‘New Class’ of Coronary Stent Shows Sustained 12-Month Benefit in the Treatment of De Novo Coronary Lesions

NEWNAN, Georgia - The CATANIA(TM) Coronary Stent System with NanoThin Polyzene(R)-F offers
sustained benefit in the treatment of de novo coronary lesions and maximizes
endothelialization, while reducing restenosis, thrombogenicity, and the need
for long-term dual-antiplatelet therapy. The CATANIA(TM) Stent may be an
alternative to both BMS and DES. These conclusions, based on 12-month data
from the ATLANTA Trial, were published in the latest issue of the Journal of
the American College of Cardiology: Cardiovascular Interventions.

Photo: (www.newscom.com/cgi-bin/prnh/20090316/CL83850)
(www.newscom.com/cgi-bin/prnh/20081001/CLW080-c)
(www.newscom.com/cgi-bin/prnh/20081007/CLTU035-a)
Logo: (www.newscom.com/cgi-bin/prnh/20081001/CLW080LOGO-b)

The ATLANTA Trial is a first-in-man (FIM), prospective, single center
study involving 55 patients treated with the CATANIA(TM) Stent for
symptomatic ischemic heart disease due to de novo, obstructive lesions of
native coronary arteries. The trial was sponsored by CeloNova BioSciences,
Inc., manufacturer of the CATANIA(TM) stent.

At 12 months, in an unusually complex FIM patient population, the results
showed zero (0.0) percent stent thrombosis, death, myocardial infarction,
stroke, or coronary artery bypass graft. Target lesion revascularization was
10.9 percent (only 3.6 percent clinically driven), with a binary restenosis
rate of 6.8 percent. All patients stopped dual anti-platelet therapy after 30
days. The procedural success rate was 100 percent.

Independent laboratories analyzed coronary angiography and intravascular
ultrasound data for all patients immediately after stent implantation and at
6-months. Analysis of 19,028 struts using optimal coherence tomography in a
subset of 15 randomly selected patients revealed complete endothelialization
and 99.5 percent stent strut coverage.

“CeloNova has started a scientific revolution involving the way
physicians think about BMS and DES. I can definitely assert that
Polyzene(R)-F is innovative, effective in several aspects, unique and
striking. The polymer is, without any doubt, the main reason for the great
results we have obtained which is why I chose the CATANIA(TM) stent to
implant in my very best friend,” said Corrado Tamburino, MD, PhD, FESC,
FSCAI, FSICI-GISE, Professor of Cardiology and Chief of the Cardiovascular
Department, Ferrarotto Hospital, Catania, Italy, and lead investigator in the
ATLANTA Trial. “The 12-month ATLANTA data indicate that the CATANIA(TM) stent
with Polyzene(R)-F is truly a new and promising class of stent.”

The rapid-exchange, cobalt-chromium CATANIA(TM) stent is currently
available for sale in Europe in 60 sizes, in lengths from 8-38mm and in
diameters from 2.0-4.0mm. The CATANIA(TM) stent surface has a 35-40 nanometer
surface treatment of Polyzene(R)-F, an inorganic, biocompatible polymer that
is anti-thrombotic, anti-inflammatory, bacterial-resistant, lubricious, and
essentially cloaks the device’s presence from the body to promote healthy
endothelial cell growth without stimulating platelet activation.

“Economically, this stent has great merit, because it costs less than
DES, does away with the costs associated with long-term dual antiplatelet
therapy, and prevents repeat procedures,” said Thomas A. Gordy, President and
Chief Executive Officer of CeloNova. “The investigators found the CATANIA(TM)
stent to be flexible in even the most tortuous anatomy. The Polyzene(R)-F
surface treatment is so slick that it improves pushability and hides the
stent from the body’s defenses, which reduces platelet aggregation and the
potential for thrombosis.”

About CeloNova BioSciences, Inc.

Headquartered in Newnan, GA, USA, CeloNova develops novel surface
treatments including the Company’s proprietary material, Polyzene(R)-F, a
lubricious, anti-thrombotic, anti-inflammatory, and bacterial-resistant
coating for any implanted medical device. Polyzene(R)-F can be applied to or
mixed with other substances in thickness from less than 40 to more than 200
nanometers on polymeric, metal, and ceramic substrates for a diverse range of
customized bioscience and industrial applications. CeloNova’s current
products include Embozene(TM) Color-Advanced Microspheres and the CATANIA(TM)
Stent. The CATANIA(TM) stent is not available in the U.S. For more
information, please visit www.celonova.com.

CONTACT: Teresa Wilson
CeloNova BioSciences
+1-770-502-0304 phone
+1-678-895-6486 mobile
twilson@celonova.com

Source: CeloNova BioSciences, Inc.

Teresa Wilson, of CeloNova BioSciences, +1-770-502-0304, or mobile, +1-678-895-6486, twilson at celonova.com / PHOTO: https://www.newscom.com/cgi-bin/prnh/20090316/CL83850 , https://www.newscom.com/cgi-bin/prnh/20081001/CLW080-c , https://www.newscom.com/cgi-bin/prnh/20081007/CLTU035-a , https://www.newscom.com/cgi-bin/prnh/20081001/CLW080LOGO-b