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-directedHome-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.
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.
| More meds (antidepressants or antipsychotics) | TMS | Spravato | ECT | VNS/DBS | 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
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
Effective
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
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
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
John Jhonson
Get the information you need
See how Proliv™Rx fits your behavioral-health workflows, coverage pathways, and TRD population.