PolyNovo North America LLC
PolyNovo Limited develops and commercialises medical devices based on a family of proprietary bioabsorbable polymer technologies. The company manufactures synthetic dermal scaffolds intended to support dermal regeneration and biodegrade in situ. It has progressed through preclinical and clinical studies and obtained multiple regional regulatory clearances while expanding manufacturing capacity and market access.
Industries
Nr. of Employees
medium (51-250)
PolyNovo North America LLC
Products
Biodegradable temporizing dermal matrix (BTM)
A multilayer synthetic dermal scaffold supplied pre-fenestrated that provides temporary structure for dermal regeneration and is designed to biodegrade in situ.
Biodegradable temporizing dermal matrix (BTM)
A multilayer synthetic dermal scaffold supplied pre-fenestrated that provides temporary structure for dermal regeneration and is designed to biodegrade in situ.
Services
On-site manufacture and supply of polymer-based dermal scaffolds and related formats with processes designed for scale-up.
Provision of Instructions For Use (IFU) and clinical guidelines covering application, dressing management, integration assessment and delamination procedures for surgical use.
Activities supporting regulatory submissions and obtaining market access across multiple jurisdictions.
Collaborative development with research organisations and government agencies to advance preclinical and clinical programs.
On-site manufacture and supply of polymer-based dermal scaffolds and related formats with processes designed for scale-up.
Provision of Instructions For Use (IFU) and clinical guidelines covering application, dressing management, integration assessment and delamination procedures for surgical use.
Activities supporting regulatory submissions and obtaining market access across multiple jurisdictions.
Collaborative development with research organisations and government agencies to advance preclinical and clinical programs.
Expertise Areas
- Bioabsorbable polymer development
- Dermal substitute and scaffold development
- Wound care and reconstructive surgical applications
- Clinical trial management and execution
Key Technologies
- Bioabsorbable polymers
- Biodegradable dermal matrices
- Thermoplastic extrusion
- Polymer filaments for textiles
News & Updates
First clinical use of the synthetic dermal matrix recorded.
Received United States 510(k) clearance enabling commercialization in the US.
Awarded US Biomedical Advanced Research and Development Authority (BARDA) contract and additional funding to complete clinical trials.
Registered with the Australian Therapeutic Goods Administration.
Received CE marking for European market and FDA Breakthrough Device designation.
First patient enrolled in the BARDA- and FDA-supported pivotal clinical trial.
First clinical use of the synthetic dermal matrix recorded.
Received United States 510(k) clearance enabling commercialization in the US.
Awarded US Biomedical Advanced Research and Development Authority (BARDA) contract and additional funding to complete clinical trials.
Registered with the Australian Therapeutic Goods Administration.
Received CE marking for European market and FDA Breakthrough Device designation.
First patient enrolled in the BARDA- and FDA-supported pivotal clinical trial.