This Could Help Treat Post-Concussion Syndrome in Children

August 29, 2023 - Baystreet.ca


Every year, an estimated 1.6 million to 3.8 million sports- and recreation-related concussions are seen, as noted by the Brain Injury Research Institute (BIRI), adding that, “During 2001-2005, children and youth ages 5-18 years accounted for 2.4 million sports-related emergency department (ED) visits annually, of which 6% (135,000) involved a concussion.” While symptoms generally resolve in a few weeks, others persist, including ongoing headaches, nausea, and dizziness, as well as mood and behavioral disorders, according to NeurAxis Inc. (NYSEAMERICAN: NRXS), which added that, “Medications are primarily used for off-label in the treatment, despite the lack of evidence to support efficacy or safety.” However, according to Brian Carrico, President and CEO of NeurAxis, we’re “working with the FDA to continue expanding pediatric indications on our PENFS™ technology, currently FDA cleared for functional abdominal pain with IBS in adolescents, to also potentially include post-concussion syndrome in children.” Aside from NRXS, other companies working on concussion treatments include Odyssey Health Inc. (OTC: ODYY), Abbott Laboratories (NYSE: ABT), Integra LifeSciences (NASDAQ: IART), and Medtronic (NYSE: MDT).

Look at NeurAxis Inc. (NYSEAMERICAN: NRXS), For Example

NeurAxis, Inc. (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today highlighted A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS™) in Patients with Post-Concussion Syndrome (PCS), a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of IB-Stim™ in children with post-concussion symptoms.

Brian Carrico, President and Chief Executive Officer of NeurAxis, said, “We are thrilled to support this research because if the data is positive and the FDA gives clearance, this would be a groundbreaking therapeutic option for post-concussion syndrome. According to literature, the majority of concussions occur in children, mainly due to sports and unstructured play with or without helmets. While symptoms generally resolve in a few weeks, others persist, including ongoing headaches, nausea, and dizziness, as well as mood and behavioral disorders. Medications are primarily used for off-label in the treatment, despite the lack of evidence to support efficacy or safety.”

“We support the ongoing pediatric post-concussion clinical research and it reinforces our commitment to evidence-based research to drive adoption for our PENFS™ technology, a minimally invasive device alternative, to meet the needs of this $2 billion market. We look forward to working with the FDA to continue expanding pediatric indications on our PENFS™ technology, currently FDA cleared for functional abdominal pain with IBS in adolescents, to also potentially include post-concussion syndrome in children,” concluded Mr. Carrico.

Currently enrolling up to 100 patients, the clinical trial’s primary endpoint is improvements in validated measures, including the Immediate Post-Concussion Assessment, Post-Concussion Symptom Scale, and Balance Error Scoring Symptom compared to placebo. The trial is being conducted at Children’s Hospital of Orange County, CA.

Other related developments from around the markets include:

Odyssey Health Inc. is developing a novel neuropharmaceutical treatment for mild Traumatic Brain Injury (mTBI) also known as a concussion. Recently, the world’s leading research agency, the National Institutes of Health (NIH), acknowledged that Chronic Traumatic Encephalopathy (CTE) is caused by repetitive head trauma, not uncommon in the field of sports and in our military. Odyssey’s lead drug candidate, ONP-002, is designed for the acute setting using an intranasal neurosteroid that works to simultaneously reduce swelling, inflammation, and oxidative stress. Odyssey has completed a Phase I clinical trial and is now preparing for a Phase II study to determine the safety and efficacy of its drug.

Abbott Laboratories received U.S. Food and Drug Administration clearance for what will be the first commercially available laboratory traumatic brain injury (TBI) blood test, making it widely available to hospitals in the United States. The test, which runs on Abbott's Alinity® i laboratory instrument, will provide clinicians with an objective way to quickly assess individuals with mild TBIs, also known as concussions. Abbott's Alinity i TBI lab test offers a new reliable result in 18 minutes to help clinicians quickly assess concussion and triage patients. For those with negative results, it rules out the need for a CT scan and can eliminate wait time at the hospital. The test measures two biomarkers in the blood that, in elevated concentrations, are tightly correlated to brain injury.

Integra LifeSciences reported financial results for the second quarter ending June 30, 2023. It saw second quarter revenues of $381.3 million, which declined 4.2%. It also reported second quarter GAAP earnings per diluted share of $0.05, as compared to $0.54 in the prior year; adjusted earnings per diluted share of $0.71, compared to $0.82 in the prior year. The company is also planning a $125 million share repurchase in the third quarter.

Medtronic approved an increase in the company's cash dividend for the second quarter of fiscal year 2024, raising the quarterly amount to $0.69 per ordinary share. This quarterly declaration is consistent with the first quarter dividend announcement made by the company in May 2023. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 46 consecutive years. The dividend is payable on October 13, 2023, to shareholders of record at the close of business on September 22, 2023.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for NeurAxis Inc. by NeurAxis Inc. We own ZERO shares of NeurAxis Inc. Please click here for disclaimer.

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