Wednesday, May 31, 2023
ABK Biomedical, an innovative medical device company specializing in advanced imageable embolic medical devices, has received FDA approval for its Investigational Device Exemption (IDE) application. This approval allows ABK Biomedical to conduct a multi-center pivotal clinical study in the United States for their Eye90 microspheres yttrium-90 (Y90) radioembolization therapy. The study, named Route90, aims to evaluate the safety and effectiveness of Eye90 microspheres in treating patients with unresectable Hepatocellular Carcinoma (HCC).
The primary endpoints of the Route90 study include assessing response rates and the duration of response of HCC tumors to Eye90 microspheres treatment. Notably, Eye90 microspheres is the first imageable Y90 microspheres device available. The study will also evaluate safety, intra-procedural visualization benefits, and the capability to perform post-treatment CT-dosimetry with imageable microspheres.
Dr. Andrew Kennedy, an esteemed radiation oncologist and a pioneer in Y90 radioembolization research and treatment, will serve as the Principal Investigator for the Route90 study. Dr. Kennedy expressed enthusiasm about the study, highlighting the significant technological advancement that Eye90 microspheres brings to Y90 radioembolization therapy.
ABK Biomedical's Chief Medical Officer, Dr. Aravind Arepally, stated that the initial results from a recent first-in-man study conducted in New Zealand were highly encouraging, with an excellent safety profile and robust tumor response rates. This success further motivates the company to proceed with the pivotal Route90 study, which is expected to provide valuable insights through a well-controlled and well-designed study.
Mike Mangano, President and CEO of ABK Biomedical, considers FDA approval of the pivotal study as a significant milestone for the company. He commended the ABK team's dedication in developing the unique technology of Eye90 microspheres, ensuring manufacturing and supply-chain efficiencies, establishing robust quality assurance processes, and actively engaging regulatory bodies for guidance. Mangano believes that the Route90 study has the potential to transform the treatment of patients with unresectable HCC by aligning with advanced Y90 treatment methods and appropriately targeting patient populations.