ABK Biomedical Announces FDA IDE Approval for a Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma
The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).
- The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).
- The Route90 study will evaluate HCC tumors' response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints.
- "We're motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study.
- Mike Mangano, President, and CEO, ABK Biomedical , said: "FDA approval of this pivotal study is a significant milestone for ABK.