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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 sizesthan any other spherical embolic on the market. They are available in 40micrometers, 100 micrometers, 250 micrometers, 400 micrometers, 500micrometers, 700 micrometers, and 900 micrometers sizes in 1 ml and 2 mlpre-filled syringes and vials. CeloNova plans to submit a supplemental 510(k)to the FDA to add three additional sizes, 75 micrometers, 1100 micrometers and1300 micrometers, for a total of ten sizes including the smallest and thelargest microspheres available for endovascular therapy. CeloNova is the onlyCompany that provides this complete range of products.
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CeloNova's Embozene(TM) Microspheres consist of a hydrogel core and anexterior shell made from Polyzene(R)-F, CeloNova's proprietary polymer whichis known to be anti-inflammatory and bacterial-resistant. Four design featuresdistinguish Embozene(TM) Microspheres from other spherical embolics:biocompatibility, precise calibration, stable suspension, and structuralstability. Embozene(TM) Microspheres are precisely calibrated, they retaintheir shape after passing through a catheter, and they can stay in suspensionfor an extended time. The unique color enhancement of the microspheres andfinely calibrated sizes make selection easy, efficient, and precise for theoperator. The result is an embolic microsphere that provides accurate andcomplete vessel occlusion.
Embolization is a minimally invasive procedure used to control or preventabnormal bleeding, to shrink tumors by blocking the blood vessels that supplythem, and to block off blood vessel malformations. Physicians use enhancedimaging techniques to visualize the blood vessel, then insert and advance acatheter to the treatment site. The embolic agent is then released into thecatheter and positioned within the blood vessel or malformation to block thetarget vessel permanently.
"Embozene Microspheres are an innovative advance in embolic technologythat has been well received outside the U.S.," said John C. Lipman, MD, FSIR,Founder and CEO of the Atlanta Interventional Institute and Director of theCenter for Image-Guided Medicine at Emory-Adventist Hospital Atlanta."Intuitively, a polymer that is anti-inflammatory and that provides morefinely calibrated bead sizes, shape integrity, prolonged suspension, and has aunique color-coded selection system that makes for more efficient procedures,will appeal to physicians as well as patients. Embozene(TM) Microspheresmaintain suspension better than any other embolic I've seen," said Dr. Lipman."I'm looking forward to using this therapy in my practice."
"From the outset, we took a different approach to developing ourEmbozene(TM) Microspheres by asking physicians and medical scientists for thequalities and characteristics that the ideal embolic device should have," saidThomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences,Inc. "Then, we engineered Embozene(TM) Microspheres to have those properties,which are made even better with Polyzene(R)-F, our proprietary polymer.Polyzene(R)-F helps make our leading-edge technology better."
For more information about CeloNova BioSciences, visit www.celonova.com.To place an order for Embozene(TM) Microspheres, call 888-388-3888 to reachyour local sales representative or e-mail [email protected].
About CeloNova BioSciences, Inc.
Headquartered in Newnan, near Atlanta, Georgia, CeloNova BioSciences, Inc.,is a developer of novel medical devices that are then enhanced by one of theCompany's proprietary materials, Polyzene(R)-F. Polyzene(R)-F is highlylubricious, anti-inflammatory, and bacterial-resistant making it an idealsurface treatment for implanted medical devices. The Company's currentproducts include its Embozene(TM) Color-Advanced Microspheres and theCATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Otherinnovative devices are currently in the company's developmental pipeline. Formore information, please visit www.celonova.com.
About Polyzene(R)-F
Polyzene(R)-F is a synthesized inorganic chemical compound with anextensive array of bioscience and industrial applications that can be appliedas a surface coating ranging in thickness from less than 50 nanometers to morethan 200 nanometers. The polymer can be applied to or mixed with othersubstances to allow for a diverse range of applications on a multitude ofsubstrates, including other polymers, metals and ceramics. Polyzene(R)-F canbe customized for the desired application and applied in a variety of waysincluding as a coating, extrusion, weaving, or electro-spinning. The basesubstrate will be endowed with the properties of the polymer.
CONTACT: Robert J. MurphyThe Storch-Murphy Group 908-276-0777
SOURCE CeloNova BioSciences, Inc.
