A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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ABK Biomedical to initiate clinical trial using Eye90 microspheres in medical treatment.

ABK Biomedical, a Canadian-based medical device company, has announced that it will be initiating a clinical trial using its Eye90 microspheres in medical treatment. The trial will be conducted in collaboration with the University of Toronto and will focus on the treatment of liver cancer.

Liver cancer is a serious and often fatal disease that affects millions of people worldwide. It is the fourth leading cause of cancer-related deaths globally, with an estimated 782,000 deaths in 2020 alone. The current treatment options for liver cancer include surgery, chemotherapy, and radiation therapy. However, these treatments can be invasive, have significant side effects, and may not be effective in all cases.

ABK Biomedical’s Eye90 microspheres offer a promising alternative to traditional treatments for liver cancer. The microspheres are small, biocompatible beads that are injected directly into the blood vessels that supply the tumor. Once inside the vessels, the microspheres release a high dose of radiation that targets the cancer cells while sparing healthy tissue.

The clinical trial will involve up to 30 patients with liver cancer who are not candidates for surgery or other traditional treatments. The patients will receive a single treatment with the Eye90 microspheres and will be monitored for up to two years to evaluate the safety and effectiveness of the treatment.

The trial is expected to begin in early 2022 and will be conducted at the Princess Margaret Cancer Centre in Toronto, one of the world’s leading cancer research centers. The study will be led by Dr. Laura Dawson, a radiation oncologist and researcher at the University of Toronto.

ABK Biomedical’s Eye90 microspheres have already been approved for use in Europe and Canada and have shown promising results in early clinical trials. The company is now seeking approval from the US Food and Drug Administration (FDA) to market the microspheres in the United States.

If successful, the clinical trial could pave the way for a new, less invasive treatment option for liver cancer patients. It could also open up new possibilities for the use of microspheres in the treatment of other types of cancer.

In conclusion, ABK Biomedical’s clinical trial using Eye90 microspheres in medical treatment is an exciting development in the fight against liver cancer. The trial has the potential to offer a safe and effective alternative to traditional treatments and could improve the quality of life for millions of people worldwide. We look forward to seeing the results of the trial and the impact it could have on cancer treatment in the future.

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