USFDA APPROVAL PROGRESS FOR TECHNEGAS AND BUSINESS UPDATE Cyclopharm Limited (ASX: CYC) is pleased to provide the following update on its progress towards gaining United States Food and Drug Administration (“USFDA”) approval to begin sales of Technegas™ into the US, preliminary (unaudited) revenue performance for FY20 and other operational matters. Highlights ? USFDA approval targeted for Q2 on track and progressing well with a pre?approval audit scheduled for the week commencing 29 March 2021.
Strong support for Technegas™ in the USA expressed from frontline healthcare workers based on safety concerns of competitive products.
Total unaudited revenue for 2020 was in line with prior year at $14m AUD.
Technegas™ procedures rebound following initial reactions to the COVID?19 pandemic.
Technegas™ H2 consumable sales recover sharply post initial COVID?19 impact: revenues up 39.2% in H2 over H1.
3rd Party Distribution up 79.1% in H2 over H1 to $1.3m AUD.
In anticipation of US market entry, the Board is considering appointing an additional Director during 2021.
Favourable progress is being made with regard to the litigation process against former employees. CYC remains confident it will achieve a successful and complete resolution to all matters in 2021.