Latest news with #NeurAxis
Yahoo
4 days ago
- Business
- Yahoo
NeurAxis Achieves Critical Milestone; Secures Key Academic Society Guidelines Recommendation for Treatment of Functional Abdominal Pain (FAP) in IBS
Practice guidelines published in the Journal of Pediatric Gastroenterology & Nutrition (JPGN) name Percutaneous Electrical Nerve Field Stimulation (PENFS) as a recommended treatment option for FAP in IBS NeurAxis's PENFS technology is the only FDA-cleared or approved treatment that is recommended in the guidelines for pediatrics, enabling momentum for large-scale insurance coverage for IB-Stim® CARMEL, Ind., June 10, 2025 (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 that its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology has been officially incorporated into newly released clinical practice guidelines issued by the leading pediatric academic society for the treatment of Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS). This inclusion represents a major catalyst for NeurAxis, unlocking the potential for large-scale insurance coverage for its flagship product, IB-Stim, and setting the stage for accelerated growth through evidence-based recommendations. 'We are thrilled that IB-Stim is now recognized as part of the standard of care for FAP in IBS,' said Brian Carrico, CEO of NeurAxis. 'This milestone offers new hope to patients and reinforces the strength of our short and long-term growth strategy. Alongside our recent FDA expanded clearances for IB-Stim and our transformative, soon-to-be-effective on January 1st, Category I CPT code, we are now well-positioned to drive substantial top-line growth and operational leverage.' He added, 'With the recent strengthening of our balance sheet and the expected rollout of more widespread insurance coverage, we are poised to accelerate our treatment option to the over 600,000 kids in the United States suffering from FAP. We estimate the addressable market for our product just in the US to be over 3 billion dollars. With these important achievements now completed, I expect that this achievement will lead to a significant expansion of insurance coverage and revenue generation.' Dr. Adrian Miranda, practicing pediatric gastroenterologist and Chief Medical Officer of NeurAxis, commented: 'Overall, consensus was reached by the committee on 25 therapies and PENFS with IB-Stim was 1 of 4 therapies that had the highest level of evidence and thus placed amongst the top in the treatment algorithm for FAP in IBS.' Dr. Miranda also added, 'IB-Stim is not available in Europe, so the treatment algorithm was formulated to establish a framework for 'shared decision making' amongst the clinician and family, as opposed to a strict top to bottom approach. This gives clinicians the option to use IB-Stim as a first-line therapy and speaks to the overall certainty of the efficacy and safety supporting our technology. We couldn't be more pleased with this result.' Developing practice guidelines for FAP in IBS in children of 4–18 years was a collaborative effort of the European and North American Societies for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN and NASPGHAN). The guidelines followed the 'Grading of Recommendations Assessment, Development and Evaluation' (GRADE) approach, which is supported by the World Health Organization (WHO). The highest GRADE therapies suggested in the guidelines include PENFS, hypnotherapy, lactobacillus rhamnosus (probiotic), and soluble fiber. This rigorous, evidence-based approach that incorporates PENFS as an important treatment option for children elevates NeurAxis's profile within the healthcare industry and supports wider market adoption of IB-Stim. Abdominal pain in IBS affects millions globally, creating a multi-billion-dollar market opportunity with limited effective treatment options. IB-Stim is the only pediatric treatment option that the FDA has cleared for FAP in IBS and abdominal pain in functional dyspepsia (to include nausea symptoms) for patients 8-21 years old. IB-Stim delivers gentle electrical impulses to cranial nerve bundles in the ear, offering a safe, non-invasive alternative to drug therapies often used off-label and many of which are not suggested in the practice guidelines from NASPGHAN / ESPGHAN. For more information about NeurAxis, please visit About 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 8-21 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 Forward-Looking StatementsCertain 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, 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. For more information, please visit For contraindications, precautions, warnings, and IFU, please see: Contacts: CompanyNeurAxis, Investor Relations Lytham PartnersBen Shamsian646-829-9701shamsian@
Yahoo
27-05-2025
- Business
- Yahoo
NeurAxis to Participate in the Lytham Partners Spring 2025 Investor Conference on May 29, 2025
CARMEL, Ind., May 27, 2025 (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, will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Spring 2025 Investor Conference, taking place virtually on Thursday, May 29, 2025. Company Webcast The webcast presentation will take place at 9:30 a.m. ET on Thursday, May 29, 2025. The webcast can be accessed by visiting the conference home page at or directly at The webcast will also be available for replay following the event. 1x1 Meetings Management will be participating in virtual one-on-one meetings throughout thae event. To arrange a meeting with management, please contact Lytham Partners at 1x1@ or register for the event at 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 8-21 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 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. Contacts: CompanyNeurAxis, Investor Relations Ben ShamsianLytham Partners646-829-9701shamsian@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
22-05-2025
- Business
- Yahoo
NeurAxis Announces Closing of $5.0 Million Registered Direct Offering
Strengthens Balance Sheet and Provides Growth Capital CARMEL, Ind., May 22, 2025 (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 closing of its previously announced registered direct offering of 1,538,461 shares of its common stock at a purchase price of $3.25 per share. The gross proceeds from the offering are approximately $5.0 million, before deducting placement agent fees and other offering expenses. 'This financing, along with the recent FDA clearance expanding indications for IB-Stim treatment of Pediatric Functional Abdominal Pain (FAP), marks a significant milestone for NeurAxis,' said Brian Carrico, President and Chief Executive Officer of NeurAxis. 'The $5.0 million raise, coupled with over $1 million obtained from warrant exercises this week, shores up our balance sheet as we continue to drive revenue growth for IB-Stim and prepare for the implementation of our CPT Category I code, effective January 1, 2026. These expanded indications for IB-Stim are a breakthrough in pediatric care, especially given the lack of FDA-approved drug therapies for children suffering from abdominal pain disorders linked to gut-brain interaction.' Craig-Hallum Capital Group acted as the exclusive placement agent for the offering. A shelf registration statement on Form S-3 (File No. 333-283798) relating to the securities offered was originally filed with the U.S. Securities and Exchange Commission (the 'SEC') on December 13, 2024, and declared effective on February 11, 2025. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the shelf registration statement. The final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC's website at Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC's website at or by contacting Craig-Hallum Capital Group LLC at 323 North Washington Avenue, Suite 300, Minneapolis, Minnesota 55401, Attention: Equity Capital Markets, by telephone at 612-334-6300, or by email at prospectus@ This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 8-21 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 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. For more information, please visit For contraindications, precautions, warnings, and IFU, please see: Contacts: CompanyNeurAxis, Investor RelationsLytham PartnersBen Shamsian646-829-9701shamsian@ in to access your portfolio
Yahoo
21-05-2025
- Business
- Yahoo
NeurAxis Announces $5.0 Million Registered Direct Offering
CARMEL, Ind., May 21, 2025 (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 that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,538,461 shares of its common stock at a purchase price of $3.25 per share in a registered direct offering priced at the market under NYSE American rules. The offering is expected to close on or about May 22, 2025, subject to the satisfaction of customary closing conditions. Craig-Hallum Capital Group is acting as the exclusive placement agent for the offering. The gross proceeds from the offering are expected to be approximately $5.0 million, before deducting placement agent fees and other offering expenses payable by the Company. NeurAxis intends to use the net proceeds from the offering for working capital and general corporate purposes. A shelf registration statement on Form S-3 (File No. 333-283798) relating to the securities being offered was originally filed with the U.S. Securities and Exchange Commission (the 'SEC') on December 13, 2024, and declared effective on February 11, 2025. The offering is being made only by means of a prospectus supplement and accompanying prospectus that form a part of the shelf registration statement. The final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at Electronic copies of the final prospectus supplement and accompanying prospectus, when filed, may be obtained on the SEC's website at or by contacting Craig-Hallum Capital Group LLC at 323 North Washington Avenue, Suite 300, Minneapolis, Minnesota 55401, Attention: Equity Capital Markets, by telephone at 612-334-6300, or by email at prospectus@ This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. 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 8-21 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 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. Contacts: CompanyNeurAxis, Investor RelationsLytham PartnersBen Shamsian646-829-9701shamsian@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-05-2025
- Business
- Yahoo
NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pediatric FAP/Functional Dyspepsia (FD) and Associated Nausea Symptoms
• Significantly expands IB-Stim's total addressable market • Clearance covers patients aged 8–21 • Seamless go-to-market strategy with existing reimbursement and provider infrastructure CARMEL, Ind., May 20, 2025 (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 that it has received FDA 510(k) clearance for IB-Stim™ for the treatment of Pediatric Functional Abdominal Pain (FAP) associated with Functional Dyspepsia, and FD related Nausea Symptoms, in patients aged 8 to 21 years. This clearance is the second successful expanded FDA indication for IB-Stim, following its initial approval for Functional Abdominal Pain associated with Irritable Bowel Syndrome (IBS). The new indication represents the first treatment ever cleared or approved by the FDA related to functional dyspepsia. It is expected to nearly double the Company's total addressable market, reinforcing NeurAxis' leadership in non-invasive, pediatric-focused neuromodulation. The indication leverages the same CPT code, insurance coverage, and provider call points as the existing IBS indication, supporting a seamless and capital-efficient go-to-market strategy. Commercial rollout for this expanded important indication will begin immediately. 'This latest FDA clearance represents a pivotal milestone in NeurAxis' growth strategy,' said Brian Carrico, President and Chief Executive Officer of NeurAxis. 'Expanding into the treatment of Pediatric Functional Dyspepsia pain that includes related nausea symptoms, not only broadens our clinical impact but also positions us to drive significant revenue growth through a capital-efficient rollout. This progress is fueled by a robust body of clinical evidence supporting our PENFS technology, which continues to gain traction among providers and payers. Notably, we are seeing expanded insurance coverage and, most recently, the American Medical Association's approval of a new CPT Category I code for IB-Stim, which will take effect in January 2026.' 'Functional dyspepsia can cause severe abdominal pain and nausea, and in adolescents, it often leads to serious secondary issues like fear of eating, weight loss, and significant dietary restriction,' said Dr. Adrian Miranda, Chief Medical Officer of NeurAxis. 'We are thrilled by the agency's decision, which gives us the opportunity to offer real hope to thousands of patients and their families who have had limited options—until now.' NeurAxis' PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) and Functional Dyspepsia in adolescents 8-21 years old. IB-Stim is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. There are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction (DGBI's). Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy. About 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 8-21 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 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. For Contraindications, Precautions, Warnings, and IFU, please see: Contacts: CompanyNeurAxis, Investor Relations Lytham PartnersBen Shamsian646-829-9701shamsian@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
