Newnan Based CeloNova BioSciences Receives FDA Market Approval

/PRNewswire/ -- CeloNova BioSciences, Inc., announced December 16 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.

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, precise calibration, stable suspension, and structural stability. Embozene(TM) 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.

Embolization is a minimally invasive procedure used to control or prevent abnormal bleeding, to shrink tumors by blocking the blood vessels that supply them, and to block off blood vessel malformations. Physicians use enhanced imaging techniques to visualize the blood vessel, then insert and advance a catheter to the treatment site. The embolic agent is then released into the catheter and positioned within the blood vessel or malformation to block the target vessel permanently.

"Embozene Microspheres are an innovative advance in embolic technology that 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 the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta. "Intuitively, a polymer that is anti-inflammatory and that provides more finely calibrated bead sizes, shape integrity, prolonged suspension, and has a unique color-coded selection system that makes for more efficient procedures, will appeal to physicians as well as patients. Embozene(TM) Microspheres maintain 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 our Embozene(TM) Microspheres by asking physicians and medical scientists for the qualities and characteristics that the ideal embolic device should have," said Thomas 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."

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