electroCore Announces Reimbursement Approval for gammaCore™ by RIZIV/INAMI in Belgium
electroCore (NASDAQ:ECOR) has secured a significant regulatory milestone as its gammaCore™ Sapphire (nVNS) device received reimbursement approval from Belgium's National Institute for Health and Disability Insurance (RIZIV/INAMI). The coverage, effective October 1, 2025, will provide Belgian patients suffering from cluster headaches access to this bioelectronic treatment.
The approval was achieved through collaboration with Silvert Medical, electroCore's distribution partner in Belgium, and is supported by strong clinical evidence demonstrating the therapy's efficacy and cost-effectiveness. Prof. Paemeleire from Ghent University Hospital's Headache Clinic endorsed the decision, highlighting the benefits of non-invasive vagus nerve stimulation for patients.
[ "Secured reimbursement approval in Belgium, expanding market access", "Partnership with established distributor Silvert Medical for market penetration", "Strong clinical evidence supporting therapy efficacy and cost-effectiveness", "Strategic position in central Europe for potential expansion to neighboring countries" ]electroCore (NASDAQ:ECOR) ha ottenuto una tappa regolatoria significativa: il dispositivo gammaCore™ Sapphire (nVNS) ha ricevuto l’approvazione al rimborso da parte dell'Istituto Nazionale per la Godimento della Salute e l'Assicurazione per le Disabilità belga (RIZIV/INAMI). La copertura, efficace dal 1 ottobre 2025, permetterà ai pazienti belgi affetti da emicrania a grappolo di accedere a questo trattamento bioelettronico.
L’approvazione è stata raggiunta grazie alla collaborazione con Silvert Medical, partner distributivo di electroCore in Belgio, ed è sostenuta da robuste evidenze cliniche che dimostrano l’efficacia e la convenienza economica della terapia. Il prof. Paemeleire dell’Headache Clinic dell’Università di Ghent ha endorsato la decisione, sottolineando i benefici della stimolazione non invasiva del nervo vago per i pazienti.
[ "Ottenuta l’approvazione di rimborso in Belgio, ampliando l’accesso al mercato", "Partnership con l’affermato distributore Silvert Medical per la penetrazione nel mercato", "Solide evidenze cliniche a supporto dell’efficacia e della convenienza economica della terapia", "Posizionamento strategico in Europa centrale per potenziali estensioni verso i paesi vicini" ]electroCore (NASDAQ:ECOR) ha alcanzado un hito regulatorio importante: su dispositivo gammaCore™ Sapphire (nVNS) recibió la aprobación de reembolso por parte del Instituto Nacional de Seguros de Salud y Discapacidad de Bélgica (RIZIV/INAMI). La cobertura, vigente a partir del 1 de octubre de 2025, permitirá a los pacientes belgas con cluster headache acceder a este tratamiento bioelectrónico.
La aprobación se obtuvo gracias a la colaboración con Silvert Medical, socio de distribución de electroCore en Bélgica, y está respaldada por sólidas evidencias clínicas que demuestran la eficacia y la rentabilidad de la terapia. El Prof. Paemeleire, de la Clínica de Cefaleas del Hospital Universitario de Gante, respaldó la decisión, destacando los beneficios de la estimulación del nervio vago no invasiva para los pacientes.
[ "Aprobación de reembolso en Bélgica, ampliando el acceso al mercado", "Asociación con el distribuidor establecido Silvert Medical para la penetración en el mercado", "Fuertes evidencias clínicas que respaldan la eficacia y la rentabilidad de la terapia", "Posicionamiento estratégico en Europa Central para posibles expansiones a países vecinos" ]electroCore (NASDAQ:ECOR)가 중요한 규제 이정표를 달성했습니다. 그들의 gammaCore™ Sapphire (nVNS) 장치가 벨기에의 보건 및 장애 보장 연구소(RIZIV/INAMI)로부터 상환 승인을 받았습니다. 이 보장은 2025년 10월 1일부로 효력을 발생하며, 벨기에 환자들이 군집 두통에 대한 이 생체 전자 치료를 이용할 수 있게 됩니다.
승인은 벨기에에서 electroCore의 유통 파트너인 Silvert Medical와의 협력을 통해 이뤄졌으며, 치료의 효과 및 비용 효율성을 입증하는 강력한 임상 증거에 의해 뒷받침됩니다. Ghent 대학교 병원 두통 클리닉의 Paemeleire 교수는 비침습적 미주신경 자극의 환자 혜택을 강조하며 이 결정을 지지했습니다.
[ "벨기에의 상환 승인을 얻어 시장 접근 확대", "확립된 유통 파트너 Silvert Medical과의 제휴로 시장 진입", "치료의 효과 및 비용 효율성을 뒷받침하는 강한 임상 증거", "중부 유럽에서의 전략적 위치 확보로 이웃 국가로의 확장 가능성" ]electroCore (NASDAQ:ECOR) a franchi une étape réglementaire majeure: son dispositif gammaCore™ Sapphire (nVNS) a obtenu l’autorisation de remboursement de l’Institut national belge pour l’assurance maladie et l’invalidité (RIZIV/INAMI). La couverture, en vigueur à partir du 1 octobre 2025, permettra aux patients belges souffrant de céphalée en grappes d’accéder à ce traitement bioélectronique.
L’approbation a été obtenue grâce à la collaboration avec Silvert Medical, partenaire de distribution d’electroCore en Belgique, et est soutenue par des preuves cliniques solides démontrant l’efficacité et la rentabilité de la thérapie. Le professeur Paemeleire du service de Cefalgies du Ghent University Hospital a approuvé la décision, soulignant les bénéfices de la stimulation non invasive du nerf vague pour les patients.
[ "Approbation du remboursement en Belgique, élargissant l’accès au marché", "Partenariat avec le distributeur établi Silvert Medical pour la pénétration du marché", "Forte preuve clinique soutenant l’efficacité et la rentabilité de la thérapie", "Positionnement stratégique en Europe centrale pour d’éventuelles expansions vers les pays voisins" ]electroCore (NASDAQ:ECOR) hat einen bedeutenden regulatorischen Meilenstein erreicht: Sein Gerät gammaCore™ Sapphire (nVNS) erhielt eine Erstattungszusage vom belgischen Institut für Gesundheits- und Behindertenversicherung (RIZIV/INAMI). Die Abdeckung tritt ab dem 1. Oktober 2025 in Kraft und ermöglicht belgischen Patienten mit Cluster-Kopfschmerzen den Zugang zu dieser bioelektronischen Behandlung.
Die Genehmigung wurde durch die Zusammenarbeit mit Silvert Medical, dem Vertriebspartner von electroCore in Belgien, erreicht und durch robuste klinische Nachweise gestützt, die die Wirksamkeit und Kosteneffizienz der Therapie belegen. Prof. Paemeleire von der Headache Clinic des Ghent University Hospital unterstützte die Entscheidung und hob die Vorteile der nicht-invasiven Vagusnervstimulation für die Patienten hervor.
[ "Erstattung in Belgien gesichert, Marktzugang erweitert", "Partnerschaft mit dem etablierten Distributor Silvert Medical für Marktdurchdringung", "Starke klinische Evidenz belegt Wirksamkeit und Kostenersparnis der Therapie", "Strategische Positionierung in Zentraleuropa für potenzielle Expansion in Nachbarländer" ]electroCore (NASDAQ:ECOR) يحقق عتبة تنظيمية مهمة حيث تلقى جهازه gammaCore™ Sapphire (nVNS) موافقة السداد من المعهد الوطني البلجيكي للصحة والتأمين ضد العجز (RIZIV/INAMI). التغطية، اعتبارًا من 1 أكتوبر 2025، ستتيح للمرضى البلجيكيين المصابين بصداع المجموعة الوصول إلى هذا العلاج البيوتكنولوجي الحيوي.
تم تحقيق الموافقة من خلال التعاون مع Silvert Medical، شريك التوزيع لشركة electroCore في بلجيكا، وتدعمها أدلة سريرية قوية تُبيّن فاعلية العلاج وكفاءته من حيث التكلفة. وقد أشاد البروفيسور بايميلير من قسم علاج الصداع بمستشفى جامعة غينت بقرار الموافقة، مسلطًا الضوء على فوائد التحفيز العصبي الوجي غير الجراحي للمرضى.
[ "الموافقة على السداد في بلجيكا، توسيع الوصول للسوق", "شراكة مع الموزع المؤسس Silvert Medical لاختراق السوق", "أدلة أرشيفية تدعم فاعلية العلاج وتكلفته", "موقع استراتيجي في وسط أوروبا لإمكانية التوسع إلى الدول المجاورة" ]electroCore (NASDAQ:ECOR) 已实现重要监管里程碑，其 gammaCore™ Sapphire (nVNS) 设备获得比利时国家健康与残障保险研究所（RIZIV/INAMI）的报销批准。该覆盖自 2025年10月1日 起生效，将使比利时的簇状性头痛患者能够获得这一生物电子治疗方法。
此次批准通过 electroCore 在比利时的分销伙伴 Silvert Medical 的合作实现，并有强有力的临床证据支持治疗的有效性与成本效益。根特大学医院头痛诊所的 Paemeleire 教授支持这一决定，强调非侵入性迷走神经刺激对患者的益处。
[ "在比利时获得报销批准，扩大市场准入", "与成熟分销商 Silvert Medical 的伙伴关系推动市场渗透", "强有力的临床证据支持治疗的有效性与成本效益", "在中欧的战略地位，为向邻国扩张铺路" ]- None.
- None.
Insights
Belgium's reimbursement approval for gammaCore gives electroCore new revenue potential in Europe, validating their non-invasive headache treatment.
electroCore has secured a significant regulatory win with Belgium's national health insurance (RIZIV/INAMI) approving long-term reimbursement for gammaCore Sapphire. This approval specifically targets cluster headache patients, a notoriously difficult-to-treat condition often called "suicide headaches" due to their extreme pain intensity.
The October 1st implementation date provides immediate market access in a strategically important European country. Belgium often serves as a reference market that can influence neighboring countries' reimbursement decisions, potentially creating a domino effect across Europe. The endorsement from Prof. Paemeleire at Ghent University Hospital adds significant clinical credibility, as university hospital adoption typically drives broader clinical acceptance.
From a commercial perspective, this partnership with Silvert Medical demonstrates electroCore's effective execution of a distributor-based European strategy. Rather than building costly direct sales infrastructure across fragmented European markets, they're leveraging local expertise to navigate complex reimbursement systems. The press release subtly signals potential expansion into neighboring markets through this same partnership.
This approval represents more than just Belgian market access - it's a clinical and regulatory validation of non-invasive vagus nerve stimulation technology that could accelerate adoption and reimbursement elsewhere. For a company commercializing novel neuromodulation technologies, each reimbursement win builds credibility with physicians, patients, and other regulatory bodies.
ROCKAWAY, N.J., Sept. 29, 2025 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, today announced that gammaCore™ Sapphire (nVNS) has been included in a long-term reimbursement policy launched by the National Institute for Health and Disability Insurance (RIZIV / INAMI) in Belgium.
Effective October 1, 2025, the policy provides coverage for gammaCore Sapphire to treat patients with cluster headaches. This coverage is based on strong clinical evidence supporting the therapy’s efficacy and cost-effectiveness and ensures broader access for Belgian patients.
“The reimbursement of gammaCore by RIZIV / INAMI is a remarkable step forward for patients suffering from cluster headaches in Belgium,” said Prof. Paemeleire, leading the Headache Clinic of the Neurology Department at Ghent University Hospital. “This decision reflects the growing recognition of the clinical and economic benefits of non-invasive vagus nerve stimulation. As a healthcare provider, I am pleased that this reimbursement will now allow more patients to access a therapy that can significantly improve their daily lives while contributing to a more sustainable healthcare system.”
This achievement was made possible through the leadership and commitment of Silvert Medical, electroCore’s distribution partner in Belgium. Silvert Medical leveraged their local expertise and strong provider relationships, playing a key role in securing reimbursement. Silvert Medical remains a vital partner in supporting the rollout of gammaCore in Belgium and is committed to extending access to gammaCore in neighboring countries.
“Securing long-term reimbursement in Belgium, in the center of Europe, is a major milestone in expanding access to our non-invasive therapies,” said Tanja Martin, Senior Director of Strategic Product Lifecycle at electroCore. “We’re proud to partner with Silvert Medical to bring gammaCore to patients in Belgium.”
Learn more about RIZIV / INAMI’s reimbursement policy for gammaCore Sapphire here.
About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic technology company whose mission is to improve health and quality of life through innovative non-invasive bioelectronic technologies. The Company’s two leading prescription products, gammaCore non-invasive vagus nerve stimulation (nVNS) and Quell neurostimulator, treat chronic pain syndromes through non-invasive neuromodulation technology. Additionally, the company commercializes its handheld, and personal use Truvaga and TAC-STIM nVNS products utilizing bioelectronic technologies to promote general wellness and human performance.
For more information, visit www.electrocore.com.
Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about reimbursement for gammaCore in Belgium and potential European expansion, the Company’s future business strategies, growth opportunities, prospects, product development, and market expansion, and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” and other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to use strategic partnerships to provide more accessibility to those looking to purchase our consumer devices, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize its products, electroCore’s results of operations and financial performance, inflation and currency fluctuations, and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall economic and market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.
Contact:
ECOR Investor Relations
(973) 302-9253
investors@electrocore.com
FAQ
When will gammaCore be covered by insurance in Belgium?
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