YD Bio Limited Announces U.S. Ophthalmology Market Entry, Advances Across Diagnostics and LSC Exosome Therapeutics

Core Insights - YD Bio Limited has achieved significant regulatory and clinical milestones, marking its first commercial entry into the U.S. eye care market with exosome-based therapeutics [1][4] - The Exovisse Contact Lenses have received FDA 510(k) clearance as a Class II medical device, allowing for legal marketing in the U.S. [1][2] - Exovisse Artificial Tears have been developed in compliance with the FDA OTC Final Monograph M018, enabling nationwide over-the-counter distribution [1][2] Regulatory Achievements - The 510(k) clearance confirms that Exovisse Contact Lenses are substantially equivalent to an already marketed device, facilitating their sale in the U.S. [2] - Compliance with the OTC monograph for Exovisse Artificial Tears ensures they meet established safety and labeling requirements, allowing for marketing without individual FDA premarket approval [2] Clinical Development - YD Bio and 3D Global Biotech are planning a small clinical trial in Taiwan to evaluate dry eye disease, collaborating with YC Biotech [3] - The company is advancing LSC Exosome Therapeutics through collaboration with 3D Global Biotech, focusing on applications for retinal and macular disorders [3] Strategic Vision - The achievements signify YD Bio's transition from laboratory innovation to patient-ready products, establishing a commercial foundation in ophthalmology [4] - The company aims to provide everyday eye care products in the U.S., indicating a pragmatic path from development to revenue in a high-demand market [4] Company Overview - YD Bio Limited is focused on advancing clinical trials, new drug development, and therapies for diseases with high unmet medical needs [5] - The company is committed to improving patient outcomes through scientific innovation and precision medicine, and has expanded into the development and distribution of post-market auxiliary products [5]