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YD Bio (Nasdaq: YDES) announced U.S. ophthalmology regulatory and clinical milestones on Nov 24, 2025 that establish its first commercial entry into U.S. eye care and advance limbal stem cell (LSC) exosome therapeutics.
Key achievements: Exovisse Contact Lenses received FDA 510(k) clearance as a Class II device; Exovisse Artificial Tears were developed in compliance with the FDA OTC Final Monograph M018 for nationwide OTC distribution; and YD Bio enrolled its LSC and LSC-derived exosomes in an FDA Drug Master File to support future therapeutics.
YD Bio (NasdaqGM: YDES) announced support for U.S. access to OkaiDx™, a cfDNA‑methylation blood test for post‑treatment breast cancer monitoring, now available through affiliate EG BioMed’s CLIA/CAP‑certified laboratory as a research‑use‑only (RUO) assay.
The company will coordinate commercialization, researcher engagement and sample logistics to enable testing for research laboratories, academic groups and industry partners. Independent validation reported 95.1% accuracy, 89.4% sensitivity and 96.5% specificity. OkaiDx™ is not FDA cleared and is not intended to diagnose, treat, cure or prevent disease.
YD Bio (Nasdaq: YDES) rang the Nasdaq Opening Bell on October 20, 2025 to mark its listing on the Nasdaq Global Market. The company said the listing strengthens its capital base, elevates its global profile and accelerates commercialization of DNA methylation cancer-detection tests and exosome-based ophthalmologic therapies.
YD Bio highlighted exclusive 20-year licenses from EG Biomed and 3D Global Biotech, plans to expand R&D and a Seattle-based CLIA and CAP certified laboratory, and indicated the listing will support product launches and long-term value for patients and investors.
YD Bio (Nasdaq: YDES) announced that its business partner EG BioMed achieved CAP accreditation for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600) on October 10, 2025. CAP accreditation, alongside existing CLIA certification, confirms laboratory quality standards and strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) supporting YD Bio’s DNA methylation-based pancreatic and breast cancer detection programs in the U.S.
YD Bio highlighted that this accreditation positions the companies to expand their diagnostic portfolio for early cancer detection and monitoring. EG BioMed’s Chief R&D Officer presented new circulating cell-free DNA biomarker findings at AACR (September 28–October 1, 2025) relevant to metastatic pancreatic cancer monitoring.
YD Bio Limited (NASDAQ:YDES) reported its H1 2025 financial results, marked by strategic developments despite financial headwinds. The company's net revenue decreased 9% to $204,007, while operating expenses increased significantly to $2.0 million, resulting in a net loss of $1.9 million.
Key developments include securing $13.2 million in PIPE financing through a business combination with Breeze Holdings, advancing DNA methylation-based cancer detection technology, and expanding into ophthalmologic innovations. The company launched a pancreatic cancer screening LDT and plans to introduce a breast cancer recurrence monitoring LDT. Additionally, YD Bio is developing corneal stem-cell and exosome-based treatments for various eye conditions, with clinical trials planned for 2027.
YD Bio Limited (NASDAQ: YDES) has successfully completed its business combination with Breeze Holdings Acquisition Corp and commenced trading on the Nasdaq Global Market. The transaction, approved on August 14, 2025, includes a PIPE offering that, combined with trust funds, will provide over $11.5 million for future operations.
Led by Chairman Dr. Ethan Shen, YD Bio focuses on three core areas: DNA methylation-based cancer detection through partnership with EG BioMed, ophthalmology therapies developed with 3D Global Biotech, and clinical trial support services. The company's cancer detection portfolio includes a pancreatic cancer screening test and an upcoming breast cancer recurrence monitoring test, while their ophthalmology program plans to initiate trials for exosome-based treatments in 2027.
YD Bio Limited (NASDAQ: YDES) has successfully completed its business combination with Breeze Holdings Acquisition Corp and will begin trading on the Nasdaq Global Market on August 29, 2025. The company secured over $11.5 million in funding through a PIPE offering and trust proceeds.
Led by Chairman Dr. Ethan Shen, YD Bio focuses on three core areas: DNA methylation-based cancer detection technology, stem cell and exosome-based ophthalmology therapies, and clinical trial support services. Key developments include a pancreatic cancer screening test available as an LDT, an upcoming breast cancer monitoring test, and planned trials for exosome-based ophthalmic treatments in 2027.
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