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December 5, 2023
ABK Biomedical’s Eye90 Microspheres Granted FDA Breakthrough Device Designation
December 5, 2023—ABK Biomedical, Inc. announced that its Eye90 microspheres have been granted Breakthrough Device designation by the FDA. This designation is for a proposed indication for the treatment of unresectable hepatocellular carcinoma (HCC).
ABK Biomedical recently initiated enrollment in the prospective, multicenter Route90 pivotal trial to establish the safety and efficacy of Eye90 microspheres in patients with unresectable HCC. The company announced FDA investigational device exemption approval for the Route90 study on May 30, 2023.
“Eye90 microspheres radioembolization marks a significant breakthrough in the treatment of HCC,” commented ABK’s Chief Medical Officer Aravind Arepally, MD, in the company’s press release. “This medical device allows us to leverage multimodality imaging, facilitates 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 the potential of ABK’s technology to improve patient outcomes.”
Eye90 microspheres are an investigational product not approved for use in any regulatory jurisdiction outside of approved clinical trials, advised the company.
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