CeloNova BioSciences — COBRA PzF Coronary Stent — Polymer-Free Drug Elution
CeloNova BioSciences partnered with bioaccess® to advance clinical evidence for their COBRA PzF™ nanocoated coronary stent system—the world's first polymer-free, nano-thin polyzene-F coated stent—in Latin American markets.
Study facts
- Sponsor / company: CeloNova BioSciences
- Indication / area: Interventional Cardiology
- Country: Brazil, Colombia
- Study type: Pivotal Clinical Trial
Key metrics
- Centers: Multi-center
- Countries: 2
- Technology: Polymer-free
- Outcome: Commercial launch
The challenge
CeloNova needed large-scale, multi-center clinical data from Latin American populations to support regulatory submissions and demonstrate the real-world performance of their novel polymer-free stent technology across diverse patient demographics.
bioaccess® solution
bioaccess® designed and managed a multi-center clinical trial across Brazil and Colombia, coordinating with interventional cardiology catheterization labs, managing ANVISA and INVIMA regulatory pathways, patient enrollment across sites, and centralized data monitoring to ensure GCP compliance and data integrity.
Results
- Multi-center trial completed across Brazil and Colombia
- Regulatory approvals obtained from ANVISA and INVIMA
- Consistent safety and efficacy data across diverse LATAM populations
- Data contributed to global clinical evidence package
- Supported commercial launch strategy in multiple LATAM markets
Frequently asked
- What did bioaccess® do for CeloNova BioSciences?
- bioaccess® designed and managed a multi-center clinical trial across Brazil and Colombia, coordinating with interventional cardiology catheterization labs, managing ANVISA and INVIMA regulatory pathways, patient enrollment across sites, and centralized data monitoring to ensure GCP compliance and data integrity.
- Where was the CeloNova BioSciences Pivotal Clinical Trial study run?
- The CeloNova BioSciences Pivotal Clinical Trial study was executed in Brazil, Colombia by bioaccess® in the interventional cardiology area.
- What was the outcome of the CeloNova BioSciences study?
- Reported outcomes for CeloNova BioSciences's device: Multi-center trial completed across Brazil and Colombia; Regulatory approvals obtained from ANVISA and INVIMA; Consistent safety and efficacy data across diverse LATAM populations.
Run a similar trial: Clinical trials in Brazil · Clinical trials in Colombia
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