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NeurAxis Announces New Medical Policy Coverage with Molina Healthcare for Over Five Million Lives Across Multiple States

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NeurAxis (NYSE: NRXS) has announced medical policy coverage with Molina Healthcare for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, IB-Stim. The coverage extends to Molina's approximately 5.1 million members across 13 states, including Michigan, Illinois, New York, and Texas.

IB-Stim is an FDA-cleared, non-surgical device that treats functional abdominal pain associated with irritable bowel syndrome (IBS) in patients aged 8-21 years through gentle electrical impulses to cranial nerve bundles in the ear. This treatment is particularly significant as there are currently no FDA-approved drug therapies for children with abdominal pain-related disorders of the gut-brain interaction.

The company has notably expanded its insurance coverage from 4 million to 51 million lives over the past year, with potential to treat approximately 600,000 individuals suffering from IBS.

NeurAxis (NYSE: NRXS) ha annunciato la copertura della policy medica con Molina Healthcare per la sua tecnologia di Stimolazione Elettrica Percutanea del Campo Nervoso (PENFS), IB-Stim. La copertura si estende ai circa 5,1 milioni di membri di Molina in 13 stati, tra cui Michigan, Illinois, New York e Texas.

IB-Stim è un dispositivo non chirurgico approvato dalla FDA che tratta il dolore addominale funzionale associato alla sindrome dell'intestino irritabile (IBS) in pazienti di età compresa tra 8 e 21 anni, attraverso impulsi elettrici delicati ai fasci nervosi craniali nell'orecchio. Questo trattamento è particolarmente significativo in quanto attualmente non ci sono terapie farmacologiche approvate dalla FDA per i bambini con disturbi legati al dolore addominale e all'interazione gut-brain.

Negli ultimi 12 mesi, l'azienda ha significativamente ampliato la propria copertura assicurativa da 4 milioni a 51 milioni di vite, con il potenziale di trattare circa 600.000 individui affetti da IBS.

NeurAxis (NYSE: NRXS) ha anunciado la cobertura de política médica con Molina Healthcare para su tecnología de Estimulación Eléctrica Percutánea del Campo Nervioso (PENFS), IB-Stim. La cobertura se extiende a aproximadamente 5.1 millones de miembros de Molina en 13 estados, incluyendo Michigan, Illinois, Nueva York y Texas.

IB-Stim es un dispositivo no quirúrgico aprobado por la FDA que trata el dolor abdominal funcional asociado con el síndrome del intestino irritable (IBS) en pacientes de 8 a 21 años a través de impulsos eléctricos suaves a los paquetes de nervios craneales en el oído. Este tratamiento es particularmente significativo ya que actualmente no hay terapias medicamentosas aprobadas por la FDA para niños con trastornos relacionados con el dolor abdominal y la interacción intestino-cerebro.

La compañía ha ampliado notablemente su cobertura de seguros de 4 millones a 51 millones de vidas en el último año, con el potencial de tratar aproximadamente a 600,000 personas que sufren de IBS.

NeurAxis (NYSE: NRXS)IB-Stim이라는 자사의 경피적 전기 신경 자극(PENFS) 기술에 대해 Molina Healthcare와 의료 보험 적용을 발표했습니다. 이 적용 범위는 미시간, 일리노이, 뉴욕 및 텍사스 등 13개 주에 걸쳐 Molina의 약 510만 회원에게 확대됩니다.

IB-Stim은 FDA 승인을 받은 비수술 장치로, 8세에서 21세 사이의 환자에서 과민성 장 증후군(IBS)과 관련된 기능적 복통을 귀의 두개 신경 다발에 부드러운 전기 충격을 통해 치료합니다. 이 치료법은 현재 복통과 장-뇌 상호작용 장애를 가진 어린이들을 위한 FDA 승인 약물이 없기 때문에 특히 중요합니다.

회사는 지난 1년 동안 보험 적용 범위를 400만에서 5100만으로 크게 확대하였으며, IBS로 고통 받는 약 60만 명을 치료할 수 있는 잠재력이 있습니다.

NeurAxis (NYSE: NRXS) a annoncé une couverture de politique médicale avec Molina Healthcare pour sa technologie de stimulation électrique nerveuse percutanée (PENFS), IB-Stim. La couverture s'étend aux environ 5,1 millions de membres de Molina dans 13 États, y compris le Michigan, l'Illinois, New York et le Texas.

IB-Stim est un appareil non chirurgical approuvé par la FDA, qui traite la douleur abdominale fonctionnelle associée au syndrome de l'intestin irritable (IBS) chez les patients âgés de 8 à 21 ans grâce à de douces impulsions électriques aux faisceaux de nerfs crâniens dans l'oreille. Ce traitement est particulièrement significatif car il n'existe actuellement aucune thérapie médicamenteuse approuvée par la FDA pour les enfants présentant des douleurs abdominales liées aux troubles de l'interaction intestin-cerveau.

Au cours de l'année écoulée, l'entreprise a considérablement élargi sa couverture d'assurance, passant de 4 millions à 51 millions de vies, avec un potentiel de traitement d'environ 600 000 individus souffrant d'IBS.

NeurAxis (NYSE: NRXS) hat eine medizinische Policendeckung mit Molina Healthcare für seine perkutane elektrische Nervenfeldstimulation (PENFS) Technologie, IB-Stim, angekündigt. Die Deckung erstreckt sich auf etwa 5,1 Millionen Mitglieder von Molina in 13 Bundesstaaten, darunter Michigan, Illinois, New York und Texas.

IB-Stim ist ein von der FDA zugelassenes, nicht-chirurgisches Gerät, das funktionelle Bauchschmerzen, die mit dem Reizdarmsyndrom (IBS) bei Patienten im Alter von 8 bis 21 Jahren verbunden sind, durch sanfte elektrische Impulse an den kranialen Nervenbündeln im Ohr behandelt. Diese Behandlung ist besonders bedeutend, da es derzeit keine von der FDA zugelassenen medikamentösen Therapien für Kinder mit bauchschmerzbezogenen Störungen der Darm-Gehirn-Interaktion gibt.

Das Unternehmen hat seine Versicherungsdeckung im vergangenen Jahr erheblich von 4 Millionen auf 51 Millionen Leben erweitert, mit dem Potenzial, etwa 600.000 Personen zu behandeln, die an IBS leiden.

Positive
  • Secured coverage with Molina Healthcare, reaching 5.1 million additional members
  • Expanded total insurance coverage from 4 million to 51 million lives in one year
  • Recently achieved CPT I code for treatment
  • Extended treatment age range from 11-18 to 8-21 years
  • Only FDA-cleared treatment option in its category for pediatric IBS
Negative
  • None.

Insights

The Molina Healthcare coverage agreement represents a significant market expansion for NeurAxis's IB-Stim device. With $19.9M market cap, this coverage of 5.1M additional lives across multiple states substantially increases their total covered lives from 4M to 51M in just one year - a 1175% growth. This expansion into major markets like Texas, New York and Illinois opens considerable revenue potential.

The addressable market of 600,000 patients, combined with no FDA-approved drug alternatives for children with IBS-related abdominal pain, positions IB-Stim uniquely. The recent CPT I code implementation is important as it standardizes billing processes, typically leading to improved reimbursement rates and wider adoption among healthcare providers. The expanded age range (8-21 years vs. previous 11-18) increases the treatable patient population by approximately 40%.

For investors, this coverage expansion reduces commercial risk and could accelerate revenue growth. The lack of competing FDA-approved treatments and the non-invasive nature of IB-Stim provides a compelling value proposition for both insurers and patients.

The strategic importance of securing Molina Healthcare coverage cannot be understated. As a non-invasive alternative to pharmacological treatments, IB-Stim addresses a critical gap in pediatric IBS treatment. The expanded coverage in states with large populations like TX, NY and IL provides access to major medical markets where pediatric gastroenterology practices are concentrated.

The timing of this coverage decision aligns perfectly with the recent CPT I code implementation, which typically accelerates device adoption by streamlining the reimbursement process. This combination of expanded insurance coverage and simplified billing could drive faster market penetration rates.

Most notably, the coverage decision by a major insurer like Molina often influences other payers' policies, potentially leading to a domino effect in coverage expansion. This could accelerate NeurAxis's path to broader market acceptance and revenue growth, particularly important for a small-cap company in the competitive medical device space.

CARMEL, Ind., Jan. 21, 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 medical policy coverage for Percutaneous Electrical Nerve Field Stimulation (PENFS), with Molina Healthcare. Molina, with over 40 years in operation, has approximately 5.1 million members across 13 states.

NeurAxis’ PENFS technology, IB-Stim, is FDA-cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 8-21 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. Off label pharmacologic treatments can often have serious side effects, and most lack scientific evidence of efficacy.

Brian Carrico, President and Chief Executive Officer of NeurAxis commented, “We are thrilled about our coverage with Molina, which marks our initial expansion into the states of MI, IL, NY, TX, and others. This milestone underscores the impact of our strong body of published research, which continues to drive broader insurance coverage for IB-Stim. As highlighted in my recent Letter to Shareholders, we've significantly increased our insurance coverage to 51 million lives—a remarkable leap from just 4 million a year ago. Additionally, our recently achieved CPT I code, and the expanded age range from 11–18 years to 8–21 years will allow us to provide care for the approximately 600,000 individuals suffering from irritable bowel syndrome.”

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 8-21 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.

For Important Information on IB-Stim/PENFS: See https://ibstim.com/important-information/

Contacts:

Company
NeurAxis, Inc.
info@neuraxis.com  

Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com


FAQ

How many lives does NeurAxis (NRXS) now cover with its insurance policies?

NeurAxis has expanded its insurance coverage to 51 million lives, up from 4 million a year ago, following the addition of Molina Healthcare's 5.1 million members.

What age range is NeurAxis's IB-Stim device approved for?

IB-Stim is FDA-cleared for patients aged 8-21 years old, recently expanded from the previous range of 11-18 years.

Which states are included in the new Molina Healthcare coverage for NRXS's IB-Stim?

The coverage includes multiple states, with specific mention of Michigan, Illinois, New York, and Texas among the 13 states where Molina operates.

How many potential IBS patients could benefit from NeurAxis's IB-Stim treatment?

According to the press release, approximately 600,000 individuals suffering from irritable bowel syndrome could potentially benefit from the treatment.

What is the treatment method of NeurAxis's IB-Stim device?

IB-Stim is a non-surgical device that delivers gentle electrical impulses into cranial nerve bundles in the ear, known as Percutaneous Electrical Nerve Field Stimulation (PENFS).

Neuraxis, Inc.

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