Reported Earlier: YD Bio Through Its Partner 3D Global Biotech, Announces Exovisse Contact Lenses Has Obtained FDA 510(k) Clearance As A Class II Medical Device, Enabling Legal Marketing In The U.S.; Its Exovisse Artificial Tears Have Been Developed In Compliance With The FDA OTC Final Monograph M018

YD Bio Limited ("YD Bio" or the "Company") (NASDAQ:YDES), a biotechnology company advancing DNA methylation-based cancer detection technology and ophthalmologic innovations, today announced that the Company has reached a set of regulatory and clinical milestones that together mark its first commercial entry into U.S. eye care and limbal stem cells ("LSC") exosome‑based therapeutics. Through its partner 3D Global Biotech Inc. ("3D Global Biotech"), Exovisse Contact Lenses have obtained FDA 510(k) clearance as a Class II medical device, enabling legal marketing in the United States. In parallel, its Exovisse Artificial Tears have been developed in compliance with the FDA OTC Final Monograph M018, permitting nationwide over‑the‑counter distribution for eye hydration and dry eye comfort without individual FDA premarket approval, and its LSC and LSC-derived exosomes has been enrolled in the FDA Drug Master File.

In plain terms, 510(k) clearance confirms the lenses are substantially equivalent to an already marketed device and can be sold in the U.S., while OTC monograph compliance confirms the artificial tears meet established safety and labeling requirements and can be marketed without case‑by‑case approval. For consumers, that means easier access to trusted solutions for comfort and clearer vision, which establishes a commercial foundation for YD Bio in ophthalmology that complements ongoing clinical development.

YD Bio and 3D Global Biotech are also planning a small clinical trial in Taiwan to evaluate dry eye disease, working with YC Biotech, a Taiwan‑based contract research organization. The Company is simultaneously advancing LSC Exosome Therapeutics through active collaboration with 3D Global Biotech, pursuing limbal stem cell–derived exosome applications via injection and eye drops for retinal and macular disorders. YD Bio has enrolled its limbal stem cells and limbal stem cell exosomes in the FDA Drug Master File, establishing quality and regulatory documentation to support future therapeutic development.