0GDW Irras Ab

Commercial partnership underway to wrap up meaningful year of growth

STOCKHOLM, Feb. 16, 2023 /PRNewswire/ -- "Q4 2022 marked the conclusion of a transformational year for IRRAS, and, as we begin the new year, we have created new opportunities that will accelerate our growth toward achieving leadership in the world of neurocritical care."

"The 4th quarter also marked the start of an extremely exciting next phase for the launch of IRRAflow, our lead product, with the announcement of our commercial partnership with Medtronic, the world's largest medical device company."

Will Martin, CEO of IRRAS

Fourth quarter, October - December 2022

• Net revenue amounted to SEK 10.6 million (7.2).
• Operating loss (EBIT) amounted to SEK -46.7 million (-43.5).
• Loss after tax amounted to SEK -46.3 million (-43.4).
• Earnings per share before and after dilution amounted to SEK -0.06 (-0.55).

Period, January - December 2022

• Net revenue amounted to SEK 40.0 million (22.4).
• Operating loss (EBIT) amounted to SEK -168.1 million (-136.5).
• Loss after tax amounted to SEK -166.6 million (-136.3).
• Earnings per share before and after dilution amounted to SEK -0.52 (-1.89).
• The Board proposes that no dividend be paid

Significant events during the quarter

IRRAS initiates commercial partnership with Medtronic

• A sales agency agreement was initiated with Medtronic, the world's largest medical device company, which gives Medtronic exclusive right to promote IRRAflow in a select number of territories in the United States. Training for Medtronic team members and first customer engagement also occurred during Q4.

IRRAS receives US FDA 510(k) clearance for its next-generation IRRAflow control unit

• Regulatory approval was received in the US for the latest system, which incorporates enhancements driven by user feedback such as interactive tutorials, software with upgraded graphics, a new drainage collection design, and added functionality that permits data transmission to the hospital's bedside monitor and central nursing station.

Significant events after the quarter

Superiority of IRRAflow system confirmed in head-to-head clinical study

• Neurosurgeons from the University at Buffalo published results of their comparative clinical study in the Operative Neurosurgery journal, which that compared outcomes when treating chronic subdural hematoma patients with IRRAflow against passive drainage alone.
• The study demonstrated that IRRAflow treatment resulted in faster hematoma clearance and a reduction in catheter-related infections, which led to favorable clinical outcomes and lower complication and revision rates.

The report is available on the company's website:  https://investors.irras.com/en/reports-presentations.

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 AB (publ) is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

USA
Will Martin
President and CEO
ir@irras.com

Europe

Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on February 16, 2023, at 8:00 a.m. (CET).

The following files are available for download:

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SOURCE IRRAS