NeurAxis Announces IB-Stim Results from a Large, Pediatric, Multi-Center Registry

Rhea-AI Summary

NeurAxis, a medical technology company, announced positive results from a multicenter study on IB-Stim for pediatric gut-brain interaction disorders. The study showed significant improvements in gastrointestinal symptoms and functionality, with 92% of patients having failed medication therapy.

Medical Research Analyst

The recent multicenter registry study on IB-Stim, conducted by NeurAxis, Inc., presents significant findings for the treatment of pediatric disorders of gut-brain interaction (DGBI). The study's focus on a patient cohort that largely failed previous medication therapies indicates a potential shift in treatment paradigms for DGBI. The reported high efficacy rate and the durability of the response over a 12-month period suggest a strong potential for IB-Stim as a long-term treatment option. It is noteworthy that the study encompasses a large sample size, strengthening the validity of the results. The implications for NeurAxis include the potential for increased market share within neuromodulation therapies, especially given the first-to-market advantage. However, it is important to consider the reimbursement landscape and the necessity for insurer buy-in, which can be a hurdle for novel medical technologies despite their clinical efficacy.

Healthcare Economist

The economic impact of introducing an effective treatment like IB-Stim for chronic and debilitating conditions such as DGBI cannot be overstated. Given the substantial portion of patients who had failed multiple medication therapies, there is a clear unmet need for alternative treatments. This translates into a market opportunity for NeurAxis to potentially reduce long-term healthcare costs associated with chronic DGBI management. The emphasis on strong publications to gain insurer acceptance is a strategic move that could lead to wider coverage and, consequently, better patient access. However, the cost-benefit analysis from a payer perspective will be pivotal. Payers will scrutinize the long-term cost savings against the upfront costs of the therapy, considering both direct treatment expenses and indirect costs such as improved quality of life and reduced hospitalizations.

Market Research Analyst

NeurAxis' announcement regarding the positive outcomes of the IB-Stim study is likely to resonate with investors, considering the therapy's potential to cater to a previously underserved patient population. The pediatric healthcare market is particularly sensitive to innovative treatments that offer both efficacy and safety. The durability of the treatment's effects, as highlighted in the study, positions the company favorably in terms of product differentiation. Moreover, the strategic focus on publication strength to facilitate insurer acceptance is an astute approach to overcoming market access barriers. This could enhance the company's reputation and credibility within the medical community. Investors should monitor the company's progress in securing payer endorsements and track the adoption rate post-commercialization to gauge the therapy's trajectory and its impact on NeurAxis' financial performance.

CARMEL, Ind., March 27, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced the results of a multicenter registry study on IB-Stim for pediatric disorders of gut-brain interaction (DGBI). IB-Stim is NeurAxis’ proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology therapy. The large and comprehensive study concluded efficacy of IB-Stim for gastrointestinal symptoms and functionality for pediatric disorders of gut-brain interaction (DGBI).             

Seven large, tertiary care centers in the US enrolled patients undergoing treatment with IB-Stim. Overall, 292 patients met Rome IV Diagnostic criteria for any pain associated disorder of the gut-brain interactions. In this cohort, 92% had failed medications therapy and 61% of patients had failed 4 or more medication when they entered the study.

Patients were asked to fill out several validated pediatric measures, including the abdominal pain index (API), a validated questionnaire that assesses frequency, duration, and intensity of abdominal pain episodes. Data was collected weekly for the first 3 weeks and at 3, 6, 9 and 12 months. Compared to baseline scores, there were significant improvements in the API after 4 weeks of IB-Stim treatment at every time point, including 6 month (p<0.001) and 12 months (p<0.001).

Dr. Adrian Miranda, Chief Medical Officer of NeurAxis stated, “To my knowledge, this is the largest, prospective, multicenter registry for any drug or device in pediatric patients with pain associated DGBIs. The results significantly highlight the durability of response after just 4 weeks of treatment, which is a commonly asked question. While I am not surprised by the impressive results, it is interesting to note that this cohort is likely to have included the most challenging patients with high disability and a significantly large symptom burden, since so many of the patients had already failed medications prior to entering the trial”.

Brian Carrico, Chief Executive Officer of NeurAxis stated, “This trial and its positive conclusion is yet another step forward in our execution to commercialize and bring our first-to-market treatment to the chronic and debilitated pediatric patients in need of this evidence-based technology. We remain steadfast in the execution of our strategy to add to our portfolio of strong publications in order to gain wider acceptance from insurers and ultimately growing our revenues.”

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.

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, the results of submissions to the FDA, the results of the shareholder vote to enable the issuance of the Preferred Stock, and 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.

This page discusses 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/.

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

FAQ

What is the focus of NeurAxis' study on IB-Stim?

The study focused on pediatric disorders of gut-brain interaction (DGBI) and the efficacy of IB-Stim, NeurAxis' proprietary therapy.

What were the key findings of the study?

The study showed significant improvements in gastrointestinal symptoms and functionality for pediatric patients with DGBI, with 92% of patients having failed medication therapy.

How many patients were enrolled in the study?

Overall, 292 patients met Rome IV Diagnostic criteria for any pain associated disorder of the gut-brain interactions.

What was the response to IB-Stim treatment?

Compared to baseline scores, there were significant improvements in the abdominal pain index (API) after 4 weeks of IB-Stim treatment at every time point, including 6 and 12 months.

Who commented on the study results?

Dr. Adrian Miranda, Chief Medical Officer of NeurAxis, and Brian Carrico, Chief Executive Officer, provided insights on the study results and the company's future plans.