CeloNova BioSciences' Embozene Microspheres receives approval

CeloNova BioSciences, Inc. has received approval from its European regulatory body, the British Standards Institution, to expand the list of medical indications for which Embozene(TM) Microspheres may be used and to add a tenth size of the product.

In Europe, Embozene(TM) Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumors of the head, neck, torso, and skeletal system; for bleeding and trauma, including nosebleeds; and for reducing the amount of bleeding before any surgery other than in the central nervous system. "Physicians throughout Europe, in Japan, the Middle East, and the United States have used Embozene(TM) Microspheres successfully to treat a variety of conditions. Physicians report that patients have less pain, speedy recovery, and are back to their regular activities sooner," said Thomas A. Gordy, President and chief Executive Officer of CeloNova BioSciences. "With the addition of a 75 micron microsphere, CeloNova now has three distinct sizes of Embozene(TM) Microspheres for physicians to use in the smallest blood vessels. With ten sizes that range from 40 microns to 1300 microns, this product is the most versatile in the market."

Embozene(TM) Microspheres are tiny, round, hydrogel beads with a coating of CeloNova's unique polymer, Polyzene®-F. The smallest ones cannot be detected by the naked eye while the largest beads are only 1300 microns (one-twentieth of an inch) in diameter. A specially trained physician, an interventional radiologist, injects them inside a blood vessel to stop the blood supply to a tumor or where there is unwanted bleeding. This minimally invasive treatment, called embolization, often replaces surgery.