Minimally Invasive Device Approved To Treat Liver Cancer, Fibroids, Tumors, And Bleeding

Main Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 14 Oct 2009 - 1:00 PST

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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.

About Embozene(TM) Microspheres

Embozene(TM) Microspheres are the first and only microspheres to be color-enhanced with a different color for each size for increased procedural safety, efficiency, and visibility. CeloNova's Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene®-F, CeloNova's proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Four design features distinguish Embozene(TM) Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability.

About CeloNova BioSciences, Inc.

Headquartered in Newnan, Georgia, CeloNova BioSciences, Inc., is a developer of novel medical devices that are enhanced by one of the Company's proprietary materials, Polyzene®-F, a lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant surface treatment for implanted medical devices. The Company's current products include Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene®-F. Both products are CE Marked. Embozene(TM) Microspheres have been approved by the FDA for the treatment of hypervascular tumors and arteriovenous malformations.

Source: CeloNova BioSciences, Inc.