ABK Biomedical Completes Enrollment in ROUTE90 Pivotal Study for Primary Liver Cancer

Final Patient Treated in FDA IDE Study Evaluating Eye90 microspheres® for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)

HALIFAX, NS, Feb. 24, 2026 /PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced imageable embolic medical devices, today announced the completion of patient enrollment in its pivotal U.S. FDA Investigational Device Exemption (IDE) study, ROUTE90. The study evaluates Eye90 microspheres®, a novel Yttrium-90 (Y90) radioembolization device, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer.

Eye90 microspheres, previously granted FDA Breakthrough Device Designation, are designed to treat unresectable liver tumors with enhanced control, visualization, and personalized dosimetry (defined as dose targeted for day of treatment without decay and based on individual patient and tumor anatomy).

The Route90 study (https://clinicaltrials.gov/study/NCT05953337) is an international, prospective, Phase III, open label, multi-center study designed to evaluate the effectiveness and safety of Eye90 microspheres in 120 patients.  The co-primary endpoint is confirmed Overall Response Rate (ORR) and Duration of Response (DoR). Enrolled patients are followed for 1 year post treatment.

Ammar Sarwar, MD, FSIR, Professor of Radiology, Chief of Interventional Radiology of UPMC and Andrew S. Kennedy, MD, FACRO, Physician-in-Chief of HCA Healthcare Sarah Cannon Cancer Network, serve as co-principal investigators of the study. "Route90's keen attention to advanced dosimetry and personalized treatment planning will generate new data to advance HCC care. Completion of Route90 represents a milestone in radioembolization history with the introduction of imageability, a streamlined delivery system, and trial execution", Dr. Sarwar said.  Dr. Kennedy commented, "We are excited to have completed this trial in record time.  This landmark TARE study is the largest prospective FDA IDE trial conducted for Y90 treatment of HCC".

"Completing ROUTE90 enrollment is a defining milestone in the evolution of ABK," said Mike Mangano, President and CEO of ABK Biomedical. "Eye90 microspheres were designed to provide treating physicians a better device offering visualization, control, ease of use, with and potentially higher certainty of clinical outcomes.  We are excited to complete patient follow up, submit our PMA for FDA approval, and share these data with the world.  We're grateful for the robust support our investor syndicate provided, enabling us to execute the highest quality prospective study in Y90 radioembolization".

Aravind Arepally, MD, FSIR, Chief Medical Officer of ABK Biomedical, added: "For over 20 years, clinicians have driven improvements in Y90 treatment outcomes despite limited device technical innovation. This pivotal 120-patient study, combined with the technological leap represented by Eye90, positions us to meaningfully provide and improve treatment options for patients with HCC." David Dobrowski, Sr. VP, Clinical Devel. & Regulatory Affairs of ABK Biomedical added, "We would like to thank our physician and research partners, clinical teams, and the 120 patients who participated in this historic study.  Without them, this would not be possible.  We are that much closer to providing this technology to patients in the United States. The quality of data coming from ROUTE90 promises to shape Interventional Oncology practice for years to come."

About ABK Biomedical, Inc.

ABK Biomedical is dedicated to researching, developing, and commercializing advanced embolic therapies to improve outcomes for patients with benign and malignant hypervascular tumors. The company holds significant intellectual property in inorganic polymer microspheres and proprietary administration systems and operates its own R&D and manufacturing facilities. Eye90 microspheres® is investigational and not approved for commercial use outside of authorized clinical trials.

SOURCE ABK Biomedical Inc.