Core Insights - Nyxoah's U.S. commercialization of the Genio system began following FDA approval on August 8, 2025, with initial revenue generation starting in September 2025, marking a transformative year for the company [2][4][7] - The company reported significant revenue growth in Q4 2025, with net revenue reaching EUR 5.6 million, a substantial increase from EUR 1.3 million in the same quarter of the previous year, driven primarily by the U.S. launch [5][15] - Nyxoah is expanding its sales force and anticipates a 25% sequential growth in U.S. revenue for Q1 and Q2 2026, supported by ongoing surgeon training and additional Value Analysis Committee (VAC) approvals [19][20] U.S. Commercialization and Market Strategy - Nyxoah has focused on the top 400 high-volume hypoglossal nerve stimulation accounts in the U.S., training 145 surgeons across 125 accounts by the end of 2025 [1][3][7] - The company completed 120 VAC submissions with 57 approvals and no rejections, indicating a strong market entry strategy [1][7] - The fourth quarter of 2025 was characterized as the first full quarter of U.S. commercialization, with management tracking key indicators related to account access and physician readiness [2][4] Financial Performance - For the full year 2025, Nyxoah reported net revenue of EUR 10 million, reflecting a 122% year-over-year increase from EUR 4.5 million in 2024 [17] - The company ended 2025 with EUR 48 million in cash, with a quarterly cash burn of approximately EUR 20 million, providing a runway into Q1 2027 [5][18] - Gross margin for Q4 2025 was reported at 64%, with total operating loss remaining stable year-over-year despite significant investments in U.S. commercialization [16][17] Reimbursement and Coding Developments - In February 2026, CMS issued interim C-codes for airway genioglossus nerve stimulation, with C8011 reimbursed at $31,526, aligning reimbursement for Genio with competitors [6][9][10] - Management noted that commercial payers accounted for about 90% of Genio's business in Q4 2025, while Medicare represented approximately 10% [8] - Nyxoah expects dedicated AGNS CPT codes to be established around 2028, while current billing practices for surgeons will remain unchanged [11][12] Clinical Data and Future Outlook - The DREAM pivotal study published in the Journal of Clinical Sleep Medicine demonstrated Genio's efficacy, which is expected to differentiate it from competitors [13] - Nyxoah anticipates 12-month data from its ACCCESS study by mid-2026, with plans to submit a PMA supplement for potential U.S. label expansion [14] - The company is also expanding its internal manufacturing capabilities to enhance competitive positioning and improve gross margins [22]

Core Insights - NeurAxis, Inc. has reported significant growth in revenues and operational milestones, indicating a new phase in its growth trajectory with the implementation of a Category I CPT code for its IB-Stim technology [3][6]. Financial Highlights - Revenues for Q4 2025 reached $968 thousand, a 27% increase from $761 thousand in Q4 2024, driven by a 35% increase in unit sales [5][6]. - For FY2025, revenues increased by 33% to $3.6 million compared to $2.7 million in FY2024, with unit sales up approximately 44% [7]. - The gross margin for Q4 2025 was 85.4%, down from 86.4% in Q4 2024, while the FY2025 gross margin was 84.2%, a decline from 86.5% in FY2024 [8]. Operational Highlights - The company has successfully transitioned to a Category I CPT code for its IB-Stim technology, enhancing market understanding and adoption potential [3][6]. - NeurAxis has secured a Veterans Affairs Federal Supply Schedule contract, facilitating access to the Veterans Affairs health system, which serves nearly 7 million patients annually [5]. - The company received FDA clearance for treating abdominal pain in functional dyspepsia for patients aged 8 and older, expanding the addressable market for IB-Stim [5]. Management Commentary - The CEO emphasized the importance of expanding medical policy coverage to increase patient access and reduce provider friction, alongside efforts to streamline reimbursement processes [4][6]. - The focus for early 2026 is on executing the commercial strategy and leveraging insights from real-world utilization to drive adoption [5][6]. Expense Overview - Selling, general, and administrative expenses for Q4 2025 were $2.5 million, a 20% increase from $2.1 million in Q4 2024, attributed to higher commissions and stock compensation costs [9]. - For FY2025, these expenses totaled $10.8 million, a 14% increase from $9.5 million in FY2024, influenced by a one-time legal settlement and increased marketing costs [10]. Loss Metrics - The operating loss for Q4 2025 was $1.7 million, up 17% from $1.5 million in Q4 2024, while the FY2025 operating loss was $7.8 million, a 9% increase from $7.2 million in FY2024 [11][12]. - The net loss for Q4 2025 was $1.7 million, an 18% increase from $1.4 million in Q4 2024, and the net loss for FY2025 was $7.8 million, a decrease of 5% from $8.2 million in FY2024 [11][12]. Cash Position - As of December 31, 2025, the company had a cash balance of $5.0 million, with short-term and long-term debt of $148 thousand and $10 thousand, respectively [13]. - Cash used in operations for FY2025 was $6.4 million, reflecting a $335 thousand increase from FY2024, primarily due to higher inventory purchases and incentive program payments [13].

Core Viewpoint - NeurAxis, Inc. is set to report its financial results for the fourth quarter and fiscal year 2025 on March 19, 2026, before market open, with a conference call scheduled for the same day to discuss the results [1]. Company Overview - NeurAxis, Inc. is a medical technology company focused on neuromodulation therapies aimed at addressing chronic and debilitating conditions in both children and adults [4]. - The company is advancing its proprietary technology, IB-Stim®, which is a Percutaneous Electrical Nerve Field Stimulation (PENFS) device, FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS), functional dyspepsia (FD), and related nausea symptoms in patients aged 8 and older [4]. - NeurAxis is conducting additional clinical trials of PENFS for various pediatric and adult conditions that have significant unmet healthcare needs [4]. Conference Call Details - The conference call will take place on March 19, 2026, at 9:00 am ET, and will be accessible via a live webcast [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]. Additional Information - A replay of the conference call will be available on the company's Investor Relations website [3]. - For further inquiries, investors can contact Lytham Partners [6].

Core Insights - NeurAxis, Inc. has achieved a significant milestone with the implementation of a Category I CPT code for its Percutaneous Electrical Nerve Field Stimulation (PENFS) therapy, which is expected to enhance commercial clarity and patient access to care [1][2][3] Group 1: CPT Code Significance - The assignment of the Category I CPT code is a breakthrough for the widespread adoption of NeurAxis' IB-Stim® therapy, establishing a recognized coding and billing pathway [2][8] - This coding reflects broad clinical acceptance and meets the American Medical Association's criteria for clinical efficacy and standards of care [2] Group 2: Business Impact - The implementation of the CPT code is anticipated to strengthen NeurAxis' business foundation by improving payer alignment and scalability across health systems [3] - The company believes that this will accelerate patient access to care, support coverage expansion, and drive long-term revenue growth [3] Group 3: Company Overview - NeurAxis focuses on neuromodulation therapies for chronic conditions in both children and adults, with its IB-Stim® technology FDA cleared for specific gastrointestinal issues in patients aged 8 and older [5] - The company is conducting additional clinical trials for PENFS in various pediatric and adult conditions with significant unmet healthcare needs [5]

Core Insights - NeurAxis, Inc. has announced significant new medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim, from a major national health insurer, expanding its coverage to approximately 100 million lives across multiple states [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 proprietary technology, IB-Stim, is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) and functional dyspepsia (FD) in patients aged 8 years and older [2][4] Product Details - IB-Stim is a non-invasive device that stimulates cranial nerve bundles in the ear to regulate pain signaling between the gut and the brain, addressing a significant unmet medical need in pediatric patients [2] - Currently, there are no FDA-approved drug therapies for pediatric patients with abdominal pain related to functional dyspepsia, making IB-Stim a unique solution in this market [2] Market Position and Future Outlook - The CEO of NeurAxis expressed optimism about securing additional coverage from large national insurers, highlighting the growing recognition of IB-Stim as an evidence-based therapy for pediatric gastrointestinal disorders [3] - With a Category I CPT code effective January 1, 2026, and incorporation into leading national society clinical practice guidelines, NeurAxis is positioned for significant revenue growth and margin expansion [3]

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]