July 26, 2017 11:24 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

Phone:

210-489-4007

Fax:

210-403-2008

Key Executives for CeloNova Biosciences, Inc.

Chief Executive Officer
Age: 75
Chairman of the Board
Age: 69
Compensation as of Fiscal Year 2017.

CeloNova Biosciences, Inc. Key Developments

CeloNova BioSciences, Inc. Receives FDA Approval of COBRA PzF™ Stent System

CeloNova BioSciences, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval of its first-in-class COBRA PzF NanoCoated Coronary Stent System. Regulatory approval of the stent system was based on findings from the pivotal PzF SHIELD clinical trial, which successfully met its primary safety and effectiveness endpoints at 9-month follow-up, demonstrating no stent thrombosis and low clinically driven target lesion revascularization (TLR) of 4.6%. Coated with a proprietary nano-thin polymer that is designed to be highly biocompatible, the COBRA PzF stent requires a minimum 30-day dual antiplatelet therapy (DAPT) regimen following intervention. The COBRA PzF stent is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of 24mm. COBRA PzF combines a unique, highly deliverable cobalt chromium platform design with a proprietary Polyzene-F nano-thin polymer. When tested in pre-clinical studies, the ultra-pure, nano-thin characteristics of Polyzene-F nanocoating have shown thrombo-resistant, anti-inflammatory and rapid healing effects.

Celonova Biosciences, Inc. Announces Clinical Results from Pivotal PzF SHIELD Clinical Trial

CeloNova Biosciences, Inc. announced the publication of primary endpoint results from its global, multicenter PzF SHIELD clinical trial evaluating the first-in-class COBRA PzF™ NanoCoated Coronary Stent. In the study, the COBRA PzF stent met pre-specified performance goals for both the primary endpoint of target vessel failure and the secondary endpoint of angiographic late lumen loss at 9-months post-intervention. The trial was conducted under an investigational device exemption from the U.S. Food and Drug Administration (FDA). As the first nanocoated stent to ever be evaluated in clinical trials in the United States, the COBRA PzFstent combines a unique, highly deliverable cobalt chromium platform design with a biocompatible Polyzene™-F nano-thin polymer. Currently, the company is further studying the COBRA PzF stent in the COBRA REDUCE trial. This randomized controlled trial will evaluate the safety and efficacy of the COBRA PzF stent to reduce the need for long-term dual antiplatelet therapy in patients to 14 days who are at high-risk for bleeding and require treatment for coronary artery disease.

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 PzF™ 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.

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