NEWNAN, Georgia, October 30 /PRNewswire/ -- CeloNova BioSciences today announced that the company is submitting to its European Notified Body a request for approval of its new, lime green, 2800 micron size Embozene(TM) Microsphere.
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Embozene(TM) Color-Advanced Microspheres are spherical embolics approved in Europe 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 use microspheres to stop bleeding before a procedure, such as the removal of a tumor, but no one to date has been able to create a microsphere that fits larger blood vessels, said Thomas A. Gordy, President and Chief Executive Officer of CeloNova. We developed this 2800 micron size to meet the needs of interventional radiologists.
In Europe, CeloNova currently offers 10 highly calibrated sizes of Embozene(TM) Microspheres in range from 40 microns to 1300 microns, making it one of the most versatile embolics in the market. The new 2800 micron size will be the largest microsphere available to physicians.
About Embozene(TM) Microspheres: Embozene(TM) Microspheres are the only microspheres to be color-enhanced with a different color for each size for increased procedural safety. They are composed of a hydrogel core and an exterior shell of Polyzene(R)-F, CeloNova's proprietary polymer which is known to be anti-inflammatory and bacterial-resistant. Embozene(TM) Microspheres have been approved by the FDA for the treatment of hypervascular tumors and arteriovenous malformations. The 75, 1100, 1300, and 2800 micron sizes are not yet available in the US.
About CeloNova BioSciences: Headquartered in Newnan, Georgia, CeloNova develops novel medical devices that are enhanced by one of the Company's proprietary materials, Polyzene(R)-F, a lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant surface treatment. The Company's current products include Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Both products are CE Marked. For more information, visit www.celonova.com.
CONTACT: Teresa Wilson CeloNova BioSciences, Inc. +1-678-895-6486 +1-770-502-0304 twilson@celonova.com
SOURCE: CeloNova BioSciences, Inc.
CONTACT: Teresa Wilson, CeloNova BioSciences, Inc., +1-678-895-6486, or+1-770-502-0304, twilson@celonova.com
