PathMaker Neurosystems Announces Initiation of Landmark European Clinical Trial Evaluating MyoRegulator™ for Non-Invasive Treatment of Spasticity
Boston, MA and Paris, France – September 5, 2018 — PathMaker Neurosystems Inc., a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of neuromotor disorders, announced that it has initiated and successfully enrolled the first patient in its European clinical trial to evaluate MyoRegulator™ for the non-invasive treatment of spasticity secondary to stroke. The clinical trial is being conducted by France’s prestigious Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière – ICM) at the Pitié-Salpêtrière Hospital in Paris, and is being sponsored by INSERM (Institut National de la Santeì Et de la Recherche Meìdicale), France’s public institute for science and technology which operates under the joint authority of the French Ministries of Health and Research.
MyoRegulator™ is an investigational, first-in-class, non-invasive neuromodulation device based on PathMaker’s proprietary DoubleStim™ technology, which provides simultaneous non-invasive stimulation at spinal and peripheral sites. MyoRegulator is the first neuromodulation device intended for the treatment of patients suffering from spasticity, a muscle control disorder characterized by tight or stiff muscles and an inability to control those muscles. MyoRegulator was one of the first “breakthrough” medical devices selected for the U.S. Food and Drug Administration’s (U.S. FDA) Expedited Access Pathway (EAP) program and is now in IRB-approved human clinical trials in the U.S. and in Europe. The landmark trial is designed as a monocentric, randomized, double-blinded, sham-controlled study that will evaluate the performance and safety of the MyoRegulator device in active versus sham treated patients, and represents the first trial evaluating the use of this device in lower limb spasticity.
Jean Charles Lamy, Ph.D., Research Associate at ICM and Head of the CENIR-PANAM core facility at ICM focused on non-invasive stimulation said, “We are excited to see the MyoRegulator clinical study begin at ICM. For patients experiencing spasticity following stroke, a serious condition that can often inhibit patients from participating in everyday activities, a non-invasive treatment is an appealing alternative to the use of injected botulinum neurotoxins which can be associated with serious adverse effects, painful repeated intramuscular injections and high costs.”
“This trial is yet another milestone for PathMaker as we advance our development strategy to rapidly bring to market an entirely novel, non-invasive approach to treating spasticity,” said Nader Yaghoubi, M.D., Ph.D., President and Chief Executive Officer of PathMaker. “We expect the results from this trial and our U.S. trial to enable regulatory approvals in both Europe and the U.S.”
About Brain and Spine Institute – ICM
The Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière – ICM) in Paris, France is a world-class research establishment cofounded by private benefactors and French public institutions such as INSERM, CNRS, APHP and Sorbonne Université. It is innovative in both its conception and its organization. By bringing together patients, doctors and researchers under the same roof, it aims to facilitate the rapid development of treatments for diseases of the nervous system so that they can be applied to patients as quickly as possible. The center has the best scientists from every domain and every country and they are conducting groundbreaking research in this area. From a scientific standpoint, the ICM’s approach is novel to the extent that its research is decompartmentalized. Its 24 research teams work independently but are associated along thematic lines that encourage the pooling of expertise and the implementation of joint projects. For more information, please visit www.icm-institute.org.
About PathMaker Neurosystems Inc.
PathMaker Neurosystems is a clinical-stage bioelectronic medicine company developing breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions. With offices in Boston (U.S.) and Paris (France), we are collaborating with world-class research institutions to rapidly bring to market disruptive products for treating spasticity, paralysis and muscle weakness. More than 48 million patients in the U.S., Europe and China suffer disabilities due to stroke, cerebral palsy, multiple sclerosis, spinal cord injury, traumatic brain injury, Parkinson’s disease and other neurological disorders. At PathMaker, we are opening up a new era of non-invasive neurotherapy for patients suffering from chronic neuromotor conditions. For more information, please visit the company website at www.pmneuro.com.
Sharon Correia, Vice President, Integrated Communications