FDA Clears Neuro20 PRO for Neuromuscular Injury and Disease

Neuro20 Technologies, a wearable device maker specializing in development of wireless, wearable textiles to treat neuromuscular injuries and disease, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Neuro20 PRO system.
 
The first-of-its kind wearable system consists of a whole-body electrical muscle stimulator suit, software, and operating system. It involuntarily contracts 42 muscles independently or by any combo of co-contraction, with control specificity for each muscle for one to ten patients at a time.
 
“Neuro20 Technologies has solved the greatest roadblock in rehabilitation: correcting old habits that were formed in response to old injuries,” Dr. Davis W. Brockenshire, D.C., of Innovative Health Solutions, a Michigan-based practice that specializes in advanced functional medicine, told the press. “The ability to retrain corrective movement patterns without injury or exhaustion allows the client to achieve a freedom of performance otherwise unattainable. I personally use the Neuro20 PRO System to re-acquire and maintain optimal movement patterns due to injuries sustained over a lifetime of athletic competitions.”
 
Neuro20 PRO’s suit has large-contoured electrodes to provide maximum motor neuron activation. The system contains four programs and nine sub-modes for strength and recovery, including proprietary PEMS (patterned electrical muscle stimulation) programs that involuntarily contract muscles through the motor chain to replicate specified movement patterns while the patient attempts to create voluntary override of the movement.
 
According to the company, electrical stimulation results demonstrate up to a 20% increase in maximum voluntary contraction, up to 30% vascular dilation, and an increase in BDNF (brain-derived neurotrophic factor) between 18%-30%, depending on gene expression. The FDA cleared Neuro20 PRO for muscle re-education, increasing local blood circulation, maintaining or increasing range of motion, relaxation of muscle spasms, and reduction or prevention of muscle atrophy.
 
“FDA clearance of our Neuro20 PRO System to treat neuromuscular injury and disease is a significant milestone for Neuro20 Technologies as we prepare to educate the market about the benefits of this technological advancement,” said Dennis M. Schmitt, CEO of Neuro20 Technologies. “Our pioneering approach to physical rehabilitation has the potential to benefit patients significantly. We are pleased to disrupt current industry practices in electrical stimulation therapy by providing safe, affordable, result-driven outcomes for providers and patients suffering from neuromuscular injury and disease. The Neuro20 PRO system is the reconceptualization of electrical muscle stimulation to make it more efficient for both provider and patient. The FDA clearance will launch electroceutical medicine forward in the 21st century, and we are excited to reframe the possibilities in this field by working with providers to demonstrate this new, efficient technology.”