Press Releases

ABK Biomedical Announces FDA IDE Approval for a Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma


HALIFAX, Nova Scotia, May 30, 2023 – ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, has received approval for its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA) to commence a multi-center pivotal clinical study in the United States for its Eye90 microspheres yttrium-90 (Y90) radioembolization therapy.

The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC). The Route90 study will evaluate HCC tumors’ response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints. Eye90 microspheres is the first and only imageable Y90 microspheres device. The study also includes endpoints to evaluate safety, the potential benefits of intra-procedural visualization, and the ability to perform post-treatment CT-dosimetry with imageable microspheres.

Andrew Kennedy, MD, FACRO, Physician in Chief of Radiation Oncology at Sarah Cannon Cancer Institute will serve as Principal Investigator for the Route90 study. Dr. Kennedy is one of the early pioneers of Y90 radioembolization research and treatment. “I’m excited to participate and lead the Route90 study. Eye90 microspheres is a significant and meaningful technology advancement to Y90 radioembolization therapy not seen in over almost two decades since the current therapies became clinically available,” said Dr. Kennedy.

“We’re motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study. We continue to build upon the results of our first-in-man Eye90 microspheres study conducted recently in New Zealand. The initial results from this study are highly encouraging with an excellent safety profile and robust tumor response rates”, said Aravind Arepally, MD, FSIR, ABK Biomedical’s Chief Medical Officer.

Mike Mangano, President, and CEO, ABK Biomedical, said: “FDA approval of this pivotal study is a significant milestone for ABK. The ABK team has worked tirelessly to develop this unique technology. We have created extensive manufacturing and supply-chain efficiencies, established robust quality assurance in all our processes, and collaboratively engaged regulatory bodies for proper guidance. We believe this will become a seminal study for treating patients with unresectable HCC. We designed our Y90 radioembolization technology to align with the most recent, advanced Y90 treatment methods, techniques, and appropriate patient populations. This has the promise to significantly improve outcomes for targeted patients living with unresectable HCC”.

About ABK Biomedical Inc.

ABK Biomedical is a clinical-stage development company focused on researching, developing, and commercializing 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. Eye90 microspheres is considered an investigational product and is not approved for use in any regulatory jurisdiction outside of approved clinical trials.


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Press Release Archive


May 30th 2023

ABK Biomedical Announces FDA IDE Approval for a Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma

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December 6th 2022

ABK Biomedical Raises USD 30M in Series C Funding

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September 12th 2022

ABK Biomedical announces FDA 510(k) clearance of Easi-Vue™ embolic microspheres for the embolization of arteriovenous malformations and hypervascular tumors

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April 19th 2022

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

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November 1st 2021

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

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March 3rd 2020

ABK Biomedical partners with the CNIC to enhance patient care

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April 8th 2019

ABK Biomedical Inc. Raises $30M USD in Series B Financing

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February 13th 2019

New Strategic Partnership with the University of Missouri Research Reactor Center (MURR®)

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July 31st 2018

ABK Biomedical Inc. Appoints Michael J. Mangano as President and CEO

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February 22nd 2018

ACOA Announces $3M in Support to ABK for Easi-Vue Embolization Microspheres

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The ABK Biomedical Team

We are dedicated to encouraging a stimulating work environment offering an opportunity to significantly expand experience and skills by researching, developing, and commercializing cutting-edge medical device technologies with a mandate to effectively treat cancer.

ABK Biomedical is an equal opportunity employer offering competitive compensation packages.

Corporate Offices

Halifax Office (Main Office)
155 Chain Lake Drive
Unit 32
Halifax, NS B3S 1B3

T. 902.442.4009


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555 Corporate Drive 
Suite 105
Ladera Ranch, CA, 92694

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. Eye90 microspheres® is considered an investigational product and is NOT FDA-approved for use.

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