ABK Biomedical, a Halifax-based medical device company, has received FDA approval to advance its groundbreaking clinical trial for Eye90 microspheres, a new treatment technology designed to help patients with liver cancer. The approval marks a key milestone in the company’s efforts to transform the landscape of liver cancer treatment, specifically for those suffering from unresectable Hepatocellular Cancer (HCC).
The FDA’s approval allows ABK to move into Stage 2 of its Route90 clinical study, a multi-center, pivotal trial that aims to assess the safety and efficacy of Eye90 microspheres. The technology, which is the first and only imageable Y90 microsphere device, is designed to improve the precision of Y90 radioembolization, a procedure that treats liver cancer by delivering radiation directly to tumors. Eye90’s unique feature—its ability to be visualized during and after treatment—could be a game-changer for doctors and patients alike.
The Route90 trial will focus on measuring the response rates of tumors to Eye90 treatment, as well as how long those responses last. The study will also track key safety outcomes and explore the technology’s potential to enhance dosimetry planning and procedural accuracy, crucial factors in successful liver cancer treatment.
ABK’s progress is being closely watched by experts in the field. Dr. Ammar Sarwar, a prominent radiology professor at Harvard Medical School, is co-principal investigator for the Route90 study. Sarwar, who is well-known for his research in Y90 therapy, sees the trial as a crucial step toward setting a new standard in liver cancer care. “This study could fill important gaps in the current research, and Eye90 microspheres could become a cornerstone of treatment for patients with unresectable HCC,” he said.
The approval to proceed to Stage 2 comes after a review of the initial safety data from the first 16 patients enrolled in the study’s first stage. While the full results of Stage 1 are not expected until later in the trial, the initial data gave the FDA enough confidence to allow ABK to expand the trial.
Dr. Eric A. Wang, a radiologist at Charlotte Radiology and another investigator in the trial, believes the technology could significantly improve the current standard of care. “With Eye90, we now have the potential to visualize and track the microspheres in real-time, something that was never possible before,” said Wang. “This could provide better treatment planning and ultimately improve patient outcomes.”
For ABK Biomedical, this FDA approval is more than just a regulatory win—it’s a sign that their technology could dramatically change the future of liver cancer treatment. “This is a monumental step forward not only for ABK but for patients with unresectable HCC,” said Mike Mangano, President and CEO of ABK Biomedical. “The potential of Eye90 microspheres to enhance treatment accuracy and improve outcomes could make a real difference in the lives of many patients.”
The Route90 study, now entering its next phase, could help establish Eye90 as the new standard in Y90 radioembolization, providing doctors with a tool that offers both precision and visibility in treating one of the most challenging forms of cancer. As ABK Biomedical moves forward, the company is poised to make a lasting impact on the field of interventional oncology and offer new hope to patients facing an otherwise bleak diagnosis.