CeloNova BioSciences, Inc.: Pioneers at the Forefront of Innovation
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Jason Cone, CEO Over the past 20 years, CeloNova BioSciences, Inc. has developed a rich history of medical innovation with over 100 patents in the U.S. and worldwide. This foundation of innovation has led to the successful manufacturing and marketing of a family of products based upon its proprietary Polyzene-F (PzF) nanocoating technology, a revolutionary surface coating designed to optimize implant interaction within the body.
Through its commitment to PzF innovation, CeloNova is transforming clinical practice and promoting positive outcomes in patients around the world. To date, CeloNova has successfully commercialized and sold its PzF coated drug-eluting microspheres (Embozene TANDEM® and ONCOZENE™), designed to deliver chemotherapy drugs to treat a variety of cancerous tumors, to Boston Scientific in 2015 and is in the early stages of commercializing the COBRA PzF NanoCoated Coronary Stent (NCS), a new category of stent designed to safely and effectively treat patients who may benefit from 1-month of dual antiplatelet therapy (DAPT).
Polyzene-F: A Distinctly Superior Surface Coating
Polyzene-F is a proprietary, ultra-pure, highly-elastic and biocompatible surface coating that is designed to optimize implant interaction with living tissue on a cellular and molecular level. The polymer possesses unique mechanical properties that, for the first time ever, allow an implant to be covered with a coating that has a nanoscale thickness of ≤0.05 μm.
"Our dedication to ongoing innovation is woven into the fabric of CeloNova’s culture, impacting every aspect of our business"
The PzF polymer coating has been extensively studied over the past 20+ years, consistently demonstrating thromboresistance, anti-inflammatory properties and rapid healing effects. Such clinical effects are achieved through a process called passivation where albumin, a healthy protein found in the blood, preferentially binds to PzF, preventing the unhealthy protein fibrinogen from forming and subsequent platelet adhesion and activation. The result is an implant that mimics the normal tissue, paving the way for faster, higher-quality healing post-implant.
“We believe that Polyzene-F is preparing the way for an entirely new class of implantable medical devices that hold tremendous clinical value to physicians and their patients. We are now seeing its impact particularly within the coronary stent market, where balancing post-procedural medication, also known as dual antiplatelet therapy, is associated with greater risk of complications in patients at higher risk of bleeding,” stated Mark Bates, MD, DSC, FACC, FSCAI, Director of the CAMC Cardiovascular Medicine Fellowship and Senior Scientist for Cardiovascular Research, and Chairman of the Board at CeloNova BioSciences.
The outcome of the COBRA REDUCE trial could revolutionize the practice of medicine; positioning COBRA PzF NCS as the standard of care
“We now have a PzF-coated implant that is able to safely and effectively treat patients with 1-month DAPT. We are excited by its promising early clinical results and look forward to exploring PzF’s unique healing properties with even shorter, 14-day DAPT with the COBRA REDUCE trial.”
Recently published preclinical findings showed that COBRA PzF NCS demonstrated superior thromboresistance, significantly greater strut coverage at 14 days and higher functioning endothelium at 28 days compared to market-leading drug-eluting stents (DES). These compelling results offer additional evidence of COBRA PzF NCS’ superior healing properties and its potential clinical benefit to high bleeding risk patients.
A Game-Changing New Coronary Stent
Finding the right DAPT balance is particularly challenging for interventional cardiologists performing percutaneous coronary intervention (PCI). Historically, physicians have been faced with the binary decision between DES and bare metal stents (BMS). However, DES, which account for 80-90 percent of coronary stent placements, require a recommended 3-12+ months of DAPT due to delayed healing of the stent. This leaves the stent exposed within the artery for a longer period of time, which can increase the risk of stent thrombosis and major cardiovascular complications post-PCI. While DAPT is beneficial to reducing clotting post-implant, it is acknowledged that prolonged DAPT leads to a greater risk of bleeding and mortality.
High bleeding risk patients, who cannot tolerate prolonged DAPT, have traditionally received BMS followed by 1-month DAPT despite a higher restenosis risk compared to DES. With few short-DAPT treatment options available for this patient population, a growing number of physicians are turning their attention to COBRA PzF NCS, an entirely new category of nanocoated stent that offers a safe and effective alternative to DES with the short DAPT duration of BMS.
COBRA PzF NCS, coated with Polyzene-F, is the world’s first and only non-DES, non-BMS that allows physicians to both safely and effectively treat patients with short, 1-month DAPT. The novel stent combines a unique thin strut, 71 microns cobalt chromium platform with the PzF nanothin polymer for optimal stent performance and exceptional deliverability through challenging coronary anatomy. Over 20,000 patients worldwide have been commercially treated to-date with COBRA PzF NCS.
COBRA PzF NCS’ first and second generation have been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide. These studies demonstrate consistently excellent results with low Target Lesion Revascularization (TLR) and low Stent Thrombosis (ST) with short DAPT regimens in a real-world patient population.
In the FDA PzF SHIELD IDE trial, COBRA PzF NCS demonstrated 0% ST, 4.6% TLR with a 1-month DAPT, minimum requirement.
Mark C. Bates MD, DSC, FACC, FSCAI & Chairman of the BoardAdditionally, CeloNova’s eCOBRA all-comers study demonstrated positive results of 0.3% late ST, 4.3% TLR at 1 year in patients at high risk of bleeding and thrombosis in a real-world setting.
Revolutionary Ultra-Short, 14-Day DAPT
The company is seeking to close the treatment gap further by evaluating COBRA PzF NCS with ultra-short, 14- day DAPT compared to FDA-approved DES with 3 or 6 months in the world’s first and only randomized global trial, COBRA REDUCE. The trial is designed to assess clinical outcomes in high bleeding risk patients, who have typically been excluded from participation in clinical studies due to a higher risk profile. High bleeding risk patients who may benefit from ultra-short DAPT include patients with renal disease, cancer, are receiving oral anti-coagulant therapy, or who have had a recent stroke.
“COBRA PzF NCS’ anti-infammatory properties and significantly faster, higher quality healing compared to market-leading DES as seen in preclinical studies suggests that it is a uniquely suitable treatment option for patients requiring ultra-short DAPT,” states Bruce Tamargo, medical device industry veteran and member of CeloNova’s Board of Directors. “The outcome of the COBRA REDUCE trial could revolutionize the practice of medicine, positioning COBRA PzF NCS as the standard of care for this greatly underserved patient population at high risk of bleeding.” says Jason Cone, CEO, CeloNova BioSciences.
The Vision to Deliver Clinically Impactful Solutions
CeloNova’s founder, Dr. James Leininger, gained tremendous success in pioneering innovative medical technologies and growing companies from the ground up. These ventures planted early seeds that have since blossomed into an innovation-driven work culture aimed at addressing key clinical treatment gaps and revolutionizing the practice of medicine.
“Our dedication to ongoing innovation is woven into the fabric of CeloNova’s culture, impacting every aspect of our business from internal processes to field support and training. This requires a team of high-performing leaders who are passionate about delivering clinically-impactful solutions to the medical community.”
CeloNova marries an innovation-focused culture with strong values of integrity and high-quality production to provide the greatest value to the clinical community in which it serves.
“Integrity in all that we do. That is our mantra,” explains Deidre Wolf, Director of Marketing at CeloNova. “It starts at the top and carries through to all aspects of our business, from product manufacturing to clinical trials, to sales and marketing, and to customer service.”
Because of how the company conducts business, CeloNova has established a sound reputation within the business community and with its customers, exposing new opportunities that continue to grow the organization.
As the company learns more about the positive clinical impact of their latest Polyzene-F product, COBRA PzF NCS, CeloNova becomes increasingly motivated to develop new PzF applications for implantable medical devices that will help patients and change the practice of medicine around the world.
- Justin Gonsalves April 08, 2019
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