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September 2, 2014
FDA Expands Indication for CeloNova's Oncozene and Embozene Microspheres to Treat Liver Cancer
September 3, 2014—CeloNova BioSciences, Inc., announced US Food and Drug Administration (FDA) 510(k) clearance expanding the indication for their Oncozene and Embozene microsphere products to now include the embolization of hepatoma (hepatocellular carcinoma).
Oncozene and Embozene microspheres are precisely calibrated embolics to treat hepatomas by stopping the blood flow. The microspheres are designed to provide selectivity, precision, and consistencies to improve patient outcomes, stated the company.
Ziv J. Haskal, MD, Professor of Interventional Radiology at the University of Virginia, commented in the company’s announcement, “It’s very exciting to see a tumor-specific indication for a spherical embolic. The CeloNova microspheres offer a great potential value to my hepatoma patients.”
According to CeloNova, hepatocellular carcinoma is the sixth most common cancer in the world, the third most common cause of cancer-related death, and the leading cause of death in patients with cirrhosis in the United States and Europe.
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