NeurAxis Awarded First Ever FDA Clearance for the Treatment of Pain in Functional Dyspepsia (FD) with associated Nausea Symptoms in the Adult Patient Population
NeurAxis (NYSE:NRXS) received FDA 510(k) clearance for its percutaneous electrical nerve field stimulation (PENFS) device to treat functional abdominal pain associated with functional dyspepsia (FD) and FD-related nausea in patients aged 8 years and older on October 24, 2025. The FDA reviewed randomized trials and real-world evidence, extrapolating pediatric data to adults. This is described as the first FDA clearance for a treatment addressing adult functional dyspepsia. NeurAxis noted the new indication will use the Category I CPT code effective January 1, 2026 to report PENFS procedures.
NeurAxis (NYSE:NRXS) ha ricevuto l'autorizzazione FDA 510(k) per il suo dispositivo di stimolazione elettrica perim esplorale del campo nervoso (PENFS) per trattare il dolore funzionale addominale associato alla dispepsia funzionale (DF) e la nausea correlata alla DF in pazienti di età 8 anni e oltre il 24 ottobre 2025. La FDA ha esaminato studi randomizzati e evidenze del mondo reale, extrapolando dati pediatrici agli adulti. Questo è descritto come la prima autorizzazione FDA per un trattamento che affronta la dispepsia funzionale negli adulti. NeurAxis ha annotato che la nuova indicazione utilizzerà il codice CPT di Categoria I valido dal 1 gennaio 2026 per segnalare le procedure PENFS.
NeurAxis (NYSE:NRXS) recibió la autorización 510(k) de la FDA para su dispositivo de estimulación eléctrica percutánea del campo nervioso (PENFS) para tratar el dolor abdominal funcional asociado con la dispepsia funcional (DF) y las náuseas relacionadas con la DF en pacientes de 8 años o más el 24 de octubre de 2025. La FDA revisó ensayos aleatorios y evidencia del mundo real, extrapolando datos pediátricos a adultos. Esto se describe como la primera autorización de la FDA para un tratamiento que aborda la dispepsia funcional en adultos. NeurAxis indicó que la nueva indicación utilizará el código CPT de Categoría I válido a partir del 1 de enero de 2026 para reportar los procedimientos PENFS.
NeurAxis (NYSE:NRXS)는 2025년 10월 24일 8세 이상 환자의 기능성 복통과 기능성 소화불량(FD)과 관련된 구역질 치료를 위한 피부 경유 전기 신경장 자극(PENFS) 기기에 대해 FDA 510(k) 승인을 받았습니다. FDA는 무작위 대조 시험과 실제 임상 증거를 검토하고 소아 데이터를 성인으로 외삽했습니다. 이는 성인 기능성 소화불량 치료를 다루는 최초의 FDA 승인으로 설명됩니다. NeurAxis는 새로운 적응증이 PENFS 시술을 보고하기 위해 2026년 1월 1일부터 적용되는 카테고리 I CPT 코드를 사용할 예정이라고 밝혔습니다.
NeurAxis (NYSE:NRXS) a reçu l'autorisation 510(k) de la FDA pour son dispositif de stimulation électrique pérenvercutanée du champ nerveux (PENFS) afin de traiter la douleur abdominale fonctionnelle associée à une dyspepsie fonctionnelle (DF) et les nausées liées à la DF chez les patients âgés de 8 ans et plus le 24 octobre 2025. La FDA a examiné des essais randomisés et des données réelles, extrapolant les données pédiatriques vers les adultes. Cela est décrit comme la première autorisation de la FDA pour un traitement qui s’attaque à la dyspepsie fonctionnelle chez l’adulte. NeurAxis a noté que la nouvelle indication utilisera le code CPT de Catégorie I en vigueur à partir du 1er janvier 2026 pour déclarer les procédures PENFS.
NeurAxis (NYSE:NRXS) erhielt am 24. Oktober 2025 von der FDA die 510(k)-Freigabe für sein perkutanes elektrisches Nervenfeldstimulationsgerät (PENFS) zur Behandlung von funktionellen Bauchschmerzen bei funktioneller Dyspepsie (FD) und damit verbundenen FD-bedingten Übelkeiten bei Patienten ab 8 Jahren. Die FDA prüfte randomisierte Studien und reale Evidenz und extrapolierte pädiatrische Daten auf Erwachsene. Dies wird als erste FDA-Freigabe für eine Behandlung beschrieben, die die funktionelle Dyspepsie bei Erwachsenen adressiert. NeurAxis vermerkte, dass die neue Indikation ab dem 1. Januar 2026 den Kategorien-I-CPT-Code zur Abrechnung von PENFS-Verfahren verwenden wird.
NeurAxis (NYSE:NRXS) حصلت على موافقة FDA 510(k) لجهاز التحفيز الكهربائي الموضعي لميدان العصب العصبي عبر الجلد (PENFS) لعلاج الألم البطني الوظيفي المصاحب للاضطراب الهضمي الوظيفي (FD) والغثيان المرتبط بـ FD لدى مرضى 8 سنوات فأكثر في 24 أكتوبر 2025. راجعت FDA تجارب عشوائية وأدلة من العالم الحقيقي، واستنتجت من بيانات الأطفال لتطبيقها على البالغين. يوصف ذلك بأنه أول موافقة FDA لعلاج يعالج dyspepsia الوظيفية لدى البالغين. وأشارت NeurAxis إلى أن المؤشر الجديد سيستخدم رمز CPT من الفئة I ساري المفعول اعتباراً من 1 يناير 2026 للإبلاغ عن إجراءات PENFS.
NeurAxis (NYSE:NRXS) 于 2025年10月24日 获得 FDA 的 510(k) 批准，用于治疗与功能性消化不良（FD）相关的功能性腹痛及 FD 相关恶心，适用于< b>8 岁及以上 的患者的经皮电刺激神经场（PENFS）设备。FDA 审查了随机试验和真实世界证据，并将儿科数据外推至成人。这被描述为 FDA 首次批准针对成人功能性消化不良的治疗。NeurAxis 指出，新适应症将使用自2026年1月1日起生效的< b>类别 I CPT 代码来报告 PENFS 程序。
- FDA 510(k) clearance for PENFS in FD with nausea
- Indication expanded to patients aged 8 years and older
- FDA extrapolated pediatric randomized trial data to adults
- First FDA clearance addressing adult functional dyspepsia
- Category I CPT code applicable starting January 1, 2026
- Positions NeurAxis to broaden commercial GI market access
- None.
Insights
FDA 510(k) clearance expands PENFS use to ages 8+ and is the first adult FD treatment cleared.
NeurAxis obtained FDA 510(k) clearance for its PENFS device to treat functional dyspepsia (FD) pain and associated nausea in patients aged
The medical effect is straightforward: a non‑surgical, percutaneous neuromodulation option now has regulatory clearance for a defined symptom set in adults and children. Key dependencies for clinical adoption include published adult efficacy data, payer coverage policies that recognize the cleared indication, and clinician education on appropriate patient selection and procedural technique.
Watch for peer‑reviewed adult outcome data, real‑world safety monitoring, and any FDA post‑market requirements over the next 6–18 months; the new procedural
Clearance plus a Category I CPT code creates a clear commercial pathway for expanded revenue in GI care.
NeurAxis gains a commercially meaningful expansion: the adult FD indication plus the same device/technology status under the upcoming Category I CPT code effective
Risks to near‑term revenue growth include the timing of payer coverage decisions, provider training rates, and the need to demonstrate reproducible adult outcomes in usual clinical settings. Concrete items to monitor: major payer policy announcements, published adult effectiveness data, and early adoption metrics over the first
- Achieves significant expansion of NeurAxis’ total addressable market
- Clearance now includes patients aged “8 years and older”
- Expanded age indication will utilize the upcoming January 1st, 2026, Category I CPT code to report PENFS procedures
CARMEL, Ind., Oct. 24, 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 received FDA 510(k) clearance for its proprietary percutaneous electrical nerve field stimulation (PENFS) technology for the treatment of functional abdominal pain (FAP) associated with functional dyspepsia (FD), and FD related nausea symptoms, in patients aged 8 years and older. The FDA reviewed the clinical literature supporting the use of NeurAxis’ PENFS technology, including randomized controlled trials and real-world evidence demonstrating the device’s safety and effectiveness in pediatric patients and individuals up to 21 years of age. Based on this comprehensive review, the FDA extrapolated the data to adults, supporting the use of PENFS in patients aged 8 years and older. This expanded indication marks a historic milestone, the first FDA clearance or approval for a treatment specifically addressing functional dyspepsia in adults.
“This latest FDA clearance represents a pivotal milestone for NeurAxis as it is the first ever FDA approved or cleared treatment in the adult market for functional dyspepsia which also includes related nausea symptoms,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “By reaching this goal, it will not only broaden our clinical impact but also positions us to drive substantial revenue growth throughout the GI space in all patients 8 years of age and older. Our upcoming January 1st, 2026, Category I CPT Code for PENFS procedures will also apply to this new adult indication, as it is the same device and same technology. This important approval positions NeurAxis as the leader in minimally invasive neuromodulation therapies.”
“Functional dyspepsia can include severe abdominal pain and nausea. In both adolescents and adults, the condition can significantly impact quality of life, leading to food avoidance, unintentional weight loss, and restrictive eating behaviors,” said Dr. Adrian Miranda, Chief Medical Officer of NeurAxis. “We are thrilled by the agency’s decision, which gives us the opportunity to offer the benefit of treatment to thousands of adult patients who have had limited options—until now.”
NeurAxis’ PENFS technology 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 (DGBIs) and no approved drug therapies for adults for pain with functional dyspepsia. Pharmacologic treatments that use drugs off-label can often have serious side effects, and most lack scientific evidence of efficacy.
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 PENFS technology by the medical, scientific, and patient communities. 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, 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.
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Contacts:
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FAQ
What did NeurAxis (NRXS) announce on October 24, 2025 about FDA clearance?
How does the October 24, 2025 FDA clearance affect NeurAxis (NRXS) market access?
Will NeurAxis (NRXS) use a CPT code to report PENFS procedures and when?
Why did the FDA approve PENFS for adults despite pediatric data in the filings for NRXS?
Does the October 24, 2025 clearance make PENFS the first FDA-cleared adult FD treatment for NRXS (NRXS)?
