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2026.01.21
[Mezoo IPO] Securities Registration Statement Filed on the 20th, March Listing Expected

Mezoo, a company specializing in mobile ambulatory remote patient monitoring (aRPM) solutions, is set to file its securities registration statement on the 20th and enter the full-scale public offering process for its KOSDAQ listing. Barring any unforeseen issues, trading is expected to begin on the KOSDAQ market in late March.

 

Market sentiment is considered favorable for proceeding with the public offering. Prior to filing the securities registration statement, Mezoo’s flagship product, HiCardi, received approval for a new reimbursement code from the Health Insurance Review and Assessment Service, creating opportunities for further market expansion. In addition, investor interest is expected to be strong, as a remote patient monitoring company that went public in 2024 has been valued at approximately KRW 1.6 trillion.

 

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In 2020, HiCardi became the first wearable device to be approved for reimbursement under the “bedside ECG monitoring” (E6544) code. Since then, it has been stably operated in real clinical environments for over five years, accumulating large-scale real-world evidence (RWE). This accumulated RWE has demonstrated HiCardi’s reliability and sustainability, forming the basis for obtaining the EX871 reimbursement code.

 

EX871 applies to patients at high risk of arrhythmia who require real-time surveillance or continuous monitoring of treatment effectiveness. While bedside ECG monitoring (E6544) is limited to patients confined to a bed, EX871 requires real-time monitoring even when patients are ambulatory during outpatient visits or hospitalization.

 

Notably, unlike conventional products that transmit data collected via patches to separate software for analysis, Mezoo has obtained regulatory approval for the device itself as a patient monitoring system. This is expected to enable the company to rapidly secure market leadership and further accelerate revenue growth. Mezoo’s revenue increased from KRW 1.4 billion in 2022 to approximately KRW 8.0 billion last year. The HiCardi series is currently used in more than 600 medical institutions, including over half of Korea’s tertiary general hospitals.


 

Source : https://www.thebell.co.kr/free/content/ArticleView.asp?key=202601191516319320103637

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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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