# Early Feasibility Clinical Study of the VitalFlow Stimulator, an Emergency Treatment for Ischemic Stroke

> **NIH NIH U44** · NERVIVE, INC. · 2020 · $107,160

## Abstract

PROJECT SUMMARY
Stroke is the world’s greatest healthcare burden for which few treatment options are available.
The long-term objective of the applicant, Nervive, Inc., is to bring to market a non-invasive
medical device, the VitalFlow stimulator, as an emergency treatment for ischemic stroke. The
VitalFlow is a novel technology that activates the autonomic components of the facial nerve
using pulsed magnetic energy, thereby dilating the arteries of the brain and increasing cerebral
blood flow (CBF). Delivery of intravenous tissue plasminogen activator (rtPA) to the site of an
obstructing blood clot will be improved by increasing CBF, and endovascular clot retrieval
catheter navigation will be facilitated by dilation of the cerebral arteries. Thus, the VitalFlow
stimulator is highly relevant to the mission of the NINDS because it seeks to improve clinical
outcomes in stroke patients and reduce the burden of stroke.
With CREATE Devices grant support, we intend to test a clinical prototype VitalFlow stimulator
that can be used in the emergency department for the treatment of acute ischemic stroke. The
following Specific Aims are proposed:
In Phase I of the CREATE Devices project, Nervive will achieve the following:
 Specific Aim 1: Write the Early Feasibility Clinical Study protocol.
 Specific Aim 2: Establish a Quality Control System and freeze VitalFlow device design.
 Specific Aim 3: Complete a Pre-IDE meeting with FDA.
In Phase II of the CREATE Devices project, Nervive will achieve the following:
 Specific Aim 4: Complete external performance testing of the VitalFlow stimulator.
 Specific Aim 5: Receive FDA IDE clearance and hospital IRB approval.
 Specific Aim 6: Conduct an Early Feasibility Clinical Study in 8 acute ischemic stroke
patients.
Nervive is pursuing Expedited Access Pre-Market Approval (PMA) regulatory clearance for the
VitalFlow. In the U.S. alone, the commercial opportunity for the VitalFlow includes the sale of
device hardware to 5700 hospitals and the sale of consumable components for more than 400k
patient treatments each year.

## Key facts

- **NIH application ID:** 10236727
- **Project number:** 3U44NS094307-02S1
- **Recipient organization:** NERVIVE, INC.
- **Principal Investigator:** STEPHANIE ADI HARRINGTON
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $107,160
- **Award type:** 3
- **Project period:** 2020-09-30 → 2021-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10236727

## Citation

> US National Institutes of Health, RePORTER application 10236727, Early Feasibility Clinical Study of the VitalFlow Stimulator, an Emergency Treatment for Ischemic Stroke (3U44NS094307-02S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10236727. Licensed CC0.

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