CeloNova Completes Enrollment in IDE Stent Trial

CeloNova BioSciences Inc. has finished enrolling patients in the global, multi-center investigational device exemption (IDE) trial for its Cobra PzF stent. Completed enrollment was ahead of schedule and supports submission for U.S. Food and Drug Administration (FDA) approval of the COBRA PzF stent with its nano-thin coating of Polyzene-F polymer.

“We are excited to have completed this important milestone, with the involvement of study investigators under the leadership of Principal Investigator Professor Donald Cutlip, M.D., of the Harvard Medical School in Boston, Mass., and Co-Principal Investigator Professor Sigmund Silber, M.D., Ph.D., of the University of Munich, Germany,” said Martin Landon, CEO of CeloNova BioSciences. “Completion of enrollment ahead of schedule suggests that there is very high interest in the disruptive potential of our stent.”

The company received FDA approval last March (2014) to begin an IDE trial of the Cobra PzF stent. Six months later, CeloNova released results from a First-in-Man clinical study that showed the stent to be a safe and effective routine interventional treatment for “real-world” and complex patients with heart disease. The prospective, single-center study included 100 patients, many of whom presented with multi-vessel disease, complex lesions, and co-morbidities such as diabetes, hypertension, dyslipidemia, atrial fibrillation, history of percutaneous coronary intervention, previous myocardial infarction, and other afflictions. Researchers achieved 100 percent angiographic success, according to the company. Following treatment, patients were placed on a 30-day anti-coagulant regimen of aspirin (1-2 mg/kg per day) and clopidogrel (1-2 mg/kg per day). After six months, the results showed no evidence of stent thrombosis or myocardial infarctions, one cardiac death due to terminal cardiac insufficiency and 3 percent target lesion revascularization, leading to a 4 percent major adverse coronary event.

CeloNova’s Cobra PzF coronary stent is made of cobalt chromium super alloy and is coated with an advanced nano-thin coating of polyzene-F polymer. The stent platform and the nano-coating technology are designed to resist thrombosis, inflammation and help promote healing.

“We wish to thank and congratulate the research teams in all participating centers for their hard work,” said professor Cutlip. “We anxiously await the final study results and look forward to a stent that potentially meets an unmet need for patients who are unable or unwilling to be compliant with long term dual anti-platelet therapy.”

“The Polyzene-F nano-coating may make the stent surface resistant to thrombus and may help reduce inflammation,” CeloNova Chief Technology Officer Jane Ren said. “Furthermore, the Cobra PzF stent’s advanced thin strut design may help minimize vessel wall injury, and may enable a more rapid and natural healing. We look forward to generating the data that will allow us to bring to market a product that may improve patient care while reducing cost across the full care continuum.”

Headquartered in San Antonio, Texas, CeloNova BioSciences develops, manufactures and markets interventional cardiology and endovascular products.