NeurAxis Inc. Issues Letter to Shareholders
NeurAxis has issued a letter to shareholders, highlighting significant achievements in 2024 and plans for 2025. The company focuses on commercializing IB-Stim for pediatric IBS and advancing the RED device for chronic constipation. In 2024, IB-Stim, supported by PENFS technology, treated about 1,000 patients and expanded insurance coverage from 4 million to 51 million lives, significantly boosting revenues. The FDA recently expanded IB-Stim's indication to ages 8-21, increasing its market by 75%. A new CPT Category I code for PENFS will take effect in 2026, enhancing patient access. Additionally, the FDA cleared the RED device for US commercialization, with initial revenues expected in Q1 2025. NeurAxis aims to achieve cash flow breakeven by 2026, supported by strong sales growth, disciplined cost management, and recent investments from healthcare funds.
NeurAxis ha inviato una lettera agli azionisti, evidenziando i risultati significativi ottenuti nel 2024 e i piani per il 2025. L'azienda si concentra sulla commercializzazione di IB-Stim per l'IBS pediatrico e sullo sviluppo del dispositivo RED per la stitichezza cronica. Nel 2024, IB-Stim, supportato dalla tecnologia PENFS, ha trattato circa 1.000 pazienti e ampliato la copertura assicurativa da 4 milioni a 51 milioni di vite, aumentando significativamente i ricavi. La FDA ha recentemente ampliato l'indicazione di IB-Stim per le età 8-21, incrementando il suo mercato del 75%. Un nuovo codice CPT Categoria I per PENFS entrerà in vigore nel 2026, migliorando l'accesso dei pazienti. Inoltre, la FDA ha autorizzato il dispositivo RED per la commercializzazione negli Stati Uniti, con ricavi iniziali attesi nel primo trimestre del 2025. NeurAxis punta a raggiungere il pareggio di flusso di cassa entro il 2026, supportato da una forte crescita delle vendite, dalla gestione disciplinata dei costi e da recenti investimenti da fondi sanitari.
NeurAxis ha emitido una carta a los accionistas, destacando los logros significativos en 2024 y los planes para 2025. La empresa se centra en la comercialización de IB-Stim para el SII pediátrico y en el avance del dispositivo RED para el estreñimiento crónico. En 2024, IB-Stim, respaldado por la tecnología PENFS, trató a aproximadamente 1,000 pacientes y amplió la cobertura de seguros de 4 millones a 51 millones de vidas, aumentando significativamente los ingresos. La FDA amplió recientemente la indicación de IB-Stim para las edades de 8 a 21 años, incrementando su mercado en un 75%. Un nuevo código CPT de categoría I para PENFS entrará en vigencia en 2026, mejorando el acceso a los pacientes. Además, la FDA aprobó el dispositivo RED para su comercialización en EE. UU., con ingresos iniciales esperados en el primer trimestre de 2025. NeurAxis tiene como objetivo lograr el equilibrio de flujo de efectivo para 2026, respaldado por un fuerte crecimiento en las ventas, una gestión de costos disciplinada y recientes inversiones de fondos de salud.
NeurAxis는 주주들에게 2024년의 주요 성과와 2025년 계획을 강조한 서한을 발송했습니다. 이 회사는 소아 IBS를 위한 IB-Stim의 상용화와 만성 변비를 위한 RED 장치의 발전에 중점을 두고 있습니다. 2024년, PENFS 기술의 지원을 받은 IB-Stim은 약 1,000명의 환자를 치료하고 보험 커버리지를 400만에서 5,100만으로 확대하여 수익을 크게 증가시켰습니다. FDA는 최근 IB-Stim의 적응증을 8세에서 21세로 확대하여 시장을 75% 증가시켰습니다. PENFS에 대한 새로운 CPT 1 등급 코드는 2026년부터 시행되어 환자의 접근성을 개선할 것입니다. 또한, FDA는 RED 장치를 미국에서 상용화하도록 승인했으며, 2025년 1분기부터 초기 수익이 예상됩니다. NeurAxis는 2026년까지 현금 흐름의 이익 균형을 달성하는 것을 목표로 하며, 이는 강력한 판매 성장, 절제된 비용 관리 및 최근 의료 자금으로부터의 투자에 의해 지원됩니다.
NeurAxis a envoyé une lettre aux actionnaires, mettant en avant des réalisations significatives en 2024 et des projets pour 2025. L'entreprise se concentre sur la commercialisation d'IB-Stim pour le syndrome du côlon irritable pédiatrique et sur l'avancement du dispositif RED pour la constipation chronique. En 2024, IB-Stim, soutenu par la technologie PENFS, a traité environ 1 000 patients et élargi la couverture d'assurance de 4 millions à 51 millions de vies, augmentant ainsi considérablement les revenus. La FDA a récemment élargi l'indication d'IB-Stim aux âges de 8 à 21 ans, augmentant ainsi son marché de 75 %. Un nouveau code CPT de catégorie I pour PENFS entrera en vigueur en 2026, améliorant l'accès des patients. De plus, la FDA a autorisé le dispositif RED pour la commercialisation aux États-Unis, avec des revenus initiaux attendus au premier trimestre 2025. NeurAxis vise à atteindre l'équilibre de flux de trésorerie d'ici 2026, soutenu par une forte croissance des ventes, une gestion rigoureuse des coûts et des investissements récents de fonds de santé.
NeurAxis hat einen Brief an die Aktionäre veröffentlicht, in dem bedeutende Erfolge im Jahr 2024 und Pläne für 2025 hervorgehoben werden. Das Unternehmen konzentriert sich auf die Vermarktung von IB-Stim für pädiatrisches Reizdarmsyndrom (IBS) und die Weiterentwicklung des RED-Geräts zur Behandlung von chronischer Verstopfung. Im Jahr 2024 behandelte IB-Stim, unterstützt durch die PENFS-Technologie, etwa 1.000 Patienten und erweiterte die Versicherungsabdeckung von 4 Millionen auf 51 Millionen Leben, was die Einnahmen erheblich steigerte. Die FDA erweiterte kürzlich die Indikation für IB-Stim auf Personen im Alter von 8 bis 21 Jahren und erhöhte damit den Markt um 75%. Ein neuer CPT Kategorie I-Code für PENFS wird 2026 in Kraft treten und den Zugang für Patienten verbessern. Darüber hinaus hat die FDA das RED-Gerät für die Vermarktung in den USA freigegeben, wobei erste Einnahmen im ersten Quartal 2025 erwartet werden. NeurAxis strebt an, bis 2026 einen ausgeglichenen Cashflow zu erreichen, unterstützt durch starkes Umsatzwachstum, diszipliniertes Kostenmanagement und kürzliche Investitionen von Gesundheitsfonds.
- IB-Stim treated approximately 1,000 patients in 2024.
- Insurance coverage expanded from 4 million to 51 million lives.
- FDA expanded IB-Stim's indication to ages 8-21, increasing the market by 75%.
- New CPT Category I code for PENFS procedures takes effect in 2026.
- FDA cleared RED device for US commercialization; initial revenues expected in Q1 2025.
- Strong sales growth and disciplined cost management.
- None.
Insights
NeurAxis's 2024 performance and 2025 outlook present compelling market opportunities. The FDA clearance expansion for IB-Stim to include ages 8-21 (previously 11-18) represents a 75% increase in the addressable market. The insurance coverage expansion from 4 million to 51 million lives in just one year demonstrates exceptional market penetration and revenue potential.
The newly secured Category I CPT code effective January 2026 is particularly significant for reimbursement stability. This, combined with the NASPGHAN's systematic review indicating highest GRADE certainty, positions IB-Stim favorably for widespread insurance adoption. The RED device's 510(k) clearance with existing Category I CPT code coverage suggests immediate revenue potential in Q1 2025.
The projection for cash flow breakeven in 2026, supported by approximately 1,000 IB-Stim prescriptions in 2024 and expanded insurance coverage, indicates a solid path to profitability.
The pediatric IBS market dynamics present a unique opportunity for NeurAxis. With IB-Stim being the first FDA-indicated treatment specifically for this condition, the company holds a significant first-mover advantage. The expansion to 16 peer-reviewed studies from leading U.S. children's hospitals strengthens the company's scientific credibility and market position.
The systematic review by NASPGHAN's subcommittee, showing IB-Stim's superior efficacy, could catalyze rapid insurance adoption. This validation from a respected medical society typically accelerates payor coverage decisions, potentially leading to substantial revenue growth in 2025. The dual revenue streams from IB-Stim and RED, combined with planned FDA submissions for adult IBS and pediatric functional dyspepsia, suggest multiple growth vectors.
CARMEL, Ind., Jan. 13, 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 CEO Brian Carrico has published a letter to shareholders highlighting the Company’s achievements in 2024 and vision for 2025.
Dear shareholders,
We are thrilled to connect with you as we celebrate NeurAxis’s remarkable achievements in 2024 and anticipate the exciting opportunities ahead. This is a pivotal time for our company as we strive to establish ourselves as an innovative leader in the gastroenterology space. Our immediate focus is on driving the growth of IB-Stim for pediatric irritable bowel syndrome (IBS) and advancing the commercialization of RED, a screening tool, for patients with chronic constipation.
Looking forward, our pipeline remains robust, with plans to submit to FDA for expanded indications in 2025, such as adult IBS and pediatric functional dyspepsia. As we prepare for 2025, our priorities are clear: to sustain exceptional revenue growth, carefully manage costs, and strengthen our balance sheet, thus delivering outstanding value to our shareholders. Thanks to our strong revenue trajectory and successful recent funding rounds with respected healthcare investors, we are well-positioned to achieve our objectives in the near-term.
2024 marked a groundbreaking year for IB-Stim, the first FDA-indicated treatment specifically designed for Pediatric IBS. Powered by our innovative and patented PENFS technology, IB-Stim was prescribed for approximately 1,000 IBS patients this year. We are deeply honored to have made a meaningful difference in the lives of so many children and young adults, offering hope where few alternatives exist and helping them return to normal activity.
In 2024, we successfully achieved our growth objectives for IB-Stim, building on the foundation that robust, peer-reviewed data, drives insurance expansion, fostering sustainable revenue and margin growth. Our PENFS technology is now supported by 16 peer-reviewed studies conducted in leading U.S. children’s hospitals. These publications have significantly expanded insurance coverage to approximately 51 million lives, a substantial increase from 4 million just a year ago. This broader coverage contributed to the strong revenue growth in the second half of 2024.
We are pleased with our recent operating results and even more excited about the opportunity to accelerate revenue growth in the coming quarters.
In November, we received FDA 510(k) clearance for an expanded indication of IB-Stim that now includes patients aged 8 to 21 years, compared to the previous range of 11 to 18 years. Additionally, the updated clearance allows for one additional device, extending the treatment to four weeks. The age expansion milestone is significant, as it increases IB-Stim's addressable market by over
In October, we announced that the American Medical Association had approved a new Current Procedural Terminology (CPT) Category I code for PENFS procedures, which will take effect on January 1, 2026. Securing a Category I code for this innovative technology marks a significant milestone in our efforts to expand patient access to IB-Stim and future PENFS technology applications.
The comprehensive, peer-reviewed published data has been instrumental in securing the new indication expansion and the CPT category I code. This reflects the scientific community's recognition of our flagship technology, which has faced barriers related to insurance policy coverage. Major commercial payers have traditionally depended on academic society guidelines to make coverage decisions, and pediatric IBS is no exception.
Independent guidelines from academic societies are the most significant validation a new technology can achieve, as they represent an impartial review of the literature and provide an assigned grade that payers use to make decisions. In October, we announced that a systematic review of the pediatric IBS literature was presented at a national meeting by a subcommittee of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN). This data suggested that our technology has the highest GRADE certainty and the largest magnitude effect for pediatric IBS, and this will be part of the clinical practice guidelines that we expect to be published in the coming months.
Based on discussions with leading insurance providers, this publication will serve as a pivotal driver for medical policy coverage, and we anticipate it will significantly accelerate insurance adoption nationwide.
In December 2024, we obtained 510(k) clearance from the FDA for our Rectal Expulsion Device (RED). This will allow us to commercialize the device in the US as a screening tool for patients with chronic constipation and pelvic floor dysfunction. The procedure benefits from a Category I CPT code and the procedure has positive policy coverage by Medicare and most commercial insurance providers, which makes us confident that we will see initial revenues as early as the first quarter of 2025.
NeurAxis's robust sales growth and disciplined cost management have set the stage for achieving cash flow breakeven in 2026. Notably, recent investments from life science-focused funds have bolstered our balance sheet, providing the financial strength to accomplish our objectives in the near-term.
Finally, we would like to extend our heartfelt gratitude to our shareholders for their unwavering support of our vision. We also sincerely thank our dedicated partners, employees, and directors for their invaluable contributions to our continued success.
Brian Carrico
President and Chief Executive Officer
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 11-18 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 http://neuraxis.com.
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:
Company
NeurAxis, Inc.
info@neuraxis.com
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com
FAQ
What are NeurAxis's plans for IB-Stim in 2025?
What does the FDA clearance mean for the RED device?
How has insurance coverage for IB-Stim changed?
What is the significance of the new CPT Category I code for PENFS?
How has NeurAxis's FDA approval impacted the addressable market for IB-Stim?
When does NeurAxis expect to achieve cash flow breakeven?
