CeloNova BioSciences Receives FDA Market Approval for Embozene(TM) Color-Advanced Microspheres Embolizatio... ( NEWNAN Ga. Dec. 16 /- CeloNova BioSci...)

CeloNova BioSciences Receives FDA Market Approval for Embozene(TM) Color-Advanced Microspheres Embolization Platform

Date:12/16/2008

NEWNAN, Ga., Dec. 16 /PRNewswire/ -- CeloNova BioSciences, Inc., announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for Embozene(TM) Color-Advanced Microspheres which are indicated for the treatment of hypervascularized tumors (tumors with a large number of blood vessels in many locations) and arteriovenous malformations (defects in the circulatory system). U.S. commercial sales of Embozene(TM) Microspheres will begin immediately.

(Photo: http://www.newscom.com/cgi-bin/prnh/20081216/CLTU022 )

(Logo: http://www.newscom.com/cgi-bin/prnh/20081001/CLW080LOGO-b )

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. They are also available in a wider range of sizes than any other spherical embolic on the market. They are available in 40 micrometers, 100 micrometers, 250 micrometers, 400 micrometers, 500 micrometers, 700 micrometers, and 900 micrometers sizes in 1 ml and 2 ml pre-filled syringes and vials. CeloNova plans to submit a supplemental 510(k) to the FDA to add three additional sizes, 75 micrometers, 1100 micrometers and 1300 micrometers, for a total of ten sizes including the smallest and the largest microspheres available for endovascular therapy. CeloNova is the only Company that provides this complete range of products.

CeloNova's Embozene(TM) Microspheres consist of a hydrogel core and an exterior shell made from Polyzene(R)-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, prec
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