CeloNova BioSciences To Showcase The CE-Marked CATANIA(TM) Coronary Stent System Featuring NanoThin Polyzene(R)-F At TCT Debut

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology
Article Date: 07 Oct 2008 - 1:00 PDT

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CeloNova BioSciences, Inc. today announced that it will showcase the technology behind the CATANIA(TM) Coronary Stent System featuring a NanoThin Polyzene(R)-F surface treatment during the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium sponsored by the Cardiovascular Research Foundation October 12-17. The CATANIA(TM) Coronary Stent System carries a CE Mark and is currently available for sale outside the United States.

The CATANIA(TM) stent surface has been modified with highly lubricious Polyzene(R)-F, a synthesized, inorganic, biocompatible polymer that is anti-thrombotic, anti-inflammatory, bacterial-resistant, and essentially cloaks the device's presence from the body to promote healthy endothelial cell growth without stimulating platelet activation. This unique combination of stent and surface treatment effectively creates a new and different stent option, one that offers many of the clinical benefits of drug-eluting stents (DES), while addressing some of the significant ongoing concerns with DES technology such as potential for thrombosis and challenges associated with costly long-term dual anti-platelet therapy following treatment, including patient compliance, bleeding risks, drug intolerance and product cost.

"CeloNova is excited to introduce our Company, its technology, and its philosophy to attendees at TCT," said Thomas A. Gordy, President and Chief Executive Officer, CeloNova BioSciences, Inc. "Beginning with the First-In-Man data presentation from the ATLANTA study during the Innovative Devices and Futuristic Therapies session during the October 13 Stent Summit, we intend to show the world that the concept of tit-for-tat commercial incremental improvements in angioplasty is passe. With physician input, CeloNova has created a new class of stent that represents a different and clear choice for physicians."

CeloNova will also host a breakfast symposium, "The CATANIA(TM) Coronary Stent with NanoThin Polyzene(R)-F: A New Stent Paradigm," Wednesday, October 15 from 6:30 to 8:00 AM, chaired by Roxana Mehran, MD, Columbia University Medical Center and The Cardiovascular Research Foundation, and including investigators Drs. Corrado Tamburino, Thierry Corcos, and Francesco Prati. A distinguished panel of experts will comment on the CeloNova technology including Drs. Antonio Colombo, George Dangas, Barry Katzen, Julio Palmaz, Augusto Pichard, Goetz Richter (pre-clinical subject expert), and Renu Virmani.

The proprietary nanothin Polyzene(R)-F polymer featured on the CATANIA(TM) stent can be applied to or mixed with other substances to allow for a diverse range of bioscience and industrial applications on a multitude of substrates, including other polymers, metals, and ceramics. Medical devices coated with Polyzene(R)-F do not cause a negative reaction in the body when introduced, eliciting a normalized and positive bodily response. Polyzene(R)-F can be customized for the desired application and applied in a variety of ways including as a coating, extrusion, weaving, or electro-spinning ranging in thickness from less than 40 nanometers to more than 200 nanometers. The base substrate will be endowed with the properties of the polymer.

The rapid-exchange, cobalt-chromium CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F is available in 60 sizes: in lengths from 8mm to 38mm, and in eight diameters from 2.0-4.0mm.

CeloNova also carries a CE Mark for Embozene(TM) Color-Advanced Microspheres, the world's first spherical embolic device specifically designed with direct feedback from physicians and scientists for the treatment of neurovascular arteriovenous malformations, uterine fibroids, hepatocellular carcinoma, hypervascularized tumors, and arteriovenous malformations. Embozene(TM) Microspheres with Polyzene(R)-F are available in nine sizes from 40 micrometers to 1300 micrometers and offer all of the advantages of spherical particles with additional design features built on four principles: biocompatibility related to Polyzene(R)-F, precise calibration, stable suspension, and structural stability.

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 the Company's proprietary materials, Polyzene(R)-F. Polyzene(R)-F is highly lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant making it an ideal surface treatment for implanted medical devices. The Company's current products include its Embozene (TM) Color-Advanced Microspheres and the CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F. Neither product is currently approved for use in the United States. Other innovative devices are currently in the company's developmental pipeline.

CeloNova BioSciences, Inc.

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