Latest news with #PercutaneousElectricalNerveFieldStimulation
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
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
20-03-2025
- Business
- Yahoo
NeurAxis Reports Strong Fourth Quarter 2024 Financial Results Driven by a 43% Increase in Revenues
Conference call will be held today, Thursday, March 20 at 9:00 am ET CARMEL, Ind., March 20, 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 fourth quarter and fiscal year 2024 for the period ended December 31, 2024. 4Q24 Financial highlights Revenues increased 43% to $761 thousand in 4Q24 compared to $531 thousand in 4Q23. Operating loss improved by 10% compared to the fourth quarter of 2023. Cash balance was $3.7 million as of December 31, 2024. 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, 'Our strong performance in 4Q24 capped off a transformational year, as we significantly expanded insurance coverage for IB Stim, received a CPT Category I code for PENFS, nearly doubled our TAM for Pediatric FAB/IBS, and received 510(k) clearance for our RED device. These important accomplishments put us in an exceptional position to continue the outsized growth we have achieved in the last two quarters. Our growth prospects in the near and medium term are robust and extend across multiple products and indications, and combined with disciplined cost management, have set the stage for achieving cash flow breakeven. Notably, recent investments from life science-focused funds have bolstered our balance sheet, providing the financial strength to accomplish our objectives. 'Positive policy coverage for approximately 51 million lives now exists, with numerous payers actively engaged in the review and policy development process. Our progress is increasingly reflected in the numbers. Over the past 12 months, more than 1,000 pediatric patients have been treated, representing just over 0.1% of the 600,000 children in the U.S. suffering from debilitating IBS and in urgent need of IB-Stim. Revenue growth has been robust, with a 43% year-over-year increase in 4Q24, building on the strong momentum of Q3's 40% sales surge. This upward trajectory has continued into 1Q25. 'Looking ahead, we expect the upcoming publication of academic society guidelines to drive significant insurance policy coverage as we look to have the majority of children in the US covered for treatment. This remaining policy coverage, coupled with the implementation of the Category I code on January 1, 2026, are the two milestones we have been working toward since the beginning to allow large-scale growth nationally. Additionally, we have submitted for FDA clearance for Functional Dyspepsia in children and we are cautiously optimistic in receiving this expanded indication for our PENFS technology in 2025. If successful, this will double our total addressable market in the pediatric market. Our vision is clear, and we will continue to hit the remaining milestones in order to achieve our growth and revenue expectations.' Fourth Quarter and Fiscal Year 2024 Financial Results Revenues in the fourth quarter of 2024 were $761 thousand, up 43% compared to $531 thousand in the fourth quarter of 2023. Unit sales increased approximately 45% 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. Revenue in fiscal year 2024 was $2.7 million, an increase of 9% compared to $2.5 million in fiscal year 2023. Unit sales increased approximately 19% due to continued growth of the Company's financial assistance program. Gross margin in the fourth quarter of 2024 remained steady at 86.4% during the fourth quarters ended December 31, 2024 and 2023. The Company maintained its gross margin by growing its higher margin full insurance reimbursement program to offset the growth of devices delivered through the discounted financial assistance program. Gross margin in fiscal year 2024 of 86.5% declined 120 basis points compared to 87.7% in fiscal year 2023 due to growth in device deliveries from the Company's financial assistant programs. Selling, general and administrative expenses in the fourth quarter of 2024 were $2.1 million, an increase of 2% compared to $2.0 million in the fourth quarter of 2023. The increase was due to the hiring of key personnel and the introduction of a short-term incentive plan in fiscal 2024, mostly offset by lower third party service costs. Selling, general and administrative expenses in fiscal year 2024 were $9.5 million, an increase of 7% compared to $8.8 million in fiscal year 2023. The increase was due to the hiring of key personnel, the introduction of a short-term incentive plan and the annualization of public company costs, one-time severance and advisory costs, partly offset by post-IPO consulting and recruiting fee and IPO bonuses that did not recur in 2024 as well as lower third party service costs in 2024. Operating loss in the fourth quarter of 2024 was $1.5 million, an improvement of 10% compared to $1.6 million in the fourth quarter of 2023. Operating loss in fiscal year 2024 was $7.2 million, an increase of 7% compared to the $6.7 million for the full year of 2023. Net loss in the fourth quarter of 2024 was $1.5 million, a decrease of 73% compared to $5.3 million in the fourth quarter of 2023 primarily due to a lower operating loss and a $3.7 million charge related to the extinguishment of debt upon the Company's IPO in 2023. Net loss for the full year 2024 was $8.2 million, a decrease of 44% compared to the $14.6 million for the full year of 2023 primarily due to the absence of debt discount, issuance cost and debt extinguishment charges triggered by the Company's IPO in 2023 partially offset by a higher operating loss. Cash on hand as of December 31, 2024, was $3.7 million. Although the Company had no long-term debt as of December 31, 2024, short-term debt of $154 thousand represented a note payable related to the financing of business insurance premiums. Cash used in operations in fiscal year 2024 of $6.1 million was $595 thousand lower than in fiscal year 2023 primarily due to more issuances of common stock instead of cash for certain services and lower interest payments. Conference Call Details Date and Time: Thursday, March 20, 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 or 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 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 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, 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@ NeurAxis, Inc. Condensed Statements of Operations Twelve Months Ended December 31, 2024 2023 Net sales $ 2,685,925 $ 2,460,049 Cost of goods sold 362,002 303,345 Gross profit 2,323,923 2,156,704 Selling expenses 324,708 323,569 Research and development 206,107 169,315 General and administrative 8,949,925 8,328,315 Operating loss (7,156,817 ) (6,664,495 ) Other (expense) income: Financing charges (230,824 ) (2,772 ) Interest expense, net (174,328 ) (476,416 ) Change in fair value of warrant liability (941 ) 844,854 Change in fair value of derivative financial instruments - 198,551 Amortization of debt discount and issuance costs (126,387 ) (4,881,622 ) Extinguishment of debt liabilities - (3,649,561 ) Other (expense) income, net (552,204 ) 4,778 Total other (expense) income, net (1,084,684 ) (7,962,188 ) Net loss $ (8,241,501 ) $ (14,626,683 )
