ABK Biomedical’s Eye90 Microspheres Granted FDA Breakthrough Status

ABK Biomedical, a company with a focus on advanced imageable embolic therapies, has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Eye90 microspheres device.
 
The designation covers Eye90 microspheres’ proposed indication treating unresectable Hepatocellular Carcinoma (HCC). The company recently began enrolling patients in Route90, an FDA investigational device exemption (IDE) approved pivotal trial to establish Eye90’s safety and efficacy in patients with unresectable 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. 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 ABK Biomedical’s president and CEO Mike Mangano.
 
ABK has intellectual property for inorganic polymer microspheres and unique administration systems. It has its own R&D and manufacturing facilities, as well.
 
Dr. Aravind Arepally, ABK Biomedical’s chief medical officer, added, “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.”