NeurAxis Inc. Announces FDA 510(k) Clearance of RED for Testing and Evaluation of Patients with Chronic Constipation
NeurAxis Inc. (NYSE: NRXS) received FDA 510(k) clearance for RED (Rectal Expulsion Device), a self-inflating balloon designed to test and evaluate patients with chronic constipation due to pelvic floor dyssynergia. The device duplicates traditional balloon expulsion test performance without requiring electronics or software.
The company plans a soft launch in Q1 2025 followed by a full launch in Q2 2025. The total addressable market is estimated at $1.5 billion, with existing Category I CPT code coverage from Medicare and most commercial insurance companies. RED can also be used to test for rectal hypersensitivity, helping identify patients with exaggerated urge to defecate.
NeurAxis Inc. (NYSE: NRXS) ha ricevuto l'approvazione 510(k) dalla FDA per RED (Dispositivo di Espulsione Rettale), un pallone auto-inflabile progettato per testare e valutare pazienti con stitichezza cronica a causa di dissinergia del pavimento pelvico. Il dispositivo riproduce le prestazioni del tradizionale test di espulsione con pallone senza richiedere elettronica o software.
L'azienda prevede un lancio soft nel Q1 2025 seguito da un lancio completo nel Q2 2025. Il mercato totale indirizzabile è stimato in 1,5 miliardi di dollari, con copertura di codice CPT di Categoria I esistente da parte di Medicare e della maggior parte delle compagnie assicurative commerciali. RED può anche essere utilizzato per testare l'ipersensibilità rettale, aiutando a identificare i pazienti con un'esagerata urgenza di defecare.
NeurAxis Inc. (NYSE: NRXS) recibió la aprobación 510(k) de la FDA para RED (Dispositivo de Expulsión Rectal), un globo auto-inflable diseñado para evaluar a pacientes con estreñimiento crónico debido a disinergia del suelo pélvico. El dispositivo reproduce el rendimiento de la prueba tradicional de expulsión con globo sin requerir electrónica o software.
La empresa planea un lanzamiento suave en el primer trimestre de 2025 seguido de un lanzamiento completo en el segundo trimestre de 2025. El mercado total accesible se estima en 1.5 mil millones de dólares, con cobertura de código CPT de Categoría I existente de Medicare y la mayoría de las compañías de seguros comerciales. RED también se puede utilizar para evaluar la hipersensibilidad rectal, ayudando a identificar a los pacientes con un impulso exagerado de defecar.
NeurAxis Inc. (NYSE: NRXS)는 만성 변비로 인한 골반 바닥 비동기증 환자를 평가하기 위해 설계된 자가 팽창풍선인 RED (직장 배출 장치)에 대해 FDA 510(k) 승인을 받았습니다. 이 장치는 전통적인 풍선 배출 테스트 성능을 전자기기나 소프트웨어 없이 복제합니다.
회사는 2025년 1분기에 소프트 출시를 계획하고 2025년 2분기에는 본격 출시할 예정입니다. 전체 주소 가능한 시장 규모는 약 15억 달러로, Medicare 및 대부분의 상업 보험 회사로부터 기존의 카테고리 I CPT 코드 커버리지를 확보하고 있습니다. RED는 직장 과민증을 테스트하는 데에도 사용될 수 있어, 배변 충동이 과도한 환자를 식별하는 데 도움을 줍니다.
NeurAxis Inc. (NYSE: NRXS) a obtenu l'approbation 510(k) de la FDA pour RED (Dispositif d'Expulsion Rectale), un ballon auto-inflable conçu pour tester et évaluer les patients souffrant de constipation chronique due à la dyssynergie du plancher pelvien. L'appareil reproduit les performances du test d'expulsion traditionnel sans nécessiter d'électronique ni de logiciel.
L'entreprise prévoit un lancement progressif au premier trimestre 2025, suivi d'un lancement complet au deuxième trimestre 2025. Le marché total adressable est estimé à 1,5 milliard de dollars, avec une couverture de code CPT de catégorie I existante de la part de Medicare et de la plupart des compagnies d'assurance commerciales. RED peut également être utilisé pour tester l'hypersensibilité rectale, aidant à identifier les patients ayant une envie exagérée de se soulager.
NeurAxis Inc. (NYSE: NRXS) erhielt die FDA 510(k) Genehmigung für RED (Rektales Expulsionsgerät), einen selbstaufblasenden Ballon, der entwickelt wurde, um Patienten mit chronischer Verstopfung aufgrund von Beckenboden-Dyssynergie zu testen und zu bewerten. Das Gerät simuliert die Leistung des traditionellen Ballon-Expulsionstests, ohne Elektronik oder Software zu benötigen.
Das Unternehmen plant einen Soft-Launch im ersten Quartal 2025, gefolgt von einem vollständigen Launch im zweiten Quartal 2025. Der insgesamt adressierbare Markt wird auf 1,5 Milliarden Dollar geschätzt, mit bestehendem CPT-Code-Coverage der Kategorie I von Medicare und den meisten kommerziellen Versicherungen. RED kann auch zur Prüfung aufrektale Hypersensibilität verwendet werden, was hilft, Patienten mit übermäßigem Stuhldrang zu identifizieren.
- FDA 510(k) clearance received for RED device
- Large addressable market of $1.5 billion
- Existing insurance coverage through Medicare and commercial insurers
- Established Category I CPT code already in place
- Revenue generation expected to begin Q1 2025
- No immediate revenue impact until Q1 2025
- Phased launch approach may delay full market penetration
Insights
RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software.
NeurAxis Inc. will begin the process of commercially marketing RED and expects initial revenues in 1Q25 as there is a Category I CPT code assigned to the procedure and the procedure is covered by Medicare and most commercial insurance companies.
CARMEL, Ind., Dec. 10, 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 the US Food and Drug Administration (FDA) granted a 510(k) clearance for RED (Rectal Expulsion Device), allowing NeurAxis to commercially market the device for testing and evaluation of patients with chronic constipation due to pelvic floor dyssynergia and who are unlikely to improve with increased laxative use.
NeurAxis will begin the process of commercially marketing RED and expects a soft launch in the first quarter of 2025 with a full launch expected in the second quarter of 2025. Management believes that providers will be able to bring this clinically beneficial technology to their practice immediately, given its clinical need and total addressable market of roughly
RED is a proprietary, self-inflating balloon that evaluates a patient’s ability to expel contents from the rectum. “For many patients with chronic constipation, traditional laxative therapy does not work well because the problem is not related to colon motility, but rather with the neuromuscular function of the pelvic floor,” said Dr. Adrian Miranda, Chief Medical Officer for NeurAxis. “Without proper testing, these patients can be missed and continue to suffer with inadequate treatments.” RED can also be used as a qualitative test for rectal hypersensitivity. It will help identify patients who have an exaggerated urge to defecate, which also changes the treatment algorithm for patients with constipation.
“The RED 510(k) clearance is another important achievement as we continue to build and expand our Gastroenterology business and accelerate meaningful revenue growth towards our goal of cash flow breakeven,” said Brian Carrico, President and Chief Executive Officer of NeurAxis. “I am excited by our multiple avenues of revenue and profitability growth, driven by the expansion of insurance coverage and age indication of our IB-Stim product for pediatric FAP/IBS and our commercial launch of RED. Looking out beyond 2025, we are excited to pursue expanded indications with the FDA, using our PENFS technology, including adult FAP/IBS and pediatric/adult Functional Dyspepsia,” 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.
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Contacts:
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info@neuraxis.com
Investor Relations
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FAQ
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