ABK Biomedical Announces FDA IDE Stage 2 Approval for Route90, a Prospective, Multi-Center, Pivotal Study of Eye90 microspheres® in unresectable Hepatocellular Cancer

HALIFAX, NS, Nov. 19, 2024 /PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, has received FDA approval to advance its Investigational Drug Exemption (IDE) study into its pre-planned, Stage 2 enrollment cycle. This FDA approval is based upon their review and assessment of interim safety outcomes from the first 16 patients treated in Stage 1 of the Route90 pivotal study.

The pivotal Route90 clinical study is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Cancer (HCC). The study will evaluate HCC tumors' response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints. The study also includes endpoints to evaluate safety, the potential benefits of intra-procedural visualization, and the ability to perform post treatment CT-dosimetry with imageable microspheres. Eye90 microspheres is the first and only imageable Y90 microspheres device.

Ammar Sarwar, MD, FSIR, Associate Professor, Radiology, Harvard Medical School, serves as Co-Principal Investigator for the Route90 study 1. Dr. Sarwar is one of the leading physicians in Y90 radioembolization research and publications advancing Y90 therapy for benefit of liver cancer patients. "I'm grateful to co-lead and collaborate on this important study.  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."

"Our clinical team is excited and motivated to continue enrollment in this pivotal study and to evaluate the Eye90 microspheres technology in a large well-designed prospective clinical trial.  While the data from Stage 1 of this study will not be revealed until the end of the trial, our assessment is that the novel delivery system and CT-based visualization of the microspheres are welcome evolutions to traditional Y90 radioembolization therapy", says investigator Eric A. Wang, MD, FSIR, Charlotte Radiology, Charlotte, NC.  

Mike Mangano, President and CEO, ABK Biomedical, said: "This FDA approval to open Stage 2 of this pivotal study is another significant milestone for ABK.  Our continued collaboration with the FDA has been instrumental in ensuring our ability to provide this new therapy to patients with HCC.  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.  The Route90 study has the potential to significantly advance the treatment paradigm and the lives of patients living with unresectable HCC."

About ABK Biomedical Inc.

ABK Biomedical is a clinical-stage development company focused on researching, developing, and commercializing medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors. ABK Biomedical holds intellectual property in the areas of inorganic polymer microspheres and unique administration systems. The company possesses  advanced intellectual capital and its own R&D and manufacturing facilities for developing and  commercializing unique embolotherapy products. Eye90 microspheres are considered investigational products and are not approved for use in any regulatory jurisdiction outside of approved clinical trials.

SOURCE ABK Biomedical Inc.