GmbH will launch two drug-eluting balloon (DEB) dilatation catheter
product families at next week's EuroPCR 2012 congress:
Paclitaxel-coated drug-eluting balloons for coronary (PRIMUS®)
and peripheral (LEGFLOW®) applications.
"We have developed an entirely new paradigm for selectively
supplying only the drug to an arterial lesion site," said Michael
Orlowski, M.D., CEO of Cardionovum. "Once an interventionalist has
finished the dilatation and has withdrawn the balloon, virtually all of
our drug-carrier-substance remains on the balloon itself."
With the proprietary Cardionovum gradient balloon coating technology,
nanocrystalline Paclitaxel is embedded only under the surface of the top
layer of a newly formulated shellolic acid drug-release-matrix.
Efficient drug release, reproducibility and clinically superior drug
in-tissue availability have been conclusively demonstrated in GLP
preclinical trials. (Note: shellolic acid is FDA-cleared under
category 'E 904' as a food additive. It is a natural resin, which is
often applied in the pharmaceutical industry for film-coating of pills
for control of pill dissolution.)
Preclinical testing was performed at CV Path Institute
(Gaithersburg, USA) and validated that Cardionovum's DEB coating does
not cause any noticeable micro-emboli, which classifies Cardionovum's
DEBs to be as safe as any uncoated angioplasty balloon catheter relative
to potential micro-embolies. Both safety features, integrity of the drug
coating composition and non-occurrence of micro-emboli, increase the
safety profile for operators and patients and fulfill safety
requirements of regulatory authorities.
Cardionovum holds worldwide multiple priority patent-pending rights for
its coating technology.
The Company's product pipeline includes: (1) Paclitaxel-coated
DEB, a novel drug-carrier-matrix that enables increased
drug-in-tissue concentration, which is designed to widen the therapeutic
window and result in an improved outcome for most patients with critical
limb ischemia (CLI) and diabetic foot syndrome (DFS), as well as
patients who have to undergo repeated interventions (e.g., diabetic
patients) and patients with dialysis fistula stenosis. (2)
DEB, for which it has been demonstrated conclusively in
preclinical trials that this technology overcomes the commonly known
difficulty of achieving a therapeutically effective drug-in-tissue
concentration of Sirolimus with DEB. (3) A
drug-eluting aortic valvuloplasty (DAVY) balloon catheter
featuring a new formulation for ultra-fast drug-elution in just four
seconds to the ring of the aortic valve for the treatment of patients
for whom TAVI is counter-indicated or to delay the necessity for valve
replacement by TAVI or open surgery.