IRVINE, Calif. - Inari Medical (TASE:PMCN), 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 Trial, comparing its efficacy to anticoagulation alone for DVT patients.
This news is based on a press release statement from Inari Medical, Inc.
In other recent news, Inari Medical reported a record revenue of $153.4 million in Q3 of 2024, marking a 21% year-over-year increase. The company raised its full-year revenue outlook to between $601.5 million and $604.5 million, driven by a surge of 76.4% in international sales, especially in Europe and Latin America. Despite a GAAP operating loss this quarter, Inari Medical is on track for operating profitability in the first half of 2025.
In addition, Canaccord Genuity maintained a Buy rating on Inari Medical following the presentation of the PEERLESS trial results. The trial demonstrated the superiority of Inari Medical's FlowTriever over catheter-directed thrombolytics (CDT) for patients with intermediate-risk pulmonary embolism. This could potentially add an additional $150 million to its total addressable market.
Despite some skepticism from clinicians about the data's potential to alter clinical practices, the forthcoming PEERLESS II trial could be a decisive factor in expanding the company's market. Canaccord Genuity's reiteration of the Buy rating reflects confidence in Inari Medical's growth trajectory. These developments highlight the company's recent advancements in the medical devices market.
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