Meaningful Commercial Acceleration Seen Globally

"During Q1, the global installed base for IRRAS products increased; the total number of IRRAflow systems increased from 73 to 84 and Hummingbird systems grew from 5 to 9.  An increase in the number of systems shipped is important, but it is more critical to convert evaluations into revenue-generating commercial customers. During the quarter, two influential US comprehensive stroke centers, Buffalo General Medical Center and West Virginia University, placed commercial disposable stocking orders for IRRAflow. The contracts signed by these customers more than doubled the number of commercial IRRAflow control units (from 9 to 19) and will generate recurring revenue as usage continues.

The patient impact was further confirmed as the team at Buffalo General also published an initial chronic subdural hematoma case series in a peer-reviewed journal that showed a 25% reduction in treatment time when using IRRAflow from 6 to 4.5 days. Such data and recent successful evaluations have provided our team with important tools to help successfully navigate the approval process for a growing list of centers interested in acquiring the IRRAflow system.

To date, more than 200 patients have been treated with IRRAflow at over 30 leading institutions globally. These treatments continue to show compelling results with zero catheter occlusions or major complications observed."

Kleanthis G. Xanthopoulos, Ph.D., CEO of IRRAS
 

• Net revenue amounted to SEK 4.0 million (1.6).
• Operating loss (EBIT) amounted to SEK -39.3 million (-35.2).
• Loss after tax amounted to SEK -39.3 million (-34.3).
• Earnings per share before and after dilution amounted to SEK -0.59 (-1.19).

Important events during the quarter

During Q1, the IRRAS manufacturing facility was successfully inspected by the US Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) and received its manufacturing license. The IRRAflow control unit can now be manufactured in-house.

In Q1, two comprehensive stroke centers in the US, Buffalo General Medical Center and West Virginia University, analyzed the outcomes from their IRRAflow evaluations, placed disposable stocking orders, and began commercial use of the system.

During the quarter, IRRAS began to transfer its international regulatory activities to a new notified body, DEKRA. DEKRA completed audits of IRRAS quality system under ISO, MDR, and MDSAP guidelines, and in the near future, will assume the existing CE Mark certificates for IRRAflow.

IRRAS is in negotiations with the European Investment Bank (EIB) regarding a financial partnership that could provide non-dilutive financing that will allow IRRAS to borrow 7-9M € over the coming years based upon the achievement of agreed-upon performance criteria. The negotiations are in advanced stages; however, final approval is still subject to EIB's internal review.

Important events after the end of the quarter

In April, the Board of Directors appointed Will Martin as President and Chief Executive Officer (CEO) of the Company. Will Martin, currently the company's President and Chief Commercial Officer, will assume his new role on July 1, 2021. He will succeed current CEO, Kleanthis G. Xanthopoulos, Ph.D., who will remain on IRRAS' Board of Directors.

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 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
Kleanthis G. Xanthopoulos, Ph.D.
CEO
ir@irras.com

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com

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 May 4, 2021 at 8:00 a.m. (CET).