ABK Biomedical today announced its Eye90 microspheres device has received FDA breakthrough device designation.
The designation is indicated for the treatment of patients living with unresectable hepatocellular carcinoma (HCC).
“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,” CEO and President Mike Mangano said in a news release. “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.”
ABK Biomedical recently began enrollment in the Route90 pivotal, prospective multi-center trial to establish the safety and efficacy of Eye90 microspheres in patients with unresectable HCC.
“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 the potential of ABK’s technology to improve patient outcomes,” said Chief Medical Officer Aravind Arepally.