# MyoRegulator: A Non-Invasive Neuromodulation Device for Treatment of Spasticity in Stroke Patients

> **NIH NIH U44** · PATHMAKER NEUROSYSTEMS, INC. · 2021 · $1,462,521

## Abstract

PROJECT SUMMARY / ABSTRACT
Stroke affects over 7.5 million patients in the U.S, with an estimated 795,000 additional cases of stroke
occurring each year. Over 30% of stroke survivors have spasticity, a disorder of muscle tone that can cause
striking impairments in functional movement. Pharmacological, surgical and physical treatments to manage
spasticity have, at best, short-term efficacy and are confounded by side effects. In this NINDS CREATE
Device project, we propose translational activities that will advance through multi-site Phase II clinical trials and
regulatory submission a recently developed neuromodulation device that non-invasively treats spasticity using
a novel approach that combines trans-spinal direct current stimulation (tsDCS) with simultaneous peripheral
nerve stimulation. The implications of the current project are far-reaching changes in clinical practice for
treating spasticity using an entirely novel approach based on non-invasive neuromodulation. PathMaker
Neurosystems Inc. is a clinical-stage neuromodulation company developing a first-in-class treatment for
treating stroke patients with spasticity. Our objective for this NINDS CREATE Device project is to carry out key
translational activities that will be essential for advancing this technology through multi-site Phase II clinical
trials and regulatory approval as a safe and efficacious new treatment for spasticity. The project consists of 5
Specific Aims: In Specific Aim 1, we will implement a GMP-compliant version of the device (MyoRegulator)
for use in a Phase II pivotal clinical study in stroke. In Specific Aim 2, we will implement a compliant Quality
Management System (QMS). In Specific Aim 3, we will complete preparations for a Phase II clinical study. In
Specific Aim 4, we will complete a multi-site double-blind controlled human clinical study. In Specific Aim 5,
we will submit De Novo 510(k) for regulatory approval for MyoRegulator. These Specific Aims will lay the
essential groundwork allowing our novel, NIH-funded technology to move rapidly through human clinical trials
and to regulatory approval. As our company works to translate the groundbreaking academic studies that have
resulted in a novel approach to the treatment of spasticity, NINDS CREATE Device support will advance this
breakthrough treatment towards the market and enable an entirely new treatment option for stroke patients
with spasticity.

## Key facts

- **NIH application ID:** 10333564
- **Project number:** 4U44NS104138-03
- **Recipient organization:** PATHMAKER NEUROSYSTEMS, INC.
- **Principal Investigator:** Nader Yaghoubi
- **Activity code:** U44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,462,521
- **Award type:** 4N
- **Project period:** 2018-02-15 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10333564

## Citation

> US National Institutes of Health, RePORTER application 10333564, MyoRegulator: A Non-Invasive Neuromodulation Device for Treatment of Spasticity in Stroke Patients (4U44NS104138-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10333564. Licensed CC0.

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