Grounded in evidence.Entering clinical pilot.
We describe our work the way clinicians would want it described — by its rationale, its collaborations, and the standards we hold ourselves to, not by results we have not yet earned the right to claim.
Clinical rationale
The rationale for taVNS
Transcutaneous auricular vagus nerve stimulation is a non-invasive approach with a substantial and growing published literature in headache and migraine. It is the basis for Auriva’s design as a non-drug option within a clinician-led pathway.
Modner’s contribution is not the discovery of vagus nerve stimulation but the disciplined, personalized way it is applied and monitored within our platform. We treat the published evidence base and our own pilot work as separate things, and we are careful never to present one as the other.
Clinical collaboration
Our clinical collaboration
Modner is working in clinical collaboration with a leading Indian government medical institute. The work is structured as an investigator-initiated study, with the institute’s clinicians leading the investigation and Modner providing the platform.
This keeps clinical judgment where it belongs and gives our development the scrutiny of an independent academic setting. We will share more about this collaboration as the work progresses.
Regulatory & standards
Pilot stageRegulatory pathway
Pursuing CDSCO Class B clearance through the appropriate State Licensing Authority route.
Safety & electrical standards
Auriva is being developed and tested against the IEC 60601 family of standards for medical electrical equipment.
Biocompatibility
Skin-contacting components are evaluated against ISO 10993 biocompatibility standards.
Current status
Pilot stage. Auriva is an investigational device and is not approved for commercial sale.