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NeurAxis Announces Capital Blue Cross Medical Policy Coverage for PENFS, effective October 1st 2024

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NeurAxis (NYSE: NRXS) announced medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS) by Capital Blue Cross, effective October 1, 2024. The coverage applies to Capital Blue Cross Medical Members in a 21-county region in Central Pennsylvania and the Lehigh Valley. IB-Stim, NeurAxis' PENFS technology, is FDA-cleared for treating functional abdominal pain associated with IBS in adolescents aged 11-18. The non-surgical device delivers gentle electrical impulses to cranial nerve bundles in the ear. The company also highlighted the upcoming implementation of a new CPT Category I code for their technology, effective January 1, 2026.

NeurAxis (NYSE: NRXS) ha annunciato la copertura della polizza medica per la Stimolazione Elettrica Percutanea del Campo Nervoso (PENFS) da parte di Capital Blue Cross, a partire dal 1 ottobre 2024. La copertura si applica ai membri medici di Capital Blue Cross in una regione di 21 contee nella Pennsylvania centrale e nella Valle del Lehigh. IB-Stim, la tecnologia PENFS di NeurAxis, è autorizzata dalla FDA per il trattamento del dolore addominale funzionale associato alla sindrome dell'intestino irritabile (IBS) negli adolescenti di età compresa tra 11 e 18 anni. Questo dispositivo non chirurgico fornisce dolci impulsi elettrici ai fasci nervosi cranici nell'orecchio. L'azienda ha anche evidenziato l'imminente implementazione di un nuovo codice CPT Categoria I per la loro tecnologia, che entrerà in vigore il 1 gennaio 2026.

NeurAxis (NYSE: NRXS) anunció la cobertura de la política médica para la Estimulación Eléctrica Percutánea del Campo Nervioso (PENFS) por parte de Capital Blue Cross, a partir del 1 de octubre de 2024. La cobertura se aplica a los miembros médicos de Capital Blue Cross en una región de 21 condados en el centro de Pennsylvania y el Valle de Lehigh. IB-Stim, la tecnología PENFS de NeurAxis, está autorizada por la FDA para tratar el dolor abdominal funcional asociado con el síndrome del intestino irritable (IBS) en adolescentes de 11 a 18 años. Este dispositivo no quirúrgico entrega suaves impulsos eléctricos a los haces nerviosos craneales en el oído. La compañía también destacó la próxima implementación de un nuevo código CPT de Categoría I para su tecnología, que será efectivo a partir del 1 de enero de 2026.

NeurAxis (NYSE: NRXS)는 2024년 10월 1일부터 Capital Blue Cross에 의해 경피적 전기 신경장 자극(PENFS)에 대한 의료 정책 적용을 발표했습니다. 이 보장은 중앙 펜실베니아와 리하이 밸리의 21개 카운티 지역 내 Capital Blue Cross의 의료 회원에게 적용됩니다. IB-Stim은 NeurAxis의 PENFS 기술로, 11-18세 청소년의 과민성 대장 증후군(IBS)과 관련된 기능성 복통 치료를 위해 FDA의 승인을 받았습니다. 이 비수술 장치는 귀에 있는 두개 신경 다발에 부드러운 전기 자극을 전달합니다. 회사는 또한 2026년 1월 1일부터 그들의 기술을 위한 새로운 CPT 1급 코드의 시행이 예정되어 있다고 강조했습니다.

NeurAxis (NYSE: NRXS) a annoncé la couverture de la politique médicale pour la Stimulation Électrique Nerveuse Percutanée (PENFS) par Capital Blue Cross, effective à partir du 1er octobre 2024. La couverture s'applique aux membres médicaux de Capital Blue Cross dans une région de 21 comtés en Pennsylvanie centrale et dans la vallée de Lehigh. IB-Stim, la technologie PENFS de NeurAxis, est homologuée par la FDA pour traiter la douleur abdominale fonctionnelle associée au syndrome de l'intestin irritable (IBS) chez les adolescents âgés de 11 à 18 ans. Cet appareil non chirurgical délivre de douces impulsions électriques aux faisceaux nerveux crâniens dans l'oreille. L'entreprise a également souligné la prochaine mise en œuvre d'un nouveau code CPT de Catégorie I pour sa technologie, qui entrera en vigueur le 1er janvier 2026.

NeurAxis (NYSE: NRXS) gab die medizinische Policendeckung für die Perkutane Elektrische Nervenfeldstimulation (PENFS) durch Capital Blue Cross bekannt, die am 1. Oktober 2024 in Kraft tritt. Die Deckung gilt für medizinische Mitglieder von Capital Blue Cross in einer 21-Kreise umfassenden Region in Zentral-Pennsylvania und im Lehigh Valley. IB-Stim, die PENFS-Technologie von NeurAxis, ist von der FDA zur Behandlung von funktionellen Bauchschmerzen, die mit dem Reizdarmsyndrom (IBS) bei Jugendlichen im Alter von 11 bis 18 Jahren verbunden sind, zugelassen. Das nicht-chirurgische Gerät gibt sanfte elektrische Impulse an die Hirnnervengebünde im Ohr ab. Das Unternehmen hob auch die bevorstehende Einführung eines neuen CPT-Kategorie-I-Codes für seine Technologie hervor, der am 1. Januar 2026 in Kraft treten wird.

Positive
  • Secured medical policy coverage from Capital Blue Cross, expanding market access
  • Obtained new CPT Category I code effective January 1, 2026, potentially improving reimbursement
  • Offers only FDA-cleared non-drug treatment option for adolescent IBS pain
Negative
  • None.

Insights

The Capital Blue Cross coverage approval for PENFS technology marks a significant milestone for NeurAxis's market expansion. This development is particularly noteworthy given the 21-county coverage region in Central Pennsylvania and Lehigh Valley, representing a substantial new market opportunity. The timing aligns strategically with the upcoming CPT Category I code implementation in 2026, which typically leads to broader insurance coverage and improved reimbursement rates.

The pediatric IBS market represents an underserved segment with FDA-approved treatments. With IB-Stim being a non-surgical alternative for ages 11-18, this coverage decision could significantly impact NeurAxis's revenue potential. The lack of FDA-approved drug therapies for children with abdominal pain-related disorders positions IB-Stim favorably as a first-line treatment option, potentially driving adoption rates among healthcare providers and patients.

CARMEL, Ind., Oct. 29, 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, today announced medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), for Capital Blue Cross Medical Members, effective October 1, 2024. Capital Blue Cross serves a 21-county region in Central Pennsylvania and the Lehigh Valley.

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.

“We are excited regarding our coverage with Capital Blue Cross, further solidifying our patient reach in the Central Pennsylvania region,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “The strong body of published research has resulted in the increased acceptance of our PENFS technology, including expanding payer coverage, as well as the recent establishment of a new CPT Category I code, effective January 1, 2026, by the American Medical Association.” Mr. Carrico concluded.

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

When will Capital Blue Cross begin covering NeurAxis (NRXS) PENFS treatment?

Capital Blue Cross will begin covering NeurAxis's PENFS treatment effective October 1, 2024.

What age group is NeurAxis (NRXS) IB-Stim FDA-cleared to treat?

IB-Stim is FDA-cleared to treat functional abdominal pain associated with IBS in adolescents aged 11-18 years old.

When will the new CPT Category I code for NeurAxis (NRXS) PENFS technology become effective?

The new CPT Category I code for NeurAxis's PENFS technology will become effective January 1, 2026.

What geographical area does the Capital Blue Cross coverage for NeurAxis (NRXS) PENFS include?

The coverage includes a 21-county region in Central Pennsylvania and the Lehigh Valley.

Neuraxis, Inc.

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