Neuro20 Technologies Announces FDA Clearance of the Neuro20 PRO System for Treatment of Neuromuscular Injury and Disease
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.
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.
Neuro20 Technologies was founded in 2021 and is a registered Delaware Corp located in Tampa, Florida. Neuro20 Technologies is located in the "Research and Innovation" building at the University of South Florida, USF CONNECT, and is a member of the Tampa Bay Technology Incubator. Neuro20 Technologies focuses on transforming health through scientific research-based practices utilizing Electrical Muscle Stimulation (EMS). We are proud to be led by a team of experts with knowledge expanding across many disciplines, with the collective goal of modernizing how technology is used to promote recovery and human performance.
Forward-Looking Statements
This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our Neuro20 PRO System; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of injuries and diseases; the timing, conduct and success of our clinical products, our ability to use our manufacturing facilities to support clinical and commercial demand; and our future operating expenses and capital expenditure requirements. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at https://www.sec.gov/. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
Investor Contact:
Harvard Business School Alumni Angels
Christian Schweitzer
[email protected]
Media Contact:
Michael Finkelstein
Neuro20 Technologies
917-503-6876
[email protected]
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