ABK Biomedical has treated the first patient in its multi-centre Route90 US investigational device exemption (IDE) trial of Eye90 microspheres in hepatocellular cancer (HCC) individuals.
The Canada-based firm is engaged in the research, development, and commercialisation of advanced imageable embolic medical devices.
Eye90 microspheres is said to be the first and only in-procedure imageable Y90 microspheres device.
The Route90 clinical trial, which secured the IDE from the US Food and Drug Administration (FDA) in May 2023, is intended to assess the effectiveness and safety of Eye90 microspheres in individuals with incurable HCC.
For the co-primary endpoints, the trial will assess the response rates and duration of response resulting from Eye90 microsphere treatment in HCC tumours.
Other endpoints include the ability to perform post-treatment CT-dosimetry using imageable microspheres, the potential advantages of intra-procedural visualisation, and safety outcomes.
ABK Biomedical clinical and regulatory affairs VP David Dobrowski said: “While Y90 radioembolisation is established as a safe and effective therapy for the treatment of HCC, rigorous prospective clinical studies are needed to establish credible data to support FDA PMA approval.
“The Route90 study will collect the high-quality data long needed with Y90 radioembolisation therapy establishing a new standard of treatment.
“We’re enthusiastic to treat our first patient and continue to work diligently with the top US Y90 treatment centres and all our highly motivated investigators on enrolling patients to complete the study.”
The Eye90 microspheres radioembolisation technique was performed by Eric Wang.
Andrew Kennedy, physician in chief of radiation oncology at Sarah Cannon Cancer Institute, is the principal investigator for the Route90 trial.
Kennedy said: “The Route90 pivotal study will not only confirm the effectiveness of Eye90 treatment but will also establish the importance of 3D radiation dosimetry in advancing therapy and patient outcomes.
“This is a significant milestone for all those involved at ABK, the clinical research team at Charlotte Radiology, and the multiple other sites that are about to begin patient enrolment.”
