PolyNovo announced the completion of its CP-002 feasibility study with results to be submitted to the US FDA in April along with Pivotal IDE package. Once the US FDA has these documents company can publicly release the outcomes. The feasibility study assessed the safety and effectiveness of the NovoSorb® Biodegradable Temporizing Matrix (BTM) in the treatment of full thickness burn injuries. The feasibility trial was a prospective, multicentre, single-arm, open label, traditional feasibility study conducted in the USA where NovoSorb® BTM was used under a US FDA Investigational Device Exemption (IDE). This 12-month clinical outcomes study recruited 15 subjects with full thickness burns within 10-70% total body surface area (TBSA) across four leading burn centres. The co-primary effectiveness endpoints were: BTM `take' rate assessed after integration and at the time of sealing membrane removal, and split-thickness skin graft (SSG) `take' rate at 7-10 days after application. Data analysis for this study has been completed and will be submitted for review by the US FDA as part of the approval for IDE to conduct a larger pivotal study of NovoSorb® BTM. In November 2019 the FDA granted NovoSorb® BTM "Breakthrough Device" designation which has facilitated greater interaction with the FDA, enabling to finalize the pivotal study design. Company anticipate approval for the larger Pivotal trial IDE in June 2020. The Pivotal trial will support a future submission leading to PMA approval for a full thickness burn indication in the US market. The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services continues to support PolyNovo in this pivotal study program.