Bioelectronic medicine firm PathMaker Neurosystems has commenced the European clinical study to assess MyoRegulator neuromodulation device for the non-invasive treatment of spasticity secondary to stroke.
MyoRegulator is an investigational, non-invasive neuromodulation device designed by using the firm’s DoubleStim technology, which offers simultaneous non-invasive stimulation at spinal and peripheral sites.
The neuromodulation device will help treat patients suffering from spasticity, a muscle control disorder characterized by tight or stiff muscles and an inability to control those muscles.
The trial, which has recruited first patient, is being carried out by France-based Brain and Spine Institute (Institut du Cerveau et de la Moelle Epinière – ICM) at the Pitié-Salpêtrière Hospital in Paris, while sponsored by Institut National de la Santeì Et de la Recherche Meìdicale (INSERM).
MyoRegulator is said to be one the first breakthrough medical devices selected for the US Food and Drug Administration’s expedited access pathway (EAP) program.
The neuromodulation device is currently under IRB-approved human clinical studies in the US and Europ.
The monocentric, randomized, double-blinded and sham-controlled study will assess the performance and safety of the MyoRegulator device in active versus sham treated patients.
MyoRegulator is claimed to be the first device being assessed for lower limb spasticity.
According to the company, over 48 million patients in the US, 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.
PathMaker president and CEO Dr Nader Yaghoubi said: “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.
“We expect the results from this trial and our U.S. trial to enable regulatory approvals in both Europe and the U.S.”
PathMaker Neurosystems is a clinical-stage bioelectronic medicine firm engaged in the development of breakthrough non-invasive systems for the treatment of patients with chronic neuromotor conditions.
The company, which has offices in Boston of US and Paris of France, collaborated with major global research institutions to work on disruptive products for treating spasticity, paralysis and muscle weakness.