The MyoRegulator™ PM-2200 is our company’s first product, and provides a breakthrough non-invasive treatment for muscle spasticity. Spasticity is a common condition seen in many patients suffering from stroke, cerebral palsy, multiple sclerosis, spinal cord injury and traumatic brain injury. Management of spasticity is currently a difficult and sometimes insurmountable challenge, and there is tremendous unmet medical need. Pharmacological, surgical, and physical treatments to manage spasticity have, at best, short-term efficacy, are confounded by adverse effects, and are often unpleasant for the patient. In US and other countries, repeated intramuscular injections of botulinum toxin have been approved for use as a treatment for spasticity. Botulinum toxin is a potent and deadly neurotoxin that has been associated with serious adverse effects at doses used for spasticity, including generalized muscular weakness, breathing difficulties, pneumonia, hypersensitivity, anaphylaxis, pain and increased mortality.
MyoRegulator is based on our proprietary DoubleStim™ technology, which provides simultaneous non-invasive stimulation at spinal and peripheral sites, resulting in suppression of hyperexcitable spinal circuits found in patients with spasticity. Early feasibility clinical use of our DoubleStim™ technology has demonstrated promising results in treating spasticity related to stroke and cerebral palsy. IRB-approved human clinical trials are now underway to support regulatory submissions for the MyoRegulator system.