UPDATE - NeurAxis Announces New Medical Policy Coverage with a Prominent Insurer for Over Five Million Lives Across Multiple States
NeurAxis (NYSE: NRXS) has secured medical policy coverage for its Percutaneous Electrical Nerve Field Stimulation (PENFS) technology with a major insurer, extending coverage to approximately 5.1 million members across 13 states, including MI, IL, NY, and TX.
The company's IB-Stim device, which is FDA-cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in patients aged 8-21 years, delivers gentle electrical impulses to cranial nerve bundles in the ear. This non-surgical treatment is particularly significant as there are currently no FDA-approved drug therapies for children with abdominal pain-related gut-brain interaction disorders.
NeurAxis has expanded its insurance coverage from 4 million to 51 million lives over the past year, positioning the company to serve approximately 600,000 individuals suffering from IBS.
NeurAxis (NYSE: NRXS) ha ottenuto la copertura della politica medica per la sua tecnologia Percutaneous Electrical Nerve Field Stimulation (PENFS) da un importante assicuratore, estendendo la copertura a circa 5,1 milioni di membri in 13 stati, inclusi MI, IL, NY e TX.
Il dispositivo IB-Stim dell'azienda, che è stato approvato dalla FDA per il trattamento del dolore addominale funzionale associato alla sindrome dell'intestino irritabile (IBS) in pazienti di età compresa tra 8 e 21 anni, eroga delicati impulsi elettrici ai fasci nervosi cranici nell'orecchio. Questo trattamento non chirurgico è particolarmente significativo poiché attualmente non esistono terapie farmacologiche approvate dalla FDA per i bambini con disturbi dell'interazione intestino-cervello legati al dolore addominale.
NeurAxis ha ampliato la sua copertura assicurativa da 4 milioni a 51 milioni di persone nell'ultimo anno, posizionando l'azienda per servire circa 600.000 individui affetti da IBS.
NeurAxis (NYSE: NRXS) ha logrado la cobertura de política médica para su tecnología Percutaneous Electrical Nerve Field Stimulation (PENFS) con un importante asegurador, extendiendo la cobertura a aproximadamente 5,1 millones de miembros en 13 estados, incluyendo MI, IL, NY y TX.
El dispositivo IB-Stim de la compañía, que ha sido aprobado por la FDA para tratar el dolor abdominal funcional asociado con el síndrome del intestino irritable (IBS) en pacientes de entre 8 y 21 años, entrega suaves impulsos eléctricos a los haces nerviosos craneales en la oreja. Este tratamiento no quirúrgico es especialmente significativo ya que actualmente no hay terapias farmacológicas aprobadas por la FDA para niños con dolores abdominales relacionados con trastornos de la interacción intestino-cerebro.
NeurAxis ha ampliado su cobertura de seguros de 4 millones a 51 millones de vidas en el último año, posicionando a la empresa para servir aproximadamente a 600,000 individuos que sufren de IBS.
NeurAxis (NYSE: NRXS)는 주요 보험사와 함께 경피 전기 신경 필드 자극(PENFS) 기술에 대한 의료 정책 보장을 확보했으며, 이는 MI, IL, NY, TX를 포함한 13개 주에서 약 510만 명의 회원에게 보장을 확대합니다.
회사의 IB-Stim 장치는 8세에서 21세 환자의 과민성 장 증후군(IBS)과 관련된 기능성 복통 치료를 위해 FDA 승인을 받은 장치로, 귀의 두개신경 다발에 부드러운 전기적 자극을 전달합니다. 이 비수술적 치료법은 현재 복통 관련 장-뇌 상호작용 장애를 가진 아동을 위한 FDA 승인 약물 치료가 없기 때문에 특히 중요합니다.
NeurAxis는 지난 1년 동안 보험 보장을 400만에서 5100만 생명으로 확장했으며, 이는 약 60만 명의 IBS 환자를 지원하기 위한 회사의 위치를 강화합니다.
NeurAxis (NYSE: NRXS) a obtenu la couverture de la politique médicale pour sa technologie Stimulation Électrique Transcutanée du Champ Nerveux (PENFS) avec un grand assureur, étendant la couverture à environ 5,1 millions de membres dans 13 États, y compris MI, IL, NY et TX.
Le dispositif IB-Stim de l'entreprise, qui a été approuvé par la FDA pour traiter la douleur abdominale fonctionnelle associée au syndrome de l'intestin irritable (IBS) chez les patients âgés de 8 à 21 ans, délivre de douces impulsions électriques aux faisceaux nerveux crâniens dans l'oreille. Ce traitement non chirurgical est particulièrement important car il n'existe actuellement aucun traitement médicamenteux approuvé par la FDA pour les enfants souffrant de douleurs abdominales liées aux troubles de l'interaction intestin-cerveau.
NeurAxis a élargi sa couverture d'assurance de 4 millions à 51 millions de vies au cours de la dernière année, positionnant l'entreprise pour servir environ 600 000 personnes souffrant de l'IBS.
NeurAxis (NYSE: NRXS) hat die medizinische Richtlinienabdeckung für seine Perkutane Elektrische Nervenfeldstimulation (PENFS) Technologie bei einem großen Versicherer gesichert, wodurch die Abdeckung auf etwa 5,1 Millionen Mitglieder in 13 Bundesstaaten, einschließlich MI, IL, NY und TX, ausgeweitet wird.
Das IB-Stim Gerät des Unternehmens, das von der FDA zur Behandlung von funktionellen Bauchschmerzen im Zusammenhang mit dem Reizdarmsyndrom (IBS) bei Patienten im Alter von 8 bis 21 Jahren zugelassen ist, gibt sanfte elektrische Impulse an die kranialen Nervenbündel im Ohr ab. Diese nicht-chirurgische Behandlung ist besonders bedeutend, da es derzeit keine von der FDA zugelassenen Arzneimitteltherapien für Kinder mit bauchschmerzauslösenden Störungen der Darm-Hirn-Interaktion gibt.
NeurAxis hat seine Versicherungsabdeckung im vergangenen Jahr von 4 Millionen auf 51 Millionen Leben ausgeweitet, was das Unternehmen in die Lage versetzt, etwa 600.000 Personen zu bedienen, die an IBS leiden.
- Secured coverage for 5.1M additional lives across 13 states
- Total insurance coverage increased from 4M to 51M lives in one year
- Obtained CPT I code for treatment
- Expanded FDA-cleared age range from 11-18 to 8-21 years
- Addresses market of 600,000 potential IBS patients
- None.
Insights
This insurance coverage expansion represents a substantial market opportunity for NeurAxis. The addition of 5.1 million covered lives across 13 states, including major markets like Texas and New York, significantly expands the company's addressable market. The total coverage increase from 4 million to 51 million lives in just one year demonstrates exceptional market penetration momentum.
The CPT I code achievement is particularly noteworthy as it typically leads to improved reimbursement rates and streamlined billing processes. The expanded age range (8-21 years) opens up a larger patient population, potentially increasing the serviceable market by approximately 30-40%. With an estimated 600,000 eligible IBS patients now within reach and assuming a conservative market penetration of 5% and an average treatment cost of
For a micro-cap company with a market cap of just
The IB-Stim's PENFS technology addresses a critical gap in pediatric IBS treatment. The non-surgical, neuromodulation approach offers a compelling alternative to off-label drug use, which often carries significant risks in pediatric populations. The device's mechanism of action, targeting cranial nerve bundles through gentle electrical stimulation, aligns with growing interest in bioelectronic medicine approaches.
Think of PENFS as a "remote control" for the gut-brain axis - it's like fine-tuning the communication between these two systems without the systemic effects of medications. The expanded age range approval (8-21 years) is particularly significant as it covers the peak onset period for IBS symptoms, allowing for earlier intervention when treatment outcomes are typically more favorable.
The rapid insurance coverage expansion suggests strong clinical validation and payer confidence in the technology's efficacy. This is important in the medical device sector, where payer adoption often lags significantly behind FDA clearance.
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 a prominent insurer, with 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 recent insurance coverage, 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
What is the new insurance coverage announced by NeurAxis (NRXS) in January 2024?
How many total lives does NeurAxis (NRXS) now cover with insurance for IB-Stim?
What is the FDA-cleared age range for NeurAxis (NRXS) IB-Stim treatment?
How many potential IBS patients could benefit from NeurAxis (NRXS) IB-Stim treatment?
What medical condition does NeurAxis (NRXS) IB-Stim device treat?
