IRRAS AB (Publ) Year-end Report January-December 2018

STOCKHOLM, Feb. 14, 2019 /PRNewswire/ --

• Net revenue totaled SEK 0.0 million (0.7).
• Operating loss (EBIT) amounted to SEK -50.1 million (-23.7).
• Loss after tax totaled SEK -50.1 million (-23.2).
• Earnings per share before and after dilution amounted to SEK -2.09 (-1.09).

Period January–December 2018

• Net revenue totaled SEK 6.0 million (12.0).
• Operating loss (EBIT) amounted to SEK -143.3 million (-61.5).
• Loss after tax totaled SEK -138.8 million (-60.9).
• Earnings per share before and after dilution amounted to SEK -5.83 (-3.40).
• The board of Directors proposes no dividend.

Important events during the fourth quarter

Launch initiated in the US
During the fourth quarter the company started the launch preparations in the US. Regional sales managers and marketing staff were hired. Contacts were established with hospitals and training of future users of IRRAflow started. IRRAS also participated in a couple of neurosurgery conferences.

New Board member
At an extraordinary general meeting on October 1, Eva Nilsagård was elected as a new Board member. Through Eva, the company is provided with long and broad experience from finance and business development in listed companies.

Important events after the end of the fourth quarter

First Patients in the United States Successfully Treated with IRRAflow®
At the beginning of January, the first patients in the United States were treated with IRRAflow. The initial treatments were performed at the University of California – Irvine (UCI) Medical Center, in Orange, California.

The team, led by UCI Health neurosurgeon Dr. Sumeet Vadera, successfully treated two patients suffering from chronic subdural hematomas, a collection of blood on the brain's surface.

Global partnership with Healthlink
IRRAS entered into a partnership with HealthLink Europe & International to serve as IRRAS' global logistics and customer service partner. Through this partnership, the companies will provide IRRAS' worldwide customer base with rapid access to the company's full range of products.

Update on re-certification of catheter CE mark
The delay of the re-certification of the catheter's CE-mark has been frustrating. The company initially submitted an application for re-recertification of all three components of the systems in the spring of 2018. The CE Marks for the control unit and the tube set were rapidly received. However, in early summer the notified body informed that the remaining third component of the system, the innovative dual lumen catheter, was deemed to be a Class III product and required more time. In the fall we were informed that the process had been initiated and the timeline for completion would be at the end of the year. IRRAS has now an ongoing and good dialogue with the notified body regarding the recertification. IRRAS has provided them with all requested documents. As previously communicated, the delay is not due to lack of product quality or documentation, but rather caused by high work load at the certification body.

This is IRRAS
IRRAS AB (Nasdaq Stockholm: IRRAS) is a publicly traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for brain surgery. The company's initial product, IRRAflow™, addresses the complications associated with the current treatment methods of intracranial bleeding with a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Regularly during treatment, the IRRAflow catheter is automatically flushed to prevent common catheter occlusions from forming. Because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures.

With its unique product portfolio protected by patents and patent applications, IRRAS is well positioned to establish itself as a leader in the medical device market. 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. The IRRAS share is listed at Nasdaq First North Premier. Wildeco is the company's Certified Adviser.

Financial information

Calendar

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, 2019 at 8:00 a.m. (CET).

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SOURCE IRRAS