STOCKHOLM, Feb. 14, 2020 /PRNewswire/ -- "The fourth quarter of 2019 was an important period of progress for IRRAS. We accomplished the remaining corporate milestones for the year, highlighted by the renewed CE Mark for the IRRAflow^® catheter in the European Union (EU) and the launch of our Hummingbird ICP Monitoring product line in the United States (US). Importantly, our impact to patients continues to broaden and deepen. Since the launch of IRRAflow, we have completed successful patient treatments in seven major markets, including the US, Germany, Finland, Austria, Hong Kong, Israel, and Kuwait.

We've been pleased with the interest in IRRAflow so far during our US launch, and we have just started the relaunch of IRRAflow in the EU and the Hummingbird line in the US, but at this point early in our products' commercialization, it remains challenging to fully project the future adoption of our products. Based on this and a slower than projected initial revenue growth in the US, our current expectation is that our previously communicated financial targets will be delayed. We will communicate new financial targets as soon as we gain better clarity about our ramp up."

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

Fourth quarter, October - December 2019

• Net revenue amounted to SEK 3.4 million (0.0).
• Operating loss (EBIT) amounted to SEK -35.7 million (-50.1).
• Loss after tax amounted to SEK -36.5 million (-50.1).
• Earnings per share before and after dilution amounted to SEK -1.27 (-2.09).

Period January - December 2019

• Net revenue amounted to SEK 5.3 million (6.0).
• Operating loss (EBIT) amounted to SEK -151.5 million (-143.3).
• Loss after tax amounted to SEK -151.1 million (-138.8).
• Earnings per share before and after dilution amounted to SEK -5.61 (-5.83).

Important events during the quarter

• IRRAS received renewed CE Mark for the IRRAflow catheter
  IRRAS received CE Mark approval for its IRRAflow catheter December 19, 2019. The CE Mark complements the two CE Marks previously obtained for the IRRAflow system's tube set with digital pump and control unit and allows IRRAS to once again commercially market the IRRAflow system in the European Union.
           
• FDA Clearance of new 510(K) filing to expand the time of use of IRRAflow
  November 21, 2019 the US FDA cleared a new 510(K) for IRRAflow. The application provided the FDA with supporting data demonstrating that extending the time of use of the product is safe and has the potential to be beneficial for neurocritical care patients.

Other key accomplishments           

• US Launch of Hummingbird Products for Neurocritical Care
  In mid-December IRRAS launched the Hummingbird ICP Monitoring product line in the US. The Hummingbird family of products helps clinicians diagnose and manage patients' intracranial pressure after traumatic brain injury, a subarachnoid hemorrhage, and/or stroke. The product line includes proprietary single and multi-lumen cranial access bolts, parenchymal intracranial pressure ICP monitoring, and a cranial access kit.
             
• IRRAflow wins CONNECT's "2019 Most Innovative New Product" Award
  In December 2019, CONNECT, a premier nonprofit helping entrepreneurs with innovative startups in technology and life science sectors, announced that IRRAS has been selected as the 2019 winner in the medical device category.
             
• Key hires to the company
  In November IRRAS announced the hiring of Dr. Coenraad Tamse as Vice President, International Sales. Dr. Tamse brings more than 20 years of commercial marketing, and executive experience in the medical device field to IRRAS.

Important events after the end of the quarter           

• No important events have taken place after the end of the quarter.

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

About IRRAS

IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS currently markets and sells its IRRAflow and Hummingbird product lines to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets. 

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 First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46-8-121-576-90.

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 14, 2020 at 8:00 a.m. (CET).

For more information, please contact:

USA
Kleanthis G. Xanthopoulos
Ph.D.
President and CEO
ir@irras.com  

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

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SOURCE IRRAS