ABK Biomedical, Inc. has received FDA approval to proceed to Stage 2 of its Investigational Device Exemption (IDE) study, Route90, following a review of interim safety data from the first 16 patients in Stage 1. 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 clinical study focuses on evaluating tumor response rates and duration of response following treatment with Eye90 microspheres as co-primary endpoints. Secondary endpoints include safety assessments, intra-procedural visualization benefits, and post-treatment CT-dosimetry using imageable microspheres. Eye90 microspheres are unique as the first and only imageable Y90 microspheres device.
Expert Perspectives on Eye90 and Route90
Ammar Sarwar, MD, FSIR, Co-Principal Investigator for the Route90 study and Associate Professor of Radiology at Harvard Medical School, emphasized the study's importance: "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 potential benefits of the technology: "The novel delivery system and CT-based visualization of the microspheres are welcome evolutions to traditional Y90 radioembolization therapy."
Significance of Eye90 Microspheres
Mike Mangano, President and CEO of ABK Biomedical, highlighted the significance of the FDA approval: "This FDA approval to open Stage 2 of this pivotal study is another significant milestone for ABK... Eye90 microspheres technology was developed with key features to overcome current procedural challenges, including advanced Y90 dosimetry planning and treatment methods. The Route90 study has the potential to significantly advance the treatment paradigm and the lives of patients living with unresectable HCC."
About Hepatocellular Carcinoma (HCC)
HCC is a primary liver cancer and a significant global health challenge. Radioembolization using Y90 microspheres is a locoregional therapy used to treat unresectable HCC. The ability to visualize and perform accurate dosimetry is crucial for optimizing treatment outcomes.
ABK Biomedical's Focus
ABK Biomedical, Inc. is dedicated to the research, development, and commercialization of advanced imageable embolic medical devices. The company holds intellectual property in inorganic polymer microspheres and administration systems, with R&D and manufacturing facilities for embolotherapy products. Eye90 microspheres are currently investigational and not approved for use outside of clinical trials.
