Latest news with #PENFS
Yahoo
3 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
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
Yahoo
12-05-2025
- Business
- Yahoo
NeurAxis Reports Strong First Quarter 2025 Financial Results Driven by a 39% Growth in Revenues
Conference call will be held today, Monday, May 12 at 9:00 am ET CARMEL, Ind., May 12, 2025 (GLOBE NEWSWIRE) -- NeurAxis, Inc. ('NeurAxis,' or the 'Company') (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the first quarter 2025 for the period ended March 31, 2025. 1Q25 Financial highlights Revenues increased 39% year over year to $896 thousand in 1Q25 compared to $647 thousand in 1Q24. Revenues increased 18% quarter over quarter to $896 thousand in 1Q25 compared to $761 thousand in 4Q24. Operating loss (excluding a one-time legal settlement) improved by 9% compared to the first quarter of 2024. Cash balance was $2.0 million as of March 31, 2025. Recent Operational Highlights Expanded total covered lives to approximately 51 million compared to 4 million as of December 31 2023. Received a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures effective January 1, 2026. Received new FDA clearance for the expansion of IB-Stim label: to allow for a larger patient population beyond 11-18 years of age to 8-21 years. to increase devices per patient to 4 devices. Received 510(k) clearance from the FDA for its rectal expulsion device (RED) product. RED's innovative design simplifies anorectal function testing and can be used without interrupting clinical workflow. The Company has just begun the commercialization process and expects the first meaningful revenues in 2Q25. The Company remains committed to clinical research in the pediatric space, with 16 peer-reviewed publications. All studies were carried out in US children's hospitals using NeurAxis' PENFS technology. This level of evidence puts NeurAxis in a great position to continue expanding payor coverage and increasing adoption of the technology. Management Commentary Brian Carrico, Chief Executive Officer of NeurAxis, commented, 'Q1 2025 marked another strong quarter for NeurAxis, with revenue growing 39% year-over-year, extending the momentum that began in Q3 2024. Our progress is becoming increasingly evident in the numbers. In the first quarter alone, 300 patients were treated through full PO or PAP programs—an annualized rate of 1,200 patients. While this marks important growth, it still represents just 0.2% of the 600,000 severely affected children in the U.S. suffering from IBS who are in urgent need of IB-Stim. This robust growth is driven by physicians gaining greater comfort with billing and coding processes, alongside broader awareness of academic society guidelines that recognize PENFS with the highest GRADE of evidence. Today, positive coverage policies now encompass approximately 51 million lives, and several additional payers are actively engaged in policy development. While our revenue trajectory has accelerated in recent quarters, it's important to recognize we are still reaching only a small fraction of our total addressable market, primarily because national policy coverage and the implementation of the Category I CPT code are still forthcoming. We expect the upcoming publication of academic society guidelines to be a significant catalyst for broader insurance coverage, with the goal of securing treatment access for the majority of affected children in the U.S. These coverage expansions, alongside the Category I code taking effect on January 1, 2026, are the two critical milestones that position us for large-scale national growth. In parallel, we have submitted for FDA clearance to expand IB-Stim's indication to include pediatric Functional Dyspepsia, and we are cautiously optimistic for approval in 2025. A successful clearance would effectively double our pediatric addressable market. Our vision is clear: we are methodically executing against our milestones to drive growth, expand access, and deliver on our revenue expectations. We anticipate meaningful acceleration in revenue growth as we move closer to cash flow breakeven, fueled by two catalysts — the continued expansion of positive payer coverage for IB-Stim (PENFS) and the commercialization of RED, alongside the Category I CPT code becoming effective in early 2026." First Quarter 2025 Financial Results Revenues in the first quarter of 2025 were $896 thousand, up 39% compared to $647 thousand in the first quarter of 2024. Unit sales increased approximately 46% year over year due to growth from patients with full insurance reimbursement and the Company's financial assistance program that offers discounts for patients without insurance coverage. The Company continues to see great improvements in recent months, gaining positive policy coverage for the PENFS technology, and recent results are indicative of that success. Gross margin in the first quarter of 2025 declined to 84.4% from 88.4% in the first quarter of 2024. Despite the increase in sales volume, the decline in gross margin is the result of higher growth from financial assistance customers with discounted pricing due to lack of insurance coverage compared to full reimbursement customers with insurance coverage and higher device manufacturing and shipping costs. Operating expenses in the first quarter of 2025 were $3.1 million, an increase of 27% compared to $2.4 million in the first quarter of 2024. The increase is due to (i) the settlement of a lawsuit, (ii) higher selling expenses corresponding directly with sales volume and (iii) higher research and development costs as the Company completed RED development and initiated expenditures on a new medical research project. Excluding the one-time legal settlement charge, the Company's operating expenses in the first quarter of 2025 would have remained relatively flat compared to the first quarter of 2024. Operating loss in the first quarter of 2025 was $2.3 million, an increase of 25% compared to $1.8 million in the first quarter of 2024. Excluding the one-time legal settlement charge, the Company's operating loss in the first quarter of 2025 would have improved 9% compared to the first quarter of 2024. Net loss in the first quarter of 2025 was $2.3 million, an increase of 8% compared to $2.1 million in the first quarter of 2024. Excluding the one-time legal settlement charge, the Company's net loss in the first quarter of 2025 would have improved 22% compared to the first quarter of 2024. Cash on hand as of March 31, 2025, was $2.0 million. Cash used in operations in the first quarter of 2025 was $271 thousand higher than in the first quarter of 2024 primarily due to past due payables in the first quarter of 2024 that was a function of the Company's liquidity position at the time. The Company has no long-term debt. Conference Call Details Date and Time: Monday, May 12, 2025, at 9:00am ET Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company's website at or For participants listening through the webcast, questions can be sent in through the portal using the 'Ask a Question' link or by emailing questions to NRXS@ Call-in Information: Interested parties can also access the live conference call by initially registering at the following link. Upon completion of the registration link, call-in participants will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details. Replay: A webcast replay will be available in the Investor Relations section of the Company's website at orhttps:// 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 the 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, 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, precaution, warnings, and IFU, please see: For important RED information, including indications, precautions, and contraindications, visit: Contacts: CompanyNeurAxis, Investor Relations Lytham PartnersBen Shamsian646-829-9701shamsian@ (Unaudited) For the Three Months EndedMarch 31, 2025 2024 Net Sales $ 895,655 $ 646,635 Cost of Goods Sold 139,475 75,081 Gross Profit 756,180 571,554 Selling Expenses 133,954 80,030 Research and Development 60,556 5,570 General and Administrative 2,856,768 2,318,074 Operating Loss (2,295,098 ) (1,832,120 ) Other income (expense): Financing charges — (230,824 ) Interest expense (2,237 ) (26,560 ) Change in fair value of warrant liability 1,831 (9,284 ) Amortization of debt discount and issuance cost — (21,683 ) Other income 16,820 — Other expense — (180 ) Total other income (expense), net 16,414 (288,531 ) Net loss (2,278,684 ) (2,120,651 ) Preferred stock dividends (213,543 ) — Net loss available to common stockholders $ (2,492,227 ) $ (2,120,651 ) Per-Share Data Basic and diluted loss per share $ (0.33 ) $ (0.32 ) Weighted Average Common Shares Outstanding Basic and diluted 7,463,578 6,550,567
