Total national coverage footprint for PENFS increases to roughly 100 million covered livesCARMEL, Ind., Dec. 19, 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 significant new medical policy coverage from a major national health insurer for Percutaneous Electrical Nerve Field Stimulation (“PENFS”). The coverage sp ...

Core Insights - NeurAxis, Inc. announced new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, increasing access to approximately 566,000 covered lives in Michigan, bringing total national coverage to about 55 million lives [1][3] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic conditions in both children and adults, with its proprietary IB-Stim technology FDA-cleared for treating functional abdominal pain associated with IBS and functional dyspepsia in patients aged 8 and older [2][4] - The IB-Stim device is non-invasive and stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and brain, addressing a significant unmet medical need as no FDA-approved drug therapies exist for pediatric patients with abdominal pain-related disorders [2][4] Market Strategy - The company is actively working to expand insurance coverage for IB-Stim, with discussions ongoing with several major insurers as they approach policy review cycles over the next eight months [3] - A Category I CPT code will take effect on January 1, 2026, which is expected to facilitate reimbursement and enhance revenue growth and margin expansion for NeurAxis [3] Clinical Development - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs, further solidifying its position in the market [4]

Core Insights - NeurAxis, Inc. reported a 22% increase in revenues for Q3 2025, reaching $811 thousand compared to $667 thousand in Q3 2024, driven by a 38% rise in unit deliveries [4][6] - The company is optimistic about significant revenue growth and margin expansion in 2026, supported by the upcoming CPT Category I code effective January 1, 2026, and recent FDA clearances [3][5] Financial Highlights - Revenues for Q3 2025 were $811 thousand, a 22% increase from $667 thousand in Q3 2024 [4][6] - Gross margin decreased to 83.3% from 85.4% year-over-year due to higher discounting and lower-margin sales from financial assistance programs [5][6] - Operating loss increased by 27% year-over-year to $2.1 million in Q3 2025, attributed to higher sales and marketing expenses [6][7] - Cash balance as of September 30, 2025, was $4.4 million, with an additional $2.8 million raised in October 2025 [6][8] Operational Highlights - The FDA granted clearance for IB-Stim to treat functional dyspepsia and nausea in patients aged 8 years and older, expanding the market opportunity [3][6] - The company secured a new CPT Category I code for PENFS procedures, effective January 1, 2026, which includes reimbursement financials [6][8] - Total covered lives increased to approximately 55 million, enhancing the potential patient base for NeurAxis's therapies [6][8] Management Commentary - The CEO expressed optimism about the company's positioning for substantial growth in 2026, emphasizing the importance of the CPT code and FDA clearances [3][5] - The company aims to treat all patients regardless of financial status, anticipating that increased demand from financial assistance patients will lead to higher gross margins once insurance coverage is established [5][6]

Core Insights - NeurAxis, Inc. has received FDA 510(k) clearance for its percutaneous electrical nerve field stimulation (PENFS) technology to treat functional abdominal pain (FAP) associated with functional dyspepsia (FD) and related nausea in patients aged 8 years and older, marking a historic milestone as the first FDA clearance for a treatment specifically addressing functional dyspepsia in adults [1][2] Company Overview - NeurAxis is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults, with a commitment to advancing science and evidence-based medicine [3] Market Expansion - The FDA clearance significantly expands NeurAxis's total addressable market by including patients aged 8 years and older, which is expected to drive substantial revenue growth in the gastrointestinal (GI) space [2][5] - The upcoming January 1, 2026, Category I CPT Code for PENFS procedures will apply to this new adult indication, facilitating broader clinical impact [2][5] Clinical Significance - Functional dyspepsia can lead to severe abdominal pain and nausea, significantly impacting quality of life, and the approval of PENFS technology provides a new treatment option for adult patients who previously had limited options [2]

Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the second quarter of 2025 on August 12, 2025, before market opening, followed by a conference call to discuss the results [1]. Financial Results Announcement - The financial results will cover the period ended June 30, 2025 [1]. - A conference call is scheduled for August 12, 2025, at 9:00 a.m. Eastern Time to review the results [1]. Conference Call Details - Interested parties can access the conference call via a live webcast available on the Company's Investor Relations website [2]. - Participants can submit questions through the webcast portal or via email [2]. - Call-in participants must register to receive dial-in information and a unique PIN [3]. Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4]. - The company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4]. - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4].

Core Insights - NeurAxis, Inc. announced medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, with two health insurers, impacting approximately 700,000 members in Connecticut and Massachusetts, bringing total national coverage to about 53 million [1][3] Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company's IB-Stim technology is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and Pediatric Functional Dyspepsia in adolescents aged 8-21 [2][4] Technology and Market Position - IB-Stim is a non-surgical device that delivers gentle electrical impulses to cranial nerve bundles in the ear, addressing a significant gap as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders [2] - The technology has been incorporated into treatment guidelines by a leading pediatric academic society, which is expected to enhance policy coverage and reimbursement [3] Future Developments - The activation of a Category I CPT code for PENFS, effective January 1, 2026, is anticipated to improve reimbursement and encourage broader adoption in children's hospitals [3] - NeurAxis is currently conducting additional clinical trials for PENFS across various pediatric and adult conditions with significant unmet healthcare needs [4]

Core Insights - NeurAxis, Inc. has announced that its PENFS technology is now included in clinical practice guidelines for treating Functional Abdominal Pain (FAP) in Irritable Bowel Syndrome (IBS), which is a significant milestone for the company [1][6] - The inclusion of IB-Stim in these guidelines is expected to enhance insurance coverage and drive growth, with an estimated addressable market exceeding $3 billion in the U.S. alone [2][3] - The guidelines were developed collaboratively by pediatric gastroenterology societies and emphasize evidence-based recommendations, positioning IB-Stim as a top-tier treatment option [2][6] Company Developments - NeurAxis's CEO highlighted the recognition of IB-Stim as part of the standard care for FAP in IBS, indicating a strong growth strategy and potential for substantial revenue generation [2] - The company has recently received FDA expanded clearances for IB-Stim and is set to implement a new Category I CPT code, further enhancing its market position [2] - The company aims to address the needs of over 600,000 children in the U.S. suffering from FAP, leveraging the new guidelines to expand treatment options [2][3] Market Context - The global market for abdominal pain in IBS presents a multi-billion-dollar opportunity, with IB-Stim being the only FDA-cleared pediatric treatment for FAP in IBS [3] - The guidelines recommend PENFS among other therapies, which elevates NeurAxis's profile and supports broader adoption of IB-Stim within the healthcare industry [2][6] - The rigorous GRADE approach used in developing the guidelines underscores the efficacy and safety of PENFS, enhancing its credibility as a treatment option [2][6]

Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4] - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4] - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions with significant unmet healthcare needs [4] Upcoming Events - NeurAxis will participate in the Lytham Partners Spring 2025 Investor Conference, with a webcast presentation scheduled for May 29, 2025, at 9:30 a.m. ET [1][2] - The webcast will be accessible via the conference homepage and will be available for replay after the event [2] - Management will also engage in virtual one-on-one meetings with investors during the conference [3]

Core Viewpoint - NeurAxis, Inc. has successfully closed a registered direct offering, raising approximately $5.0 million to strengthen its balance sheet and support growth initiatives, particularly for its IB-Stim therapy targeting chronic abdominal pain in pediatric patients [1][2]. Group 1: Financial Details - The offering consisted of 1,538,461 shares of common stock priced at $3.25 per share, resulting in gross proceeds of about $5.0 million before expenses [1]. - In addition to the offering, NeurAxis secured over $1 million from warrant exercises, further enhancing its financial position [2]. Group 2: Product and Market Impact - The recent FDA clearance for expanded indications of the IB-Stim treatment for Pediatric Functional Abdominal Pain (FAP) is a significant milestone for the company, addressing a critical need in pediatric care [2]. - The IB-Stim therapy is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21, with ongoing clinical trials for various pediatric and adult conditions [5]. Group 3: Future Outlook - The funds raised will be utilized to drive revenue growth for IB-Stim and prepare for the implementation of a CPT Category I code effective January 1, 2026, which is expected to enhance reimbursement and adoption of the therapy [2].

Core Viewpoint - NeurAxis, Inc. has announced a registered direct offering of 1,538,461 shares of its common stock at a price of $3.25 per share, aiming to raise approximately $5.0 million for working capital and general corporate purposes [1][2]. Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies for chronic and debilitating conditions in both children and adults [5]. - The company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [5]. - NeurAxis is conducting additional clinical trials of its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology for various pediatric and adult conditions with significant unmet healthcare needs [5]. Offering Details - The offering is expected to close on or about May 22, 2025, pending customary closing conditions [2]. - Craig-Hallum Capital Group is serving as the exclusive placement agent for this offering [2]. - The gross proceeds from the offering are anticipated to be around $5.0 million before deducting fees and expenses [2]. Regulatory Information - A shelf registration statement on Form S-3 was filed with the SEC on December 13, 2024, and was declared effective on February 11, 2025 [3]. - The offering will be conducted through a prospectus supplement and accompanying prospectus that are part of the shelf registration statement [3].