IRVINE, Calif. – Inari Medical (TASE:), Inc. (NASDAQ: NARI), a $3.04 billion market cap company focusing on treatments for vascular diseases, announced Monday that its ClotTriever Thrombectomy System for deep vein thrombosis (DVT) has received national reimbursement approval in Japan. According to InvestingPro data, the company maintains impressive gross profit margins of 86.82% while showing strong revenue growth of 22.41% over the last twelve months. The approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) on Sunday follows the device’s regulatory clearance by the Pharmaceuticals and Medical Devices Agency (PMDA) in December last year.
The MHLW has established a new functional category for the ClotTriever system, reflecting its unique method for removing blood clots, which is distinct from other catheter-based treatments. This categorization includes a reimbursement premium, acknowledging the system’s demonstrated safety and efficacy through clinical data. With a “GOOD” overall financial health score from InvestingPro and operating with moderate debt levels, Inari Medical appears well-positioned to execute its expansion plans. Discover 8 more exclusive ProTips and comprehensive analysis in the Pro Research Report.
To support the launch and commercialization in Japan, Inari has partnered with Medikit Co., Ltd., a leader in vascular medical devices. The collaboration aims to expedite the initiation of a 100-patient Post Market Surveillance study and subsequent broader commercial rollout.
Drew Hykes, CEO of Inari, highlighted the significance of the reimbursement approval as a transformative milestone, expressing enthusiasm for the partnership with Medikit to address the clinical needs of Japanese DVT patients.
The ClotTriever system, which is 510(k)-cleared by the U.S. FDA and CE-Marked, has been used in over 75,000 procedures worldwide. Recent data from the ClotTriever CLOUT Registry, which includes two-year outcomes from 500 patients, has shown promising safety and effectiveness, with low rates of post-thrombotic syndrome. Trading at $52.12, between its 52-week range of $36.73 to $67.13, analysts suggest the stock may be slightly overvalued at current levels.
Inari Medical’s mission is to create innovative solutions for unmet and underserved health needs, focusing on education, clinical research, and program development to enhance patient outcomes. The ClotTriever is currently the subject of the DEFIANCE Randomized Controlled…
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