ABK Biomedical has secured the Investigational Device Exemption (IDE) application from the US Food and Drug Administration (FDA) to start the Route90 trial for its Eye90 microspheres yttrium-90 (Y90) radioembolisation therapy in the US.
Eye90 microsphere is an investigational product and is said to be the first and only imageable Y90 microsphere device.
Route90 is a multi-centre clinical study, designed to assess the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).
ABK Biomedical, a Canadian medical device company, said that the study will evaluate the HCC tumours’ response rates and duration of response from Eye90 microspheres therapy as co-primary endpoints.
Additionally, the Route90 trial includes endpoints to assess the safety and potential benefits of intra-procedural visualisation. The endpoints will also evaluate the ability to perform post-treatment CT dosimetry with imageable microspheres.
ABK Biomedical president and CEO Mike Mangano said: “FDA approval of this pivotal study is a significant milestone for ABK.
The ABK team has worked tirelessly to develop this unique technology.
“We have created extensive manufacturing and supply-chain efficiencies, established robust quality assurance in all our processes, and collaboratively engaged regulatory bodies for proper guidance. We believe this will become a seminal study for treating patients with unresectable HCC.
“We designed our Y90 radioembolisation technology to align with the most recent, advanced Y90 treatment methods, techniques, and appropriate patient populations. This has the promise to significantly improve outcomes for targeted patients living with unresectable HCC.”
In November 2021, the company enrolled patients in the clinical study with Eye90 microspheres for the treatment of liver tumours in collaboration with New Zealand’s Auckland Hospital Research Unit.
In December last year, ABK raised $30m in a Series C financing round to support the IDE approval.
