CANADA — Canadian medical technology company ABK Biomedical has achieved a significant milestone with the US Food and Drug Administration (FDA) granting breakthrough device designation for its pioneering Eye90 microspheres device.
The breakthrough designation specifically recognizes the potential of Eye90 microspheres in treating patients with unresectable hepatocellular carcinoma (HCC), marking a crucial step toward advancing innovative radioembolization therapies.
Eye90 microspheres represent a cutting-edge technology for radioembolization, designed with ABK Biomedical’s proprietary, imageable glass composition.
This unique feature enables real-time visualization during procedures through fluoroscopy, X-ray, and CT imaging modalities.
The investigational device is strategically focused on Y90 radioembolization therapy, also known as Trans-arterial Radiation Therapy (TARE) or Selective Internal Radiation Therapy (SIRT).
Manufactured at ABK Biomedical’s state-of-the-art facility in Halifax, Nova Scotia, Canada, Eye90 is positioned as a pivotal player in the realm of imageable embolic therapies.
The breakthrough designation from the FDA reflects the potential of Eye90 microspheres to bring about a substantial improvement in patient outcomes.
Strategic move toward market accessibility
ABK Biomedical President and CEO, Mike Mangano, expressed satisfaction with the FDA’s decision, emphasizing the significance of Eye90 in advancing radioembolization technology.
He stated, “This confirms our belief that Eye90 represents an important evolution of radioembolization technology with the potential to significantly improve patient outcomes.”
Mangano further highlighted the positive implications of the breakthrough designation, enabling streamlined interactions with the FDA and expediting the path to market for Eye90.
The company looks forward to executing its Route90 trial, an FDA investigational device exemption (IDE) approved pivotal prospective multicenter study.
ABK Biomedical has initiated recruitment for the Route90 trial, a critical step in assessing the safety and effectiveness of Eye90 microspheres in patients with unresectable HCC.
The trial, designed as a pivotal prospective multicenter study, aims to provide valuable insights into the potential of Eye90 as an advanced therapeutic option for HCC patients.
The company treated its first patient in the Route90 trial in October 2023, marking a significant milestone in its commitment to advancing medical solutions for hypervascular tumors.
The company’s focus extends to both benign and malignant hypervascular tumors, with Eye90 microspheres positioned as a flagship product in its portfolio.