NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS) today announced the publication of Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction, a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of IB-Stim™ in children with post-concussion symptoms, featured in the September 2023 Frontiers in Pain Research.
CARMEL, Ind., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Neuraxis Ltd., (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies that address chronic and debilitating conditions in children and adults, today announced the publication of Prospective study of the effect of auricular percutaneous electrical nerve field stimulation on quality of life in children with pain related disorders of gut-brain interaction, a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of IB-Stim™ in children with post-concussion symptoms, featured in the September 2023 Frontiers in Pain Research.
The publication, led by investigators from Children’s Hospital of Orange County, investigated changes in gastrointestinal symptoms and quality of life in 31 adolescent patients aged 11 – 18 years with functional abdominal pain disorders (FAPDs) before and after treatment with IB-Stim. The patients were treated for 4 weeks and data were collected prospectively from both the patient and the parents using validated questionnaires. Following IB-Stim™ treatment, the study noted that:
- patients reported significant reductions in abdominal pain, nausea, disability, and anxiety from baseline to week 4 (p < 0.05);
- parent assessments reported significant improvement in the child’s quality of life based on physical function, psychosocial function, and generic core scale scores (p < 0.05); and
- parents also reported reduced abdominal pain, functional disability, and somatization in their child. The global health scores also significantly improved based on both patient and parent reports (p < 0.05).
Dr. Adrian Miranda, Chief Medical Officer of NeurAxis said, “We are pleased that outcomes post IB-Stim treatment continue to be replicated at centers of excellence across the country. Further, this study is unique in that it not only found improvements in gastrointestinal symptoms, but also in the child’s quality of life based on the parent’s report.” Dr. Miranda added, “The ability to improve a child’s quality of life is something that NeurAxis is extremely proud of and we will continue to work tirelessly towards our goal to ensure that every child has access to necessary treatment.”
Brian Carrico, President and Chief Executive Officer of NeurAxis, said, “We are pleased to highlight the 10th peer reviewed publication, focused on our PENFS technology, as the body of clinical evidence supporting our IB-Stim™ therapy grows. We are actively leveraging IB-Stim™ publications to expand written policy coverage with a goal to drive guideline changes that support IB-Stim as the standard of care for FAPDs.”
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, as well as factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com/.
This page discusses ongoing research activities with percutaneous electrical nerve field stimulator (PENFS) technology. Please note, the research being described includes information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS IB-Stim™ device for uses beyond those that are cleared by the U.S. FDA. See https://ibstim.com/important-information/.
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