ABK Biomedical, Inc.

SHERIDAN, WYOMING - April 12, 2026 - ABK Biomedical has completed enrollment of all 120 patients in ROUTE90, its pivotal U.S. FDA Investigational Device Exemption study evaluating Eye90 microspheres® for unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer. The milestone positions the Halifax-based medical device company to finalize one-year patient follow-up, then submit a Premarket Approval (PMA) application to the FDA. Eye90 microspheres hold FDA Breakthrough Device Designation, signaling regulatory recognition of the device's potential to address an unmet clinical need in liver cancer care.