"The 4th quarter of 2021 served as an encouraging end to an eventful year for our IRRAS team.  Each consecutive quarter of 2021 showed the progress that IRRAS is making toward becoming a leader in neurocritical care, and we are poised to continue this progress into 2022."

"All told, we are pleased with our accomplishments throughout all of 2021.  During the year, our team progressed across all aspects of our business, and these accomplishments resulted in revenue growth of more than 200% during 2021."

Will Martin, President and CEO of IRRAS

Fourth Quarter, October - December 2021

• Net revenue amounted to SEK 7.2 million (2.5)
• Operating loss (EBIT) amounted to SEK -43.5 million (-36.8)
• Loss after tax amounted to SEK -43.4 million (-38.1)
• Earnings per share before and after dilution amounted to SEK -0.55 (-0.57)

Period, January - December 2021

• Net revenue amounted to SEK 22.4 million (7.4)
• Operating loss (EBIT) amounted to SEK -136.5 million (-134.3)
• Loss after tax amounted to SEK -136.3 million (-135.9)
• Earnings per share before and after dilution amounted to SEK -1.89 (-2.46)

Important events during the quarter

CE Mark received for enhanced IRRAflow Drainage Catheter

• Enhanced catheter with improved kink resistance and drainage capabilities approved for use in European Union.

ACTIVE clinical study initiated by Aarhus University Hospital

• Aarhus University Hospital, a leading hospital in Denmark, began commercial patient treatments with IRRAflow and will capture its results in the ACTIVE clinical trial to prove the system's superiority versus traditional drainage systems.

First patients enrolled in ARCH clinical study

• Dr. Behnam Rezai Jahromi from Helsinki University Hospital enrolled the first patient in the ARCH clinical study, which compares use of IRRAflow with clot-busting medication versus traditional drainage systems in IVH patients.
• Study will further document ability and safety of using IRRAflow to safely deliver intracranial medication.

Partnership with Lovell Government Services (LGS) Announced to Accelerate Launch into US Military and Veterans' Hospitals

• IRRAS signed an agreement with LGS, a Service-Disabled Veteran-Owned Small Business, to serve as its vendor for product orders and contract from US government facilities.

The Board of Directors proposes no dividend

Important events after the end of the quarter

Expanded Intellectual Property Portfolio with Issuance of Additional Patent for IRRAflow System

• The third patent issued for the IRRAflow system provides coverage of the system's ability to administer therapeutic drugs using its catheter's dual-lumen design and controlled irrigation capabilities into targeted areas of treatment.

First patients enrolled in ACTIVE clinical study

• Dr. Anders Korshøj from Aarhus University Hospital, a leading hospital in Denmark, enrolled the first patient in the ACTIVE clinical study to evaluate the efficacy and safety of IRRAflow compared to traditional drainage systems

Largest IRRAflow dataset to date presented, confirming improved patient outcomes

• Surgeons from West Virginia University Hospital presented data from their first 45 IRRAflow patient treatments at the Neurosurgical Society of the Virginias annual meeting.  Data showed 0% occlusion rate and reduced incidence of infection, vasospasm, and shunt dependence compared to traditional passive drainage.

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, 2022, at 8:00 a.m. (CET).