IRRAS strengthens executive team with appointment of Kellie Fontes as Senior Director of Human Capital

San Diego, California, Stockholm, Sweden, February 28, 2018 – IRRAS (NASDAQ STOCKHOLM: IRRAS), a commercial-stage medical technology company developing breakthrough devices for a broad range of intracranial bleeding applications and procedures, today announced the appointment of Kellie Fontes as Senior Director, Human Capital and a member of the executive management team. Ms Fontes brings nearly 30 years of experience and knowledge in all facets of Human Resources. Ms Fontes will report directly to the President CEO of IRRAS, Kleanthis G. Xanthopoulos, Ph.D., from the San Diego site in California.

“I am very pleased to welcome Kellie to the executive team of IRRAS,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS.  “Kellie’s results-oriented HR skills and recognized focus on the creation of strong teams will be of great value to IRRAS as we continue to build a leading, global medical technology company focus on the treatment of intracranial bleedings.”

Ms. Fontes commented, “Working within the medical technology sector, helping patients in need and being part of creating the solutions of tomorrow, is extremely exciting to me. I am very pleased to join the team of IRRAS and to strengthen the strategic work of talent management and HR compliance.”

Ms. Fontes has a vast experience of Human Resources within the pharmaceutical and high-technology industries and brings in-depth knowledge of HR compliance and risk management. She is recognized for her strong skills in developing strategies to strengthen compliance and mitigate risk as well as driving change and facilitating the creation of strong teams. She has led extensive coaching of senior leaders on building personal capabilities and execution of business strategy. Most recently, she acted as Employee Relations and Compliance Director at the high-technology systems company General Atomics. Prior to General Atomics, she held several leading HR positions for nearly ten years at GlaxoSmithKline and acted as a US Director. She holds a BSc in Speech Communication from Montana State 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.

About IRRAS AB
IRRAS AB (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 February 28, 2018 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS AB (PUBL) YEAR-END REPORT 2017

Quarter October-December 2017

  • Revenue accounted to MSEK 0.7 (0.0).
  • Operating profit (EBIT) was MSEK -23.7 (-10.1).
  • Net profit amounted to MSEK -23.2 (-10.4).
  • Earnings per share before and after dilution amounted to SEK -1.09 (-0.60).
       

Period January-December 2017

  • Revenue accounted to MSEK 12.0 (0.0).
  • Operating profit (EBIT) was MSEK -61.5 (-30.8).
  • Net profit amounted to MSEK -60.9 (-31.9).
  • Earnings per share before and after dilution amounted to SEK -3.40 (-2.12).
  • The Board of Directors proposes no dividend.
       

Significant events during the quarter  

New issue and listing on Nasdaq First North Premier
In November, IRRAS carried out a new issue worth a total of SEK 293 million before issue expenses. The money raised through the issue will be used for the company’s neurosurgery business, including the launch of the company’s product IRRAflow in Europe, the USA and the rest of the world. The money raised through the issue will also be used to finance development of IRRAflow for other indications. In connection with the issue, IRRAS was listed on Nasdaq First North Premier. The first day of trading was 22 November 2017.
   

Significant events during the quarter

Launch of IRRAflow version 2.5
IRRAS has launched an updated and improved version of IRRAflow. IRRAflow has been updated both aesthetically and mechanically and the battery configuration has been updated with a new medical grade product from a German supplier. The temporary hold on selling issued in December 2017 has been lifted and products have been delivered.  Sales in the first quarter of 2018 will be limited, however.
   

About IRRAS AB

IRRAS is a 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 La Jolla, CA, USA.

IRRAS started to sell IRRAflow in Europe the summer 2017. A 510 (k) application was submitted in June 2017.
   

Financial information

Calendar

Interim Report first quarter June 1, 2018
Annual General Meeting June 1, 2018
Interim Report second quarter            
August 31, 2018
Interim Report third quarter November 8, 2018


For further information, please contact:

Kleanthis G. Xanthopoulos,
Ph.D. President CEO
kleanthis@irras.com


Fredrik Alpsten
CFO and Deputy CEO
+46 706 67 31 06
fredrik@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 21 February 2018 at 07.30 a.m. (CET).

 IRRAS AB (PUBL) YEAR-END REPORT 2017 (PDF)

IRRAS AB – Year-end Report 2017 – invitation to conference call and webcast

Stockholm, Sweden, 10.00 CET, February 20, 2018 – IRRAS, a commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, will publish its Year-end Report for January-December 2017 on Wednesday, February 21, 2018 at 07.30 a.m. CET.

The Company will also host a conference call and an online presentation on the same day (Wednesday, February 21, 2018) at 08:00 a.m. CET.

The dial-in numbers for the conference call are:

SE: +46 8 5063 9549

UK: +44 20 3008 9807

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

https://financialhearings.com/event/10808

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

    
Notes to Editor

About IRRAS™

IRRAS is a 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 La Jolla, CA, USA.

IRRAS started to sell IRRAflow in Europe the summer 2017. A 510 (k) application was submitted in June 2017. IRRAS is traded on the Nasdaq First North Premier in Stockholm under the symbol IRRAS.

The information was released for public disclosure, through the agency of the contact person above, on February 20 at 10.00 a.m. (CET).

 Press release (PDF)

IRRAS introduces IRRAflowTM v 2.5 with several upgrades including an updated battery configuration

San Diego, CA, USA, Laichingen, Germany and Stockholm, Sweden January 18, 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 launch of a significantly improved version of its flagship IRRAflow product in the European Union (EU). IRRAflow version 2.5 incorporates several aesthetic and mechanical upgrades, as well as 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.

IRRAS has transitioned to a new manufacturer for the battery pack contained in all IRRAflow devices. The new manufacturer is based in Germany, and the specific battery pack chosen has been used since 2012 in tens of thousands medical devices and by over a dozen medical device companies. In February 2018, the first IRRAflow v 2.5 units will be ready for shipment to customers. IRRAS will re-introduce the optimized devices to the current customers and will begin to record sales shortly thereafter.

“The rapid response to the IRRAflow single battery malfunction incident during a sales demonstration reflects IRRAS’ ongoing commitment to developing quality medical technology products. We are pleased to have introduced an updated medical grade battery configuration from a qualified German vendor,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “Looking ahead, we are sharply focused on accelerating our commercial plans to expand sales in the EU markets, in the United States pending approval by the FDA, and in other selective worldwide markets.”

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@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 18 January 2017 at 08.30 a.m. (CET).

 Press release (PDF)

ABG Sundal Collier has notified IRRAS that stabilisation measures regarding IRRAS´ shares have been effected and that the stabilisation period ends

As previously announced, ABGSC has acted as stabilisation manager in connection with the offer to acquire shares in the Company and the listing on Nasdaq First North Premier (the ”Offering”).The Company has been informed by ABGSC that the stabilisation period has ended and that no further stabilisation measures will be undertaken.

In order to cover potential over-allotment in relation to the Offering, the Company has, at the request of ABG Sundal Collier AB in its capacity as Sole Global Coordinator, committed to issue not more than 966,666 new shares, corresponding to 15 percent of the total number of shares in the Offering (the “Over-allotment Option”). ABGSC has informed the Company that it will not exercise the Over-allotment Option.

ABGSC has announced that ABGSC (contact: Carl Rosenius, tel: +46 8 566 286 85), has performed stabilisation (in accordance with Article 3.2(d) of the EU Market Abuse Regulation) on Nasdaq First North Premier in accordance with what is set out below.

Stabilisation information: 
Issuer: IRRAS AB 
Securities: Shares (SE0008321202) 
Offering size: 6,444,444
Offering price: 45 SEK 
Ticker: IRRAS 
Stabilisation manager: ABG Sundal Collier AB 

The stabilisation period regarding the Offering has now ended and no further stabilisation transactions will be effected. Specified below are the stabilisation transactions which have been effected during the stabilisation period. No stabilisation transactions have been effected on other dates than those specified below.

Stabilisation transactions: 
Date  Quantity  Price (highest)  Price (lowest)  Price (weighted average)  Currency  Market place 
2017-11-22  600,165  44.30  37.50  43.3444  SEK Nasdaq First North Premier 
2017-11-23  271,938  40.00  37.40  38.9144  SEK Nasdaq First North Premier 
2017-11-24  94,563  39.90  38.40  39.6419  SEK Nasdaq First North Premier 

 
For further information, please contact:
Kleanthis G. Xanthopoulos, Ph.D., President and CEO
kleanthis@irras.com 

Fredrik Alpsten, CFO and Deputy CEO
fredrik@irras.com 

This information is such 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 persons above, on 22 December, 2017 at 7.00 p.m (CET).

About IRRAS
IRRAS is a 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.

Important information
This announcement is not being made in and copies of it may not be distributed or sent, directly or indirectly, into the United States, Australia, Canada, Hong Kong, Japan, New Zeeland, Singapore, South Africa or any other state or jurisdiction in which release, publication or distribution would be unlawful.

This announcement is not an offer of securities for sale in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. IRRAS has not, and does not intend to, register any of the securities in the United States or to conduct a public offering of the securities in the United States.

This announcement does not constitute an offer of the securities to the public in the United Kingdom. No prospectus has been or will be approved in the United Kingdom in respect of the securities. This announcement is being distributed to and is directed only at (i) persons who are outside the United Kingdom or (ii) persons who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). Any investment activity to which this announcement relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialise or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forwardlooking statements in this presentation are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this presentation or any obligation to update or revise the statements in this presentation to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forwardlooking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

 Press release (PDF)

IRRAS announces voluntary recall on its IRRAflow™ device due to an isolated incident of a battery manufacturing failure

IRRAS AB (IRRAS), a commercial-stage medical technology company focused on designing, developing and commercializing innovative solutions for various brain pathologies, announces that it has notified customers of a voluntary recall and a temporary stop of selling of IRRAflow™, the company’s closed-circuit medical device for the treatment of intracranial bleedings. The reason for the voluntary recall is that the battery, supplied by a well validated external manufacturer, overheated on an IRRAflow™ control unit while charging in standby mode during a routine office demonstration. No patients were present and no procedures were scheduled, as this was only an office demonstration. IRRAS is taking this action as a precaution. IRRAS is now working with the battery supplier to understand the specific cause for the failure of the battery. As part of our quality systems all batteries undergo charge and discharge testing as well as a 24-hour use period to screen for any potential manufacturing defects. Therefore, IRRAS believes this is an isolated incident of a manufacturing failure. Relevant regulatory bodies will be notified of the voluntary recall.

As a reminder of the impact IRRAflow™ has on neurosurgery critical care of intracranial bleedings, to date, IRRAflow™ has been used in 94 clinical procedures in four different EU countries. There have been no occlusions or blockages in the catheters and no infections reported. Of the 94 real-world clinical cases, the total treatment time in the hospital for each patient was significantly reduced from the current standard of care treatment. IRRAS does not anticipate any long-term impact in the adoption and clinical use of its IRRAflow™ device due to this isolated incident, especially given the successful clinical usage thus far, and expects sales to resume as soon as the new batteries are available.

The voluntary recall will affect the 2017 sales of IRRAflow™ on two fronts, both as the sales have now temporary stopped and IRRAS has offered to repurchase the previously sold products. The company has already initiated a process to replace the specific lot of batteries in the control units. IRRAS estimates that the replacement and validation of the new lot can be ready within 1 to 3 months, therefore delaying the sales plan accordingly. The 2020 objective of sales exceeding 250 MSEK remains intact.

About IRRAS
IRRAS is a 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 La Jolla, 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@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 13 December 2017 at 07.25 a.m. (CET).

 Press release (PDF)

ABG Sundal Collier AB has notified IRRAS AB (“IRRAS” or the ”Company”) that stabilisation measures regarding the Company’s shares have been effected.

As previously announced, ABGSC is acting as stabilisation manager in connection with the offer to acquire shares in the Company and the listing on Nasdaq First North Premier (the ”Offering”), and ABGSC may, acting as a stabilisation manager, effect transactions aimed at supporting the market price of the shares at levels above those which might otherwise prevail in the open market.

Such stabilisation transactions may be effected on Nasdaq First North Premier, the OTC market, or otherwise, at any time during the period starting on the date of commencement of trading in the shares on Nasdaq First North Premier and ending no later than 30 calendar days thereafter. ABGSC is however not required to undertake any stabilisation, and there is no assurance that stabilisation will be undertaken. Stabilisation, if undertaken, may furthermore be discontinued at any time without prior notice. In no event will transactions be effected to support the market price of the shares at levels above the price in the Offering.

In order to cover potential over-allotment in relation to the Offering, the Company has, at the request of ABG Sundal Collier AB in its capacity as Sole Global Coordinator, committed to issue not more than 966,666 new shares, corresponding to approximately SEK 43.5 million (before issue expenses) and 15 percent of the total number of shares in the Offering (the “Over-allotment Option”).

ABGSC has announced that ABGSC (contact: Carl Rosenius, tel: +46 8 566 286 85), has performed stabilisation (in accordance with Article 3.2(d) of the EU Market Abuse Regulation) on Nasdaq First North Premier in accordance with what is set out below.

Stabilisation information: 
Issuer: IRRAS AB 
Securities: Shares (SE0008321202) 
Offering size: 6,444,444
Offering price: 45 SEK 
Ticker: IRRAS 
Stabilisation manager: ABG Sundal Collier AB 


Stabilisation transactions: 
Date  Quantity  Price (highest)  Price (lowest)  Price (weighted average)  Currency  Market place 
2017-11-22  600,165  44.30  37.50  43.3444  SEK Nasdaq First North Premier 
2017-11-23  271,938  40.00  37.40  38.9144  SEK Nasdaq First North Premier 
2017-11-24  94,563  39.90  38.40  39.6419  SEK Nasdaq First North Premier 
2017-11-27            Nasdaq First North Premier 
2017-11-28            Nasdaq First North Premier 
2017-11-29            Nasdaq First North Premier 
2017-11-30          Nasdaq First North Premier 

 

For further information, please contact:

Kleanthis G. Xanthopoulos, Ph.D., President and CEO
kleanthis@irras.com
 

Fredrik Alpsten, CFO and Deputy CEO
fredrik@irras.com
 

This information is such 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 persons above, on 30 November, 2017 at 7.00 p.m (CET).

About IRRAS
IRRAS is a 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.

Important information
This announcement is not being made in and copies of it may not be distributed or sent, directly or indirectly, into the United States, Australia, Canada, Hong Kong, Japan, New Zeeland, Singapore, South Africa or any other state or jurisdiction in which release, publication or distribution would be unlawful.

This announcement is not an offer of securities for sale in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. IRRAS has not, and does not intend to, register any of the securities in the United States or to conduct a public offering of the securities in the United States.

This announcement does not constitute an offer of the securities to the public in the United Kingdom. No prospectus has been or will be approved in the United Kingdom in respect of the securities. This announcement is being distributed to and is directed only at (i) persons who are outside the United Kingdom or (ii) persons who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). Any investment activity to which this announcement relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialise or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forwardlooking statements in this presentation are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this presentation or any obligation to update or revise the statements in this presentation to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forwardlooking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

 Press release (PDF)

Announcement of acquisitions of shares in IRRAS made by board members and senior management in the Company

The following members of the Board of Directors and senior management in IRRAS AB (publ) (“IRRAS” or the “Company”), as well as Serendipity Ixora AB, a major shareholder of IRRAS, have today notified the Company about acquisition of shares made by them today on Nasdaq First North Premier, directly or indirectly via related companies, as set out below.

Number of shares Amount (SEK)
Anders Wiklund, Chairman of the Board of Directors 13,182 500,105
Kleanthis G. Xanthopoulos, Board member and CEO 39,546 1,500,316
Fredrik Alpsten, CFO and deputy CEO 9,200 349,034
Sabina Berlin, VP Finance 1,345 51,027
Serendipity Ixora AB 52,727 2,000,383

The total number of shares acquired in the above transactions amounts to 116,000 shares. The total purchase price amounts to SEK 4,400,866 and the average price was SEK 37.94. The acquired shares are subject to lock-up arrangements as described in the prospectus prepared in connection with the IPO of IRRAS.    

For further information, please contact:
Fredrik Alpsten, CFO and Deputy CEO
Tel. +46 706 67 31 06
fredrik@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 23 November 2017 at 19.45 p.m. (CET).

 Press release (PDF)

Board members and senior management in IRRAS have notified their intention to acquire shares in the Company

As previously announced by IRRAS AB (publ) (“IRRAS” or the “Company”), trading in the Company’s shares on Nasdaq First North Premier commenced on 22 November 2017. The following members of the Board of Directors and senior management in IRRAS, as well as Serendipity Ixora AB, a major shareholder of IRRAS, have today notified the Company about their intention, directly or indirectly via related companies, to acquire shares in the Company today on Nasdaq First North Premier up to the amounts stated below for each party.

Anders Wiklund, Chairman of the Board MSEK 0.5
Kleanthis G. Xanthopoulos, Board member, President and CEO   MSEK 1.5
Fredrik Alpsten, CFO and deputy CEO MSEK 0.3
Sabina Berlin, VP Finance MSEK 0.1
Serendipity Ixora AB MSEK 2.0

In total, the above intentions to acquire shares amount to MSEK 4.4. The acquired shares will be subject to the lock-up arrangements described in the prospectus prepared in connection with the IPO of IRRAS. The Company will later today announce information about the acquisition of shares as described above.    

For further information, please contact:

Fredrik Alpsten, CFO and Deputy CEO
Tel: +46 706 67 31 06

fredrik@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 23 November 2017 at 08.00 a.m. (CET).

 Press release (PDF)

Final price in IRRAS initial public offering set – trading on Nasdaq First North Premier commences today

IRRAS AB (“IRRAS” or the “Company”) hereby announces the outcome of the offering of newly issued shares in the Company (“the Offering”) and its listing on Nasdaq First North Premier.

About IRRAS

IRRAS is a 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.

Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS:

“We are happy and proud of the strong support and trust from specialists and generalists, as well as existing and new investors in our IPO, from both Sweden and internationally. The support confirms the large potential in the flagship commercial platform technology IRRAflowTM. The technology meets much needed demand of innovation in the neurosurgical field and brings clear benefits to patients, physicians and payors alike. The IPO will provide us with the necessary capital to grow sales of IRRAflowTM in the EU, and if approved by the FDA, we expect to launch the product in the US. In addition, we aim to expand our core technology into new applications in neurosurgery, body pathologies and drug delivery, which we believe will create significant long-term value for existing and new shareholders.”

The Offering in brief 

  • The final price in the Offering has been set to SEK 45 per share, corresponding to a market value of SEK 1,108 million based on the total number of shares in IRRAS following the Offering, providing the Over-allotment option (defined below) is exercised in full.

  • In total, 6,444,444 new shares in IRRAS are issued in the Offering, corresponding to gross proceeds of SEK 290 million and net proceeds of SEK 263 million after expenses related to the Offering.

  • In order to cover potential over-allotment in relation to the Offering, the Company has, at the request of ABG Sundal Collier AB in its capacity as Sole Global Coordinator, committed to issue not more than 966,666 new shares, corresponding to approximately SEK 43.5 million (before issue expenses) and 15 percent of the total number of shares in the Offering (the “Over-allotment Option”).

  • The total number of shares in IRRAS after the Offering will amount to 23,661,863 shares if the Over-allotment option is not exercised, and 24,628,529 shares if the Over-allotment option is exercised in full.

  • Through the Offering, the existing shareholders Serendipity Ixora AB (publ) and Vandel Medical Equipment (CY) Limited, have agreed to subscribe for shares in the Offering, corresponding to a total of SEK 35 million, which corresponds to 12 percent of the Offering (excluding the Over-allotment Option).

  • In addition to the previously communicated subscription from existing shareholders, the main shareholders including its affiliates have subscribed for additional shares in the Offering, corresponding to a total of SEK 17 million, which corresponds to 6 percent of the Offering (excluding the Over-allotment Option). In total, the above mentioned shareholders including its affiliates have subscribe for shares in the Offering corresponding to SEK 52 million, which corresponds to 18 percent of the Offering (excluding the Over-allotment Option).

  • In addition, the Company’s President and CEO Kleanthis G. Xanthopoulos, Ph.D., has increased his ownership in the Company and subscribed for SEK 4 million, corresponding to approximately 1 percent of the Offering (excluding the Over-allotment Option).

  • Trading in the Company’s shares on Nasdaq First North Premier commences today, 22 November 2017, under the ticker “IRRAS” (ISIN code: SE0008321202).

  • Trading is conditional until the settlement day, which is expected to be 24 November 2017.

The Offering is described in full in the offering circular that was published on 13 November 2017, which is available on the Company’s website.

Advisors

ABG Sundal Collier AB is Sole Global Coordinator. Vator Securities AB is Financial Advisor. Setterwalls Advokatbyrå AB is legal advisor to the Company and Baker McKenzie Advokatbyrå KB is legal advisor to the Sole Global Coordinator and Vator Securities AB as to Swedish and US law. Wildeco Ekonomisk Information AB acts as Certified Advisor to the Company. 

For further information, please contact:

Kleanthis G. Xanthopoulos, Ph.D., President and CEO
kleanthis@irras.com 

Fredrik Alpsten, CFO and Deputy CEO
fredrik@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 22 November 2017 at 08.00 a.m. (CET).

Important information

This announcement is not being made in and copies of it may not be distributed or sent, directly or indirectly, into the United States, Australia, Canada, Hong Kong, Japan, New Zeeland, Singapore, South Africa or any other state or jurisdiction in which release, publication or distribution would be unlawful.

This announcement is not an offer of securities for sale in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended. IRRAS has not, and does not intend to, register any of the securities in the United States or to conduct a public offering of the securities in the United States.

This announcement does not constitute an offer of the securities to the public in the United Kingdom. No prospectus has been or will be approved in the United Kingdom in respect of the securities. This announcement is being distributed to and is directed only at (i) persons who are outside the United Kingdom or (ii) persons who are investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) and (iii) high net worth entities, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “Relevant Persons”). Any investment activity to which this announcement relates will only be available to and will only be engaged with, Relevant Persons. Any person who is not a Relevant Person should not act or rely on this document or any of its contents.

Matters discussed in this announcement may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and may be identified by words such as “believe”, “expect”, “anticipate”, “intend”, “may”, “plan”, “estimate”, “will”, “should”, “could”, “aim” or “might”, or, in each case, their negative, or similar expressions. The forward-looking statements in this release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialise or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward‐looking statements in this presentation are free from errors nor does it accept any responsibility for the future accuracy of the opinions expressed in this presentation or any obligation to update or revise the statements in this presentation to reflect subsequent events. Undue reliance should not be placed on the forward-looking statements in this document.

The information, opinions and forward-looking statements contained in this announcement speak only as at its date and are subject to change without notice. The Company does not undertake any obligation to review, update, confirm or to release publicly any revisions to any forward‐looking statements to reflect events that occur or circumstances that arise in relation to the content of this announcement.

In connection with the Offering, the Sole Global Coordinator may carry out transactions in order to provide support for the shares’ market price at a level higher than that which might otherwise prevail on the market. Such stabilization transactions may be carried out on Nasdaq First North Premier, the OTC market or otherwise, and may be carried out at any time during the period beginning on the first day when the shares are traded on Nasdaq First North Premier and ending no later than 30 calendar days thereafter.

However, the Sole Global Coordinator is under no obligation to carry out stabilization of any kind, nor is there any guarantee that stabilization will be carried out. Moreover, where undertaken, stabilization may be discontinued at any time without prior notice. No transactions will be carried out under any circumstances in order to provide support for the shares’ market price at a level higher than the price set in the Offering. Within a week of the expiry of the stabilization period, the Sole Global Coordinator, through the Company, will publish information on whether or not any stabilization has been carried out, the date when stabilization was undertaken, the last date when stabilization was carried out, as well as the price range within which stabilization was undertaken for all of the dates when stabilization transactions were carried out.

 Press release (PDF)

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