SAN ANTONIO--(BUSINESS WIRE)--CeloNova BioSciences, Inc. (CeloNova) announced today its key activities at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) Annual Congress, which will take place October 29 – November 2 in Washington, D.C. Preliminary clinical data, including primary endpoint, from the COBRA PzF NanoCoated Coronary Stent development program will be presented. Additionally, pre-clinical data comparing tissue response characteristics of the COBRA PzF NanoCoated Coronary Stent to leading polymer-based drug eluting stents will be presented in a poster session.
As the first nanocoated stent to ever be evaluated in clinical trials in the United States, the COBRA PzF stent combines a unique cobalt chromium platform design with a biocompatible Polyzene-F nano-thin polymer.
“The unveiling of our preliminary data findings from our novel Polyzene-F core clinical development program represents a significant milestone as we work to transform the treatment of cardiovascular disease,” said Dennert Ware, interim CEO and Executive Chairman of the Board of CeloNova. “Our currently enrolling COBRA REDUCE trial is evaluating the potential to reduce the need for long-term dual antiplatelet therapy for patients who are at high-risk for bleeding but require treatment for coronary disease.”
The following COBRA PzF presentations will take place at TCT 2016:
Virtual Didactic Session: Next Generation Metallic Drug Eluting Stents and Dedicated Devices
- Session 1: Metallic Platforms With Durable Permanent Polymers
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Presentation: Can Passive Coatings Make a Difference: Results With
the COBRA PzF NanoCoated Coronary Stent
- Monday, October 31 from 8:00 a.m. – 8:51 a.m. ET
- Location: Room 305, Level 3
Prof. Dr. Sigmund Silber, MD, from the Heart Center at the Isar in Munich, will present primary endpoint results from the PzF SHIELD trial comparing the COBRA PzF NanoCoated Coronary Stent to conventional bare metal stent performance. This presentation will take place from 8:22 a.m. – 8:29 a.m. ET.
Corporate-Sponsored Satellite Program: Rethink DAPT: Optimizing PCI in high-bleeding risk patients with the COBRA PzF NanoCoated Stent (NCS)
- Tuesday, November 1 from 11:30 a.m. – 12:30 p.m. ET
- Location: Presentation Theatre 2
Don Cutlip, MD, Director, Cardiac Catheterization Laboratory in The Cardiovascular Institute at Beth Israel Deaconess Medical Center, and Professor of Medicine at Harvard Medical School, will present primary findings from the PzF SHIELD trial as well as provide an update on enrollment of the COBRA REDUCE Trial. This latter trial, which began enrollment in February, is evaluating whether the COBRA PzF NanoCoated Coronary Stent can help reduce bleeding as compared to drug eluting stents, by shortening the duration of DAPT to 14 days in patients treated with oral anticoagulation and undergoing percutaneous coronary intervention (PCI). CeloNova’s comprehensive clinical program consists of approximately 4,000 patients worldwide, including 2,000 patients treated with the first generation of PzF stents.
The didactic symposium will feature other renowned faculty members from across the globe, including Robert Byrne, MD, from the German Heart Center Munich in Munich, Germany; Aloke Finn, MD, from CV Path Institute in Gaithersburg, MD; and Rajiv Jauhar, MD, from North Shore University Hospital in Manhasset, NY.
Abstract 2589: Endothelial Cell Coverage and Inflammation Comparing COBRA Polyzene-F (PzF) Coated Stent to Durable Fluoropolymer and Biodegradable Polymer Drug-Eluting Stents in a Rabbit Model
- Presented by Drs. Kazuyuki Yahagi and Renu Virmani from CV Path Institute in Gaithersburg, MD
- Saturday, October 29 from 6:00 – 8:00 p.m. ET
- Location: Exhibit Hall, Level 2
About the COBRA PzF NanoCoated Coronary Stent
The COBRA PzF NanoCoated Coronary Stent, the first nanocoated stent to ever be evaluated in clinical trials in the United States, combines a unique highly deliverable cobalt chromium platform with a Polyzene-F nano-thin polymer. Polyzene-F nanocoating is a proprietary, ultra-thin polymer that is designed to be durable, elastic and biocompatible, acting as a barrier between metal, blood and circulating elements. The COBRA PzF NanoCoated Coronary stent received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013. It is currently an investigational device and not approved for sale in the United States.
About CeloNova BioSciences
CeloNova BioSciences, Inc., is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next-generation nanocoating is the result of years of rigorous scientific research and German-engineering, and has been extensively published in numerous academic articles to date. For additional information about CeloNova BioSciences, please visit the company website at http://celonova.com/.
COBRA PzF, PzF, and Polyzene are trademarks of CeloNova BioSciences, Inc.
Forward-looking statements contained in this press release are based on estimates and assumptions of CeloNova management and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made. We do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied based on a number of factors, including but not limited to, unexpected clinical trial timing and outcomes, results of expanded clinical experience and unanticipated impacts of regulatory decisions.
