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Published Saturday, December 27, 2008 in Business

Device developed locally to help with treatment of tumors

By Jeff Bishop

The Newnan Times-Herald

Tumor-sufferers from all over the world may soon be getting treatment involving a cutting-edge medical tool that was developed in Newnan by CeloNova BioSciences, Inc.

CeloNova announced this week that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for Embozene Color-Advanced Microspheres for the treatment of hypervascularized tumors, which are tumors with a large number of blood vessels in many locations, and arteriovenous malformations, which are defects in the circulatory system.

U.S. commercial sales of Embozene Microspheres will begin immediately, according to company CEO Thomas A. Gordy.

"Embozene Microspheres are an innovative advance in embolic technology that has been well received outside the U.S.," said John C. Lipman, MD, Founder and CEO of the Atlanta Interventional Institute and director of the Center for Image-Guided Medicine at Emory-Adventist Hospital Atlanta. "Intuitively," he said, "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 Microspheres maintain suspension better than any other embolic I've seen," Lipman said. "I'm looking forward to using this therapy in my practice."

"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," said Gordy, president and CEO of CeloNova BioSciences, Inc.

"Then, we engineered Embozene 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."

Headquartered in Newnan, with an office on Spring Street, CeloNova BioSciences, Inc., is a developer of novel medical devices that are then enhanced with Polyzene(R)-F, which is highly lubricious, anti-inflammatory, and bacterial-resistant, Gordy said, making it an ideal surface treatment for implanted medical devices.

The company's current products include its Embozene Color-Advanced Microspheres and the CATANIA Coronary Stent System with NanoThin Polyzene(R)-F.

Other innovative devices are currently in the company's developmental pipeline, Gordy said.

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, Gordy said. The CeloNova microspheres are also available in a wider range of sizes than any other spherical embolic on the market, 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 also 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 10 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 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.

According to CeloNova, their design features distinguish Embozene Microspheres from other spherical embolics: biocompatibility, precise calibration, stable suspension, and structural stability.

Embozene Microspheres are precisely calibrated, Gordy said, in that 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.

"We're glad to get the word out to Newnan that we are here," said Gordy. "Until now, we've kind of been in 'stealth mode.'"