Neuro20 Technologies Corp today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s 510(k) pre-market approval application for its Neuro20 PRO System.
| Neuro20 Technologies becomes the first US-based company to produce an FDA-cleared medical electrical muscle stimulation textile that closes the loop between diagnostics and interventions in a wireless operating system TAMPA, Fla., March 2, 2023 /PRNewswire/ -- Neuro20 Technologies Corp, a wearable medical device manufacturing company specializing in the development of next-generation wireless wearable textiles to treat neuromuscular injuries and disease while enhancing human performance outcomes, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s 510(k) pre-market approval application for its Neuro20 PRO System. A first-of-its-kind wearable, the Neuro20 PRO System Whole-Body Electrical Muscle Stimulator Suit, Software and Operating System involuntarily contracts 42 muscles independently or by any combination of co-contraction, with control specificity for each muscle for 1 to 10 patients at a time. “Neuro20 Technologies has solved the greatest roadblock in rehabilitation: correcting old habits that were formed in response to old injuries,” said Dr. Davis W. Brockenshire, D.C., of Innovative Health Solutions, a Michigan-based practice that specializes in advanced functional medicine. “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.” The Neuro20 PRO System’s Suit has large-contoured electrodes to cover maximum motor neuron activation, distinguishing it from current electrical muscle stimulation systems on the market. The Neuro20 PRO System has four programs and nine sub-modes for strength and recovery, including proprietary PEMS (Patterned Electrical Muscle Stimulation) programs that involuntarily contract muscles throughout the motor chain replicating specified patterns of movement while the patient attempts to create a voluntary override of the movement. 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 the Neuro20 PRO System for the following Indications for Use: Muscle Re-education, Increasing Local Blood Circulation, Maintaining or Increasing Range of Motion, Relaxation of Muscle Spasms, 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, Chief Executive Officer 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.” About Neuro20 Technologies Corp. Forward-Looking Statements Investor Contact: Media Contact:
SOURCE Neuro20 Technologies Corp. |
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