PathMaker Neurosystems Inc, a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announces the initiation of its US multi-center MyoRegulator clinical trial for the non-invasive treatment of post-stroke upper-limb spasticity.
The trial is funded by a $4.9M NINDS Cooperative Research to Enable and Advance Translational Enterprises for Devices (CREATE Devices) grant from the National Institute of Neurological Disorders and Stroke (NINDS) and is being conducted with the Spaulding Rehabilitation Hospital in Charlestown, Mass.
MyoRegulator is a first-in-class, non-invasive neuromodulation device using PathMaker’s proprietary DoubleStim technology, which delivers simultaneous stimulation at spinal and peripheral sites. It is the first and only neuromodulation device treating muscle spasticity without the need for drugs or surgery. It has been designated by the US FDA as a “breakthrough” medical device and has been utilized in two completed clinical studies in the U.S. and in Europe.
Evaluate Efficacy and Safety
This pivotal trial is designed as a multi-center, randomized, double-blind, sham-controlled trial that will evaluate the efficacy and safety of the treatment of post-stroke lower-limb spasticity with MyoRegulator in active versus sham-treated subjects, with expected enrollment of 76 subjects.
J. Leon Morales-Quezada, MD, PhD, Director of the Integrative Rehabilitation Lab and Research Associate Director, Spaulding Neuromodulation Center at Spaulding Rehabilitation Hospital, and Study Site Principal Investigator for this study says, “There is a pressing need for novel therapeutic options that do not involve drugs or surgery for the treatment of spasticity. The MyoRegulator device represents potential new hope for millions of patients living with this disorder around the world. We are thrilled to be involved in this trial with PathMaker and explore bringing this technology closer to clinical practice.”
“The launch of this multi-center trial is an important milestone in the development of our first-in-class product, MyoRegulator,” says Nader Yaghoubi, MD, PhD, President and Chief Executive Officer of PathMaker. “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.”
Brooks Gross, PhD, program director at NINDS, says, “This platform has advanced and is ready for further testing in clinical trials. We are hopeful that clinical trial success could get us closer to a potentially new treatment modality.”
The MyoRegulator clinical trial was supported by a NINDS CREATE Devices grant (U44 NS104138).
[Source(s): PathMaker Neurosystems Inc, GlobeNewswire]