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)

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)

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)

Stockholm, Sweden, May 11, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on developing and commercializing innovative solutions for brain surgery, has today published the 2017 Annual Report at the company’s homepage 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, USA. For more information, please visit www.irras.com.

 Annual report 2017 (PDF)

Stockholm, Sweden, May 9, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, today announced that its scientific founder Dr. Christos Panotopoulos, M.D., Ph.D., has been appointed to a new role as Special Advisor and a member of the IRRAS Clinical Advisory Board. Concurrently with his new position, Dr. Panotopoulos will transition from his prior role as Chief Scientific Officer and member of the management team effective June 1, 2018.

“Dr. Christos Panotopoulos is the scientific founder of IRRAS and one of our industry’s leading neurosurgeons. He was instrumental in the development of the company’s products. We are thrilled to appoint Dr Panotopoulos as Special Advisor and a member of the IRRAS Clinical Advisory Board,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “As our company advances, his clinical work will be strategic to advise IRRAS on the growth of our IRRAflow™ product pipeline. Dr. Panotopoulos will also focus on expanding our network of clinical advisors and further establishing the clinical utility of our products in neurosurgery and other surgical pathologies.”

“I am happy to assist IRRAS in its mission to transform the treatment of intracranial bleedings and look forward to expanding our clinical advisory network as we introduce our products into new pathologies”, said Dr. Panotopoulos. “Since the commercial launch in the EU in May 2017, the ongoing post market survey has demonstrated absence of blockage and infection for more than a hundred consecutive patient treatments in Germany, in different intracranial pathologies.

It is well established that blockage and infection compromise significantly neurosurgical patients’ outcomes and increase significantly patient days in the hospital and costs to hospitals and healthcare providers” continued Dr. Panotopoulos.

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 designing, 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 may also potentially 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 with corporate offices in Munich and San Diego. 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 May 9, 2018 at 08.05 a.m. (CET).

 Press release (PDF)

Stockholm, Sweden May 9, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for brain surgery, today announced that it received an updated ISO 13485:2016 certificate and updated CE marks for its control unit and tube set. Both products are class II products. The ISO certificate and CE marks are valid until 2021. It is typical for a class III product, such as the IRRAS catheter, to require more time for auditing. Regardless, an updated CE mark for the IRRAS catheter is expected in the near future.  

IRRAS has completed an audit of its quality system and IRRAflow products with the company’s new Notified Body, LNE/G-MED. A Notified Body is an entity that has been accredited by a Member State in the EU to assess whether a product to be placed on the market meets certain preordained standards. IRRAS previous Notified Body Intertek (AMTAC) decided earlier not to continue to support certain device categories. Intertek’s customers within these categories therefore had to get new ISO and CE certificates from a new Notified Body. This has created a long list of companies that are seeking to be re-certified.

Following completion of the audit by LNE/G-MED, IRRAS was issued new CE certificates for two of its three products while the third CE mark for the catheter is under review and is expected soon. As the catheter is a class III product the recertification takes a somewhat longer time.

“We are happy to have both rapidly identified a new Notifying Body and to have received an updated ISO and CE mark for two of our products. We are confident that we will have the remaining CE mark for the catheter in place shortly. Potentially the delay can affect sales in Q2 but we do not foresee any effect on sales for the full year”, said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

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 designing, 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 may also potentially 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, 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 May 9, 2018 at 08.00 a.m. (CET).

 Press release (PDF)

The shareholders in IRRAS AB (publ), reg. no. 556872-7134, are hereby invited to attend the annual general meeting (“AGM”) to be held on Friday, June 1, 2018 at 11.00 am at IVA Konferenscenter, Grev Turegatan 16 in Stockholm, Sweden.

Notification to attend etc.

Shareholders who wish to attend the AGM must

• be recorded in the share register kept by Euroclear Sweden AB no later than on Friday 25 May 2018; and
• notify the company of their intention to attend the AGM at the latest by Monday, May 28, 2018.

Notification to participate in the AGM must be in writing via the booking form available on the company’s website www.irras.com or by e-mail to AGM2018@irras.com. Notification can also be made by telephone at +46 10 211 51 70. The notification shall state name, personal identification number/ company registration number, address, telephone number and number of shares held. 

Proxies

Shareholders represented by proxy must issue a written, signed and dated proxy. If the proxy is issued by a legal entity, a certified copy of the valid registration certificate (Sw. registreringsbevis) of the legal entity (or similar document for non-Swedish legal entity) must be attached to the proxy. The proxy may not be older than one year unless it states that it is valid for a longer period of time (the validity of the proxy may not exceed five years).

In order to facilitate the registration, proxies in its original as well as registration certificates and other authorization documents should be sent to the company address, IRRAS AB (publ), Att: Sabina Berlin, Vasagatan 16, SE-111 20 Stockholm, Sweden well in advance before the meeting.

Proxy forms for shareholders who wish to attend the meeting by proxy will be available on the company website, www.irras.com.

Shareholding in the name of a nominee

In order to be entitled to participate in the meeting, shareholders who hold their shares through nominees (Sw. förvaltare) must request a temporary registration of the shares in their own name, with Euroclear Sweden AB. Shareholders who wishes to obtain such registration must contact the nominee regarding this well in advance of May 25, 2018.

Proposal for agenda

1. Opening of the meeting
2. Election of chairman of the meeting
3. Preparation and approval of the voting list
4. Approval of the agenda
5. Election of one or two persons to approve the minutes
6. Determination as to whether the meeting has been duly convened
7. Presentation of the annual report and the auditor’s report as well as the consolidated annual report and the auditor’s report on the consolidated annual report
8. Statement by the CEO
9. Adoption of the profit and loss statement and the balance sheet as well as the consolidated profit and loss statement and the consolidated balance sheet
10. Resolution in respect of appropriation of the company’s profit or loss as set forth in the adopted balance sheet
11. Resolution in respect of discharge of the board members and the CEO from liability
12. Determination of number of board members and auditors
13. Determination of fees for board members and auditors
14. Election of board members and chairman of the board
15. Election of auditor
16. Resolution in respect of guidelines for remuneration for senior executives
17. Resolution to implement an incentive scheme for employees of the Group
18. Resolution to authorise the Board of Directors to issue warrants
19. Resolution in respect of authorization for the board to issue shares and/or convertible bonds
20. Closing of the meeting

Proposals by the Nomination Committee

The Nomination Committee has consisted of Christer Hellström, Chairman of the Nomination Committee, appointed by Serendipity Group AB and Serendipity Ixora AB, Anders P. Wiklund, Chairman of the Board of Directors of IRRAS AB, Marios Fotiadis, appointed by Lexington Holding Assets Limited (BVI) and Bacara Holdings Limited, and Christos Panotopoulos, appointed by F.EX Endotherapy Limited.

Election of Chairman of the Meeting (item 2)

The Nomination Committee proposes that Anders P. Wiklund is elected as Chairman of the Meeting.

Determination of number of board members and auditors (item 12)

The Nomination Committee proposes that the Board of Directors shall consist of five board members elected by the General Meeting. The nomination committee also proposes that the Company shall have one registered auditing company as auditor.

Determination of fees for board members and auditors (item 13)

The Nomination Committee proposes that the total remuneration for the Board of Directors shall amount to SEK 1,100,000, of which SEK 500,000 shall be paid to the Chairman of the Board of Directors and SEK 200,000 shall be paid to each of the other board members elected by the General Meeting and who are not employees of the group.

The Nomination Committee proposes that the audit fees shall be paid in accordance with approved invoices.

Election of board members and Chairman of the Board of Directors (item 14)

As members of the Board of Directors until the end of the next Annual General Meeting, the Nomination Committee proposes re-election of Anders P. Wiklund, Kleanthis G. Xanthopoulos, Marios Fotiadis, Saeid Esmaeilzadeh and Anita Tollstadius.

The nomination committee also proposes re-election of Anders P. Wiklund as the Chairman of the Board of Directors.

Election of auditor (item 15)

The Nomination Committee proposes that the registered auditing company KPMG AB shall be re-elected as auditor for the period until the next AGM. KPMG AB has informed that, if KPMG AB is re-elected as auditor, Duane Swanson will continue as the responsible auditor. The Nomination Committee’s proposal is recommended by the Company’s Audit Committee.  

Proposals by the Board of Directors

Dividend (item 10)

The Board of Directors proposes that the AGM shall resolve not to distribute any dividends for the financial year 2017.  

Resolution in respect of guidelines for remuneration of senior management (item 16)

The Board of Directors proposes that the AGM decides on guidelines for remuneration and other terms of employment for senior executives according to the following.

The Company’s starting point is that salary and other terms and conditions shall enable the group to attract and retain qualified management persons at a reasonable cost for the Company. The remuneration for management persons shall be decided in accordance with IRRAS remuneration policy. The remuneration for management persons consist of fixed salary, variable remuneration, pension and other benefits. In order to avoid that the management persons take unnecessary risks there shall be a fundamental balance between fixed and variable remuneration. Furthermore, the annual general meeting in IRRAS may, if so is ordered, offer long-term incentive schemes such as share or share price related incentive schemes.

Each management person shall be offered a market level fixed salary based on the degree of difficulty, responsibilities, experience and performance. In addition, each management person may from time to time, be offered a variable remuneration (bonus) to be paid in cash. The variable remuneration shall be based on clear predetermined and measurable performance criteria and economic results, as well as predetermined individual objectives and business objectives, and shall also be designed to promote IRRAS long-term value creation. Variable remuneration may not exceed 12 months’ fixed salary.

Management persons shall be offered pension terms that are in accordance with market practice in the country where the management persons habitually resides. Non-monetary benefits shall facilitate the work of the management persons and shall correspond to what is considered reasonable in relation to market practice. The fixed salary during the notice period shall, together with severance pay, not exceed 24 months’ fixed salary. Insofar board members who are elected by the General Meeting carry out work in addition to work on the Board of Directors, it shall be possible to remunerate them for such work. The remuneration shall be in accordance with market terms and shall be approved by the Board of Directors.

The Board of Directors shall, before every Annual General Meeting, consider whether or not additional share or share price-related incentive schemes shall be proposed to the General Meeting. It is the General Meeting that resolves upon such incentive schemes. Incentive schemes shall promote long-term value growth. New share issues and transfers of securities resolved upon by the general meeting in accordance with the rules of Chapter 16 of the Swedish Companies Act are not covered by the guidelines to the extent the Annual General Meeting has taken, or will take, such decisions.

The Board of Directors shall be entitled to deviate from the guidelines in individual cases if there are special reasons for doing so.

Resolution to implement an incentive scheme for employees of the Group (item 17)

The Board of Directors proposes that the AGM resolves to adopt an incentive scheme for employees of the Group. The rationale for the proposal is to create opportunities to reward, motivate, keep and to recruit competent employees and to increase the motivation amongst the employees. The Board of Directors considers that the adoption of the incentive scheme as described above is in the favour of the Company and its shareholders.

The Board of Directors proposes the issuance of stock options to employees or full time consultants. Under the incentive scheme participants will free of charge be assigned a certain number of stock options. Subject to vesting, the stock options may be exercised for purchase of shares until and including June 15, 2022. The incentive scheme shall comprise up to 732,000 stock options, representing approximately 3.00 per cent of the share capital and votes after dilution, based on the current number of shares in the Company.

The allocation of the options shall be decided by the Board of Directors in accordance with the following guidelines:

– President CEO up to 150,000 options,

– Present and new senior executives up to 150,000 options each,

– Present and new managers up to 55,000 options each, and

– Present and new other employees up to 25,000 options each.

Provided that the participant is still an employee of the Group at the time of exercise of the options, each option entitles the participant to acquire one share in IRRAS at a price equal to 100 per cent of the average closing price of the Company’s shares on Nasdaq First North during the period from 1 June 2017 up to and including 15 June 2017.

The Board of Directors shall be responsible for preparing the detailed terms and conditions of the incentive scheme, in accordance with the above mentioned terms and guidelines. As a main rule, the stock options shall be subject to a three year vesting period and vesting shall be linear on a monthly basis for the three year period.

The Board of Directors shall be entitled to make adjustments in the incentive scheme to meet foreign regulations or market conditions. The Board of Directors may also make other adjustments if significant changes in the IRRAS group, or its markets, result in a situation where the decided terms and conditions for exercising the options become inappropriate.

Furthermore, in case of special circumstances, the Board of Directors shall be authorized to resolve that options will be kept and exercised despite the fact that the participant’s engagement in the IRRAS group have ceased, for example due to illness.

No compensation for ordinary dividends on the underlying shares shall occur. In case of an extraordinary dividend, the Board of Directors shall have the right to resolve on whether the options’ exercise price shall be subject to recalculation.

The options may not be transferred or pledged.

The incentive scheme allows employees of the Group to be granted stock options entitling them to acquire shares in the Company. Such transfers fall within the scope of Chapter 16 of the Swedish Companies Act, which means that a resolution to approve the incentive scheme is valid only where supported by shareholders holding not less than nine-tenth of both the shares voted and of the shares represented at the General Meeting.

Resolution to authorise the Board of Directors to issue warrants (item 18)

To ensure delivery of shares to participants in the incentive schemes described under items 17 above, it is proposed that the Board of Directors be authorised, on one or more occasions until the next AGM, to issue up to 732,000 warrants, representing approximately 3.00 per cent of the share capital and votes after dilution, based on the current number of shares in the Company. The warrants shall be issued free of charge and, with disapplication of the shareholders’ preferential rights, may be subscribed for by IRRAS AB or a subsidiary of the Company.

A valid resolution by the General Meeting pursuant to the proposal above requires that the resolution be supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the General Meeting.

Resolution in respect of authorization for the board to resolve to issue of shares and/or convertible bonds (item 19)

The Board of Directors proposes that the AGM authorizes the Board of Directors to, on one or several occasions during the period until the next AGM, with or without deviation from the shareholders’ preferential rights, resolve on share issues and/or issues of convertible bonds that involve the issue of or conversion to a maximum of 2,366,000 shares, corresponding to a dilution of approximately 10.0 percent of the share capital and the voting rights, based on the current number of shares in the Company.

The purpose of the authorization and the reason for the deviation from the shareholders’ preferential rights, if any, is to enable the Company to carry out issues of shares and/or convertible bonds in a time-efficient way to finance acquisitions or investments in new or existing businesses. The issuance of shares or convertible bonds under the authorisation shall, in case of deviation from the shareholders’ preferential rights, be made at a subscription price according to the prevailing market conditions at the time of the issuance of the shares and/or convertible bonds. Payment for subscribed shares and/or convertible bonds shall be made in cash, in kind or by way of set-off.

A valid resolution by the General Meeting pursuant to the proposal above requires that the resolution be supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the General Meeting.

OTHER INFORMATION

Number of shares and votes

As per May 3, 2018 the total number of shares and votes in the Company amounts to 23,661,863. The Company holds no shares in the Company.  

Documents

The complete proposal by the Board of Directors pursuant to item 17 above and the Nomination Committee’s statement regarding the proposals relating to the Board of Directors and information regarding the proposed board members will, no later than on May 11, 2018, be held available at the Company’s website, www.irras.com, at the Company’s office at Vasagatan 16 in Stockholm and will be sent free of charge to shareholders who so request and provide their postal address or email address.  The annual report and the audit report will be available at the Company’s website and at the Company’s office at the address set out above no later than on May 11, 2018. 

The shareholders’ right to submit questions

The board and the CEO shall, if any shareholder so requests and the board believes that it may be done without significantly harming the company, provide information regarding circumstances that may affect the assessment of an item on the agenda, circumstances that can affect the assessment of the company’s or its subsidiaries’ financial position and the company’s relationship to other companies within the group as well as the consolidated financial statements. Anyone wishing to submit questions in advance can do so by sending them to the company at the address mentioned above.

Stockholm, May 2018

IRRAS AB (PUBL)

The Board of Directors

 NOTICE TO ATTEND THE ANNUAL GENERAL MEETING (PDF)

– Requests for certain technical clarifications and labeling definition –
– Financial targets remain unchanged –

San Diego, CA, USA, Munich, Germany and Stockholm, Sweden March 12, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing, and commercializing innovative solutions for various brain pathologies, announced that it received a response from the U.S. Food and Drug Administration (FDA) regarding the company’s 510(k) application for the approval of IRRAflow™, a CE-marked, fully integrated, closed-circuit medical device system that enables intelligent intracranial fluid management as well as accurate, real-time monitoring of intracranial pressure.

The FDA has asked for technical clarifications and updates of certain reports primarily relating to IRRAS’ third party contractors’ biocompatibility and sterility testing and software. Recommendations and clarifications of the proposed labeling have also been provided. The requests by the FDA are not unusual for a complex, software-driven surgical device like IRRAflow™ and will be addressed by IRRAS in a timely manner.

“The feedback from the FDA is both appreciated and addressable, and we believe this communication brings us closer to the approval of IRRAflow™ in the United States,” said Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS. “With the completion of our dialog on labeling and the technical clarifications with the FDA, we anticipate a potential launch of IRRAflow™ in the U.S. in the second half of 2018. We are working closely with the FDA to bring this innovative medical device to the U.S. market, offering patients, neurosurgeons, and hospitals an effective, intelligent solution to treat intracranial bleedings.”

About IRRAflow™

IRRAS has developed and commercialized a revolutionary intelligent brain fluid management device stemming from its core IRRAflow™ technology that addresses the complications associated with the occurrence of intracranial bleedings. Currently available devices do not address the complications that lead to death because they do not prevent occlusion (or blockage) in the catheter during treatment and they do not accurately monitor intracranial pressure (ICP). IRRAS’ products provide a transformative solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device.

About IRRAS AB

IRRAS (NASDAQ Stockholm: IRRAS), is a publicly-traded, commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, with a goal of dramatically improving patient outcomes, reducing patient-time in the intensive care unit and medical ward, and providing significant health economic benefits to hospitals and healthcare providers. The Company’s initial product focus is on intracranial fluid management solutions that utilize its proprietary platform technology, IRRAflow™, which is a CE-marked, fully integrated, closed-circuit medical device system that enables intelligent intracranial fluid management as well as accurate, real-time monitoring of intracranial pressure.

With its unique product portfolio, protected by key intellectual property patents and patent applications, IRRAS is well-positioned to improve patient outcomes and establish a leadership position in the medical device market. IRRAS maintains its headquarters in Sweden with corporate offices in Germany and San Diego, CA, USA. For more information, please visit www.irras.com.

Investor and Media Contact:

Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik.alpsten@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 March 12, 2018 at 08.00 a.m. (CET).

 Press release (PDF)

San Diego, CA, USA, Laichingen, Germany and Stockholm, Sweden March 5, 2018 – IRRAS AB (NASDAQ Stockholm: IRRAS), a commercial-stage medical technology company focused on designing, developing, and commercializing innovative solutions for various brain pathologies, today announced the appointment of Will Martin as Chief Commercial Officer and a member of the executive management team. Mr. Martin has amassed nearly 20 years of commercial, marketing, and executive experience in the medical device field with expertise in driving aggressive revenue growth for multiple product platforms in both emerging and large companies. In this newly created role, Mr. Martin will report directly to the President CEO of IRRAS, Kleanthis G. Xanthopoulos, Ph.D., from the San Diego site.

“We’re thrilled to welcome Will to the IRRAS team as we accelerate the commercial planning for our IRRAflow™ products,” said Kleanthis G. Xanthopoulos, President and CEO of IRRAS. “Will’s commercial and leadership experience will be invaluable to IRRAS as we build our commercial infrastructure to realize revenue growth in Europe while expanding into attractive new markets like the United States.”

Mr. Martin commented, “I have dedicated much of my career to providing patients with access to innovative medical devices, and, by joining IRRAS, I am pleased to continue this work by guiding the commercial strategies for IRRAflow™. We have a tremendous opportunity to revolutionize the treatment of hemorrhagic strokes, and I look forward to working with the experienced team at IRRAS to accomplish our goals.”

Most recently, Mr. Martin served as General Manager of the Peripheral Vascular (PV) devices business for Philips Healthcare, a global healthcare technology conglomerate. In this role, Mr. Martin oversaw the growth and expansion of Philips into the PV interventional space, was responsible for defining and owning the global PV business strategy, and played a key role in the acquisition of Spectranetics for more than $2B. During his tenure, the PV segment was one of the fastest growing businesses in Philips.

Prior to Philips, Mr. Martin was Vice President of Commercial Operations and Vice President of Marketing and Business Development at AtheroMed, Inc. (acquired by Volcano, Inc). In this key leadership role, he developed the global launch strategy for the Phoenix Atherectomy System and hired and led the initial US sales force during the product’s successful initial market introduction.   He served as Vice President of Sales and Marketing at Hotspur Technologies, Inc. (acquired by Teleflex), the VP of International Sales at AccessClosure, Inc. (acquired by Cardinal Health), and held other key commercial roles at Boston Scientific Corporation, Aventis Pharmaceuticals, and Corning, Inc.

Mr. Martin was a Lieutenant in the U.S. Navy. Mr. Martin received a BA from Notre Dame and an MBA from Johns Hopkins University.

About IRRAflow™

IRRAS has developed and commercialized a revolutionary intelligent brain fluid management device stemming from its core IRRAflow™ technology that addresses the complications associated with the occurrence of intracranial bleedings. Currently available devices do not address the complications that lead to death because they do not prevent occlusion (or blockage) in the catheter during treatment and they do not accurately monitor intracranial pressure (ICP). IRRAS’ products provide a transformative solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device.

In February 2018, IRRAS launched a significantly improved version of IRRAflow™ in the EU, which incorporated several aesthetic and mechanical upgrades and an updated battery configuration. The new battery configuration was optimized in response to a voluntary recall and temporary hold on selling the device following an isolated incident of a battery malfunction that occurred in December 2017. The hold has now been lifted.

About IRRAS AB

IRRAS (NASDAQ Stockholm: IRRAS), is a publicly-traded, commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, with a goal of dramatically improving patient outcomes, reducing patient-time in the intensive care unit and medical ward, and providing significant health economic benefits to hospitals and healthcare providers. The Company’s initial product focus is on intracranial fluid management solutions that utilize its proprietary platform technology, IRRAflow™, which is a CE-marked, fully integrated, closed-circuit medical device system that enables intelligent intracranial fluid management as well as accurate, real-time monitoring of intracranial pressure.

With its unique product portfolio, protected by key intellectual property patents and patent applications, IRRAS is well-positioned to improve patient outcomes and establish a leadership position in the medical device market. IRRAS maintains its headquarters in Sweden with corporate offices in Germany and San Diego, CA, USA. For more information, please visit www.irras.com.

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

This information is 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 March 5, 2018 at 08.30 a.m. (CET).

 Press release (PDF)