CeloNova BioSciences, Inc., today announced U.S. Food and Drug Administration (FDA) 510(k) clearance expanding the indication for their innovative Oncozene® and Embozene® microsphere products to now include the embolization of Hepatoma. Hepatoma, also known as Hepatocellular Carcinoma (HCC), 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 Europe1. Oncozene® and Embozene® microspheres are precisely calibrated embolics to treat Hepatomas by stopping the blood flow.
“CeloNova is committed to providing the best treatment options for patients with liver cancer,” said Jane Ren, Ph.D., Senior Vice President and Chief Technology Officer of CeloNova. “Oncozene and Embozene microspheres are designed to provide selectivity, precision and consistencies with the goal of supporting our physicians to improve patient outcomes.”
Ziv J. Haskal, M.D., a tenured Professor of Interventional Radiology at the University of Virginia, commented, “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.”
“The FDA’s clearance of Oncozene and Embozene for the embolization of Hepatoma provides support for another treatment option for physicians and patients in their battle against primary liver cancer,” said Martin J. Landon, President and CEO of CeloNova. “This clearance marks an industry first and represents another milestone in our journey to improve patient lives and become a leader in this space through the development of innovative technologies that help change the practice of medicine.”
About the Company
CeloNova BioSciences, Inc., headquartered in San Antonio, Texas, is a global medical device company that develops, manufactures and markets a family of Interventional Cardiology and Endovascular products. Our products are developed and manufactured in Carlsbad, California, U.S.A. and Ulm, Germany. The Company’s regional offices are located in Germany, France, United Kingdom, Netherlands and Austria. For additional information about CeloNova BioSciences, see the company website at www.celonova.com.
References:
1. Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005;55:74–108.
