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 Wednesday 8 May 2019; and
• notify the company of their intention to attend the AGM at the latest by Thursday 9 May 2019.

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 AGM2019@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 8 May 2019.

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 of Directors
15. Election of auditor
16. Resolution in respect of guidelines for remuneration for senior executives
17. Resolution in respect of authorization for the Board of Directors to issue shares and/or convertible bonds
18. Closing of the meeting

Proposals by the Nomination Committee

The Nomination Committee has consisted of Christer Hellström, Chairman of the Nomination Committee, appointed by Bacara Holdings Limited, Anders P. Wiklund, Chairman of the Board of Directors of IRRAS AB, Marios Fotiadis, appointed by Lexington Holding Assets Limited (BVI) 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 1,360,000, of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 240,000 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 a fee of SEK 100,000 shall be paid to the Chairman of the Audit Committee and the Remuneration Committee, respectively, and that a fee of SEK 50,000 shall be paid to each of the other members of the Committees. The total remuneration of SEK 1,360,000 as set out above assumes that the Audit Committee consists of two members and the Remuneration Committee consists of three members.

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, Anita Tollstadius and Eva Nilsagård. The Nomination Committee further intends to propose an additional Board member, who will be presented as soon as possible and no later than in connection with the Annual General Meeting. Board member Saeid Esmaeilzadeh has declined to be re-elected.

The Nomination Committee 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, the authorised public accountant 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 2018.

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 in respect of authorization for the Board of Directors to resolve to issue of shares and/or convertible bonds (item 17)

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.

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.

The Board of Directors’ complete proposal will be available as set out in section “Documents” below no later than on 23 April 2019.

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 15 April 2019, the total number of shares and votes in the Company amounts to 24,017,974. Currently, the Company holds no own shares.

Documents

The Nomination Committee’s reasoned statement regarding the proposals relating to the Board of Directors and information regarding the proposed board members are available at the Company’s website, www.irras.com and 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 complete proposal pursuant to item 17 above, and 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 23 April 2019.

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, April 2019

IRRAS AB (PUBL)

The Board of Directors

 NOTICE TO ATTEND THE ANNUAL GENERAL MEETING OF IRRAS AB (PUBL) (PDF)

Stockholm, March 13, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company, today announced the company plans to evaluate a possible relisting of its shares from Nasdaq First North Premier to Nasdaq Stockholm’s main market during 2019. IRRAS has engaged Carnegie Investment Bank as financial advisor to explore this potential relisting and to evaluate other strategic financial initiatives.

A transition to Nasdaq’s main market in Sweden is part of the company’s business strategy to become a leading medical technology company and industry leader in the space of intracranial bleedings.

“Applying for a listing of IRRAS’ shares to Nasdaq Stockholm’s main list has been a goal since we were first listed in 2017, and it reflects the significant progress and achievements we have made since that time, including our commercial-stage product pipeline and global sales initiatives,” said President and CEO Kleanthis G. Xanthopoulos, Ph.D. “Our successful clinical cases to date illustrate how using IRRAflow can result in fewer complications, reduce treatment time for the patient, and lower the costs of treatment for hospitals and health care providers.”

The information was released for public disclosure, through the agency of the contact person below on March 13, 2019 at 08.00 a.m. (CET).
  

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
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. Wildeco is reached at + 46 8 545 271 00, or at info@wildeco.se.

 Press release (PDF)

Stockholm, March 11, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company announced today that it has appointed Vinny Podichetty, MD, MS. as Vice President of Global Clinical Affairs. Dr. Podichetty will report to the President and Chief Executive Officer, Kleanthis G. Xanthopoulos, Ph.D., and will serve as a member of the Executive Management team.

Dr. Podichetty brings more than 17 years of experience in clinical, medical and regulatory affairs and global execution of clinical trials for medical devices. He has developed and successfully managed high-profile clinical programs for Class II and Class III products, post-market clinical research studies and regulatory plans for small and established organizations.

Prior to joining IRRAS, he held senior positions in Clinical Affairs at Edwards Lifesciences, MicroVention Terumo and Zimmer Biomet Inc. Dr. Podichetty launched his career in clinical research at the prestigious Cleveland Clinic Foundation in Ohio. Subsequently in his other industry roles, he served in various leadership capacities in program management, clinical affairs, strategic planning and portfolio management with key responsibilities in IDE and early feasibility/R&D study execution. Dr. Podichetty holds a Diploma in Medicine from India and a Master of Science degree from Cleveland State University.

“I am excited to join IRRAS, and ready to work in achieving the company’s mission of developing innovative solutions that transform fluid management in patients. IRRAS’s commercial portfolio and scope of initiatives from a clinical and scientific perspective are impressive, and I see tremendous potential in its product pipeline to provide optimal patient care therapies,” said Vinny Podichetty.

“Vinny is a valuable addition to the IRRAS management team. His expertise and vast array of experiences will be important as we work to expand our clinical evidence and scientific initiatives over the next several years to support our IRRAflow system and accelerate our plans to become a global leader in the world of neurocritical care,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

For more information, please contact:

US

Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
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. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

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 11, 2019 at 08.00 a.m. (CET). 

 Press release (PDF)

Stockholm, March 6, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical science and technology company, today announced that its board has resolved to revise the company’s financial targets.

The financial targets that will apply effective today are:

– Revenue exceeding SEK 275 million in 2021
– Gross margin exceeding 72 % in 2021
– Cash-flow positive by Q4 2021

“IRRAS has worked hard to build the foundations for growth, and we are optimistic in our ability to continue to develop innovative products that will change the lives of millions,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.

“Sharing our future commercial projections is a sign that we are confident in our life-saving technology and our ability to deliver value to our shareholders.” 

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 6, 2019 at 08.00 a.m. (CET). 

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
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. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

 Press release (PDF)

Fourth quarter, October–December 2018

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

Period January–December 2018

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

Important events during the fourth quarter

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

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

Important events after the end of the fourth quarter

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

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

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

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

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

With its unique product portfolio protected by patents and patent applications, IRRAS is well positioned to establish itself as a leader in the medical device market. IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com. The IRRAS share is listed at Nasdaq First North Premier. Wildeco is the company’s Certified Adviser.

Financial information

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

Calendar

Q1 2019 Interim Report	May 7, 2019
Q2 2019 Interim Report	August 29, 2019
Q3 2019 Interim Report	November 8, 2019
Annual Shareholders’ meeting	May 14, 2019
Annual report	April 23, 2019

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on February 14, 2019 at 8:00 a.m. (CET).

 IRRAS AB (PUBL) YEAR-END REPORT 2018 (PDF)

On Thursday February 14, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q4 2018 interim 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 42 704
Rest of the world: +44 3333 00 9262

The presentation will also be webcast and can be accessed from the following web address:
https://financialhearings.com/event/11739

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

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

 Press release (PDF)

Stockholm, January 10, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company, today announced that the first patient in the United States was successfully treated with IRRAflow, the company’s initial product that offers an innovative, therapeutic approach to the fluid management of patients with intracranial bleeding.

“The US is the largest market for intracranial procedures, and we are making significant progress engaging neurocritical care centers and specialty hospitals across the country,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We’re thrilled to see the first patient treated in the United States and remain confident that IRRAflow will dramatically improve the outcomes for many future patients.”

This first IRRAflow patient treatment in the US was performed at the University of California – Irvine (UCI) Medical Center, located in Orange, California. The team, led by UCI Health neurosurgeon Dr. Sumeet Vadera, successfully treated a patient suffering from a chronic subdural hematoma that formed after a recent fall.

“We are excited to be the first site in the United States to use the IRRAflow system,” said Dr. Vadera, Associate Professor of Neurological Surgery, UCI School of Medicine. “At UCI, we pride ourselves on providing our patients the latest in cutting-edge treatment options, and we can now provide the first active, therapeutic treatment to manage intracranial fluid with IRRAflow.”

IRRAflow addresses the complications associated with current passive treatment methods by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Since receiving US Food and Drug Administration (FDA) clearance in 2018 to market the system in the United States, IRRAS has taken many needed steps to launch the product, including establishing a customer service and shipping partnership with global logistics specialist, HealthLink Europe & International, hiring Territory Managers, and developing needed marketing and training materials.

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 below on January 10, 2019 at 08.00 a.m. (CET).

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
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. Wildeco is reached at + 46 706 67 31 06 or at info@wildeco.se.

 Press release (PDF)

Under the terms of the agreement, HealthLink will be responsible for receiving customer orders, processing customer invoices, and storing and shipping IRRAS products. With state-of-the-art facilities in both the United States and the Netherlands, HealthLink will enable IRRAS’ customers around the world to seamlessly order and quickly receive their products.

“IRRAS’ ability to ship to patients in need around the world has increased tremendously with our partnership with HealthLink Europe & International,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We are very pleased with our progress thus far with our US launch, which has already established relationships with several neurocritical care centers that are currently evaluating IRRAflow, and this agreement only enhances our ability to support these customers.”

Will Martin, IRRAS’ Chief Commercial Officer added, “This pact allows IRRAS to focus our resources on product development and commercial execution, while HealthLink will manage the logistics and ensure that we can rapidly ship products to any destination around the world. This partnership is an exciting start to 2019 and we look forward to continuing to advance our medical device portfolio.”

For more information, please contact:
US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
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 group of products, 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 January 3, 2019 at 08.00 a.m. (CET). 

 Press release (PDF)

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

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).

 IRRAS AB (Publ) INTERIM FINANCIAL REPORT JANUARY – SEPTEMBER 2018 (PDF)

On Thursday November 8, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q3 2018 interim report (which is published the same day at 08.00 a.m. CET).

The dial-in numbers for the conference call are: 

Sweden: +46 8 566 426 91
Rest of the world: +44 20 3008 9810

The presentation will also be webcast and can be accessed from the following web address:
https://financialhearings.com/event/10811

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

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

 Press release (PDF)