First U.S. implants of Embozene color-advanced microspheres embolization technology



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Against the backdrop of a flagging economy, bailouts, and bleak predictions, there is a biotechnology firm in suburban Atlanta with a future as bright as New Year’s Eve fireworks.

Only days after receiving FDA approval to market the Embozene Color-Advanced Microspheres embolization platform 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), CeloNova BioSciences today announced that the product has been successfully used to treat several patients at two Atlanta area hospitals: Emory-Adventist Hospital in Smyrna and WellStar Windy Hill Hospital in Marietta.

Dr. John Lipman, who performed the procedures at both hospitals, said, “I was really impressed with the Embozene Color-Advanced Microspheres. The material handled well, going immediately into suspension and, importantly, staying in suspension. The fact that Embozene Microspheres are color coded to size is an appealing feature that allows good visibility of the material and clearly creates a higher and important safety profile. CeloNova has apparently carefully engineered these beads to be extremely ‘friendly’ for the physician to use. I found in these first patients that the product was highly manageable during the procedure. I achieved the procedural goals to devascularize the tumors quickly, using much less material than other products, having far less radiation time for the patient, and requiring less contrast media. These are all important and present features.”

Embozene 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, 100, 250, 400, 500, 700, and 900 micron sizes in 1 ml and 2 ml pre-filled syringes and vials.

CeloNova’s Embozene 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 Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability. Embozene Microspheres are precisely calibrated, they retain their shape after passing through a catheter, and they can stay in suspension for an extended time. The unique color enhancement of the microspheres and finely calibrated sizes make selection easy, efficient, and precise for the operator. The result is an embolic microsphere that provides accurate and complete vessel occlusion.

“Dr. Lipman is a recognized leader in embolization therapy and we are extremely pleased that he was the first U.S. physician to implant our newly approved Embozene Microspheres with such wonderful results,” said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. “From the outset, we took a different approach to developing our Embozene Microspheres by asking physicians and medical scientists for the qualities and characteristics that the ideal embolic device should have. Then, we engineered in those properties physicians wanted and engineered out those properties that physicians did not want. Embozene Microspheres are made even better with Polyzene-F, our proprietary polymer. Polyzene-F helps make our leading- edge technology better.”

http://www.celonova.com/

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