Pioneers at the Forefront of Surface Coated Innovation

CeloNova Biosciences has a 20+ year legacy in developing next-generation coatings for medical device implants.

CeloNova aims to be an expert partner to medical device OEM’s looking for coating technologies to enhance biocompatibility and provide anti-inflammatory, thromboresistance and healing properties. *1-5

Critical Areas of Expertise:

Medical device and implant coating process development
Advanced Polymer Chemistry
Pre-clinical and clinical expertise with novel coatings
Regulatory & Quality Management expertise based on Class III PMA, EU MDR certifications.
Registered and actively engaged in FDA Case for Quality Voluntary Improvement Program
Flexible manufacturing options in Lab or Class 7 cleanroom environments.
ISO 13485 certified

State-of-the-Art Facilities

Located in Carlsbad, CA our facilities include a 2,500 sq. ft., ISO 14644 Class 7 Cleanroom with production and pre-clinical/clinical device manufacturing capabilities and a 700 sq. ft. R&D and PzF Synthesis laboratory.

On-site equipment availability is focused on the core competencies of catheter/angioplasty balloon manufacturing, polymer synthesis, polymer coating, and analysis of surface chemistry and drug delivery kinetics.

Commercial Successes

To date, CeloNova has successfully commercialized and sold its PzF coated drug-loadable microsphere and embolic bead product lines for treating arteriovenous malformations and hypervascular tumors to Boston Scientific in 2015.

Additionally, CeloNova has commercialized 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). *6

COBRA PzF - NanoCoated Coronary Stent (NCS) - Instructions for Use

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