Inari Medical Announces Reimbursement Approval for ClotTriever® Thrombectomy System in Japan and New Distribution Partnership with Medikit Co., Ltd.
Inari Medical (NASDAQ: NARI) has received national reimbursement approval from Japan's Ministry of Health, Labor and Welfare for its ClotTriever Thrombectomy System for DVT treatment. The system received a new functional category with a reimbursement premium based on clinical safety and efficacy data. Inari has partnered with Medikit Co., for distribution in Japan, planning to initiate a 100-patient Post Market Surveillance study followed by commercial expansion. The ClotTriever system has been used in over 75,000 procedures globally and has shown strong safety profile and low rates of post-thrombotic syndrome in recent two-year outcomes from the 500-patient ClotTriever CLOUT Registry.
Inari Medical (NASDAQ: NARI) ha ricevuto l'approvazione nazionale per il rimborso dal Ministero della Salute, del Lavoro e del Welfare del Giappone per il suo ClotTriever Thrombectomy System per il trattamento della TVP. Il sistema ha ottenuto una nuova categoria funzionale con un premio di rimborso basato su dati clinici di sicurezza ed efficacia. Inari ha collaborato con Medikit Co. per la distribuzione in Giappone, pianificando di avviare uno studio di Sorveglianza Post-Mercato su 100 pazienti, seguito da un'espansione commerciale. Il sistema ClotTriever è stato utilizzato in oltre 75.000 procedure a livello globale e ha dimostrato un profilo di sicurezza solido e basse percentuali di sindrome post-trombotica nei recenti risultati biennali del Registro ClotTriever CLOUT su 500 pazienti.
Inari Medical (NASDAQ: NARI) ha recibido la aprobación nacional de reembolso del Ministerio de Salud, Trabajo y Bienestar de Japón para su ClotTriever Thrombectomy System para el tratamiento de la TVP. El sistema recibió una nueva categoría funcional con un premio de reembolso basado en datos de seguridad y eficacia clínica. Inari ha establecido una asociación con Medikit Co. para la distribución en Japón, planeando iniciar un estudio de Vigilancia Post-Marketing con 100 pacientes seguido de una expansión comercial. El sistema ClotTriever ha sido utilizado en más de 75,000 procedimientos en todo el mundo y ha mostrado un sólido perfil de seguridad y bajas tasas de síndrome post-trombótico en los resultados recientes de dos años del Registro ClotTriever CLOUT con 500 pacientes.
Inari Medical (NASDAQ: NARI)는 일본 보건복지부로부터 DVT 치료를 위한 ClotTriever Thrombectomy System에 대한 국가적인 보험 급여 승인을 받았습니다. 이 시스템은 임상 안전성과 효능 데이터 기반으로 새로운 기능 카테고리를 받았으며, 보험 급여 프리미엄이 적용됩니다. Inari는 일본에서의 유통을 위해 Medikit Co.와 파트너십을 맺고, 100명의 환자를 대상으로 한 마켓 서베일런스 연구를 시작하고 상업적 확장을 계획하고 있습니다. ClotTriever 시스템은 전 세계적으로 75,000건 이상의 시술에 사용되었으며, 최근 500명의 환자에 대한 ClotTriever CLOUT 등록의 2년 결과에서 강력한 안전 프로필과 낮은 포스트 혈전증 증후군 발생률을 보여주었습니다.
Inari Medical (NASDAQ: NARI) a reçu l'approbation nationale du remboursement du Ministère de la Santé, du Travail et du Bien-être du Japon pour son ClotTriever Thrombectomy System pour le traitement de la TVP. Le système a obtenu une nouvelle catégorie fonctionnelle avec un supplément de remboursement basé sur des données de sécurité et d'efficacité cliniques. Inari s'est associé à Medikit Co. pour la distribution au Japon, prévoyant de lancer une étude de surveillance post-commercialisation de 100 patients suivie d'une expansion commerciale. Le système ClotTriever a été utilisé dans plus de 75 000 procédures dans le monde entier et a montré un solide profil de sécurité ainsi que de faibles taux de syndrome post-thrombotique dans les résultats récents de deux ans du Registre ClotTriever CLOUT sur 500 patients.
Inari Medical (NASDAQ: NARI) hat die nationale Erstattungsgenehmigung des japanischen Ministeriums für Gesundheit, Arbeit und Wohlfahrt für sein ClotTriever Thrombectomy System zur Behandlung von TVT erhalten. Das System erhielt eine neue Funktion Kategorie mit einem Erstattungspreis basierend auf klinischen Sicherheits- und Wirksamkeitsdaten. Inari hat eine Partnerschaft mit Medikit Co. für den Vertrieb in Japan geschlossen und plant, eine Nachmarktforschungsstudie mit 100 Patienten zu starten, gefolgt von einer kommerziellen Expansion. Das ClotTriever-System wurde weltweit in über 75.000 Verfahren eingesetzt und zeigt ein starkes Sicherheitsprofil sowie niedrige Raten von postthrombotischem Syndrom in den aktuellen Zwei-Jahres-Ergebnissen des 500-Patienten ClotTriever CLOUT Registers.
- Received reimbursement approval in Japan with premium pricing
- Secured distribution partnership with market leader Medikit Co.
- ClotTriever system has been used in over 75,000 procedures globally
- Positive two-year clinical outcomes from 500-patient registry
- None.
Insights
The reimbursement approval in Japan represents a significant market expansion opportunity for Inari Medical. Japan's healthcare market, the world's third-largest, offers substantial growth potential with its aging population and advanced healthcare system. The creation of a new functional category with premium reimbursement is particularly noteworthy, as it recognizes ClotTriever's unique value proposition and could support stronger pricing power.
The partnership with Medikit Co., is strategically valuable, leveraging their established presence in Japan's vascular device market. With over 75,000 global procedures completed and strong clinical data backing, ClotTriever is well-positioned to capture market share in Japan's DVT treatment space. The planned 100-patient Post Market Surveillance study will further strengthen local market acceptance and adoption.
The premium reimbursement approval is backed by compelling clinical evidence, particularly the two-year outcomes from the 500-patient CLOUT Registry demonstrating safety and efficacy. The creation of a separate functional category by MHLW validates ClotTriever's unique mechanical thrombectomy approach and positions it distinctly from other catheter-based therapies. The ongoing DEFIANCE trial comparing ClotTriever to anticoagulation alone could further strengthen its clinical positioning and drive adoption.
The Japanese approval pathway, requiring both PMDA and MHLW clearance, has been successfully navigated, indicating strong regulatory confidence in the technology's safety and efficacy profile. This comprehensive validation process typically leads to faster market acceptance in Japan's conservative medical community.
Reimbursement approval supports expanded access to effective, safe thrombus removal for patients suffering from deep vein thrombosis (DVT) in Japan
IRVINE, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Inari Medical, Inc. (NASDAQ: NARI) (“Inari”), a medical device company with a mission to treat and transform the lives of patients suffering from venous and other vascular diseases, announced today that on December 1, 2024, it received national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for its ClotTriever Thrombectomy System for DVT. This announcement follows the regulatory approval of the ClotTriever system by the Pharmaceuticals and Medical Devices Agency (PMDA) in December 2023.
Due to ClotTriever’s unique mechanism of action for complete, wall-to-wall thrombus removal in patients suffering from DVT, MHLW created a new functional category that is separate from other catheter-based therapies. This new functional category comes with a reimbursement premium based upon ClotTriever’s wealth of clinical data showing safety and efficacy in removing various types of thrombi.
To facilitate commercialization of the ClotTriever system in Japan, Inari has entered into a distribution agreement with Medikit Co., Ltd., a market leading vascular medical device manufacturer serving Japan, the U.S. and over 30 other countries. With this new partnership, Inari plans to accelerate initiation of its 100-patient Post Market Surveillance study, followed by broader commercial expansion.
“MHLW’s approval of reimbursement for ClotTriever under a newly designated functional category marks a transformative milestone for Inari in Japan,” said Drew Hykes, Chief Executive Officer of Inari. “This decision underscores the value of ClotTriever in addressing unmet clinical needs, and we are thrilled to collaborate with Medikit to bring this innovative solution to Japanese DVT patients, improving lives and advancing care in the near future. Over time, we look forward to bringing our broader portfolio of purpose-built tools to the Japanese market.”
The ClotTriever system is 510(k)-cleared by U.S. FDA and CE-Marked for treatment of DVT. More than 75,000 procedures have been conducted with ClotTriever globally. Recently, two-year outcomes were reported from the 500-patient ClotTriever CLOUT Registry showing a strong safety profile, significant clot removal, and low rates of post-thrombotic syndrome.1,2,3 ClotTriever is the most studied thrombectomy device for DVT, including the ongoing Randomized Controlled Trial, DEFIANCE, comparing ClotTriever to anticoagulation alone for patients with DVT.4
About Inari Medical, Inc.
Patients first. No small plans. Take care of each other. These are the guiding principles that form the ethos of Inari Medical. We are committed to improving lives in extraordinary ways by creating innovative solutions for both unmet and underserved health needs. In addition to our purpose-built solutions, we leverage our capabilities in education, clinical research, and program development to improve patient outcomes. We are passionate about our mission to establish our treatments as the standard of care for venous thromboembolism and four other targeted disease states. We are just getting started. Learn more at www.inarimedical.com and connect with us on LinkedIn, X (Twitter), and Instagram.
About Medikit Co., Ltd.
Medikit Co., Ltd., based in Tokyo, established in 1973, is a global medical device company and is publicly traded on the Tokyo Stock Exchange (Code: 7749). Medikit’s mission is to deliver the highest standards of excellence in operating as a health care company whose products and services help to enhance healthy life by minimizing unnecessary suffering and death from disease. Medikit is a market leader in Japan in interventional products, including vascular access devices such as hemodialysis catheters, intravenous catheters, sheaths, and guiding catheters. Medikit products are sold in Japan, the United States, and over 30 other countries. The company has sales, R&D, and manufacturing capabilities with more than 1,300 consolidated employees. For more information, visit the company’s website at www.medikit.co.jp.
Investor Contact:
Neil Bhalodkar
IR@inarimedical.com
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1 Bisharat, et al. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. JSCAI. 2024.
2 Shaikh, et al. Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry. Cardiovasc Int Rad. 2023.
3 Dexter, D. Interim two-year outcomes from the fully enrolled CLOUT registry. Presented at AVF 2024 (Tampa, FL).
4 Abramowitz, et al. Rationale and Design of the DEFIANCE Study: A Randomized Controlled Trial of Mechanical Thrombectomy Versus Anticoagulation Alone for Iliofemoral Deep Vein Thrombosis. American Heart Journal. doi.org/10.1016/j.ahj.2024.10.016
FAQ
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