ROUTE90 Pivotal Study of ABK’s Eye90 Microspheres for Primary Liver Cancer Completes Enrollment

February 25, 2026—ABK Biomedical, Inc. announced the completion of patient enrollment in the ROUTE90 pivotal study evaluating the company’s Eye90 microspheres, an yttrium-90 (Y90) transarterial radioembolization (TARE) device for the treatment of hepatocellular carcinoma (HCC). The study is being conducted under an FDA investigational device exemption (IDE).

According to ABK Biomedical, the ROUTE90 IDE trial is an international, prospective, phase 3, open-label, multicenter study designed to evaluate the effectiveness and safety of Eye90 microspheres in 120 patients. The coprimary endpoints are confirmed overall response rate and the duration of response. Enrolled patients will be followed for 1 year post treatment.

Ammar Sarwar, MD, and Andrew S. Kennedy, MD, serve as Coprincipal Investigators of the study. Dr. Sarwar is Professor of Radiology, Chief of Interventional Radiology of UPMC in Pittsburgh, Pennsylvania. Dr. Kennedy is Physician-in-Chief of HCA Healthcare Sarah Cannon Cancer Network in Nashville, Tennessee.

“Route90’s keen attention to advanced dosimetry and personalized treatment planning will generate new data to advance HCC care,” commented Dr. Sarwar in the company’s press release. “Completion of Route90 represents a milestone in radioembolization history with the introduction of imageability, a streamlined delivery system, and trial execution.”

Dr. Kennedy added, “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.”

The company stated that Eye90 microspheres are designed to treat unresectable liver tumors with enhanced control, visualization, and personalized dosimetry, which the company defines as “dose targeted for day of treatment without decay and based on individual patient and tumor anatomy.” In December 2023, the company announced that Eye90 microspheres were granted FDA Breakthrough Device designation.