Bio Nova currently manufactures replacement blood vessels that are sold globally through a vast network of distributors or directly to end users. Based in Melbourne, Australia, the manufacturing operations have purpose-designed clean room facilities for processing and sterilisation that operate to the requirements of Good Manufacturing Practices for the manufacture of therapeutic devices (ISO 13485).

The Company’s research and testing laboratories are equipped to conduct many specialised evaluations on the physico-chemical characteristics of graft materials. The operations and facilities are licensed by the Australian Therapeutic Goods Administration (TGA), TÜV Rheinland Product Safety GmbH (European Notified Body for CE Mark) and TÜV North America (for Canadian Health Ministry) and are subject to routine audits from all bodies.