The FDA has granted the designation for the proposed indication of the Eye90 microspheres in the treatment of patients with unresectable hepatocellular carcinoma
FDA grants breakthrough device status to ABK Biomedical’s Eye90 microspheres device. (Credit: Piron Guillaume on Unsplash)
ABK Biomedical has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Eye90 microspheres device.
The FDA has granted the designation for the proposed indication of the Eye90 microspheres in the treatment of patients with unresectable hepatocellular carcinoma (HCC).
Eye90 microspheres is a new technology for radioembolisation made with the company’s proprietary, imageable glass composition for in-procedure visualisation through fluoroscopy, X-ray, and CT imaging modalities.
The investigational device is focused on the minimally invasive Y90 radioembolisation therapy, which is also known as Trans-arterial Radiation Therapy (TARE) or Selective Internal Radiation Therapy (SIRT).
Eye90 is manufactured at ABK Biomedical’s manufacturing and clean-room facility in Halifax, Nova Scotia, Canada. The company is engaged in developing and commercialising imageable embolic therapies.
ABK Biomedical president and CEO Mike Mangano said: “We are pleased with the FDA’s decision to grant Breakthrough Device Designation for Eye90 microspheres Y90 radioembolisation device.
“This confirms our belief that Eye90 represents an important evolution of radioembolisation 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 company has recently started recruitment for the Route90 trial, which is an FDA investigational device exemption (IDE) approved pivotal prospective multicentre study.
The goal of the trial is to determine the safety and effectiveness of Eye90 microspheres in patients with unresectable HCC. In October 2023, ABK Biomedical treated the first patient in this trial.
ABK Biomedical is involved in the research, development, and marketing of medical device therapies to enhance patient outcomes and the quality of life of patients with benign and malignant hypervascular tumours.
The firm has its own production and research and development facilities, as well as advanced intellectual capital, which it uses to create and market embolotherapy solutions.