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)

IRRAS AB – Q1 Report 2019 – invitation to conference call and webcast

Today Tuesday May 7, at 04.00 p.m. CET IRRAS will host a conference call and an online presentation of its Q1 2019 interim report (which was published earlier today 08.00 a.m. CET).

The dial-in numbers for the conference call are:
 

Sweden:
+46 8 5664 2707
Rest of the world:
+44 33 3300 9034

The presentation will also be webcast and can be accessed from the following web address:
https://financialhearings.com/event/11740

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

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


About IRRAS

IRRAS AB (Nasdaq First North Premier: IRRAS) is a publicly-traded, commercial-stage medical technology company focused on developing and commercializing innovative solutions for brain surgery.

The company’s initial product, IRRAflow, 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.

 Press release (PDF)

IRRAS AB (PUBL)INTERIM REPORT JANUARY–MARCH 2019

First quarter, January – March 2019

  • Net revenue totaled SEK 0.0 million (5.9).
  • Operating loss (EBIT) amounted to SEK -39.1 million (-21.1).
  • Loss after tax totaled SEK -38.7 million (-17.8).
  • Earnings per share before and after dilution amounted to SEK -1.61 (-0.75).
      

Important events during the quarter

First patients in the US successfully treated with IRRAflow®
At the beginning of January, the first patients in the United States were treated with our lead product, IRRAflow. The successful treatments were performed at the University of California– Irvine.

New financial targets
In February the company presented new financial targets. The targets are:

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

Strengthened executive management team
In March, Vinny Podichetty, MD, MS, was hired as VP of Global Clinical Affairs. He is reporting to the President, CEO, and will serve as a member of the executive team.

Evaluates possible listing on Nasdaq Stockholm’s main market*
The company announced its plans to evaluate a possible listing of its share at the Nasdaq Stockholm’s main market in 2019. In addition to Carnegie, IRRAS has also engaged Pareto as a financial advisor.
  

Important events after the end of the first quarter

Collaboration with AMI-USC
The company entered into an agreement with the Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California (AMI-USC). Under the terms of the agreement, IRRAS will acquire assets and intellectual property from DermaPort, Inc.

Update on CE-mark recertification
The company received
a response from G-MED, its Notified Body, that requests clarifications and additional information regarding the CE Mark recertification of the company’s IRRAflow Catheter.
G-MED asked for additional technical clarifications and updates of certain previous older reports performed by the previous Swedish development partner. The requests are part of the routine review cycle and will be addressed by IRRAS in a timely manner.

First sales in US reported
Physician support for IRRAflow has been generated at more than 35 US hospitals. The product approval process is underway at more than 20 hospitals, and almost 10 additional sites are actively evaluating the technology. The feedback thus far has been positive. The first US sales were reported first week of April.

Strengthened position in US by acquiring assets 
IRRAS has strengthened its position in the US by acquiring assets of InnerSpace Neuro Solutions. The assets, including four FDA-cleared products, complement IRRAflow and will support IRRAS’ positioning as a leading company in the space. The sales of the new products are expected to start in Q3.
  

Comments from the President and CEO 

Launch in US
The launch in the US continues according to plan. The first patients were successfully treated in January, and the initial treated patients have been followed with great interest by a number of US hospitals. At the moment, we have support from physicians at more than 35 US hospitals, and our commercial team is taking the needed steps for these facilities to evaluate IRRAflow.
In April, AANS (American Association of Neurological Surgeons) held its yearly scientific meeting in San Diego. IRRAS participated and generated significant interest. Our direct sales team is now following up with these leads across the US. In connection with AANS, we had also our first US KOL meeting, which was very well received by the participants.
We believe that the sales process in the US for a new technology takes up to 6 months after initial contact with a new customer before revenue is generated. Our US launch commenced during Q4 2018, and our launch remains on track with the first purchase orders shipped to customers in early April.

Strengthened position in US by acquiring assets, including four FDA-cleared neurocritical care products
We have strengthened our position in US by acquiring the assets of InnerSpace Neuro Solutions. These assets include four FDA-cleared products that complement IRRAflow and will support IRRAS’ positioning as a leading player in the space. We will initiate sales of the acquired products in Q3. The acquired patents and expertise overlap with planned IRRAflow product development and will result in an accelerated timeline and significantly reduced development costs. The acquired products have been used in over 2 000 patients, and their clinical utility is supported by a number of scientific publications.
This acquisition fits perfectly with our strategy to use our innovative fluid exchange technology as a cornerstone to become domain dominant in neurocritical care. We have been following InnerSpace for over a year and are very pleased to complete this transaction. By adding these products to our portfolio, we will use their existing sales channels to introduce IRRAflow to new customers, and our team can now offer US hospitals additional cutting edge products to treat neurocritical care patients. This is a unique opportunity for IRRAS to strengthen our position and become a leading supplier in US, the world’s most important neurosurgical market.

Update received on CE Mark re-certification of IRRAflow
In April, we received the feedback from G-MED after a lengthy period. G-MED has asked for additional technical clarifications and updates of certain previous older reports. The requests are part of the routine review cycle, and we believe that all of their comments are addressable. Having established a productive dialogue with the notified body, we have a clear path forward, and we anticipate responding shortly to the list of questions. We will continue to work closely with the G-MED team to reintroduce this innovative medical device to the EU market, offering patients, neurosurgeons, and hospitals an effective, intelligent solution to treat intracranial bleeding.

First quarter financial overview
The first US sales were reported first week of April. Thus, due to the delay in the recertification of the CE mark in the EU and pending sales in the US, no sales were reported during the first quarter of 2019.
EBIT for the first quarter of the year was SEK -39.1 million (-21.1). The increased costs are primarily attributable to the planned organizational expansion within sales and marketing, production, R&D and administration. The average number of employees in the first quarter of 2019 was 32, compared with 17 in the year-earlier period.
Our available liquidity as of March 31, 2019 amounted to SEK 116 million, including short- and long-term financial investments.

Building for future growth at IRRAS
At IRRAS, our mission is clear: to change the lives of millions by creating medical products that transform the current treatment of intracranial bleedings. We believe that IRRAflow will ultimately become the new standard of care in this field, and, during the quarter, we continued to make progress toward accomplishing this mission.
With the US launch, the anticipated recertification of the CE mark in the EU, our registration of our product in additional countries, and our portfolio of differentiated technology and unique products, we believe that we are setting the foundation to become domain dominant in the neurocritical care market.
    

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

Calendar
Q2 2019 Interim Report August 29, 2019
Q3 2019 Interim Report November 8, 2019
Annual Shareholders’ meeting          
May 14, 2019

Financial information

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

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 7, 2019 at 8:00 a.m. (CET).

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

IRRAS strengthens position in neurocritical care by acquiring proprietary assets, including four US FDA-cleared products

Assets complement IRRAflow® and support positioning as a leading company in the space
Sales of the acquired products will be initiated in the US in Q3
Acceleration of IRRAS’ product development plans and significant cost savings

Stockholm, May 7, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a medical technology company focused on commercializing innovative solutions for neurocritical care, announced today it has acquired the assets of InnerSpace Neuro Solutions Inc. with immediate effect. These include proprietary single and multi-lumen cranial access bolts, parenchymal ICP (Intracranial Pressure) monitoring, and cranial access kit. The total purchase price for these assets, which are 510(K) FDA cleared in the United States but have not yet received CE Mark, was 700,000 USD.

The InnerSpace products have been used in over 2 000 patients, and their clinical utility is supported by a number of scientific publications. They complement IRRAS’ current IRRAflow product line and substantially expand the company’s available product portfolio. Sales are expected to be initiated by the IRRAS’ US commercial organization in Q3 2019.

“This is a unique opportunity for IRRAS to strengthen its position and become a leader in the neurocritical care market. These innovative and proprietary products are a perfect fit to our product portfolio. In addition, we will use established InnerSpace sales channels to introduce IRRAflow to new customers,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO.

There are clear and immediate commercial synergies that will provide IRRAS with innovative solutions across the treatment spectrum in neurocritical care. Furthermore, the acquired patents and expertise will result in accelerated timeline and significantly reduced development costs of planned IRRAflow products.
  

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.
  

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 7, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS’s nomination committee proposes Ms. Catherine Gilmore-Lawless as new board member

Stockholm, May 3, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company, today announced that the company’s nomination committee recommends Ms. Catherine Gilmore-Lawless to be a new IRRAS board member.

On April 15, 2019, in the notice for the Annual General Meeting, the nomination committee for IRRAS presented its proposals to the AGM, which will be held on May 14, 2019. The notice stated that the nomination committee intended to propose an additional board member to be presented as soon as possible, no later than in connection with the AGM.

Ms. Gilmore-Lawless is an American citizen and has 30 years of experience in the neuroscience sector. Her experience includes more than 15 years in several leading positions at Elekta Instrument AB, including President of the company’s US subsidiary where she was instrumental in introducing new neurosurgical technology including image guidance and radiosurgery to the U.S. market. Other roles at Elekta included Senior Vice President, Marketing and Vice President, Clinical Intelligence, Neuroscience. 

Ms. Gilmore-Lawless also served as Chief Development Officer of Neurosource Inc., a neuroscience consulting and practice management firm and CEO of CINN Foundation, a non-profit organization dedicated to improving the lives of individuals afflicted with neurological disorders.

The nomination committee’s assessment is that Ms. Gilmore-Lawless is well suited to be a board member of IRRAS and that she will add valuable additional expertise and experience from the North American neurosurgery market. Ms. Gilmore-Lawless is deemed to be independent both in relation to IRRAS and to the company’s major shareholders. 

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. 
   

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

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on May 3, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS Provides Update on CE Mark Re-Certification of IRRAflow®

Stockholm, April 24, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical technology company focused on developing and commercializing innovative solutions for neurocritical care, announced today that it received a response from G-MED, its designated European Notified Body, that requests clarifications and additional information regarding the company’s CE Mark re-certification of IRRAflow Catheter.

G-MED has asked for additional technical clarifications and updates of certain previous older reports performed by the previous Swedish development partner. The requests are part of the routine review cycle and will be addressed by IRRAS in a timely manner.

“We finally received the feedback from G-MED after a lengthy period,” said Kleanthis G. Xanthopoulos, Ph.D, President and CEO of IRRAS. “We believe that all of their comments are addressable. Having established a productive dialogue with the notified body, we now have a clear path forward, and we anticipate responding shortly to the list of questions. We will continue to work closely with the G-MED team to reintroduce this innovative medical device to the EU market, offering patients, neurosurgeons, and hospitals an effective, intelligent solution to treat intracranial bleeding. In the meantime, the launch of IRRAflow in the United States is on track since our 510(k) clearance last year, and our plans to open other global markets remain unchanged.”
  

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. IRRAflow received FDA-clearance in July 2018.

Regularly during treatment, the IRRAflow catheter is automatically flushed to prevent common catheter occlusions from forming. Because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

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

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.
  

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 April 24, 2019 at 08.00 a.m. (CET).

 Press release (PDF)

IRRAS publishes the 2018 Annual Report

Stockholm, April 23, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company focused on developing and commercializing innovative solutions for intracranial bleeding pathologies, announced today it has published its 2018 annual report on 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. IRRAflow received FDA clearance in July 2018.

Regularly during treatment, the IRRAflow catheter is automatically flushed to prevent common catheter occlusions from forming. Because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

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

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

This document is considered information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on April 23, 2019 at 05.00 p.m. (CET).

 Press release (PDF)

IRRAS Establishes Collaborative Relationship with AMI-USC Through Acquisition of Complementary Medical Device Technology

Stockholm, April 23, 2019 – IRRAS AB (Nasdaq First North Premier: IRRAS), a commercial-stage medical-technology company focused on developing and commercializing innovative solutions for intracranial bleeding pathologies, announced today it has entered into an agreement with the Alfred E. Mann Institute for Biomedical Engineering at the University of Southern California (AMI-USC). Under the terms of the agreement, IRRAS will acquire assets and intellectual property from DermaPort, Inc., a development stage company associated with the AMI-USC, that include innovative access technology that is complementary to IRRAS’ core neurocritical care business and designed to improve clinical outcomes and patient experience.  

IRRAS will gain exclusive rights to intellectual property related to a medical device product consistent with AMI-USC’s mission to bridge the gap between biomedical innovation and the creation of commercially successful medical products. In addition, IRRAS and AMI-USC will explore and collaborate to develop other related new technologies and products over time.

“Working with a world-class biomedical engineering center like AMI-USC is a great privilege for IRRAS. We are very pleased to enter into this agreement and look forward to finding future opportunities to work together,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO of IRRAS. “We are committed to be industry leaders with innovative solutions in this field, and these types of partnerships will play a key role for our future plans.”

Jonathan G. Lasch, Ph.D., Executive Director of AMI-USC said, “This relationship is the latest in a series of successful strategic endeavors from AMI-USC. We feel that IRRAS is a high quality medical device company, and we are thrilled to be able to work with their team to expand our mission and continue to advance the most innovative technologies.”

About AMI-USC

The Alfred E. Mann Institute for Biomedical Engineering is a 501(c)(3) organization affiliated with the University of Southern California and was founded in 1998. AMI-USC has the mission of accelerating the commercialization of biomedical technology invented at USC. For development of its biomedical technology, the institute partners with researchers throughout the university, where it is developed to a mature stage, validated, patented, and can be licensed to an industry partner or used for the formation of a start-up company along with external investment.

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. IRRAflow received FDA clearance in July 2018.

Regularly during treatment, the IRRAflow catheter is automatically flushed to prevent common catheter occlusions from forming. Because IRRAflow is a completely closed system, it is designed to reduce the documented infection risk of these procedures. Additionally, IRRAflow incorporates ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

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

IRRAS AB (publ) is listed on Nasdaq First North Premier. Wildeco is certified adviser of the company. Wildeco is reached at + 46 8 545 271 00 or at info@wildeco.se.

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
 

The information was released for public disclosure, through the agency of the contact person above, on April 23, 2019 at 08.00 a.m. (CET). 

 Press release (PDF)

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