SAN ANTONIO, Feb. 8, 2019 /PRNewswire/ -- CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced that it has signed a three-year group purchasing agreement with HealthTrust for its novel COBRA PzF™ NanoCoated Coronary Stent (NCS) System.
The agreement (contract number: 39949), which became effective on February 1, 2019, provides HealthTrust's more than 1,500 member hospitals and health systems with access to the world's first non drug-eluting, nanocoated coronary stent designed to help physicians safely and effectively treat patients who may benefit from short, 1-month minimum dual antiplatelet therapy (DAPT).1 DAPT has been shown to increase bleeding and mortality risks, which is of greater concern for non-compliant patients or those who are at increased risk of bleeding.2
"We are very pleased to be partnering with HealthTrust to offer a personalized DAPT treatment option to its members," stated Jason Cone, CEO of CeloNova. "COBRA PzF NCS is a new category of coronary stent, unlike any other on the market, that offers a safe and effective clinical solution to physicians treating complex patients requiring short DAPT."
COBRA PzF NCS is nanocoated with Polyzene-F (PzF), a revolutionary surface coating that acts as a barrier between the device, intimal surface and circulating elements in the blood. Through a process called passivation, albumin preferentially binds to PzF, preventing fibrinogen deposition and subsequent platelet adhesion and activation, resulting in thromboresistance, anti-inflammatory properties and rapid healing.+3-6
Today, CeloNova is seeking to further close the treatment gap with the world's first and only randomized, global 14-day DAPT study. The COBRA REDUCE trial is designed to assess clinical outcomes with COBRA PzF NCS with 14-day DAPT as compared to FDA-approved drug-eluting stent with 3 or 6 months DAPT. For more information, visit ClinicalTrials.gov.
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 nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.
About HealthTrust
HealthTrust (Healthtrust Purchasing Group, L.P.) is committed to strengthening provider performance and clinical excellence through an aligned membership model and the delivery of total spend management advisory solutions that leverage its operator experience, scale and innovation. Headquartered in Nashville, Tennessee, HealthTrust (www.healthtrustpg.com) serves over 1,500 hospitals and health systems, and more than 31,000 other member locations including ambulatory surgery centers, physician practices, long-term care and alternate care sites.
The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ?24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only.
+ AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
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The agreement (contract number: 39949), which became effective on February 1, 2019, provides HealthTrust's more than 1,500 member hospitals and health systems with access to the world's first non drug-eluting, nanocoated coronary stent designed to help physicians safely and effectively treat patients who may benefit from short, 1-month minimum dual antiplatelet therapy (DAPT).1 DAPT has been shown to increase bleeding and mortality risks, which is of greater concern for non-compliant patients or those who are at increased risk of bleeding.2
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"We are very pleased to be partnering with HealthTrust to offer a personalized DAPT treatment option to its members," stated Jason Cone, CEO of CeloNova. "COBRA PzF NCS is a new category of coronary stent, unlike any other on the market, that offers a safe and effective clinical solution to physicians treating complex patients requiring short DAPT."
COBRA PzF NCS is nanocoated with Polyzene-F (PzF), a revolutionary surface coating that acts as a barrier between the device, intimal surface and circulating elements in the blood. Through a process called passivation, albumin preferentially binds to PzF, preventing fibrinogen deposition and subsequent platelet adhesion and activation, resulting in thromboresistance, anti-inflammatory properties and rapid healing.+3-6
Today, CeloNova is seeking to further close the treatment gap with the world's first and only randomized, global 14-day DAPT study. The COBRA REDUCE trial is designed to assess clinical outcomes with COBRA PzF NCS with 14-day DAPT as compared to FDA-approved drug-eluting stent with 3 or 6 months DAPT. For more information, visit ClinicalTrials.gov.
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 nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.
About HealthTrust
HealthTrust (Healthtrust Purchasing Group, L.P.) is committed to strengthening provider performance and clinical excellence through an aligned membership model and the delivery of total spend management advisory solutions that leverage its operator experience, scale and innovation. Headquartered in Nashville, Tennessee, HealthTrust (www.healthtrustpg.com) serves over 1,500 hospitals and health systems, and more than 31,000 other member locations including ambulatory surgery centers, physician practices, long-term care and alternate care sites.
The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ?24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only.
+ AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
- Levine G, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10):e123-55.
- Généreux P, et al. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2015;66:1036-45.
- Jinnouchi, H, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy. EuroIntervention. 2018 Oct. Online ahead of print.
- Koppara T, et al. Preclinical evaluation of a novel polyphosphazene surface modified stent. International Journal of Cardiology. 2016; 222:217-225.
- Mrowietz C, et al. Haemocompatibility of polymer-coated stainless steel stents as compared to uncoated stents. Clinical Hemorheology and Microcirculation. 2005; 32:89–103. 7. Richter G, Stampfl U, Stampfl S, et al. A New Polymer Concept for Coating of Vascular Stents Using PTFEP (poly(bis(trifluoroethoxy)phosphazene) to Reduce Thrombogenicity and Late In-Stent Stenosis. Investigative Radiology. 2005; 40(4):210-218.
- Radeleff B, et al. Restenosis of the CYPER-Select, TAXUS-Express, and Polyzene-F NanoCoated Cobalt-Chromium Stents in the Minipig Coronary Artery Model. Cardiovasc Intervent Radiol. 2007.
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SOURCE CeloNova BioSciences, Inc.
