MANHASSET, NY – North Shore University Hospital today announced that it has enrolled the first patient in the highly anticipated COBRA REDUCE trial that recently received conditional approval from the US Food & Drug Administration to study the COBRA PzFTM nanocoated coronary stent (NCS) system in patients at high risk of bleeding.
The first stent in the trial, led by CeloNova BioSciences, Inc. (CeloNova), was implanted at Northwell Health’s North Shore University Hospital, Manhasset, NY, by Loukas Boutis, MD. Eventually, 844 patients will be enrolled in the clinical trial both in the U.S. and Europe.
“We are excited to be part of this second, very important, trial with the COBRA PzF stent. We were the highest enrolling center in the initial PzF SHIELD trial with the COBRA PzF stent and hope to repeat our achievement,” said Rajiv Jauhar, MD, chief of cardiology and director of cardiac catheterization at North Shore University Hospital.
About one in five patients are at high risk of bleeding after stenting. Complications from bleeding after percutaneous coronary intervention, or angioplasty, occur more frequently than myocardial infarctions and have a greater impact on mortality.[i] 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.
“For patients with high risk of bleeding such as those on triple therapy, the optimal duration of DAPT and type of stent are important questions,” said Adnan Kastrati, MD, professor of medicine at Deutsches Herzzentrum, München, Germany and the principal investigator of the trial. ”If the COBRA PzF stent, with its novel nanocoating, is able to reduce the duration of DAPT to only two weeks and to reduce bleeding, while maintaining parity with DES in thrombosis and restenosis, it could be a very compelling new treatment option.”
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 2000 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.
“The COBRA PzF stent is designed to satisfy the unmet market need for a device that reduces the need for long-term blood-thinning agents, but with the possibility of lower restenosis rates,” said Martin Landon, president and CEO, CeloNova Biosciences, Inc. "This study is another major milestone in providing compelling clinical evidence. With the enrollment of the first patient in this randomized trial, led by Professor Kastrati, one of the leading researchers in the world, we have taken a very important next step in demonstrating the positive patient benefits of our technology."
The COBRA PzF coronary stent system is an investigational device in the United States. The COBRA PzF coronary stent system received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013.
About CeloNova BioSciences, Inc.
CeloNova BioSciences, Inc., is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene F technology for patients with cardiovascular disease. For additional information about CeloNova BioSciences, please visit the company website at http://celonova.com/
About North Shore University Hospital
One of the cornerstones of Northwell Health, North Shore University Hospital is a 764 bed teaching hospital that provides a full spectrum of clinical health care services, including a world-class cardiothoracic surgery and cardiology programs. It offers a wide range of specialty and subspecialty residency programs, postgraduate training programs and clinical fellowships for research and education. The hospital is an academic campus of the Hofstra Northwell School of Medicine, and employs more than 6,000 highly trained physicians, nurses and other medical staff.
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