure suite
Extensive

QR and implant
No infrastructure required
Scalability
High
Limited
Limited
Limited
Limited
High scalability
Adherence
Unknown
High Dropout
High dropout
Limited
N/A
96% adherence + Treatment monitoring
Total Cost Impact
Moderate-High

Rising cost - especially with augmentation
High
High
Very high
Very high
$35K annual cost avoidance per member
Meds
TMS
Spravato
ECT
VNS/DBS
Other At-Home Neuromodulation
Efficacy
Limited benefit

Even with augmentation

Effective - even in this severe patient population
Flexible care setting
Home
Home, physician directed
Accessibility
High
High accessibility
Workforce burden
Moderate
Low- NO added staff
Infrastructure required
None
No infrastructure required
Scalability
High
High scalability
Adherence
Unknown
96% adherence + Treatment monitoring
Total Cost Impact
Moderate-High

Rising cost especially with augmentation

$35K annual cost avoidance per member
Efficacy
Effective
Effective - even in this severe patient population
Flexible care setting
Clinic Only
Home, physician directed
Accessibility
Limited
High accessibility
Workforce burden
High
Low- NO added staff
Infrastructure required
Extensive

Clinic, Machine and Staff

No infrastructure required
Scalability
Limited
High scalability
Adherence
High Dropout
96% adherence + Treatment monitoring
Total Cost Impact
High
$35K annual cost avoidance per member
Efficacy
Effective

But short lasting

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

Clinic, Machine and Staff

No infrastructure required
Scalability
Limited
High scalability
Adherence
96% adherence + Treatment monitoring
Total Cost Impact
High
$35K annual cost avoidance per member
Efficacy
Effective

But reserved for severe cases and with substantial side-effects

Effective - even in this severe patient population
Flexible care setting
Hospital only
Home, physician directed
Accessibility
Limited
High accessibility
Workforce burden
Very High
Low- NO added staff
Infrastructure required
Extensive

Procedure suite

No infrastructure required
Scalability
Limited
High scalability
Adherence
Limited
96% adherence + Treatment monitoring
Total Cost Impact
Very high
$35K annual cost avoidance per member
Efficacy
Effective

But invasive and reserved for very severe cases side-effects

Effective - even in this severe patient population
Flexible care setting
Hospital only
Home, physician directed
Accessibility
Very limited
High accessibility
Workforce burden
Very High
Low- NO added staff
Infrastructure required
Extensive

QR and implant

No infrastructure required
Scalability
Limited
High scalability
Adherence
N/A
96% adherence + Treatment monitoring
Total Cost Impact
Very high
$35K annual cost avoidance per member
Efficacy
N/A Not approved for patients who failed medication
Effective - even in this severe patient population
Flexible care setting
N/A Not approved for patients who failed medication
Home, physician directed
Accessibility
N/A Not approved for patients who failed medication
High accessibility
Workforce burden
N/A Not approved for patients who failed medication
Low- NO added staff
Infrastructure required
N/A Not approved for patients who failed medication
No infrastructure required
Scalability
N/A Not approved for patients who failed medication
High scalability
Adherence
N/A Not approved for patients who failed medication
96% adherence + Treatment monitoring
Total Cost Impact
N/A Not approved for patients who failed medication
$35K annual cost avoidance per member
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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.
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More Information
  • Depression severity levels:
    Very Severe, Severe, Moderate, Mild, No Depression.
    After completion of a 16-week therapy program.
  • Placebo:
    Explained