IRRAS Receives US FDA 510(k) Clearance for its Next Generation IRRAflow Control Unit

• IRRAS received US FDA 510(k) clearance for its class II next-generation IRRAflow control unit that enhances the procedural workflow for health care professionals treating critically ill patients suffering from intracranial bleeds.
• The cleared enhancements made to the next-generation IRRAflow control unit include additional functionality to the system’s user interface software that permits communication and data transmission to the hospital’s bedside monitor. 

Stockholm, December 12, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it received regulatory clearance from the United States Food, Drug, and Administration (FDA) to active all of the functionality on the next generation control unit for its flagship product, IRRAflow, the world’s first and only active fluid exchange system.

Earlier this year, IRRAS introduced this next-generation IRRAflow system, which included embedded interactive tutorials, intuitive software with upgraded graphics, refined treatment workflow, and a new drainage collection design, to its customers in the US.  This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station.

The IRRAflow system advances treatment options for patients suffering from intracranial bleeding as the first irrigating drainage system that enables active fluid exchange. IRRAflow combines automated irrigation, controlled drainage, and continuous monitoring of the patient’s intracranial pressure (ICP) into one intelligent system.  Its unique mechanism of action uses recurring irrigation to prevent solid particles from blocking the drainage holes on the catheter tip and to also dilute collected toxic material, making it easier to remove.

“IRRAS prides itself on consistently upgrading its products to better meet the needs of its customers, and the US regulatory clearance of the next generation IRRAflow control unit is the latest example of our team delivering upon that promise,” said Will Martin, President and Chief Executive Officer of IRRAS.  “Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize care for their critically ill patients.  Being able to introduce the latest IRRAflow functionality is the exciting next step toward accomplishing our mission to becoming a global leader in the neurocritical space.”

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 December 12, 2022, at 8:00 (CET).