IRRAS Announces Participation at the 19th European Congress of Neurosurgery

Stockholm, September 24, 2019 – IRRAS, a medical technology company focused on commercializing innovative solutions for neurocritical care, announced today it will be exhibiting at EANS2019, the 19thEuropean Congress of Neurosurgery, hosted by the European Association of Neurological Societies. EANS2019 is being held at the Convention Center Dublin, in Dublin, Ireland, on September 24-28, 2019.

Conference attendees are invited to visit IRRAS in booth #29 to learn more about IRRAflow®, the world’s first irrigating ventricular drainage system. IRRAflow’s unique mechanism of action addresses the complications associated with the current methods of managing intracranial fluid by using a dual-lumen catheter that combines automated irrigation, controlled drainage, and continuous ICP monitoring.

Dr. Behnam Rezai Jahromi, a leading neurosurgeon from Helsinki University Hospital, in Helsinki, Finland, will lead educational sessions in the IRRAS booth each day at 10:15 am. Dr. Rezai Jahromi will present his clinical experience using the novel system and answer questions about best practices using the device.

“With nearly 1,800 health care professionals in the neurosurgical space attending EANS2019, we are excited to have the opportunity to share our cutting-edge technology with neurosurgeons from around the world,” said Will Martin, Chief Commercial Officer of IRRAS.

About IRRAS

IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

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 Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.
  

For more information, please contact:

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

Europe
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on September 24, 2019 at 5:15 p.m. (CET).

 Press release (PDF)

IRRAS announces changes in management and key hires with leadership roles in Regulatory Affairs and Hummingbird Product Line

Stockholm, September 13, 2019 – IRRAS AB, a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that Vinny Podichetty VP, Clinical, Regulatory Affairs & Quality has resigned for personal reasons, and two key appointments to drive IRRAS’ continued growth.

Niloufa Insanally, Ph.D., joins as Head of Regulatory Affairs. Dr. Insanally has over 15 years’ experience in the medical device, pharmaceutical and biotechnological areas with extensive expertise with both US and international regulatory approval processes. She holds a Bachelor of Science from University of Toronto, Canada, and a Ph.D. from University of North London, UK.

Dave Asbury is appointed Director, Project Engineering, and will lead product development for the company’s Hummingbird intracranial pressure (ICP) monitoring product line. Prior to joining IRRAS, Asbury was Director of R&D for InnerSpace Neuro Solutions where he played an integral role in the early design and evolution of the Hummingbird ICP product family. After IRRAS’ acquisition of the Hummingbird ICP assets earlier this year, he will now lead the integration of these new Hummingbird products into the current IRRAS product portfolio. Asbury has over 15 years’ experience in developing new technologies for medical device companies and holds a Bachelor of Science in Bioengineering Pre-Medicine from University of California, San Diego.
  

About IRRAS

IRRAS AB is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

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 Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.
  
 
For more information, please contact: 

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

Europe
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com

 
The information was released for public disclosure, through the agency of the contact person above, on September 13, 2019 at 13:45 a.m. (CET).

 Press release (PDF)

Q2 Report 2019 – invitation to conference call and audiocast

Today Thursday August 29, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q2 2019 interim report (which was published earlier today at 08.00 a.m. CET).  

The dial-in numbers for the conference call are:  

Sweden: +46 8 5664 27 06 
Rest of the world: +44 33 3300 9032 

The presentation will also be webcast and can be accessed from the following web address: 
https://financialhearings.com/event/11741 

Speakers: President CEO Kleanthis G. Xanthopoulos, Ph.D., CCO Will Martin and CFO Sabina Berlin 
  

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

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. Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.
  

For more information, please contact:

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

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
  

The information was released for public disclosure, through the agency of the contact person above, on August 29, 2019 at 9:00 a.m. (CET).

 Press release (PDF)

IRRAS publishes Interim Report for the period January to June 2019

“During the second quarter, we reached a significant milestone by recording our first IRRAflow revenue in the United States (US). The US is the world´s largest market for neurosurgical procedures, and with the ongoing CE Mark recertification process, we have focused much of our team´s resources toward supporting a successful early market introduction in the US.”

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

Second quarter, April – June 2019

  • Net revenue totaled SEK 1.1 million (0.1)
  • Operating loss (EBIT) amounted to SEK -40.7 million (-32.1)
  • Loss after tax totaled SEK -40.2 million (-29.1)
  • Earnings per share before and after dilution amounted to SEK -1.55 (-1.23)

Period January – June 2019

  • Net revenue totaled SEK 1.1 million (6.0)
  • Operating loss (EBIT) amounted to SEK -79.8 million (-53.2)
  • Loss after tax totaled SEK -78.9 million (-47.0)
  • Earnings per share before and after dilution amounted to SEK -3.15 (-1.99)

Important events during the quarter

  • Acquisition of complementary medical device technology
    In April, IRRAS entered into an agreement with the Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California (AMI-USC) to acquire assets and intellectual property from DermaPort Inc.
     
  • Position strengthened through acquisition of proprietary assets 
    IRRAS strengthened its position as a market leader by acquiring the assets of InnerSpace Neuro Solutions, including four US FDA-cleared products that complement IRRAflow.
  • IRRAflow wins regulatory approval in Israel and Costa Rica
    In June, IRRAS received regulatory approval in Israel and Costa Rica for the company’s flagship product, IRRAflow.
     
  • Update on CE Mark re-certification of IRRAflow
    In April, IRRAS announced that the company had received a response from G-MED, its designated European Notified Body, that requested clarifications and additional information regarding the company’s CE Mark re-certification of the IRRAflow catheter. 
  • New Board member
    The Annual General Meeting in May elected Catherine Gilmore-Lawless as a new Board member of IRRAS. Gilmore-Lawless is an American citizen and has 30 years of experience in the neuroscience sector.
  • Changes in management group
    In June, IRRAS announced that the company’s CFO, Fredrik Alpsten, would be leaving the company and that Sabina Berlin had been promoted to the position of CFO. The company also announced that Lance Boling, VP Product Development, would revert to a consultant position for the company.
  • Raising capital through directed share issue
    In May, the company completed a directed share issue and net proceeds to the company amounted to SEK 97.3 million. The subscribers in the issue were a number of Swedish and international institutional investors.

Important events after the end of the quarter

  • No important events have taken place after the end of the quarter.
     

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets.  

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. Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone 08-121 576 90.

For more information, please contact:

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

Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@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 August 29, 2019 at 8:00 a.m. (CET).

 IRRAS AB (PUBL) INTERIM REPORT JANUARY–JUNE 2019 (PDF)

IRRAS Announces Issuance of New Patent for Core IRRAflow® Technology

Stockholm, August 1, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, today announced the issuance of United States (U.S.) Patent No. 10,293,105 for its “Fluid Exchange Catheter System” technology upon which the company’s lead IRRAflow technology is based.

The patent includes both system and method claims for performing fluid exchange with a catheter that uses aspiration and irrigation lumens and a synchronized pattern of negative and positive pressures to remove any blockages in the aspiration lumen. The patent is part of a family of patents and patent applications that protect the core fluid management platform in the IRRAflow Fluid Management System. These patients include U.S. Patent No. 8,398,581, issued on March 19, 2013, and U.S. Patent No. 9,623,177, issued on April 18, 2017. IRRAS now has more than 45 patents granted or pending worldwide for a variety of neurocritical care innovative products.

“We are pleased to strengthen our intellectual property portfolio with the addition of our third U.S. patent for IRRAflow. Our growing patent estate protects and supports the commercialization of our products in the U.S., which we believe offers the most innovative solutions in neurocritical care”, said Will Martin, Chief Commercial Officer of IRRAS. “We look forward to further advancing our products in the U.S. market throughout the remainder of this year.”

About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a global healthcare company focused on delivering innovative medical technologies to our customers and their patients. IRRAS designs, develops and commercializes products that improve patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methods in neurocritical care. IRRAS markets and sells its products to hospitals worldwide through its direct sales organizations in the U.S. and select European countries and a network of distribution partners in other markets. 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.

For more information, please contact:
US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO
info@irras.com

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on August 1, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS wins regulatory approval of IRRAflow® in Israel and Costa Rica

Stockholm, June 25, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received regulatory approval for its flagship product, IRRAflow, from the Ministries of Health in Israel and Costa Rica. As a result of these approvals, IRRAS will expand its global commercialization and can now begin to market and sell IRRAflow in both countries.

“We are pleased to advance our global regulatory strategy with the approval of IRRAflow in important markets like Israel and Costa Rica,” said Vinny Podichetty, Vice President, Clinical, Regulatory Affairs & Quality at IRRAS. “These approvals are signs that our global regulatory strategy is progressing as planned, and we continue the work needed to receive clearance for IRRAflow in additional markets, including the EU.”

“The ability to commercialize IRRAflow outside of the United States represents a significant milestone in our efforts to expand IRRAS’ neurocritical care portfolio across the globe,” said Will Martin, Chief Commercial Officer at IRRAS. “With regulatory approval now in place in Israel and Costa Rica, our first Latin American country, we can build upon the enthusiastic response that we’ve seen for IRRAflow in the US by initiating patient treatments and generating revenue in these markets in the second half of 2019.”

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 neurocritical care.

The company’s flagship product, IRRAflow, is the world’s first irrigating ventricular drain. Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAS also has several other innovative neurocritical care products that are commercially available in the US, including the Hummingbird intracranial pressure (ICP) monitoring system.

With its unique and comprehensive product portfolio, protected by multiple 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.

For more information, please contact:

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

Europe
Sabina Berlin
CFO
sabina.berlin@irras.com

The information was released for public disclosure, through the agency of the contact person above, on June 25, 2019 at 08.00 a.m. (CET). 

 Press release (PDF)

IRRAS announces changes in management group

Stockholm, June 18, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that Fredrik Alpsten, Chief Financial Officer (CFO), will leave IRRAS to pursue another opportunity outside of the company. However, he will remain at IRRAS until July 31 and will continue to support the company to ensure a seamless transition of responsibilities.

Furthermore, Lance Boling, Vice President, Product Development, will revert to a consultant position for the company, a role he previously held since 2013 before joining the management group at IRRAS in 2017.

Effective June 24, 2019, there will be a single IRRAS management group, which will replace the previous structure with both executive and extended management teams. The management team will consist of the following persons:

Kleanthis G. Xanthopoulos, Ph.D.       
President & CEO
Sabina Berlin CFO
Will Martin   
Chief Commercial Officer
Adam Sampson
Vice President, Product Excellence
Vinny Podichetty  
Vice President, Clinical, Regulatory Affairs & Quality
Kellie Fontes Senior Director, Human Capital

Mrs. Berlin, who is promoted to CFO, has been with IRRAS since 2014 and was previously Vice President, Finance, and deputy CFO. Kleanthis G. Xanthopoulos, Ph.D., President & CEO will take over the responsibility for investor relations. Adam Sampson, Vice President, Product Excellence, will assume responsibility for IRRAS’ new product development. Additionally, David Asbury, former Director of R&D at the recently acquired InnerSpace Neuro Solutions, is consulting with the company to complement the R&D team.

“The Board and I want to thank Fredrik and Lance for their major contributions and service to IRRAS during the last several years. Since they joined us, IRRAS has been transformed from an R&D company to a commercial-stage, publicly-traded company with a comprehensive portfolio of products for neurocritical care. Both Fredrik and Lance have played important roles in this process and have contributed significantly to our progress,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO of IRRAS AB.

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 neurocritical care.

The company’s flagship product, IRRAflow, is the world’s first “irrigating ventricular drain.” Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAS also has several other innovative neurocritical care products that are commercial available in the US, including the Hummingbird intracranial pressure (ICP) monitoring system.

With its unique and comprehensive product portfolio, protected by multiple 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.

For more information, please contact:

US
Kleanthis G. Xanthopoulos, Ph.D.
President & CEO

info@irras.com
 

Europe
Sabina Berlin
CFO
sabina.berlin@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 18, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS has completed a directed share issue of approximately SEK 106 million

IRRAS AB (“IRRAS” or the “Company”) (Nasdaq First North Premier: IRRAS) today announces that the Company has successfully completed a directed share issue of approximately SEK 106 million.  

The Board of Directors of IRRAS has, based on the issue authorization granted by the Annual General Meeting held on 14 May 2019, and as indicated in the Company’s press release on 22 May 2019, resolved on a directed share issue of 4,800,000 new shares at a subscription price of SEK 22 per share (the “Issue”), which means that the Company will receive gross proceeds of approximately SEK 106 million. The subscription price in the Issue has been determined through an accelerated bookbuild procedure. Subscribers in the Issue are a number of Swedish and International institutional investors. 

The proceeds from the Issue will support IRRAS’ ongoing launch of IRRAflow in the United States and globally, including the EU pending CE Mark recertification. This will also allow IRRAS to build up its product inventory and ramp up its sales and marketing activities. As a result of the Issue, IRRAS is capitalized until Q3/Q4 2020.

The Issue entails a dilution of approximately 20 percent of the number of shares and votes in the company. Through the share issue, the number of outstanding shares and votes increases by 4,800,000 from 24,017,974 to 28,817,974. The share capital increases by SEK 144,000 from SEK 720,539 to SEK 864,539.

The reasons for deviation from the shareholders’ pre-emptive rights are to raise capital in a time-efficient and cost-efficient manner and to diversify the shareholder base with additional institutional investors.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 180 calendar days after the settlement date. In addition, larger shareholders[1] have undertaken not to sell any shares IRRAS for a period of six months following the resolution to issue the new shares in the Issue, subject to customary exceptions.

“We are very pleased to welcome new shareholders. Attracting high-quality and long-term investors demonstrates the strength of our commercial product portfolio and our ability to execute on our corporate goals,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “There is a large market for intracranial procedures and the proceeds from this share issue provide funding to help make IRRAflow a potential first-line treatment for intracranial fluid drainage.”

Carnegie Investment Bank acted as sole Global Coordinator and Joint Bookrunner and Pareto Securities acted as Joint Bookrunner in connection with the transaction. Setterwalls Advokatbyrå acted as legal advisor.

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
 

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 22, 2019 at 22.30 pm (CET). 

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®, is the world’s first “irrigating ventricular drain.” Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAflow received FDA-clearance in July 2018. IRRAflow received FDA clearance in July 2018.

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.

Important Information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction where such offer would be considered illegal. This press release does not constitute an offer to sell or an offer to buy or subscribe for shares issued by the Company in any jurisdiction where such offer or invitation would be illegal. In a member state within the European Economic Area (“EEA”) that has implemented Directive 2003/71/EC (together with applicable implementation measures in any member state, the “Prospectus Directive”), shares referred to in the press release may only be offered (a) to a qualified investor as defined in the Prospectus Directive; or (b) in any other respect in accordance with Article 3(2) of the Prospectus Directive.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities 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 US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into the United States, Canada, Japan, South Africa or Australia, or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

This press release is not a prospectus for the purposes of Prospectus Directive and has not been approved by any regulatory authority in any jurisdiction. IRRAS has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus has been or will be prepared in connection with the Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive. This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. Such information has not been independently verified by the Joint Bookrunners. The Joint Bookrunners are acting for the Company in connection with the transaction and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the transaction or any other matter referred to herein.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares in IRRAS have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in IRRAS may decline and investors could lose all or part of their investment; the shares in IRRAS offer no guaranteed income and no capital protection; and an investment in the shares in IRRAS is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Issue.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in IRRAS.

Each distributor is responsible for undertaking its own target market assessment in respect of the shares in IRRAS and determining appropriate distribution channels. 


[1] Lexington Holdings Assets Limited (BVI), Bacara Holdings Limited, F.EX Endotherapy Limited, Anders P. Wiklund, Kleanthis G. Xanthopoulos and Fredrik Alpsten.

 Press release (PDF)

IRRAS intends to make a directed share issue

IRRAS AB (“IRRAS” or the “Company”) (Nasdaq First North Premier: IRRAS) today announces, supported by the issue authorization granted by the Annual General Meeting held on 14 May 2019, its intention to execute a directed share issue to Swedish and international institutional investors (the “Issue”). The Company has retained Carnegie Investment Bank AB (publ) and Pareto Securities AB as Joint Bookrunners in connection with the Issue.

The subscription price and the total number of new shares in the Issue will be determined through an accelerated bookbuild procedure (the “Bookbuilding”). The number of new shares will however not exceed 20 per cent of the currently issued and outstanding number of shares in the Company (i.e. amount to a maximum of 4,803,594 shares).

The Bookbuilding will start immediately following this announcement. Pricing and allocation of the new shares is expected to take place before beginning of trading on Nasdaq Stockholm at 09:00 CET on 23 May 2019. The timing of the closing of the Bookbuilding, pricing and allocations are at the discretion of the Company and the Joint Bookrunners. The Company will announce the outcome of the Issue after closing of the Bookbuilding in a subsequent press release.

The proceeds from the Issue will support IRRAS’ ongoing launch of IRRAflow in the United States and globally, including the EU pending CE Mark recertification. This will also allow IRRAS to build up its product inventory and ramp up its sales and marketing activities. As a result of the Issue, IRRAS is capitalized until Q3/Q4 2020.

The reasons for deviation from the shareholders’ pre-emptive rights are to raise capital in a time-efficient and cost-efficient manner and to diversify the shareholder base with additional institutional investors.

In connection with the Issue, the Company has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 180 calendar days after the settlement date. In addition, larger shareholders[1] have undertaken not to sell any shares in IRRAS for a period of six months following the resolution to issue the new shares in the Issue, subject to customary exceptions.

Carnegie Investment Bank acts as sole Global Coordinator and Joint Bookrunner and Pareto Securities acts as Joint Bookrunner in connection with the transaction. Setterwalls Advokatbyrå acts as legal advisor.

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
 

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 22, 2019 at 17:30. (CET). 

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®, is the world’s first “irrigating ventricular drain.” Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAflow received FDA-clearance in July 2018. IRRAflow received FDA clearance in July 2018.

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.

Important Information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction where such offer would be considered illegal. This press release does not constitute an offer to sell or an offer to buy or subscribe for shares issued by the Company in any jurisdiction where such offer or invitation would be illegal. In a member state within the European Economic Area (“EEA”) that has implemented Directive 2003/71/EC (together with applicable implementation measures in any member state, the “Prospectus Directive”), shares referred to in the press release may only be offered (a) to a qualified investor as defined in the Prospectus Directive; or (b) in any other respect in accordance with Article 3(2) of the Prospectus Directive.

This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities 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 US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into the United States, Canada, Japan, South Africa or Australia, or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

This press release is not a prospectus for the purposes of Prospectus Directive and has not been approved by any regulatory authority in any jurisdiction. IRRAS has not authorized any offer to the public of shares or rights in any member state of the EEA and no prospectus has been or will be prepared in connection with the Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Directive. This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. Such information has not been independently verified by the Joint Bookrunners. The Joint Bookrunners are acting for the Company in connection with the transaction and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the transaction or any other matter referred to herein.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares in IRRAS have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in IRRAS may decline and investors could lose all or part of their investment; the shares in IRRAS offer no guaranteed income and no capital protection; and an investment in the shares in IRRAS is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Issue.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in IRRAS.

Each distributor is responsible for undertaking its own target market assessment in respect of the shares in IRRAS and determining appropriate distribution channels.


[1] Lexington Holdings Assets Limited (BVI), Bacara Holdings Limited, F.EX Endotherapy Limited, Anders P. Wiklund, Kleanthis G. Xanthopoulos.

 Press release (PDF)

Bulletin from Annual General Meeting in IRRAS on May 14, 2019

The Annual General Meeting (the ”AGM”) on May 14, 2019 decided to adopt the balance sheet, income statement, consolidated income statement and consolidated balance sheet for 2018. Furthermore, it was decided that no dividend will be distributed and disposable profits as of 2018-12-31 are carried forward to future periods.

The AGM also decided to discharge the board members and the CEO from liability for 2018.

The AGM approved the nominating committee’s proposal that the board shall consist of six board members.

The AGM decided that the total board renumeration shall amount to SEK 1,946,000 whereof the remuneration to the chairman of the board shall amount to SEK 540,000 and that the remuneration to the other board members not employed by the company shall be SEK 240,000 each. For the elected not employed board member living in the US an additional remuneration of SEK 96,000 is paid. The renumeration to the chairmen in the audit and remuneration committee is SEK 100,000 each and SEK 50,000 each to the other members in the committees. 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 AGM meeting will consist of the members Anders P. Wiklund, Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius, Eva Nilsagård and Catherine Gilmore-Lawless. Anders P. 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 AGM of 2019.

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

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 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®, is the world’s first “irrigating ventricular drain.” Its unique mechanism of action 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. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels. IRRAflow received FDA-clearance in July 2018.

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.

The information was released for public disclosure, through the agency of the contact person above, on May 14, 2019 at 07.30 p.m. (CET).

 Press release (PDF)

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