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Cardionovum® Poised for Rapid Commercialization of Its Drug-Coated Balloons (DCB) and Drug-Eluting Stents (DES) in 57 Countries Outside of U.S.

Company featured in IN VIVO magazine

BONN, Germany--(BUSINESS WIRE)-- Cardionovum GmbH announced today that it has established its distribution network in 57 countries since the beginning of 2012.

The Company is commercializing its CE-marked Paclitaxel-coated drug-coated balloon (DCB) for (1) coronary (PRIMUS®) and (2) peripheral (LEGFLOW®) applications since March 2012. Additionally, Cardionovum expects to launch before year-end a next-generation Sirolimus-eluting coronary stent system—PROLIMUS® Biograde, whose design combines proven pro-healing features to promote early re-endothelialization.

“We believe that Cardionovum is at the head of the class of interventional cardiology innovation,” said Michael Orlowski, M.D., CEO of Cardionovum. “We are confident about our growth prospects as we provide new clinical therapies for the successful treatment of coronary and endovascular artery diseases.”

About PRIMUS® DCB

PRIMUS represents a new-generation DCB with an innovative carrier matrix that facilitates effective transfer of paclitaxel to the arterial vessel wall. The PRIMUS DCB showed in preclinical studies at 28 days sustained fibrin deposition, an indirect measurement of drug efficacy in arterial tissue that is associated with the protection of the treated vessel wall against smooth muscle cell proliferation; whereas fibrin was absent at 28 days in control group vessels treated with another currently marketed DCB. These results support more persistent drug tissue effects with the PRIMUS DCB. Another clinically important result of the preclinical studies validated that Primus DCB dilatation, compared to DCBs that are coated with a highly water soluble drug excipient, such as contrast media/PTX mixtures and other hydrophilic/drug balloon surface coatings, did not cause any noticeable micro-emboli that may be associated with myocardial damage.

About PROLIMUS® Biograde DES

PROLIMUS Biograde is coated with Titanium, which is highly biocompatible and functions as a barrier against “metal-ion-bleeding” that prevents any stent-associated hypersensitivity reaction. Especially high-risk patients such as diabetics will benefit from Cardionovum’s “following nature” stent philosophy. The clinically anti-proliferative drug Rapamycin (Sirolimus) is coated onto PROLIMUS Biograde with a natural and biodegradable polymer. Due to the controlled, six-weeks drug release, the long-term inhibition of re-endothelialization is successfully eliminated. The new PROLIMUS Biograde DES technology promotes early re-endothelialization and rapid healing. Its pro-healing Titanium stent surface promises long-term patient safety. The entire composition of all technical elements is designed to allow for a reduction of oral antiplatelet therapy in favor of the patient´s quality of life after stenting.

About Cardionovum

Based on its breakthrough and proprietary ‘PTX’ Gradient and High Intensity “EXPRESS” balloon-coated drug transfer technology, Cardionovum has developed and is commercializing in Europe clinically advanced medical therapies that are designed to improve upon current patient treatment standards for drug-eluting stents and drug-coated balloons to treat coronary and peripheral artery disease.

NOTICE: Cardionovum’s products are not available for sale in the United States.

Cardionovum
Ida Beerhalter, +49 (0) 611 7166578
Director Corporate Affairs

Source: Cardionovum