ABK Biomedical Announces Enrollment Initiation of First-in-Human Clinical Study with Eye90 microspheres™ for treatment of liver tumors

ABK Biomedical, Inc., an innovative, clinical stage medical device company dedicated to the research, development and commercialization of advanced embolic therapies, announced the approval and initiation of a First-in-Human study with Eye90 microspheres™, a Y90 radioembolization device, in collaboration with Auckland Hospital Research Unit, New Zealand.

The prospective, single-center, open-label study will evaluate the safety and effectiveness of Eye90 microspheres™ in patients with unresectable hepatocellular carcinoma (HCC) or metastatic colorectal cancer (mCRC). Patients will receive a single Eye90 microspheres radioembolization treatment with follow-up visits for one year to assess safety, effectiveness, and quality of life measures.

Eye90 microspheres are radiopaque glass microspheres that are visible on x-ray and CT imaging and contain the Yttrium 90 (Y90) radiotherapeutic element. Y90 radioembolization, a local brachytherapy, is currently used to treat malignant liver tumors.  HCC is the most common primary liver cancer with over 40,000 cases annually in the US with >70% of patients diagnosed with unresectable disease. Colorectal cancer is the third most diagnosed cancer with metastatic disease (mCRC) present in up to 60% of patients at initial diagnosis.

About ABK Biomedical, Inc.

ABK Biomedical is focused on researching, developing, and commercializing breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. ABK Biomedical holds intellectual property in the areas of inorganic polymer microspheres, and unique administration systems. The company possesses advanced intellectual capital and its own R&D and manufacturing facilities for developing and commercializing unique embolotherapy products.