NeurAxis Announces New CPT® Category I Code for Percutaneous Electrical Nerve Field Stimulation
NeurAxis, Inc. (NYSE American: NRXS) has announced that the American Medical Association (AMA) has established a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures, effective January 1, 2026. This development is significant for NeurAxis' PENFS technology, IB-Stim, which is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 11-18 years.
IB-Stim is a non-surgical device that sends gentle electrical impulses into cranial nerve bundles in the ear. This advancement is particularly important as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction. The new Category I code recognizes the strong clinical evidence and utilization of PENFS procedures, led by IB-Stim, and is expected to drive patient awareness and access to this FDA-cleared treatment option for IBS.
NeurAxis, Inc. (NYSE American: NRXS) ha annunciato che l'American Medical Association (AMA) ha stabilito un nuovo codice CPT di Categoria I per le procedure di Stimolazione Elettrica Percutanea del Campo Nervoso (PENFS), a partire dal 1 gennaio 2026. Questo sviluppo è significativo per la tecnologia PENFS di NeurAxis, IB-Stim, che ha ricevuto l'approvazione della FDA per il dolore addominale funzionale associato alla sindrome dell'intestino irritabile (IBS) negli adolescenti di età compresa tra 11 e 18 anni.
IB-Stim è un dispositivo non chirurgico che invia dolci impulsi elettrici ai fasci nervosi cranici nell'orecchio. Questo progresso è particolarmente importante poiché attualmente non esistono terapie farmacologiche approvate dalla FDA per i bambini con disturbi addominali legati all'interazione intestino-cervello. Il nuovo codice di Categoria I riconosce le solide evidenze cliniche e l'utilizzo delle procedure PENFS, guidate da IB-Stim, e si prevede che aumenterà la consapevolezza e l'accesso dei pazienti a questa opzione terapeutica approvata dalla FDA per l'IBS.
NeurAxis, Inc. (NYSE American: NRXS) ha anunciado que la American Medical Association (AMA) ha establecido un nuevo código CPT de Categoría I para los procedimientos de Estimulación Eléctrica Per-cutánea de Campo Nervioso (PENFS), que entrará en vigor el 1 de enero de 2026. Este desarrollo es significativo para la tecnología PENFS de NeurAxis, IB-Stim, que ha sido aprobada por la FDA para el dolor abdominal funcional asociado con el síndrome del intestino irritable (IBS) en adolescentes de 11 a 18 años.
IB-Stim es un dispositivo no quirúrgico que envía suaves impulsos eléctricos a los haces nerviosos craneales en la oreja. Este avance es especialmente importante ya que actualmente no existen terapias farmacológicas aprobadas por la FDA para niños con trastornos relacionados con el dolor abdominal en la interacción intestino-cerebro. El nuevo código de Categoría I reconoce la sólida evidencia clínica y la utilización de los procedimientos PENFS, liderados por IB-Stim, y se espera que aumente la conciencia y el acceso de los pacientes a esta opción de tratamiento aprobada por la FDA para el IBS.
NeurAxis, Inc. (NYSE American: NRXS)는 미국 의사 협회(American Medical Association, AMA)가 현재 수술 절차 용어(CPT) 1범주 코드를 경피적 전기 신경 필드 자극(PENFS) 절차에 대해 2026년 1월 1일부터 시행한다고 발표했습니다. 이 개발은 NeurAxis의 PENFS 기술인 IB-Stim에게 중요한 의미가 있으며, 이는 11세에서 18세 사이의 청소년을 위한 과민성 장 증후군(IBS)과 관련된 기능성 복통에 대해 FDA 승인을 받은 장치입니다.
IB-Stim은 귀의 두개 신경 다발에 부드러운 전기 자극을 보내는 비수술적인 장치입니다. 이 발전은 현재 복통 관련 장-뇌 상호작용 장애를 앓고 있는 어린이를 위한 FDA 승인 약물 치료가 없기 때문에 특히 중요합니다. 새로운 1범주 코드는 IB-Stim에 의해 주도된 PENFS 절차의 강력한 임상 증거와 활용도를 인정하며, IBS에 대한 이 FDA 승인 치료 옵션에 대한 환자 인식과 접근을 촉진할 것으로 기대됩니다.
NeurAxis, Inc. (NYSE American: NRXS) a annoncé que l'American Medical Association (AMA) a établi un nouveau code de catégorie I de la Classification des Procédures Courantes (CPT) pour les procédures de Stimulation Électrique Percutanée des Champs Nerveux (PENFS), qui sera en vigueur à partir du 1er janvier 2026. Ce développement est significatif pour la technologie PENFS de NeurAxis, IB-Stim, qui a reçu l'approbation de la FDA pour les douleurs abdominales fonctionnelles associées au syndrome de l'intestin irritable (IBS) chez les adolescents de 11 à 18 ans.
IB-Stim est un dispositif non chirurgical qui envoie de douces impulsions électriques dans les faisceaux nerveux crâniens de l'oreille. Cette avancée est particulièrement importante car il n'existe actuellement aucune thérapie médicamenteuse approuvée par la FDA pour les enfants souffrant de douleurs abdominales liées aux troubles de l'interaction intestin-cerveau. Le nouveau code de catégorie I reconnaît les solides preuves cliniques et l'utilisation des procédures PENFS, menées par IB-Stim, et devrait accroître la sensibilisation et l'accès des patients à cette option de traitement approuvée par la FDA pour l'IBS.
NeurAxis, Inc. (NYSE American: NRXS) hat bekannt gegeben, dass die American Medical Association (AMA) einen neuen Current Procedural Terminology (CPT) Kategorie-I-Code für perkutane elektrische Nervenfeldstimulation (PENFS) Verfahren, gültig ab dem 1. Januar 2026, eingeführt hat. Diese Entwicklung ist bedeutend für die PENFS-Technologie von NeurAxis, IB-Stim, die von der FDA für funktionale Bauchschmerzen, die mit dem Reizdarmsyndrom (IBS) bei Jugendlichen im Alter von 11-18 Jahren verbunden sind, zugelassen wurde.
IB-Stim ist ein nicht-chirurgisches Gerät, das sanfte elektrische Impulse in die Hirnnervenschnüre im Ohr sendet. Dieser Fortschritt ist besonders wichtig, da es derzeit keine von der FDA zugelassenen medikamentösen Therapien für Kinder mit bauchschmerzbezogenen Störungen der Hirn-Darm-Interaktion gibt. Der neue Kategorie-I-Code erkennt die starken klinischen Beweise und die Nutzung der PENFS-Verfahren, die von IB-Stim geleitet werden, an und wird voraussichtlich das Bewusstsein der Patienten und den Zugang zu dieser von der FDA genehmigten Behandlungsmöglichkeit für IBS fördern.
- New CPT Category I code established for PENFS procedures, effective January 1, 2026
- IB-Stim is FDA-cleared for functional abdominal pain associated with IBS in adolescents 11-18 years old
- Recognition of strong clinical evidence and utilization of PENFS procedures
- Potential increase in patient awareness and access to FDA-cleared IBS treatment
- None.
Insights
The establishment of a new CPT Category I code for PENFS procedures is a significant development for NeurAxis. This code, effective January 1, 2026, will likely enhance the reimbursement landscape for the company's IB-Stim device. Category I codes are typically associated with widely performed procedures and often lead to better insurance coverage and reimbursement rates compared to temporary Category III codes.
This development could potentially increase adoption of IB-Stim among healthcare providers, as it simplifies billing processes and may improve financial feasibility for both clinics and patients. The recognition by the AMA also lends credibility to the PENFS technology, which could drive increased acceptance in the medical community.
However, investors should note that the implementation date is over a year away, which means immediate financial impact may be The long-term prospects look promising, especially considering the lack of FDA-approved drug therapies for children with IBS-related abdominal pain. This positions NeurAxis favorably in a niche market with significant unmet needs.
The introduction of a Category I CPT code for PENFS is a game-changer in pediatric gastroenterology. IB-Stim offers a non-pharmacological approach to treating functional abdominal pain in adolescents with IBS, addressing a critical gap in current treatment options. The lack of FDA-approved drug therapies for this population has been a long-standing challenge, often leading to off-label use of medications with potential side effects.
NeurAxis's IB-Stim, being non-surgical and utilizing gentle electrical stimulation, presents a safer alternative with potentially fewer side effects compared to pharmacological interventions. This could significantly impact treatment protocols for adolescent IBS patients, potentially becoming a first-line therapy option.
The new CPT code may accelerate adoption among pediatric gastroenterologists, as it reduces administrative barriers and potentially improves access for patients. This could lead to increased usage of IB-Stim, benefiting both patients and NeurAxis's market position in the pediatric GI space.
CARMEL, Ind., Oct. 22, 2024 (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, announced that the American Medical Association (AMA) has established a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures effective January 1, 2026.
NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 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. Pharmacologic treatments which use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy.
“This is a wonderful day for children and adolescents suffering from IBS. The availability of a Category I code recognizes the strong clinical evidence and utilization of PENFS procedures, led by IB-Stim. Obtaining a Category I code for this important technology is a key milestone for our initiatives to drive patient awareness of FDA cleared options for IBS and access for PENFS treatment,” said Brian Carrico, President and Chief Executive Officer of NeurAxis.
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.
This page discusses ongoing activities concerning percutaneous electrical nerve field stimulator (PENFS) technology. For details on instructions for use, precautions, warnings and important information, see https://ibstim.com/important-information/.
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
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