PathMaker Neurosystems has commenced the multi-centre clinical trial of MyoRegulator for the non-invasive treatment of post-stroke spasticity in the US.
The non-invasive neuromodulation device is designed to suppress hyperexcitable spinal motor neurons.
It uses the company’s DoubleStim technology, which enables simultaneous stimulation at spinal and peripheral sites.
The randomised, sham-controlled, multi-centre, double-blind clinical trial is designed to assess the safety and efficacy of post-stroke lower-limb spasticity treatment with MyoRegulator in sham-treated and active participants.
It is being conducted with the Spaulding Rehabilitation Hospital in Charlestown, Massachusetts, and is expected to recruit 76 subjects.
The National Institute of Neurological Disorders and Stroke (NINDS) is providing a $4.9m NINDS Cooperative Research to Enable and Advance Translational Enterprises for Devices (CREATE Devices) grant for the pivotal clinical study.
PathMaker CEO and president Nader Yaghoubi said: “The launch of this multi-centre trial is an important milestone in the development of our first-in-class product, MyoRegulator.
“We are very pleased to be working with the world-class team at Spaulding, and are grateful to have the support of NINDS as we advance this product towards commercial launch.”
MyoRegulator is claimed to be the first and only neuromodulation device developed to treat muscle spasticity without using drugs or surgery.
It has been designated as a breakthrough medical device by the US Food and Drug Administration (FDA) and used in two completed clinical trials conducted in Europe and the US.
In 2019, PathMaker announced positive data from a clinical trial of the MyoRegulator device for the treatment of upper extremity spasticity in chronic stroke patients.