Press Releases

ABK Biomedical Announces that its Eye90 microspheres® device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)

HALIFAX, Nova Scotia, December 5, 2023 – ABK Biomedical, Inc., an innovative, medical device company
dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces its Eye90 microspheres device has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation is for the proposed Eye90 microspheres indication for the treatment of patients living with unresectable Hepatocellular Carcinoma(HCC). Breakthrough designation is granted to devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved alternative exists.

“We are pleased with the FDA’s decision to grant Breakthrough Device Designation for Eye90 microspheres Y90 radioembolization device. This confirms our belief that Eye90 represents an important evolution of radioembolization technology with the potential to significantly improve patient outcomes. Our discussions with the FDA have been productive, and this designation will allow us to streamline interactions with FDA and bring this product to market in an efficient manner. We look forward to executing our Route90 trial and our continued collaboration with the FDA”, said Mike Mangano, President, and CEO of ABK Biomedical.

ABK Biomedical recently initiated enrollment in Route90, an FDA IDE approved pivotal, prospective, multicenter trial to establish the safety and efficacy of Eye90 microspheres in patients with unresectable HCC. Dr. Aravind Arepally, Chief Medical Officer of ABK Biomedical, stated, “Eye90 microspheres radioembolization marks a significant breakthrough in the treatment of HCC. This medical device allows us to leverage multi-modality imaging, facilitate controlled visual administration and offers personalized dosimetry. This gives us the opportunity to further advance the field of Y90 radioembolization. We’re excited that FDA also recognizes thte potential of ABK’s technology to improve patient outcomes.”

About FDA Breakthrough Devices Program
The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and device-led
combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), premarket notification (510(k)), or De Novo classification request (De Novo request). This program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for PMA approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

About ABK Biomedical, Inc.
ABK Biomedical is a 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

2023

October 24th 2023

ABK Biomedical Announces First Patient Treated in its Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma

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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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2022

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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2021

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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2020

March 3rd 2020

ABK Biomedical partners with the CNIC to enhance patient care

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2019

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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2018

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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MORE THAN JUST AN EMPLOYER

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.

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

T. 902.442.4009

 

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Ladera Ranch, CA, 92694
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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. Eye90 microspheres® is considered an investigational product and is NOT FDA-approved for use.

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