First Time in Human Study

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

HALIFAX, Nova Scotia, Nov 1st, 2021 – 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 US1 with >70% of patients diagnosed with unresectable disease2. Colorectal cancer is the third most diagnosed cancer with metastatic disease (mCRC) present in up to 60% of patients at initial diagnosis3.

“The ABK team has worked tirelessly over the past three years to bring our technology to patients suffering from HCC and mCRC liver tumors,” said Mike Mangano, President and CEO of ABK Biomedical. We are pleased to partner with Dr. Andrew Holden and the team at Auckland Hospital to be the first to treat patients in New Zealand with Eye90 microspheres™. Our Eye90 microspheres™ device is designed with key advancements over the currently marketed Y90 radioembolization therapies with the goal of improving the physician experience and patient outcomes. Eye90 microspheres™ combine in-procedure, tumor-targeting visualization of radiopaque microspheres, and an advanced delivery system allowing physician control of administration, with the proven clinical benefits of Y90 radioembolization therapy.”

Andrew Holden, MD, MBChB, FRANZCR, EBIR, ONZM, study principal investigator, “We are enthusiastic to partner with ABK Biomedical to conduct this important First-in-Human clinical study. We are eager to evaluate the advancements of the Eye90 device and report on the initial safety and efficacy for the treatment of HCC and mCRC liver tumors.”

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.

Contacts

ABK Biomedical, Gary Donofrio, 617-513-9575, g.donofrio@abkbiomedical.com

1: American Cancer Society. Cancer Facts and Figures, 2021. 2: Van Thai et al, BMC Gastroenterology, 2021. Efficacy and safety of selective internal radiation therapy with Y90 for the treatment of unresectable HCC. 3: Van Cutsem E, et al, Ann Oncology, 2014. ESMO working group metastatic colorectal cancer: ESMO Clinical Practice guidelines for diagnosis, treatment and follow-up.

 

 

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ABK Biomedical Inc. provides and continues to provide accurate information on its website. However, ABK Biomedical Inc. assumes no responsibility for the accuracy and/or completeness, express or implied, as to the information contained or omitted and/or the products described. Furthermore, ABK Biomedical Inc. may change the products mentioned, and their stage in development, at any time without notice. ABK Biomedical Inc. is a clinical-stage company engaged in the research and development of new medical devices. ABK Biomedical inc. products are considered investigational products and are NOT FDA approved for use. Y90 radioembolization

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