December 26, 2014 3:29 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: 72
Chairman of the Board
Age: 66
Compensation as of Fiscal Year 2014.

CeloNova Biosciences, Inc. Key Developments

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.

CeloNova BioSciences, Inc. Receives Expanded Indication in Liver Cancer

CeloNova BioSciences, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance expanding the indication for their innovative Oncozene(R) and Embozene(R) microsphere products to now include the embolization of Hepatoma. Hepatoma, also known as Hepatocellular Carcinoma (HCC). The FDA's clearance of Oncozene and Embozene for the embolization of Hepatoma provides support for another treatment option for physicians and patients in their battle against primary liver cancer.

CeloNova BioSciences, Inc. Receives FDA Approval to Start Investigative Device Exemption Trial for Cobra PzF(TM) Coronary Stent System

CeloNova BioSciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval to start an investigative device exemption (IDE) trial for its novel coronary stent system -- the Cobra PzF(TM) coronary stent system. Coronary stents are thin wire mesh devices used in minimally invasive heart surgery to prop open clogged blood vessels of the heart. The Cobra PzF coronary stent is made of Cobalt Chromium Super Alloy and is coated with an advanced nano-thin coating of Polyzene(R)-F polymer, which is approximately 100 times thinner than coating on currently available commercial coronary stents. Earlier generation Polyzene-F stents have been studied and results published in scientific journals. The company's Cobra PzF stent builds on this knowledge and improves on the earlier generation Polyzene-F stent technology. The IDE trial will study the Cobra PzF, Polyzene-F stent technology in patients with heart disease. It will enroll patients in multiple research centers across the United States and in Europe.

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