NeurAxis Inc. Announces Strong Preliminary Unaudited Fourth Quarter 2024 Results; Revenues Increased 50% Year-Over-Year
NeurAxis (NYSE: NRXS) reported preliminary Q4 2024 results showing significant growth. Q4 revenues reached approximately $800,000, marking a 50% increase compared to Q4 2023, accelerating from 40% growth in Q3. Full-year 2024 revenues were approximately $2.7 million, up 11% year-over-year.
The company's IB-Stim technology, supported by 16 peer-reviewed studies from leading U.S. children's hospitals, has expanded insurance coverage to approximately 45 million lives, up from 4 million a year ago. The company ended 2024 with a cash balance of $3.7 million.
Recent developments include FDA 510(k) clearance expanding IB-Stim's indication to patients aged 8-21 years (previously 11-18 years), new Category I CPT code for PENFS procedures, and upcoming commercialization of the FDA-approved Rectal Expulsion Device in Q1 2025.
NeurAxis (NYSE: NRXS) ha riportato risultati preliminari per il Q4 2024 che mostrano una crescita significativa. I ricavi del Q4 hanno raggiunto circa 800.000 dollari, segnando un 50% di aumento rispetto al Q4 2023, accelerando rispetto al 40% di crescita nel Q3. I ricavi totali per l'anno 2024 sono stati di circa 2,7 milioni di dollari, in crescita dell'11% rispetto all'anno precedente.
La tecnologia IB-Stim dell'azienda, sostenuta da 16 studi peer-reviewed provenienti dalle principali ospedali pediatrici statunitensi, ha ampliato la copertura assicurativa a circa 45 milioni di persone, rispetto ai 4 milioni di un anno fa. L'azienda ha concluso il 2024 con un saldo di cassa di 3,7 milioni di dollari.
Sviluppi recenti includono l'approvazione FDA 510(k) che espande l'indicazione di IB-Stim ai pazienti di età compresa tra 8 e 21 anni (precedentemente 11-18 anni), un nuovo codice CPT di Categoria I per le procedure PENFS, e la prossima commercializzazione del Dispositivo di Espulsione Rettale approvato dalla FDA nel Q1 2025.
NeurAxis (NYSE: NRXS) informó resultados preliminares para el Q4 2024 que muestran un crecimiento significativo. Los ingresos del Q4 alcanzaron aproximadamente 800.000 dólares, marcando un 50% de aumento en comparación con el Q4 2023, acelerándose desde el crecimiento del 40% en el Q3. Los ingresos totales del año 2024 fueron de aproximadamente 2,7 millones de dólares, un incremento del 11% año tras año.
La tecnología IB-Stim de la empresa, respaldada por 16 estudios revisados por pares de los principales hospitales infantiles de EE. UU., ha expandido la cobertura de seguros a aproximadamente 45 millones de vidas, en comparación con 4 millones hace un año. La empresa terminó el 2024 con un saldo de efectivo de 3,7 millones de dólares.
Los desarrollos recientes incluyen la aprobación 510(k) de la FDA que expande la indicación de IB-Stim a pacientes de 8 a 21 años (anteriormente de 11 a 18 años), un nuevo código CPT de Categoría I para procedimientos PENFS, y la próxima comercialización del Dispositivo de Expulsión Rectal aprobado por la FDA en el Q1 2025.
NeurAxis (NYSE: NRXS)는 Q4 2024의 예비 결과를 발표하며 상당한 성장을 보여주었습니다. Q4의 수익은 약 800,000달러에 도달하여 Q4 2023과 비교하여 50% 증가하였으며, Q3의 40% 성장에서 가속되었습니다. 2024년 전체 연도 수익은 약 270만 달러로, 전년 대비 11% 증가했습니다.
회사의 IB-Stim 기술은 미국 주요 아동 병원의 16개 동료 검토 연구에 의해 지원되어 약 4,500만 명의 생명에 대한 보험 적용 범위를 확대하였으며, 이는 1년 전의 400만 명에서 증가한 숫자입니다. 회사는 2024년을 370만 달러의 현금 잔고로 마감했습니다.
최근 개발 사항으로는 8-21세 환자로 IB-Stim의 적응증을 확장하는 FDA 510(k) 승인, PENFS 절차에 대한 새로운 범주 I CPT 코드, 그리고 2025년 1분기에 FDA 승인된 직장 배출 장치의 상업화가 예정되어 있습니다.
NeurAxis (NYSE: NRXS) a annoncé des résultats préliminaires pour le Q4 2024 montrant une croissance significative. Les revenus du Q4 ont atteint environ 800 000 dollars, marquant une augmentation de 50% par rapport au Q4 2023, s'accélérant par rapport à une croissance de 40% au Q3. Les revenus annuels de 2024 s'élevaient à environ 2,7 millions de dollars, en hausse de 11% par rapport à l'année précédente.
La technologie IB-Stim de l'entreprise, soutenue par 16 études évaluées par des pairs des principaux hôpitaux pédiatriques américains, a élargi la couverture d'assurance à environ 45 millions de vies, contre 4 millions il y a un an. L'entreprise a terminé 2024 avec un solde de trésorerie de 3,7 millions de dollars.
Les développements récents incluent l'approbation FDA 510(k) élargissant l'indication d'IB-Stim aux patients âgés de 8 à 21 ans (auparavant 11-18 ans), un nouveau code CPT de catégorie I pour les procédures PENFS, et la prochaine commercialisation du Dispositif d'expulsion rectale approuvé par la FDA au premier trimestre 2025.
NeurAxis (NYSE: NRXS) berichtete von vorläufigen Ergebnissen für das Q4 2024, die ein signifikantes Wachstum zeigen. Die Q4-Einnahmen beliefen sich auf etwa 800.000 US-Dollar, was einem 50% Anstieg im Vergleich zum Q4 2023 entspricht und sich von 40% Wachstum im Q3 beschleunigt hat. Die Gesamteinnahmen für das Jahr 2024 lagen bei etwa 2,7 Millionen US-Dollar, ein Anstieg von 11% im Vergleich zum Vorjahr.
Die IB-Stim-Technologie des Unternehmens, die von 16 begutachteten Studien führender US-Kinderkliniken unterstützt wird, hat den Versicherungsschutz auf etwa 45 Millionen Leben erweitert, von 4 Millionen vor einem Jahr. Das Unternehmen schloss das Jahr 2024 mit einem Cash-Bestand von 3,7 Millionen US-Dollar ab.
Zu den aktuellen Entwicklungen gehören die FDA 510(k)-Genehmigung, die das Anwendungsgebiet von IB-Stim auf Patienten im Alter von 8 bis 21 Jahren (zuvor 11 bis 18 Jahre) ausdehnt, ein neuer CPT-Code der Kategorie I für PENFS-Verfahren und die bevorstehende Kommerzialisierung des von der FDA genehmigten Rektalausstoßgeräts im Q1 2025.
- Q4 2024 revenue growth of 50% YoY to $800,000
- Insurance coverage expanded to 45 million lives from 4 million
- FDA approval expanding IB-Stim age range to 8-21 years
- New Category I CPT code obtained for PENFS procedures
- Strong cash position of $3.7 million at year-end
- Full-year 2024 revenue growth slowed to 11% compared to 50% in Q4
- Company not yet cash flow positive
Insights
The Q4 2024 results showcase impressive momentum with
Insurance coverage expansion from 4 million to 45 million lives represents a critical growth catalyst. The
The introduction of Category I CPT codes typically leads to better reimbursement rates and wider adoption among healthcare providers. Combined with the RED device launch and expanded insurance coverage, these factors create multiple growth vectors for 2025. However, investors should monitor cash burn rate and potential need for additional funding before reaching breakeven.
The PENFS technology's validation through 16 peer-reviewed studies at leading children's hospitals represents substantial clinical credibility. This scientific backing directly translated to expanded insurance coverage, demonstrating the important link between clinical evidence and commercial success in medical devices.
The recent FDA clearance expanding IB-Stim's indicated age range is particularly significant for pediatric applications. The inclusion of younger patients (8-10 years) and young adults (19-21 years) opens up treatment options for previously underserved age groups. The timing of RED's commercialization in Q1 2025 diversifies the product portfolio and provides an additional revenue stream in the gastrointestinal space.
The combination of expanded insurance coverage, broader FDA-cleared age range and new CPT coding positions NeurAxis favorably in the neuromodulation market, particularly in pediatric applications where treatment options are often
- Revenues in 4Q24 increased approximately
50% versus 4Q23 - Cash balance as of 12/31/24 was approximately
$3.7 million
CARMEL, Ind., Jan. 08, 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 preliminary, unaudited revenues for the three and twelve months ended December 31, 2024. Revenues for 4Q24 were approximately
Brian Carrico, Chief Executive officer of NeurAxis, commented: “We are pleased with our continued strong revenue growth in 4Q24. Our revenues increased approximately
“We expect continued robust revenue growth in 2025 and beyond, driven by expanding insurance coverage policy, the recently announced FDA 510(k) clearance for an expanded indication of IB-Stim that now includes patients aged 8 to 21 years, compared to the previous range of 11 to 18 years, as well as new Category I Current Procedural Terminology (CPT) code for PENFS procedures. In addition, in 1Q25, we will begin the commercialization of our Rectal Expulsion Device (RED), which recently received FDA approval.
“Importantly, we believe we are well positioned to achieve our near-term growth objectives with our strengthened balance sheet, including reaching cash flow breakeven. Our focus remains on strong growth combined with a prudent expense structure, which should result in shareholder value.”
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.
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
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