Stockholm, March 11, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it received the initial regulatory approvals for its flagship 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.
“As the world’s population continues to age, there is an increased risk of stroke,” said Will Martin, President and Chief Executive Officer of IRRAS. “The recent regulatory approval of IRRAflow in Australia is a clear sign that our global regulatory strategy is progressing as planned. We are thrilled to offer IRRAflow’s cutting-edge technology to neurosurgeons in Australia, so they can provide advanced treatment options for their patients suffering from intracranial bleeding.”
“With this new regulatory clearance, IRRAS will now be able to offer Australian caregivers the most innovative solution for intracranial bleeding,” said Coenraad Tamse, MD, VP of International Sales of IRRAS. “We will now continue the commercial momentum that we’ve seen in both the United States and Europe by building relationships with key Australian surgeons in the near future.”
About the Australian Register of Therapeutic Goods (ARTG)
The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of therapeutic goods in Australia. The ARTG is a database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. It is the reference database of the Therapeutic Goods Administration (TGA).
About IRRAS
IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172
The information was released for public disclosure, through the agency of the contact person above, on March 11, 2022, at 8:30 (CET).
