September 27, 2016 7:05 PM 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: 74
Chairman of the Board
Age: 68
Compensation as of Fiscal Year 2016.

CeloNova Biosciences, Inc. Key Developments

CeloNova BioSciences, Inc. Enrolls First Patient in Cobra Reduce Trial for Patients at High Risk of Bleeding

CeloNova BioSciences, Inc. announced that the first patient has been enrolled in its highly anticipated COBRA REDUCE trial. The COBRA REDUCE trial recently received conditional FDA approval and will study the COBRA PzFTM nanocoated coronary stent (NCS) system in patients at high risk of bleeding. The first stent in the trial was implanted at the Northshore University Hospital, New York by Loukas Boutis, MD. Eventually, 844 patients will be enrolled in the clinical trial both in the U.S. and Europe. About one in five patients are at high risk of bleeding after stenting. Complications from bleeding after PCI occur more frequently than myocardial infarctions and have a greater impact on mortality.1 The trial will evaluate if the COBRA PzF stent, with its novel Polyzene™-F nanocoating and advanced thin-strut design, can help reduce bleeding as compared to drug eluting stents (DES), by shortening the duration of dual antiplatelet therapy (DAPT) to 14 days in patients treated with oral anticoagulation and undergoing PCI. The COBRA REDUCE trial is the second major interventional cardiology trial for CeloNova and follows a successful early enrollment completion of the PzF SHIELD IDE study last year. Positive results from the PzF SHIELD study will allow the company to complete its PMA application to the FDA for the COBRA PzF stent. These trials are part of a comprehensive clinical program studying over 2,000 patients worldwide. Previous peer-reviewed studies with over 700 patients implanted with the prior generation stent coated with the Polyzene-F nanocoating demonstrated low TLR and no stent thrombosis. The COBRA PzF stent has thin struts made of Cobalt Chromium Super Alloy and is coated with an advanced Polyzene-F nanocoating, which may reduce fibrinogen and platelet adhesion as shown in preclinical studies. Furthermore, the stent platform is designed to minimize vessel wall injury and lower inflammation as demonstrated in preclinical studies.

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.

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