Skip to content

FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment


ABK Biomedical successfully secured Breakthrough Device Designation from the FDA on December 5, 2023, for its Eye90 microspheres device, which is indicated for the treatment of unresectable Hepatocellular Carcinoma (HCC). The FDA’s Breakthrough Device Program is designed to speed up the development, assessment, review for premarket approval, 510(k) clearance, and de novo marketing authorization of medical devices “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” This program replaces the FDA’s Expedited Access Pathway and Priority Review for medical devices. Clearance of the Eye90 device was supported by ABK Biomedical’s recently initiated Route90 trial, an FDA Investigational Device Exemption-supported multicenter trial. The trial evaluated tumor response rates and the duration of response in patients living with unresectable HCC from treatment with Eye90 microspheres. The Route90 study follows a previous study performed on the Eye90 product conducted in New Zealand, which provided encouraging results. In its announcement, Mike Mangano, President, and CEO of ABK Biomedical said:

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.

The Halifax-headquartered ABK Biomedical was founded in 2012 at Dalhousie University by Dr. Robert Abraham, Dr. Daniel Boys, and Sharon Kehoe. The company develops and commercializes therapies directed to treatment of benign and malignant hypervascular tumors using a platform built on “x-ray visible” glass microspheres. The company has previously received FDA 510(k) clearance for its EasiVue embolic microspheres medical device product. The EasiVue product is designed for the treatment of patients with arteriovenous malformations and hypervascular tumors. According to Dr. Aravind Arepally, Chief Medical Officer of ABK Biomedical, the approval of Eye90 provides the opportunity for ABK Biomedical to further advance the field of Y90 radioembolization. Receiving Breakthrough Device Designation is expected to allow ABK Biomedical to bring the Eye90 product to market in an efficient manner.



, , , ,

FDA Clears ABK Biomedical’s Eye90 Microspheres for Hepatocellular Carcinoma Treatment Headshot

Matthew Ruth

Matthew Ruth’s practice focuses on global patent prosecution and intellectual property portfolio management. He is also experienced with issues involving U.S. regulatory governance and antitrust.

Matthew assists clients in a range of technical fields including artificial intelligence, clean energy, electrical engineering, and electromechanical devices.

Matthew received his J.D. from the Sandra Day O’Connor College of Law at Arizona State University, where he worked with the Center for Law, Science, and Innovation on matters relating to the governance of emerging environmental technologies and artificial intelligence. Matthew also served as Senior Executive Editor of Jurimetrics, The Journal of Law, Science and Technology. During law school, Matthew worked with small business clients handling employment and IP contracting through the Innovation Advancement Clinic. He also worked as an advocate for small businesses in Washington D.C. on matters relating to antitrust, data privacy, and patents in the year prior to graduation. Upon graduation, Matthew received the Strouse Prize recognizing his contributions to the Law, Science, and Technology program at Arizona State.

Before attending law school, Matthew worked as an independent consultant specializing in geographic data analysis and interned as a telecommunications engineer.

Matthew joined the firm in 2022.

View all posts published by Matthew Ruth
By using this blog, you agree and understand that no information is being provided in the context of any attorney-client relationship. You further agree and understand that nothing herein is intended to be legal advice. This blog is solely informational in nature, and is not intended as, and should not be used as, a substitute for competent legal advice from a retained and licensed attorney in your state. Knobbe Martens LLP makes no representations or warranties as to the accuracy, completeness, timeliness or availability of the information in this blog. Knobbe Martens LLP will not be liable for any injury or damages relating to your use of, or access to, any such information. Knobbe Martens LLP undertakes no obligation to correct or update information on this blog, which may be incorrect or become incorrect or out of date over time. Knobbe Martens LLP reserves the right to alter or delete content or information on the blog at any time. This blog contains links and references to other websites and publications that you may find of interest. Knobbe Martens LLP does not control, promote, endorse or otherwise have any affiliation with any other websites or publications unless those websites or publications expressly state such an affiliation. Knobbe Martens LLP further has no responsibility for, and makes no representations regarding, the content, accuracy or any other aspect of the information in such websites or publications.
close modal