Phased Commercial Strategy Aligned with Global Platform Partnerships Woori IO is pursuing a two-phase commercialization strategy designed to balance speed, regulatory discipline, and long-term clinical ambition: The FDA has clarified that consumer wearable products providing non-medical, wellness-oriented health insights—when appropriately labeled and marketed—generally fall outside the scope of medical device pre- market review. Woori IO believes this regulatory clarity enables the Company to meaningfully ...