ABK Biomedical Concludes Patient Enrollment in Pivotal ROUTE90 Study for Liver Cancer Treatment

ABK Biomedical CompletesEnrollment in ROUTE90 Pivotal Study for Primary Liver Cancer

ABK Biomedical, Inc., a pioneering medical device company, has officially announced that it has completed the enrollment of patients in its ROUTE90 pivotal study. This study is crucial as it evaluates the effectiveness of Eye90 microspheres®, a newly developed Yttrium-90 (Y90) radioembolization device targeted at treating hepatocellular carcinoma (HCC), which is the predominant type of primary liver cancer affecting countless patients worldwide.

Eye90 microspheres, recognized for their innovative design and previously granted FDA Breakthrough Device Designation, are engineered to tackle unresectable liver tumors with enhanced features, including improved control, visualization, and personalized dosimetry, which ensures that the targeted dose remains consistent throughout the treatment.

The ROUTE90 study is structured as an international, prospective Phase III open-label trial, enrolling 120 patients across multiple centers. The co-primary endpoints of this study include tracking the Overall Response Rate (ORR) and the Duration of Response (DoR). After receiving treatment, patients will be monitored for an entire year to assess the long-term effectiveness and safety of the Eye90 microspheres.

Notably, prominent figures in the medical community are leading this groundbreaking research. Dr. Ammar Sarwar, a Professor of Radiology and Chief of Interventional Radiology at UPMC, and Dr. Andrew S. Kennedy, Physician-in-Chief of the HCA Healthcare Sarah Cannon Cancer Network, serve as co-principal investigators for the ROUTE90 study. Dr. Sarwar stated, "ROUTE90’s focus on advanced dosimetry and individualized treatment plans is poised to generate vital data that will reshape HCC care. Completing this trial represents a remarkable milestone in the history of radioembolization."

Dr. Kennedy added, "We are thrilled to have completed this pivotal trial in record time. ROUTE90 marks the largest prospective FDA IDE trial conducted specifically to evaluate Y90 treatment for HCC." This excitement echoes the sentiments of countless stakeholders eager to see the emerging data.

Mike Mangano, ABK Biomedical’s President and CEO, expressed his enthusiasm regarding the recent developments, stating, "Successfully completing enrollment in ROUTE90 signifies a key milestone in the evolution of ABK. The Eye90 microspheres are specifically designed to empower treating physicians with a superior device that enhances visualization, control, and ease of use, potentially leading to improved clinical outcomes. We are eagerly looking forward to the completion of patient follow-ups, submitting our PMA for FDA approval, and sharing the significant findings globally. We owe a great deal of gratitude to our investor syndicate for their unwavering support that made this high-caliber prospective study possible."

Furthermore, Dr. Aravind Arepally, ABK Biomedical’s Chief Medical Officer, emphasized the technological advancements signaled by Eye90 and the robust impact of this pivotal study. "For over two decades, clinicians have made strides in Y90 treatment outcomes amid a scarcity of technological innovations. This study, coupled with the breakthrough presented by Eye90, positions us in a strong place to significantly enhance treatment options available to patients dealing with HCC."

David Dobrowski, Sr. VP for Clinical Development and Regulatory Affairs at ABK Biomedical, extended his appreciation to the physician partners, clinical teams, and the 120 patients who participated in this landmark study, highlighting that without their commitment, this endeavor wouldn’t have been attainable. He concluded by stating, "The high-quality data generated from ROUTE90 is set to influence Interventional Oncology practices for years to come."

About ABK Biomedical, Inc.

ABK Biomedical is committed to the research, development, and commercialization of advanced embolic therapies aimed at improving patient outcomes for both benign and malignant hypervascular tumors. With a wealth of intellectual property surrounding inorganic polymer microspheres and proprietary administration systems, ABK operates its own dedicated research, development, and manufacturing facilities. It is important to note that Eye90 microspheres are still investigational and have not received approval for commercial use outside of relevant clinical trials.