IRRAS TO PARTICIPATE IN KEY UPCOMING NEUROSURGERY CONFERENCES

IRRAflow® system to be demonstrated at both CNS and EANS tradeshows in October

Stockholm, Sweden, October 3, 2018 – IRRAS AB (“IRRAS”), a commercial-stage medical technology company focused on developing and commercializing transformative treatments to manage intracranial fluids, today announced that the company will be participating in the Congress of Neurological Surgeons (CNS) 2018 Annual Meeting from October 6 – 10 in Houston, TX, and the 18th EANS European Congress of Neurosurgery from October 21 – 25 in Brussels, Belgium. These two meetings are key forums for the latest research and technology in the world of neurosurgery, and both attract attendees from all over the world.

“Exhibiting at the CNS and EANS Congresses is an exciting next step in the introduction of IRRAflow to the global neurosurgery communities,” stated Will Martin, Chief Commercial Officer of IRRAS. “With our recent US 510(k) clearance and eagerly anticipated CE mark re-certification that will then allow us to conitnue sales in Europe, we are ready to begin the broader launch of our transformational technology at these important events.”

The IRRAflow system will be on display at CNS in IRRAS’ booth 917 and EANS in IRRAS’ booth 14. To schedule a hands-on demonstration of the IRRAflow system at either event, please contact the company at info@irras.com.

For more information, please contact:
US

Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
+1 800 213 4604
info@irras.com

Europe
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06

fredrik.alpsten@irras.com
 

 
About IRRAS

IRRAS AB (NASDAQ First North Premier: 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 methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. IRRAflow received FDA clearance in July 2018.

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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well positioned to establish a leadership position 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.

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company. 

The information was released for public disclosure, through the agency of the contact person above, on October 3 , 2018, at 8.30 a.m. (CET).

 Press release (PDF)

Eva Nilsagård elected new IRRAS board member

Stockholm, Sweden, October 1, 2018 – The shareholders of IRRAS AB (“IRRAS”), a commercial-stage medical-technology company focused on developing and commercializing innovative solutions for various brain pathologies, voted to approve Eva Nilsagård as new member of the Group’s board of directors at today’s extraordinary shareholders’ meeting.

Nilsagård has an impressive background in finance and business development, including Finance Manager at SKF AB, Senior Vice President of strategy and business development at Volvo AB and various finance rolls at Astra Tech, a former unit of AstraZeneca focusing on dental implants and other medical devices for urology and surgery. She has also been CFO at Plastal Industri AB and Vitrolife AB.

Nilsagård is currently on the board of Svensk Exportkredit, AddLife and Bufab and she is chairman of the audit committee of AddLife and a member of the audit committee of Svensk Exportkredit and Bufab.

“I’m very excited to join the board of IRRAS. As an innovative medical device maker, the IRRAS products have the potential to save thousands of lives,” said Eva Nilsagård. “I look forward to helping IRRAS to establish IRRAflow as the standard of care in intracranial bleedings, and continue to innovate dependable solutions for neurocritical care medical professionals around the world.”

“Eva is an important addition to our board and we are eager to have her join us as we look toward establishing IRRAS’ position as an innovative company with transformative products. Her strong financial background is exactly the type of experience we need to help take IRRAS to the next level,” said Chairman Anders P. Wiklund.

For more information, please contact:
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com

 

About IRRAS
IRRAS AB (Nasdaq First North Premier: 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 methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. IRRAflow received FDA clearance in July 2018.

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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well positioned to establish a leadership position 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.

IRRAS AB is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company.

The information was released for public disclosure, through the agency of the contact person above, on October 1, 2018 at 11.00 a.m. (CET).

 Press release (PDF)

IRRAS STRENGTHENS US COMMERCIAL ORGANIZATION WITH HIRING OF MULTIPLE KEY TALENTS

Stockholm, Sweden, September 27, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS) announced today that it has added key talent to its commercial organization to drive sales of the company’s lead product, IRRAflow®, in the United States. Steve Crowell, John Gessert, Anthony Maestas, and Bryan Whalen have joined IRRAS as Territory Managers. In addition, John Unser has joined IRRAS as a Senior Product Manager to lead the marketing efforts for IRRAflow. These individuals have over 60 years of relevant commercial medical device experience and have shown significant success in bringing innovative technologies to market and building them toward standard of care.

After the addition of these first four Territory Managers, IRRAS plans to continue the growth of its US salesforce in coming months to meet growing interest for IRRAflow and establish national clinical coverage.

“The United States is the largest medical device market globally, and the recent FDA clearance of IRRAflow offers a great opportunity to enter this critically important market. The hiring of these experienced, successful sales professionals will be a great asset for our company as we finalize our plans to launch in the US,” said Will Martin, Chief Commercial Officer of IRRAS.

“We are very excited about the possibilities for IRRAflow in the US, and our ability to hire key sales professionals is of paramount importance to our ability to capture market share,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

For more information, please contact:
Sweden
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com

USA
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com

About 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 methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. IRRAflow received FDA clearance in July 2018.

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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well positioned to establish a leadership position 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.

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the Company. 

The information was released for public disclosure, through the agency of the contact person above, on September 27, 2018 at 8.00 a.m. (CET).

 Press release (PDF)

NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN IRRAS AB (PUBL)

The shareholders in IRRAS AB (publ), reg. no. 556872-7134 (the “Company”), are hereby given notice to attend the extraordinary general meeting held on Monday, 1 October 2018 at 10:00 a.m. (CEST) at the premises of Setterwalls Advokatbyrå with address Sturegatan 10 in Stockholm, Sweden. Registration for the meeting commences at 9:30 a.m. (CEST).

Notice

Shareholders wishing to participate at the meeting must:

(i) be entered in the shareholders’ register, kept by Euroclear Sweden AB (the Swedish Central Securities Depository & Clearing Organisation), on the record day which is Tuesday 25 September 2018; and

(ii) notify the Company of their attendance and any assistant no later than Tuesday 25 September 2018. Notification can be made via letter to Setterwalls Advokatbyrå AB, Attn: Linnea Björkstrand, P.O. Box 1050, SE-101 39 Stockholm, Sweden or by e-mail to linnea.bjorkstrand@setterwalls.se.

Notification shall include full name, personal identification number or corporate registration number, address and daytime telephone number and, where appropriate, information about representative, proxy and assistants. The number of assistants may not be more than two. In order to facilitate entry to the meeting, notification should, where appropriate, be accompanied by powers of attorney, registration certificates and other documents of authority.

Nominee registered shares

Shareholders who have their shares registered in the name of a nominee must request temporary entry in the transcription of the share register kept by Euroclear Sweden AB in order to be entitled to participate and vote for their shares at the meeting. The shareholder must inform the nominee well in advance of 25 September 2018, at which time the register entry must have been made.

Proxy

A shareholder represented by proxy shall issue a power of attorney which shall be dated and signed by the shareholder. If issued by a legal entity the power of attorney shall be accompanied by registration certificate or, if not applicable, equivalent documents of authority. Power of attorney forms for those shareholders wishing to participate by proxy are kept available as is stated under “Documents” below. The power of attorney shall also be presented in original at the meeting.           

Proposed agenda

  1. Opening of the meeting and election of chairman of the meeting;
  2. Preparation and approval of the voting list;
  3. Approval of the agenda;
  4. Election of one or two persons who shall approve the minutes of the meeting;
  5. Determination of whether the meeting has been duly convened;
  6. Determination of the number of members of the board of directors, election of new board member and determination of the fees payable to the new board member; and
  7. Closing of the meeting.

The nomination committee’s resolution proposals

The nomination committee is composed of the chairman of the nomination committee Christer Hellström (appointed by Serendipity Group AB and Serendipity Ixora AB) and the committee members Anders P. Wiklund (chairman of the board of directors in the Company), Christos Panotopoulos (appointed by F.EX Endotherapy Limited) and Marios Fotiadis (appointed by Lexington Holding Assets Limited (BVI) and Bacara Holdings Limited). The nomination committee has presented the following resolution proposals in relation to items 1 and 6 on the proposed agenda.                            

Item 1. Election of chairman

The chairman of the board of directors, Anders P. Wiklund, is proposed as chairman of the extraordinary general meeting.

Item 6. Determination of the number of members of the board of directors, election of new board member and determination of the fees payable to the new board member

The board of directors currently consists of the following five (5) ordinary members: Anders P. Wiklund (chairman), Anita Tollstadius, Kleanthis G. Xanthopoulos (Ph.D.), Marios Fotiadis and Saeid Esmaeilzadeh (Ph.D.). The board of directors has no deputy members. It is proposed that the board of directors shall consist of six (6) ordinary members without deputy members until the end of the next annual general meeting.

Eva Nilsagård is proposed to be elected as new board member for the period until the end of the next annual general meeting, in addition to the board members elected at the annual general meeting of 2018.

It is proposed that the fees payable to Eva Nilsagård for the period until the end of the next annual general meeting shall amount to SEK 133,333 for ordinary board work (corresponding to an annual fee of SEK 200,000) and SEK 66,666 for work as chairman of the Company’s audit committee (corresponding to an annual fee of 100,000).

Information regarding the proposed board member’s principal education and work experience, work performed for the Company and any other significant professional commitments etc. as well as the nomination committee’s motivated statement pursuant to what is stated in item 4.1 of the Swedish Corporate Governance Code, with regards to the composition of the board of directors, is kept available as is stated under “Documentation” below.

Shareholders’ right to request information

Pursuant to Chapter 7 section 32 of the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)) the board of directors and the managing director are under a duty to, if any shareholder so requests and the board of directors deems that it can be made without material damage to the Company, provide information, regarding circumstances which may affect the assessment of a matter on the agenda. Such duty to provide information also comprises the Company’s relation to the other group companies, the consolidated financial statements and such circumstances regarding subsidiaries which are set out in the foregoing sentence.

Number of shares and votes in the Company 

The total number of shares and votes in the Company as of 12 September 2018 amounts to 24,017,974. The Company does not hold any of its own shares.

Documentation

Power of attorney forms and other documents to be addressed at the extraordinary general meeting are kept available at the Company’s offices with address Vasagatan 16 in Stockholm, Sweden and will be sent free of charge to shareholders who so request and state their postal address. The documents are also kept available on the Company’s website www.irras.com. All the abovementioned documents will also be presented at the extraordinary general meeting.

_____

Stockholm, September 2018

The board of directors

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the Company.


For more information, please contact:

Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com
 


About 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 methods of managing intracranial fluid by using 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well positioned to establish a leadership position 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.

This document is considered information that the Company is obliged to disclose pursuant to the Nasdaq First North Rulebook. The information was released for public disclosure, through the agency of the contact person above, on September 13, 2018 at 07.00 a.m. (CET).

 NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN IRRAS AB (PUBL)

IRRAS AB (Publ) INTERIM FINANCIAL REPORT JANUARY – JUNE 2018

Preparation for US launch ongoing, still waiting for updated catheter CE-mark

Second quarter, April – June 2018

  • Net revenue totaled SEK 0.1 (0.0) million.
  • Operating loss (EBIT) totaled SEK -32.1 (-19.1) million.
  • The result after taxes totaled SEK -29.1 (-18.9) million.
  • Result per share before and after dilution was SEK -1.23 (-1.10).

Period January – June 2018

  • Net revenue totaled SEK 6.0 (0.0) million.
  • Operating loss (EBIT) totaled SEK -53.2 (-30.6) million.
  • The result after taxes totaled SEK -47.0 (-30.4) million.
  • Result per share before and after dilution was SEK -1.99 (-1.77).

Important events during the quarter
Updated ISO and CE certificates for IRRAflow®, valid through 2021
In May 2018, IRRAS received an updated ISO 13485:2016 certificate and updated CE approvals for the control unit and the tube set in the IRRAflow system. These are valid through 2021. IRRAS expects to receive an updated CE approval also for the catheter in the near future, but as a result of the pending CE mark for the catheter, IRRAS was not able to sell any IRRAflow systems in Europe during the quarter.

Transition of Scientific founder Dr. Panotopoulos to advisory role
In June, the company’s scientific founder, Dr. Christos Panotopoulos, was appointed Special Advisor and member of the IRRAS Clinical Advisory Board transition from his prior role as Chief Scientific Officer and member of the company’s management group.

Annual shareholders’ meeting re-elected full Board and approved employee incentive program 
At the annual shareholders’ meeting on June 1, 2018 Anders P. Wiklund, Kleanthis G. Xanthopoulos, Ph.D., Marios Fotiadis, Saeid Esmaeilzadeh, Ph.D., and Anita Tollstadius were re-elected as members of the Board of Directors. Anders P. Wiklund was re-elected Chairman of the Board. In addition, the Board’s proposal for an incentive program for the employees of the company was approved.

Important events after the end of the quarter
FDA clearance of IRRAflow
In July, IRRAS received 510(k) clearance from the US Food and Drug Administration (FDA) for US registration of 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. This allows IRRAS to move on to clinical validations in routine surgery and develop key reference centers.

Comments from the President and CEO

 IRRAS is pleased with the advancements made in the quarter and during the summer, highlighted by the FDA clearance for IRRAflow, and the updated ISO and CE certifications. Once we also receive an updated CE approval for the catheter the company will re-commence product sales in the EU.

The FDA clearance is a major milestone for the company – it has opened the door for our next phase in the US – to allow selected clinics to generate experience and establish the product clinically. It will also facilitate the recruitment of qualified employees in the US and accelerate the registration process in several new important markets. All told, this progress during the recent quarter underscore IRRAS’ mission to become a leading commercial-stage medical device company transforming the treatment of intracranial bleedings around the globe.

Sale and earnings

Due to the delayed CE mark for the catheter, IRRAS did not record any sales in the second quarter. IRRAS anticipates that the lack of this approval, which is the last remaining CE mark of the IRRAflow system, will also impact product sales in the third quarter. Currently, IRRAS is hopeful to receive the last CE mark in the very near future.

EBIT for the second quarter of 2018 totaled SEK -32.1 million (-19.1). The increased expenses are primarily attributable to the increase in headcounts with respect to marketing and sales, development, and quality and regulatory control. Preparations for a US launch later in the year, following the FDA clearance, have also contributed to increased planned expenses.

Our liquidity as of June 30, 2018 in cash and cash equivalents is SEK 217 million,

Building for IRRAS’ Future Growth

IRRAS made great advances in our efforts to build a global medical technology company in the second quarter. Due to the expansion of IRRAflow in the largest market in the world, the United States, IRRAS has added 3 new hires in key functional areas such as commercial and sales, increasing the headcount to 19 employees in Sweden, the US and Germany.

The second quarter of 2018 demonstrated IRRAS’ ability to execute well on our strategic goals. Looking ahead, we remain very hopeful to achieve new significant milestones. With a clear regulatory path in the EU, US and a global ongoing plan for registration to many countries around the world, we are excited about IRRAS’ future.  

President 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 August 27, 2018 at 08.00 a.m. (CET).

 IRRAS AB (Publ) INTERIM FINANCIAL REPORT JANUARY – JUNE 2018

IRRAS AB – Q2 Report 2018 – invitation to conference call and webcast

On Monday August 27, 2018, at 09.00 a.m. CET IRRAS will host a conference call and an online presentation of its Q2 2018 report (which is published the same day at 08.00 a.m. CET).

The dial-in numbers for the conference call are:
 

Sweden
: +46 8 566 42 662
R
est of the world: +44 20 300 89 806

The presentation will also be webcast and can be accessed from the following web address:
https://financialhearings.com/event/10810

Hosts: President CEO Kleanthis G
. Xanthopoulos, Ph.D. and CFO and Deputy CEO Fredrik Alpsten

Investor and Media Contact:

Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com

About IRRAS AB

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 methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Regularly during treatment, the 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. Additionally, IRRAflow incorporates ICP monitoring into this catheter and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well-positioned to establish a leadership position 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 information was released for public disclosure, through the agency of the contact person above, on
August 24 at 10.00 a.m. CET.

 Press release (PDF)

IRRAS Receives FDA Clearance for IRRAflow® in the US

Stockholm, Sweden, July 16, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on developing and commercializing transformative treatments to manage intracranial fluids, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for IRRAflow, its integrated, closed medical device system that enables controlled cerebrospinal fluid (CSF) management as well as accurate, continuous monitoring of intracranial pressure (ICP). IRRAS expects to launch IRRAflow in the U.S. later this year.

When the brain is injured or becomes infected, the normal flow of fluids within the brain can be disrupted, leading to fluid build-up and swelling. This excess fluid must be drained, or pressure can rise to life-threatening levels. This rise in ICP and complications from attempted treatment result in high rates of disability and death. IRRAflow is designed to provide patients with a safer, more effective treatment than traditional drainage devices by integrating aspiration, fluid irrigation, and ICP monitoring in a single system that is automated by a proprietary software that tailors treatment to each patient’s changing condition.



“The United States is the world’s largest market for intracranial procedures and the FDA clearance of IRRAflow is a significant milestone for IRRAS,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We are committed to advancing new and transformative treatments for neurosurgical patients that result in fewer complications, disabilities, and deaths.”

“We are thrilled to introduce IRRAflow to neurosurgeons in the United States. Following successful case outcomes and significant customer interest in Europe across a variety of neurosurgeries, we are confident that IRRAflow will significantly improve the outcomes of US patients with its unique mechanism of action,” said Will Martin, IRRAS’ Chief Commercial Officer.  

For more information, please contact:
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com 
 
 
About 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 methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Regularly during treatment, the 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. Additionally, IRRAflow incorporates ICP monitoring into this catheter and uses a proprietary software to regulate treatment based on desired pressure levels.

With its unique product portfolio, protected by property patents and patent applications, IRRAS is well-positioned to establish a leadership position 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.

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 July 16, 2018 at 8.00 a.m. (CET).

 Press release (PDF)

Bulletin from Annual General Meeting in IRRAS AB on June 1, 2018

The Annual General Meeting (the ”AGM”) on June 1, 2018 decided to adopt the balance sheet, income statement, consolidated income statement and consolidated balance sheet for 2017. Furthermore, it was decided that no dividend will be distributed and disposable profits as of 2017-12-31 are carried forward to future periods.

The AGM also decided to discharge the board members and the CEO from liability for 2017. The AGM approved the nominating committee’s proposal that the board shall consist of five board members without deputies.

The AGM decided that the remuneration to the chairman of the board shall amount to SEK 500,000 and that the remuneration to the other board members not employed by the company shall be SEK 200,000 each. No additional remuneration is proposed for committee work. The total remuneration to the board is hence amounted to SEK 1,100,000.  

The AGM also decided that the remuneration to the auditor, as previous, will be on specified current account.
The AGM decided that the board until the end of the next Annual General Meeting will consist of the members
Anders Wiklund, Kleanthis G. Xanthopoulos, Marios Fotiadis, Saeid Esmaeilzadeh and Anita Tollstadius. Anders Wiklund was re-elected chairman of the board.
KPMG AB was re-elected as the company’s auditor, with Duane Swanson as auditor in charge, until the end of the Annual General Meeting of 2019.

The AGM approved the proposed instructions for the nomination committee.
The AGM approved the board’s proposed remuneration guidelines for senior management.

The AGM approved the board’s proposals of a new incentive program for the employees of the company.
 

The AGM approved the board’s proposal to be authorized to increase share capital through the issue of new shares and/or convertibles.                                                              
Complete proposals regarding the AGM’s decisions are available on IRRAS AB:s website
www.irras.com. 

For more information, please contact:
Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com
 

About 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 catheter is automatically flushed to prevent common catheter occlusions from forming. Additionally, 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 property patents and patent applications, IRRAS is well-positioned to establish a leadership position 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.

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 June 1, 2018 at 22.00 p.m. (CET). 

 Press release (PDF)

Solid sales in the quarter and updated CE approval partially in place

First quarter, January – March 2018

  • Net revenue totaled SEK 5.9 (0.0) million.
  • Operating loss (EBIT) totaled SEK -21.1 (-11.5) million.
  • The result after taxes totaled SEK -17.8 (-11.5) million.
  • Result per share before and after dilution was SEK -0.75 (-0.67).

Important events during the quarter

Re-launch of IRRAflow
IRRAS launched an upgraded version of IRRAflow in February. The product was upgraded both esthetically and mechanically and received a new battery configuration. The new configuration was developed in response to a voluntary recall and temporary stop of sales for the product after a battery defect in December 2017. The launch resulted in a total sales of SEK 5.9 million in the quarter.  

Strengthening of the management group
IRRAS strengthened the company’s management group during the quarter. Will Martin was hired as Chief Commercial Officer and Kellie Fontes as Senior Director Human Capital. Both report to Dr. Kleanthis G. Xanthopoulos, IRRAS President and CEO and are based at the company’s US offices in San Diego.

Update relating to 510 (K) application
During the quarter, the company received a response from the FDA (American Food and Drug Administration) regarding the company’s 510 (K) application.
In their communication to the company, the FDA requested clarifications and updating of certain reports, primarily related to bio-compatibility, sterilization tests and software of IRRAS suppliers. IRRAS is finalizing a compilation of the respective documents and still foresees that IRRAflow will be launched in the US towards the end of 2018.

Important events after the end of the quarter

Updated ISO and CE certification
IRRAS’ previous notified body Intertek had decided not to continue certifying certain products. Therefore, IRRAS and hundreds of Intertek’s customers needed to obtain updated ISO certification and CE mark approval from new notified bodies.

In May, IRRAS received both an updated ISO 13485:2016 certificate and updated CE approvals for both the control unit and the cassette in the IRRAflow system. Both products are Class II products. The ISO certificate and CE approvals are valid through 2021. For Class III products, such as the IRRAS catheters, significantly more time is required for review. The company expects to receive an updated CE approval for the Class III catheter product in the near future.

Change in the company’s management group
The company’s scientific founder, Dr. Christos Panotopoulos, has been appointed as Special Advisor and member of the IRRAS Clinical Advisory Board. He assumes his new role on June 1, 2018, and leaves his earlier role as Chief Scientific Officer and member of the company’s management group.


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 catheter is automatically flushed to prevent common catheter occlusions from forming. Additionally, 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 property patents and patent applications, IRRAS is well-positioned to establish a leadership position 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


Calendar

Annual shareholders’ meeting June 1, 2018
Quarter 2 interim financial report August 27, 2018
Quarter 3 interim financial report November 8, 2018


Financial information
Kleanthis G. Xanthopoulos, Ph.D. President and CEO Fredrik Alpsten CFO and Deputy CEO
+1 858 247 7033 +46 706 67 31 06
kleanthis.xantopoulos@irras.com fredrik.alpsten@irras.com

 IRRAS AB (publ) First quarter January – March 2018 (PDF)

IRRAS AB – Q1 Report 2018 – invitation to conference call and webcast

The Company will also host a conference call and an online presentation on the same day (Tuesday, May 29, 2018) at 09:00 a.m. CET.

The dial-in numbers for the conference call are:

SE: +46 8 5063 9549

UK (and rest if the world): +44 20 3008 9807

The presentation will also be webcast and can be accessed from the following web address:

https://financialhearings.com/event/10809

Hosts: President CEO Kleanthis G Xanthopoulos, Ph.D. and CFO and Deputy CEO Fredrik Alpsten

Investor and Media Contact:

Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@irras.com

About IRRAS AB

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 catheter is automatically flushed to prevent common catheter occlusions from forming. Additionally, 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 property patents and patent applications, IRRAS is well-positioned to establish a leadership position 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 information was released for public disclosure, through the agency of the contact person above, on May 28 at 12.00 a.m. (CET).

 Press release (PDF)

Irras Radio Irras Academy

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