Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

IRRAS AB (PUBL) Interim Report January-September 2018


News provided by

IRRAS

08 Nov, 2018, 08:03 GMT

Share this article

Share toX

Share this article

Share toX

Preparation for US launch of IRRAflow® ongoing, CE mark catheter re-certification now expected at YE 2018

STOCKHOLM, Nov. 8, 2018 /PRNewswire/ -- Third quarter, July–September 2018

  • Net revenue totaled SEK 0.0 million (11.3).
  • Operating loss (EBIT) amounted to SEK -40.0 million (-7.2).
  • Loss after tax totaled SEK -41.8 million (-7.3).
  • Earnings per share before and after dilution amounted to SEK -1.75 (-0.42).

Full year to date January–September 2018

  • Net revenue totaled SEK 6.0 million (11.3).
  • Operating loss (EBIT) amounted to SEK -93.2 million (-37.8).
  • Loss after tax totaled SEK -88.8 million (-37.7).
  • Earnings per share before and after dilution amounted to SEK -3.74 (-2.19).

Important events during the third quarter

FDA clearance of IRRAflow 

IRRAS received 510(k) clearance from the US Food and Drug Administration (FDA) for the company's IRRAflow system and consumable products. The FDA decision means that the company now has the right to market and sell IRRAflow in the US. Preparations for US launch are ongoing and include contacts with key neurosurgery centers in the US and numerous marketing activities that are planned through the end of the year.

Preparation launch in the US

IRRAS has started the sales preparations in the US and recruited four regional managers with significant experience bringing medical devices to large markets.

Important events after the end of the third quarter

New Board member

At an extraordinary general meeting on October 1, Eva Nilsagård was elected as a new Board member. Eva Nilsagård has a long and broad experience in finance and business development of listed companies.

Update on re-certification of catheter CE mark

LNE/G-MED, the company's certification body expects that the re-certification process of the IRRAflow catheter to be completed by the end of the year.

Expanded management team

As of October 19, IRRAS's executive management group consists of Kleanthis Xanthopoulos, Fredrik Alpsten, Will Martin, Lance Bolling and Kellie Fontes. The expanded management group also includes Adam Sampson, Dino De Cicco, Dessi Lyakov and Sabina Berlin.

Comments from the President and CEO                   

During the third quarter of 2018, IRRAS obtained its most significant milestone as a company to date – we were pleased to receive the FDA clearance for our innovative IRRAflow device, which we believe will become the new standard for safe, efficient, and controlled drainage of intracranial fluids. The United States is our most important market and we are hopeful to begin recording sales revenues in the US at year-end 2018.

To ensure we have a successful launch in the US, we have, during the third quarter, significantly enhanced our sales and commercial teams in the US with highly qualified individuals who have advanced numerous medical devices to large markets.

At the beginning of October, we participated, for the first time with an approved product, at the Congress of Neurological Surgeons (CNS) in Houston, Texas. The initial feedback on our product from physicians in the US has been very positive and we look forward to working within these networks to grow recognition and future use of IRRAflow.

While preparing for launch in the US, we also focused substantial efforts on the EU market during the third quarter. The catheter CE mark re-certification has been delayed due to notified body's backlog and we now expect to receive the certificate by the end of the year and anticipate that sales can be resumed in EU in the beginning of 2019.

Third quarter financial overview

Due to the delay in the re-certification of the CE mark in the EU and pending launch in the US, no sales were reported during the third quarter of 2018.

EBIT for the third quarter of the year was SEK -40.0 million (-7.2). The increased costs are primarily attributable to the planned organizational expansion. The average number of employees in the third quarter of 2018 was 21, compared with 8 in the year-earlier period. The preparations for a launch in the US later this year also contributed to the increased costs. In addition, operating expenses in this period include one-time extra costs of SEK 11 million. The one-time costs mainly refer to extra costs in 2018 due to the delayed CE-mark of the catheter and remaining costs for the two product recalls in 2017.

Our available liquidity as of September 30, 2018 is SEK 190 million, including short- and long-term financial investments.

Building for future growth at IRRAS

At IRRAS, our mission is clear: to change the lives of millions by creating medical products that transform the current treatment of intracranial bleedings. We believe that IRRAflow will ultimately become the new standard of care in this field and we continue to make progress toward accomplishing this mission.

With the recent FDA clearance in the US and the anticipated re-certification of the CE mark in the EU, as well as registration of our product in additional countries, we believe the future of IRRAS is bright.

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

The full interim report is enclosed.

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 November 8, 2018 at 8:00 a.m. (CET).

Investor and Media Contact:
Fredrik Alpsten
CFO and Deputy CEO
+46-706-67-31-06
fredrik.alpsten@irras.com

This information was brought to you by Cision http://news.cision.com

http://news.cision.com/irras/r/irras-ab--publ--interim-report-january-september-2018,c2666923

The following files are available for download:

http://mb.cision.com/Main/16550/2666923/941087.pdf

IRRAS AB (Publ) INTERIM FINANCIAL REPORT JANUARY â€" SEPTEMBER 2018 (PDF)

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.