PathMaker Neurosystems Announces Completion of Pivotal European Clinical Trial Evaluating MyoRegulator® for the Non-Invasive Treatment of Post-Stroke Spasticity
BOSTON and PARIS, Sept. 27, 2021 (GLOBE NEWSWIRE) — PathMaker Neurosystems Inc., (“PathMaker”), a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders such as Stroke and Amyotrophic Lateral Sclerosis (ALS), announced today the successful completion of a pivotal European trial evaluating the company’s MyoRegulator® device in the treatment of post-stroke lower-limb spasticity. Globally, over 13 million people per year will have a stroke and an estimated 38% will suffer painful, post-stroke spasticity and its costly, debilitating effects. This clinical trial was conducted at the Paris Brain Institute (ICM) in the Pitié-Salpêtrière Hospital in Paris, France and was sponsored by INSERM.
The single-site, sham-controlled, randomized study enrolled 44 chronic stroke subjects with lower-limb spasticity and evaluated the effects of 20-minute treatment sessions with MyoRegulator® delivered daily for five consecutive days on ankle spasticity as measured by the Modified Tardieu Scale (MTS), a validated clinical measure of spasticity. Secondary endpoints as well as safety of the treatment were also evaluated. The results of the study will be announced following their publication in a peer-reviewed journal.
“We are pleased to have completed this clinical trial to evaluate our MyoRegulator® device,” commented Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker. “Our proprietary neuromodulation technology has the unique potential to non-invasively treat spasticity. Completion of this trial is an important step in advancing this product as a novel approach to the treatment of spasticity that does not require injected neurotoxins or sedating pharmaceuticals.”
This is the second study evaluating MyoRegulator® in post-stroke spasticity. In 2019, PathMaker announced positive results from an IRB-approved feasibility trial in the US, showing that 5 consecutive days of daily 20-minute treatments with MyoRegulator® results in a statistically significant reduction in wrist spasticity in chronic stroke patients, as well as statistically significant improvements in motor function. These results were published in a peer-reviewed journal in July 2019.
ABOUT PATHMAKER NEUROSYSTEMS INC.
PathMaker Neurosystems is a near-commercial stage neuromodulation company developing breakthrough non-invasive systems for the treatment of patients 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 serious neurological disorders with high unmet medical need. More than 48 million patients in the U.S., Europe and Asia suffer disabilities due to stroke, ALS, spinal cord injury, multiple sclerosis, traumatic brain injury, cerebral palsy and other neurological disorders. MyoRegulator® will be the world’s first non-invasive neuromodulation device for the treatment for muscle spasticity, and will enable the treatment of patients 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 US Food and Drug Administration (FDA) as a “breakthrough medical device” and FDA has confirmed that clinical trials with MyoRegulator® are considered non-significant risk (NSR). 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 replace the need for drugs or surgery for patients suffering from serious neurological disorders. For more information, please visit the company website at www.pmneuro.com.
ABOUT THE PARIS BRAIN INSTITUTE
Created in 2010, the Brain Institute is an international scientific and medical research centre of excellence, located in Paris at the heart of the Pitié-Salpêtrière Hospital. Its innovative model brings together patients, doctors, researchers and entrepreneurs with a common goal: to understand the brain and accelerate the discovery of new treatments for nervous system diseases. The Institute thus includes a network of more than 700 researchers and clinicians (APHP, Sorbonne University, Inserm and CNRS), 10 cutting-edge technological platforms, 1 clinical investigation centre, 1 training organisation and more than 2,000m² dedicated to incubating startups. Since 2017, it has also been the health partner of Station F; this location gives it a competitive advantage in the field of connected health. In 2020, the Brain Institute celebrated its 10th anniversary.
Source: PathMaker Neurosystems Inc.