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2026.03.12
‘HiCardi’ at the Forefront, Knocking on the Door of the World’s Largest North American Market


 

[DealSite Reporter Da-eun Lee] Mezoo is accelerating its push into North America, the world’s largest medical device market, following its KOSDAQ listing. The company plans to focus on securing early references through collaborative research with local hospitals and technology demonstrations of its ambulatory Remote Patient Monitoring (aRPM) platform, ‘HiCardi.’


According to the securities registration statement disclosed by Mezoo this month, approximately KRW 16.3 billion out of the total KRW 22.1 billion raised from the public offering will be invested in expanding overseas operations. The funds will be used for marketing in North America and Europe, engaging global business development (BD) agencies, developing localized solutions, and establishing overseas subsidiaries.


In the early stage of entering the North American market, Mezoo is building its market entry foundation by conducting technology demonstrations and proof-of-concept (PoC) clinical studies primarily with tertiary hospitals. The company has previously considered several strategies for entering the U.S. market, including establishing a local subsidiary, acquiring an Independent Diagnostic Testing Facility (IDTF), and forming a joint venture (JV). However, it is currently placing greater emphasis on securing hospital-centered references rather than pursuing an IDTF acquisition.


Cho Sung-pil, Vice President of Mezoo, stated, “At this stage, we are conducting technology demonstrations and PoC clinical studies with local hospitals and institutions to establish a foundation for market entry. Based on the results, we plan to further define our business structure and consider various strategies such as establishing a subsidiary, partnering with distribution channels, or forming joint ventures.”


source : https://dealsite.co.kr/articles/158248

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하이카디® 시스템은 인허가에 따라 신생아, 소아, 청소년, 18세 이상 환자의 ECG 데이터를 측정하여 부정맥을 진단하는 의료기기로서 의료전문가가 사용하도록 설계되었습니다. 한국 KFDA로부터 의료기기 2등급 인증을 받았습니다. 유럽의료기기 지침(2007/47/EC에 따라 개정된 MDD 93/42/EEC)에 따라 준수된 Class IIb (CE2265). 의료기기 제품으로 CE 승인되었습니다. 미국 FDA는 Class II 510K로 승인 완료 예정입니다.

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