CeloNova BioSciences Commercializes CATANIA(TM) Coronary Stent With NanoThin Polyzene(R)-F in Europe and Middle East

December 3, 2008

NEWNAN, Ga., Dec. 3 /PRNewswire/ — CeloNova BioSciences, Inc., announced
today that it has expanded the areas in which it is commercializing the
CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F — a stent
system that has not had any stent thrombosis in clinical studies. It is CE
Marked and available for purchase throughout Europe and now some Middle
Eastern countries with aggressive world-wide expansion ongoing. Concurrently,
CeloNova notes that it has received regulatory approval to increase the shelf
life for the stent from two years to three years.

(Photo: http://www.newscom.com/cgi-bin/prnh/20081203/CLW056 )

(Logo: http://www.newscom.com/cgi-bin/prnh/20081001/CLW080LOGO-b )

The CATANIA(TM) Polyzene(R)-F surface treatment is an inorganic polymer
that confers superior biocompatibility and lubricity to the substrates it
coats. The Polyzene(R)-F treated surface is anti-inflammatory, promotes quick
and complete vessel healing, reduces peri-operative and post-procedural
platelet activation, and helps to prevent tissue reactions that lead to

“After having evaluated the Polyzene(R)-F coating many years ago, it is
interesting to see this concept coming back with experimental and initial
clinical data quite encouraging toward prevention of stent thrombosis,” said

Antonio Colombo, MD, Director of the Cardiac Catheterization Laboratory at
Columbus Hospital and Chief of Invasive Cardiology at San Raffaele Hospital,
both in Milan, Italy, who recently added the CATANIA(TM) stent to his practice.

The 1-year data for the first-in-man (FIM) presented at the recent
Transcatheter Cardiovascular Therapeutics conference shows that at 12 months,
in an unusually complex FIM patient population, the results showed zero (0.0)
percent stent thrombosis (Academic Research Consortium, or ARC-defined), death,
myocardial infarction, stroke, or coronary artery bypass graft. Target lesion
revascularization was 10.9 percent (only 3.6 percent clinically driven, 7.3
percent non-clinically driven), with a binary restenosis rate of 6.8 percent
(five of 74 lesions analyzed at twelve months). Of note, all patients stopped
dual anti-platelet therapy after 30 days, but continued aspirin (100 mg/d)
throughout the 12-month period.

The acute angiographic and procedural success rate in the ATLANTA Trial
was 100 percent. Independent core laboratories analyzed quantitative coronary
angiography and intravascular ultrasound (IVUS) data for all patients
immediately after stent implantation and at 6-month follow-up. Further
analysis of 1,904 cross sections (19,028 struts) by investigators using
Optimal Coherence Tomography at baseline and again at 6-month follow-up in a
subset of 15 randomly selected patients revealed complete endothelialization
and 99.5 percent stent strut coverage.

“We agree with Albert Einstein who said that we should strive to design
solutions that are as simple as possible. The CATANIA(TM) stent, while it is
superbly engineered to include the highly developed Polyzene(R)-F, is a simple
solution to a complex problem. It has no drugs, no thick polymeric coating, no
substance to artificially stimulate cell growth, and no additives. And, it
does not force patients to take dual antiplatelet therapies for months on end,
further complicating their lives,” said Thomas A. Gordy, President and Chief
Executive Officer, CeloNova BioSciences, Inc. “The ‘CAT(TM)’ stent is an
elegant, yet simple solution to the problem of clogged arteries.”

For more information about CeloNova BioSciences, visit www.celonova.com.
To place an order for the CATANIA(TM) stent, call +1 770-502-0304 to reach
your local sales representative or e-mail info@celonova.com.

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-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. Other
innovative devices are currently in the company’s developmental pipeline. For
more information, please visit www.celonova.com.

About Polyzene(R)-F

Polyzene(R)-F is a synthesized inorganic chemical compound with an
extensive array of bioscience and industrial applications that 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.

CONTACT: Robert J. Murphy

              The Storch-Murphy Group

SOURCE CeloNova BioSciences, Inc.

Source: newswire

comments powered by Disqus