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February 09, 2016 5:07 AM ET

Healthcare Equipment and Supplies

Company Overview of CeloNova Biosciences, Inc.

Company Overview

CeloNova Biosciences, Inc. develops, manufactures, and markets products based upon the properties of Polyzene. It offers Embozene Microspheres, a spherical embolic device for the treatment of neurovascular arteriovenous malformations, hepatocellular carcinoma, hypervascularized tumors, and arteriovenous malformations. The company also provides CATANIA, a coronary stent system with nanothin Polyzene for the treatment of symptomatic ischemic heart disease due to de novo and obstructive lesions of native coronary arteries. It sells its products through distributors worldwide. CeloNova Biosciences, Inc. was formerly known as IMED Devices, Inc. and changed its name to CeloNova Biosciences, Inc. i...

18615 Tuscany Stone

Suite 100

San Antonio, TX 78258

United States

Founded in 2000





Key Executives for CeloNova Biosciences, Inc.

Chief Executive Officer
Age: 73
Chairman of the Board
Age: 67
Compensation as of Fiscal Year 2015.

CeloNova Biosciences, Inc. Key Developments

CeloNova BioSciences, Inc. Receives FDA Approval to Start Randomized Trial for COBRA PzF Coronary Stent System

CeloNova BioSciences, Inc. announced that it has received conditional approval to start an investigational device exemption (IDE) trial to study the COBRA PzF coronary stent system in patients at high risk of bleeding. This multicenter, prospective, randomized trial will be referred to as the COBRA-REDUCE trial. The trial will evaluate if the COBRA PzF coronary stent, with its novel Polyzene-F nano-coating and advanced thin-strut design, can help reduce bleeding as compared to drug eluting stents, by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing PCI.

CeloNova BioSciences, Inc. Announces Enrolment of First Patient in Multicenter e-COBRA Clinical Study in France

CeloNova BioSciences, Inc. announced that it enrolled the first patient in its multicenter e-COBRA clinical study in France. This prospective registry will further assess the safety and efficacy of the novel COBRA PzF coronary stent system in real world and complex patients with heart disease. Previous preclinical and First-in-Man studies suggest that the COBRA PzF coronary stent system, with its advanced nano-coating and thin-strut design, is associated with rapid healing and re-endothelialization, and may reduce stent thrombosis and restenosis without the use of long term blood thinning medication. The e-Cobra registry is expected to enroll up to 1,000 patients from 50 centers in France. Its primary endpoint will assess the rate of MACE (cardiac death, myocardial infarction and clinically driven target lesion revascularization) at 12 months. The study is supervised by Principal Investigator Luc Maillard, MD, Director of the Department of Cardiology, Clinique Axium, Aix-en-Provence, France, with a distinguished scientific committee composed of Loic Belle, MD; Jacques Berland, MD; and Nicolas Delarche, MD.

CeloNova's Super-Selective Embolic Microsphere with Drug Loading Capabilities Could Mean Improved Quality of Life and Overall Survival for Liver Cancer Patients

CeloNova BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval to start an investigational device exemption (IDE) clinical trial for its novel ONCOZENE(TM) embolic microspheres, loaded with doxorubicin, a chemotherapy drug used in the treatment of Hepatocellular Carcinoma (HCC). HCC is the most common primary liver cancer and accounts for approximately 600,000 deaths annually on a worldwide basis. Untreated HCC patients have a median survival time of less than 12 months. CeloNova's ONCOZENE(TM) microspheres small sizes and precise calibration allow for super selective embolization combined with distal penetration which may greatly increase the chemotherapeutic impact at the tumor site, while lowering the toxicity in other parts of the body, thereby potentially improving the patient's tolerance of the treatment. CeloNova's TANDEM(TM) microspheres are available in Europe and bear the European Union's CE mark since it was granted in 2012 for embolization of HCC, with or without delivery of doxorubicin.

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