“The MyoRegulatorTM device has clear and groundbreaking benefits for patients with serious neurological conditions. Our partnership with PathMaker represents an opportunity for us to contribute to the advancement of a truly novel technology that is moving the field of bioelectronic medicine forward,” said Dr. David Guez, the General Director. “This is WeHealth’s first-ever partnership in the field of neurology”.
As part of the agreement, WeHealth will fund a recently initiated European clinical trial evaluating MyoRegulator for non-invasive treatment of lower limb spasticity secondary to stroke, which is currently 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. WeHealth will also fund a larger European clinical trial intended to support reimbursement coverage. PathMaker will receive an upfront payment, clinical/regulatory milestones and commercial royalties from future sales of the device and disposables (single-use electrodes) in the Servier territories.
About the solution
Spasticity is a chronic condition characterized by painful muscle contractions and is common in patients following stroke, spinal cord injury, traumatic brain injury, cerebral palsy, multiple sclerosis and other neurological disorders. It affects an estimated 12 million people worldwide. Current treatments of the disorder include pharmacological agents, botulinum toxin injections and intrathecal baclofen, which are often costly and result in undesired side-effects.
The MyoRegulator system is a microprocessor-controlled device that uses PathMaker’s patent-protected DoubleStim technology to deliver synchronized stimulation at two sites along the neural axis via two pairs of disposable skin-surface electrodes. Through precisely sequenced and targeted multi-site stimulation directed at the spinal outflow and peripheral nerve leading to the muscle of interest, this proprietary approach modulates neural activity to suppress hyperexcitable spinal neurons involved in spasticity. At the Society for Neuroscience meeting in November 2018, the largest annual meeting of the neuroscience field, clinical trial results from a recently completed US study at Northwell Health evaluating the effect of MyoRegulator treatment on post-stroke spasticity of upper limbs were recently presented.