Global Expansion Strategy

1. H2V Rapid Test

FDA Pre-Submission in Progress (2026)
Global Launch (2027-2028)
USA

  • - Patients: ~10M (Annual New: ~1M)

  • - Partnerships & Joint PoC / Initiation of Clinical Validation

  • - FDA SaMD Submission & Approval

  • - CPT Category III - Reimbursement Code Value-Based Care Model with Insurers

Japan

  • - Super-Aged Society: 30% Population

  • - Health Management Focused on Regular Check-ups

  • - Partnerships with Health Check-up Centers

  • - Clinical Research Initiated with National & University Hospitals

  • - Market Entry via HTA(Health Technology Assessment) Exemption

  • - Global Market Expansion (2029~)

Singapore

  • - Digital Health Hub Strategy in Progress

  • - Active PoCs Linking

  • - Government - Hospitals - Insurers Pilots with Public Healthcare Institutions

  • - Leveraging as a Hub for Expansion into Southeast Asia

China

  • - Cardiovascular disease is the leading cause of death worldwide

  • - Chronic Diseases: Fastest Growth in Patient Population Clinical Data
    Acquisition through Collaboration with Tertiary Hospitals AI

  • - Medical Device Approval (Class II·III)

2. Healthcare Platform

Global Expansion (2029~)
Japan

  • - 14 Types of Senior Housing, Facilities, 56,741 Sites in Operation

  • - Emergence of Premium Senior Homes for Active Seniors
    (e.g., Parkwell State, Sakuravia Seijo)

  • - Market Entry through Partnerships with Matsui Real Estate & Daiwa
    House

China

  • - Expansion of Resort-style & Branded Premium Complexes for
    Affluent Seniors

  • - Premium Senior Communities & H2V Packages Linked with BAT
    (Baidu, Alibaba, Tencent)

  • - Commercialization Following PoC

Desired Partnership

  • Co-development with hospitals and research centers

  • Strategic investment (VC, corporate VC, pharma)

  • Distribution partnership with medical device vendors, insurers

  • Digital health platform & product collaborations
    (smartphones, AI speakers, mobility, housing, etc.)

  • Strategic localization partnerships with hospitals, insurers,
    and digital health companies in the US, Japan, Singapore,
    and China to accelerate market entry and regulatory approval