Development

Bicurra is developing a taVNS platform for research, clinical, and consumer use.

Investigational Device. The Bicurra taVNS device is currently in development and has not been evaluated by the FDA or any other regulatory body. It is being prepared for investigational use in a planned clinical study and is not available for commercial distribution.

Development Roadmap

Patent Filing

Completed

A patent application has been filed for the underlying taVNS technology.

Functional Prototype

Completed

A working device has been built and tested with a custom earpiece for targeted stimulation of the cymba concha region.

Clinical Study Preparation

In Progress

Preparing for an IRB-approved clinical study to evaluate device performance and safety.

Clinical / Medical Device

Future

A regulated medical device for clinical use under healthcare professional supervision.

Consumer Device

Future

A consumer wellness device backed by clinical investigation, for personal use.

Two Development Paths

Our goal is to develop both a clinical/medical device and a consumer wellness device, informed by the same research and development process.

Clinical / Medical Device

Designed for clinical use under healthcare professional supervision. This path involves regulatory clearance, clinical trials, and compliance with medical device standards.

Consumer Device

A personal wellness device informed by the clinical research and technology developed for the medical version.

Research & Evidence

The development of Bicurra's taVNS technology is informed by the broader body of published research on transcutaneous vagus nerve stimulation.

For a detailed overview, see About the Vagus Nerve.