IRRAS announced that it received the initial regulatory approvals for its product, IRRAflow, from the Australian Department of Health and Therapeutic Goods Administration (TGA) for commercial distribution in Australia. As a result of this approval, IRRAS is now listed on the Australian Register of Therapeutic Goods (ARTG), allowing the company to expand its global commercialization and begin to market IRRAflow to Australian customers. TGA clearance has been received for both the class II IRRAflow control unit and digital pump and tube set, while clearance for the class III IRRAflow dual-lumen catheter is expected in the near future.

The successful TGA certification process is the culmination of in-depth assessment of the quality and safety of IRRAS products, which began with last year's Medical Device Single Audit Program (MDSAP) certification. In 2018, an estimated 387,000 Australian residents had suffered a stroke at some time in their lives, according to the Australian Bureau of Statistics 2018 Survey of Disability, Ageing, and Carers. Stroke also accounted for 5.3% of all deaths in Australia during the same survey.