CeloNova BioSciences, Inc.
CeloNova BioSciences, Inc. is developer and manufacturer of a portfolio of novel surfaced coated technologies, including the proprietary Polyzene-F nanocoating. This next-generation nanocoating is the result of years of rigorous scientific research and German-engineering and has been widely published in numerous academic articles to date. Our core business focuses on creating partnership and co-development opportunities with medical device manufacturers seeking to optimize implant interaction within the body. Moving forward, CeloNova BioSciences is looking to develop new PzF applications for implantable medical devices that will help patients and change the practice of medicine around the world.
Company details
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- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
About Us
CeloNova has a strong product development and commercialization history, bringing multiple products to market in the US and Europe. In 2015, CeloNova BioSciences interventional radiology product lines were acquired by Boston Scientific. Read more here.
In January 2018, CeloNova became one of a handful of companies in the U.S. selected to support advancements in medical device quality and safety through partnership with the FDA’s Case for Quality Voluntary Improvement Program (CFQ VIP).
This program identifies device manufacturers that consistently produce high-quality devices to help better focus FDA resources and promote best practices to help other manufacturers raise their level of quality and safety. Through the program’s partnership, CeloNova aims to further advance quality of care in patients in the U.S. 1
CeloNova was recently featured in a case study by the CMMI Institute for our dedication to compliance and quality, and you can read more about our journey and success by reading the full CMMI CeloNova Case Study, and also in a recent CMMI blog post.
In addition, CeloNova is ISO 13485:2016 certified.
Our Expertise
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
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Medical device and implant coating process development
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Advanced Polymer Chemistry
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Pre-clinical and clinical expertise with novel coatings
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Regulatory & Quality Management expertise based on Class III PMA, EU MDR certifications.
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Registered and actively engaged in FDA Case for Quality Voluntary Improvement Program
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Flexible manufacturing options in Lab or Class 7 cleanroom environments.
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ISO 13485 certified
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.
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