PathMaker Neurosystems Inc. announced initiation of its U.S. multi-center clinical trial to evaluate MyoRegulator® for the non-invasive treatment of post-stroke upper-limb spasticity.
BOSTON and PARIS, March 07, 2022 (GLOBE NEWSWIRE) -- PathMaker Neurosystems Inc., (“PathMaker”), a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announced initiation of its U.S. multi-center clinical trial to evaluate MyoRegulator® 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, MA.
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 U.S. FDA as a “breakthrough” medical device and has been utilized in two completed clinical studies in the U.S. and in Europe.
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, M.D., Ph.D., 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 said, “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®,” said Nader Yaghoubi, M.D., Ph.D., 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, Ph.D., program director at NINDS, said, “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 trial was supported by a NINDS CREATE Devices grant (U44 NS104138).
ABOUT PATHMAKER NEUROSYSTEMS INC.
PathMaker Neurosystems is a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of people with serious neurological disorders such as stroke and amyotrophic lateral sclerosis (ALS). With offices in Boston (U.S.) and Paris (France), PathMaker is collaborating with world-class institutions on rapidly bringing to market disruptive products for treating brain and other neurological disorders with high unmet medical need. More than 48 million people in the U.S., Europe and Asia suffer profound disabilities due to stroke, ALS, spinal cord injury, multiple sclerosis, traumatic brain injury, cerebral palsy and other related neurological disorders. MyoRegulator® is expected to be the world’s first non-invasive neuromodulation device to treat muscle spasticity, enabling treatment without the need for drugs or surgery. MyoRegulator® is based on PathMaker’s proprietary DoubleStim® technology for suppression of hyperexcitable spinal motor neurons. MyoRegulator® has been designated by the US Food and Drug Administration (FDA) as a “breakthrough medical device.” MyoRegulator® is an investigational medical device and is limited by Federal law to investigational use only. At PathMaker, we are opening up a new era of non-invasive therapy that promises to restore mobility and function in people with serious neurological disorders. For more information, please visit the company website at www.pmneuro.com.
ABOUT SPAULDING REHABILITATION NETWORK
A member of the Mass General Brigham Health System, the Spaulding Rehabilitation Network includes Spaulding Rehabilitation Hospital, with a main campus in Charlestown the 3rd ranked rehabilitation hospital in the country by U.S. News & World Report, along with Spaulding Rehabilitation Hospital Cape Cod, Spaulding Hospital Cambridge, Spaulding Nursing and Therapy Center Brighton, and over 25 outpatient sites throughout Eastern Massachusetts. An acclaimed teaching hospital of Harvard Medical School and home to the Department of Physical Medicine and Rehabilitation, Spaulding is recognized as the top residency program in the U.S. in the 2020/2021 Doximity Residency Navigator. Spaulding also was recognized by the 2021 Disability Equality Index as a “Best Places to Work for Disability Inclusion.” For more information, visit www.spauldingrehab.org.
Source: PathMaker Neurosystems Inc.
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