ABK Biomedical's Eye90 Microspheres Receives FDA Clearance to Advance Pivotal HCC Trial

Key Insights

• ABK Biomedical has received FDA approval to advance its Route90 IDE study into Stage 2, following a review of safety outcomes from the initial 16 patients.
• The Route90 pivotal study evaluates the safety and efficacy of Eye90 microspheres in treating unresectable Hepatocellular Carcinoma (HCC).
• Eye90 microspheres is the first and only imageable Y90 microspheres device, potentially setting a new standard for HCC radioembolization with personalized dosimetry.

ABK Biomedical, Inc. has received FDA approval to proceed to Stage 2 of its Investigational Device Exemption (IDE) study, Route90, following a positive review of interim safety data from the first 16 patients. The Route90 study is a prospective, multi-center pivotal trial designed to assess the safety and efficacy of Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC).

The Route90 trial will evaluate the response rates and duration of response of HCC tumors following treatment with Eye90 microspheres, serving as co-primary endpoints. Secondary endpoints include safety assessments, the benefits of intra-procedural visualization, and the ability to conduct post-treatment CT-dosimetry using the imageable microspheres. Eye90 microspheres are the first and only imageable Y90 microspheres device.

Expert Perspectives

Ammar Sarwar, MD, FSIR, Associate Professor of Radiology at Harvard Medical School and Co-Principal Investigator for the Route90 study, stated, "This rigorously designed, prospective, multi-center pivotal trial should help illuminate missing data points in the Y90 radioembolization space. This study seeks to establish Eye90 microspheres therapy in conjunction with advanced personalized dosimetry and best treatment practices as a new standard for HCC radioembolization."

Eric A. Wang, MD, FSIR, an investigator at Charlotte Radiology, noted, "The novel delivery system and CT-based visualization of the microspheres are welcome evolutions to traditional Y90 radioembolization therapy."

Significance of Eye90 Microspheres

Eye90 microspheres are designed to address existing challenges in Y90 radioembolization, including advanced Y90 dosimetry planning and treatment methods. The Route90 study aims to significantly improve the treatment paradigm and outcomes for patients with unresectable HCC.

Company Statement

Mike Mangano, President and CEO of ABK Biomedical, said, "This FDA approval to open Stage 2 of this pivotal study is another significant milestone for ABK... We believe this is a monumental study in the field of interventional oncology for treating patients with unresectable HCC. Eye90 microspheres technology was developed with key features to overcome current procedural challenges, including advanced Y90 dosimetry planning and treatment methods."