The result of the rights issue in IRRAS AB (publ) (“IRRAS” or the “Company”) (Nasdaq First North Premier Growth Market: IRRAS), for which the subscription period ended 9 April 2020, shows that 21,274,760  shares, corresponding to approximately 56.8 percent of the offered shares, were subscribed for by exercise of subscription rights. Additionally, subscription applications corresponding to 616,244 shares, equivalent of approximately 1.6 percent of the offered shares, have been received for subscription without the exercise of subscription rights. Guarantee undertakings corresponding to 15,572,362 shares, approximately 41.6 percent of the shares in the rights issue, will thus be utilized. Through the rights issue IRRAS will receive approximately SEK 217 million before the deduction of transaction costs.

“During these unprecedented SARS-CoV-2 times across the globe, IRRAS’ focus remains on the patients and physicians who need our support and access to our neurocritical care products,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO of IRRAS.  “This round of financing and outcome of the rights issue, which was completed in very difficult market conditions, enables IRRAS to focus and expand our commercial capabilities and deliver our innovative IRRAflow and Hummingbird technologies to additional markets and distribution partners around the world.” 

The shares that have been subscribed for without the exercise of subscription rights have been allotted to the subscribers in accordance with the principles outlined in the prospectus. Notice of the allotment to persons who have subscribed for share without the exercise of subscriptions rights will be distributed on 15 April 2020. Such allotted shares must be paid in cash in accordance with the instructions on the transaction note. Nominee registered shareholders receive notice of allocation and payment according to each nominee’s routines. Only those who have been slotted shares will receive a notice.

Through the rights issue, IRRAS’ share capital will increase with SEK 1,123,901 to SEK 1,988,440 and the total number of shares will increase with 37,463,366 shares. The number of shares in IRRAS after the rights issue will amount to 66,281,340 shares.

The new shares are expected to be listed for trading on Nasdaq First North Premier Growth Market around 22 April 2020.

Advisors

Carnegie Investment Bank is acting as Global Coordinator and Joint Bookrunner in the transaction while Pareto Securities is acting as Joint Bookrunner. Setterwalls Advokatbyrå is acting as legal adviser.

About IRRAS

IRRAS is a global medical technology company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.  

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 +46 8 121 576 90. 

For more information, please contact:

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

This information is information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on 14 April 2020 at 21:30 (CET).

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”), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

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.

A prospectus regarding the Rights Issue described in this release was published by the Company on  24 March 2020. This release is not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. IRRAS has not authorized any offer to the public of shares or rights in any other member state of the EEA. 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 Regulation. 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 Rights 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 Rights 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.

 Release

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

The press release published on March 24 at 13:30 CET incorrectly referenced the EU Market Abuse Regulation. The reference is removed in the press release below, which otherwise correspond to the previously published press release.

The correction was submitted for publication on March 26 2020 at 18:45 CET.

The prospectus relating to the rights issue in IRRAS AB (publ) (“IRRAS” or the “Company”) (Nasdaq First North Premier Growth Market: IRRAS) of approximately SEK 217 million before issue costs has today 24 March 2020 been approved and registered by the Swedish Financial Supervisory Authority, and is available on IRRAS’ website www.irras.com, together with all other information relating to the rights issue. The prospectus is also available on Carnegie’s website www.carnegie.se and Pareto Securities’ website www.paretosec.com and will within a couple of days also be published on the Swedish Financial Supervisory Authority’s prospectus register, https://fi.se/sv/vara-register/prospektregistret/. The approval of the Prospectus should not be understood as an endorsement of the shares. In order to fully understand the potential risks and rewards associated with the decision to invest in the Offering, potential investors should read the Prospectus before making an investment decision.

Advisors

Carnegie Investment Bank is acting as Global Coordinator and Joint Bookrunner in the transaction while Pareto Securities is acting as Joint Bookrunner. Setterwalls Advokatbyrå is acting as legal adviser.

About IRRAS

IRRAS AB is a global medical technology 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) shares are traded on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46 8 121 576 90.

For more information, please contact:

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 24 March 2020 at 13:30 CET.

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”), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

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.

A prospectus regarding the Rights Issue described in this release has been published by the Company on 24 March 2020. This release is however not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. IRRAS has not authorized any offer to the public of shares or rights in any other member state of the EEA. 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 Regulation. 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 Rights 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 Rights 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.

 Release

Stockholm, March 25, 2020 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced a long-term collaboration with Dr. Nika Niemela, Professor and Chairman of Neurosurgery, and Dr. Behnam Rezai Jahromi from the University of Helsinki, one of the world’s leading neurosurgical institutions, to utilize the company’s IRRAflow system in a variety of neurocritical applications.  The initial area of focus  will be  in the treatment of patients suffering from intraventricular hemorrhage (IVH).

IRRAflow is the world’s first “irrigating intracranial drain,” and 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 automated irrigation, controlled drainage, and continuous ICP monitoring, all into one system.  IRRAflow was introduced into the U.S. market in 2019 following the receipt of 510(k) clearance by the United States Food and Drug Administration (FDA) and is currently being reintroduced into the European Union (EU) after the recertification of the system’s CE Mark in December 2019. 

“It is my belief that the system’s combination of automated irrigation and controlled drainage should contribute to better long-term outcomes for these critically ill patients, and I am excited to explore that hypothesis in greater detail,” said Dr. Mika Niemelä. “My early experience with the IRRAflow system has shown impressive acute results in draining collected toxic material out of the ventricles without catheter blockages,” said Dr. Rezai Jahromi.  “

Traditional treatment options for IVH patients generally utilize an external ventricular drainage (EVD) system, which is a passive approach that relies solely on gravity to facilitate drainage. Although an EVD is currently the most common treatment option for intracranial bleeding or elevated ICP, the technology is associated with several well-known complications such as catheter blockage, infections, and incomplete drainage.  All of these complications can negatively impact patient outcome, which can subsequently increase the length of time needed in the hospital and the overall cost of care.  

HUH Neurosurgery is world-famous for its expertise in all subsections of neurosurgery. It is considered the leading center in Europe in the microneurosurgical treatment of cerebral blood vessel diseases and complex brain tumors and is also ranked among the very best units in the world. Due to this reputation as one of the world’s leading centers in cerebrovascular problems, some of the most complex cases in the field are referred to Helsinki from other parts of the world. Each year, more than 3,200 patients undergo neurosurgical treatment at Helsinki, and nearly 200 neurosurgeons from all around the world visit the facility to learn the latest techniques in neurosurgery. 

“This collaboration with Dr. Rezai Jahromi and the University of Helsinki represents an important component of our launch strategy for IRRAflow,” said Will Martin, Chief Commercial Officer of IRRAS. “There is a compelling need for transformative technologies, such as IRRAflow, to treat patients with intracranial bleeding, and we believe that this collaboration will advance the treatment of IVH and also accelerate the product’s awareness to a wider group of neurocritical care specialists.”

About IRRAS

IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.  

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 +46 8 121 576 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 March 25, 2020 at 08:00 a.m. (CET).

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

 

The prospectus relating to the rights issue in IRRAS AB (publ) (“IRRAS” or the “Company”) (Nasdaq First North Premier Growth Market: IRRAS) of approximately SEK 217 million before issue costs has today 24 March 2020 been approved and registered by the Swedish Financial Supervisory Authority, and is available on IRRAS’ website www.irras.com, together with all other information relating to the rights issue. The prospectus is also available on Carnegie’s website www.carengie.se and Pareto Securities’ website www.paretosec.com and will within a couple of days also be published on the Swedish Financial Supervisory Authority’s prospectus register, https://fi.se/sv/vara-register/prospektregistret/. The approval of the Prospectus should not be understood as an endorsement of the shares. In order to fully understand the potential risks and rewards associated with the decision to invest in the Offering, potential investors should read the Prospectus before making an investment decision.

Advisors

Carnegie Investment Bank is acting as Global Coordinator and Joint Bookrunner in the transaction while Pareto Securities is acting as Joint Bookrunner. Setterwalls Advokatbyrå is acting as legal adviser.

About IRRAS

IRRAS AB is a global medical technology 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) shares are traded on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46 8 121 576 90.

For more information, please contact:

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

This information is information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on 24 March 2020 at 13:30 (CET).

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”), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

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.

A prospectus regarding the Rights Issue described in this release has been published by the Company on 24 March 2020. This release is however not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. IRRAS has not authorized any offer to the public of shares or rights in any other member state of the EEA. 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 Regulation. 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 Rights 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 Rights 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.

 Release

IRRAS´s annual report 2019 has today been published on the company´s website.

The report is available on: https://investors.irras.com/en/reports-presentations 

The financial year covers the period from 1 January to 31 December 2019.

 

About IRRAS

IRRAS is a global medical device company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners.  

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 +46 8 121 576 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 March 20, 2020 at 4:30 p.m. (CET).

 Release

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

 

The Board of Directors of IRRAS AB (publ) (“IRRAS” or the “Company”) (Nasdaq First North Premier Growth Market: IRRAS) has resolved, supported by the issue authorization granted by the Extraordinary General Meeting held on the 2 March 2020, to carry out a share issue of approximately SEK 217 million with preferential rights to the Company’s existing shareholders (the “Rights Issue”).

Summary

• The net proceeds from the Rights Issue will primarily be used to finance the continued commercialization of the Company’s products, IRRAflow and Hummingbird, general corporate purposes and minor product development
• IRRAS has received subscription undertakings corresponding to approximately 25 percent of the Rights Issue from existing shareholders. The Company’s larger shareholders Lexington Holding Assets Ltd and Bacara Holdings Limited[1], the Fourth Swedish National Pension Fund and Carl-Olof and Jenz Hamrin’s Foundation all have, in addition to entering into subscribing undertakings for their pro rata share, also committed to underwrite an amount of SEK 129 million in the Rights Issue[2], subject to customary conditions
• The remaining part of the Rights Issue is underwritten by several external investors
• Shareholders in IRRAS have preferential right to subscribe for thirteen (13) new shares per every ten (10) existing shares
• The subscription price is SEK 5.80 per share, which amounts to proceeds of approximately SEK 217 million before deduction of transaction related costs, provided that the Rights Issue is fully subscribed
• The record date for participation in the Rights Issue is 24 March 2020. The subscription period in the Rights Issue is expected to commence on 26 March 2020 and close on 9 April 2020

Background and intention

IRRAS is a medtech company focused on delivering innovative medical solutions for those suffering from brain injuries and intracranial bleeding. IRRAS designs, develops and commercializes products to 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 organization in the US and select European markets and through a network of distribution partners in other markets.

IRRAS’ product portfolio consists of the Company’s original product IRRAflow as well as the Hummingbird ICP Monitoring product line which was acquired in Q2 2019. IRRAflow, an FDA cleared and CE-marked, fully integrated, closed-end system that enables both intelligent intracranial draining and real-time monitoring of intracranial pressure. The Hummingbird ICP Monitoring product line includes 10 (ten) FDA-cleared products that help doctors diagnose and manage intracranial pressure for patients with a traumatic brain injury, subarachnoid hemorrhage and/or stroke. The combination of IRRAflow and Hummingbird creates a unique product portfolio and given its strong patent-protection, IRRAS has the potential to establish itself as a leading player within neurocritical care.

On 19 December 2019, the Company received CE-mark recertification for the IRRAflow catheter in the European Union (EU) and during Q4 2019, the Hummingbird product line was launched in the US. Going forward the Company’s focus lies on broadening the use of the products.

The Board of Directors has resolved to carry out a Rights Issue to ensure continued and successful development of the Company, in accordance with its business plan and strategy. The intention with the Rights Issue is primarily to finance the continued commercialization of the product portfolio, general corporate purposes and minor product improvements. Furthermore, IRRAS intends to strengthen its sales and marketing organization to increase the awareness as well as establish, maintain and develop relations with potential customers in markets that the Company considers as interesting. IRRAS has, with regards to the prospectus to be prepared for the Rights Issue, decided to bring forward the publication of the annual report for 2019 to 20 March 2020.

Subscription undertakings and guarantee commitments

IRRAS has received subscription undertakings amounting to approximately 25 percent of the Rights Issue from existing shareholders. The Company’s larger shareholders Lexington Holding Assets Ltd and Bacara Holdings Limited[3], the Fourth Swedish National Pension Fund and Carl-Olof and Jenz Hamrin’s Foundation all have, in addition to subscribing for their pro rata share in the Rights Issue, also committed to underwrite an amount of SEK 129 million in the Rights Issue[4]. The remaining part of the Rights Issue is underwritten by several external investors.

Terms and expected timetable for the Rights Issue

Pursuant to the terms of the Rights Issue, IRRAS’ existing shareholders will have preferential rights to subscribe for new shares in line with the shares owned per the record date 24 March 2020. For each share held on the record date, shareholders will receive one (1) subscription right. Ten (10) subscription rights entitles to subscription for thirteen (13) new shares. Application for subscription without subscription rights will also be possible.

The subscription price for the Rights Issue is SEK 5.80 per share. Provided that the Rights Issue is fully subscribed, IRRAS will receive approximately SEK 217 million before the deduction of transaction costs. The Company will issue of a maximum of 37,463,366 shares. The number of shares in IRRAS after the Rights Issue will amount to a maximum of 66,281,340 shares.

The subscription period will run from 26 March 2020 up until 9 April 2020. Trading of subscription rights will take place on Nasdaq First North Premier Growth Market and run from 26 March 2020 up until 7 April 2020.

Shareholders who choose not to participate in the Rights Issue will have their shareholding diluted by approximately 57 percent, but are able to compensate financially for this dilution by selling their subscription rights.

More information on the Rights Issue and the Company can be found in the prospectus, which is expected to be published on or about 24 March 2020.

The timetable below for the Rights Issue is preliminary and may be subject to changes. Any changes will be publicly announced through press releases.

20 Mar	Last day of trading in shares including the right to participate in the Rights Issue
24 Mar	Record date for participation in the Rights Issue i.e. shareholders registered in the share register as of this date will receive subscription rights that allow the shareholder to participate in the Rights Issue
24 Mar	Expected date for publishing of the prospectus
26 Mar – 7 Apr	Trading in subscription rights
26 Mar – 9 Apr	Subscription period
26 Mar – 16 Apr	Trading in interim shares (BTA)
15 Apr	Expected date for publishing the outcome of the Rights Issue

 

Advisors

Carnegie Investment Bank is acting as Global Coordinator and Joint Bookrunner in the transaction while Pareto Securities is acting as Joint Bookrunner. Setterwalls Advokatbyrå is acting as legal adviser.

About IRRAS

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) shares are traded on Nasdaq First North Premier Growth Market (ticker: IRRAS). Redeye AB is certified adviser of the company with email certifiedadviser@redeye.se or phone +46 8 121 576 90.

For more information, please contact:

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

This information is information that IRRAS is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person above, on 17 March 2020 at 07:30 (CET).

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”), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

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.

A prospectus regarding the Rights Issue described in this release will be published by the Company on or about 24 March 2020. This release is however not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. IRRAS has not authorized any offer to the public of shares or rights in any other member state of the EEA. 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 Regulation. 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 Rights 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 Rights 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 Holding Assets Ltd (BVI) and Bacara Holdings Limited are controlled by Marios Fotiadis together with related parties.

[2] Lexington Holding Assets Ltd (BVI) and Bacara Holdings Limited commits to underwrite SEK 100 million, the Fourth Swedish National Pension Fund SEK 19 million and Carl-Olof and Jenz Hamrin’s Foundation SEK 10 million.

 

[3] Lexington Holding Assets Ltd (BVI) and Bacara Holdings Limited are controlled by Marios Fotiadis together with related parties.

[4] Lexington Holding Assets Ltd (BVI) and Bacara Holdings Limited commits to underwrite SEK 100 million, the Fourth Swedish National Pension Fund SEK 19 million and Carl-Olof and Jenz Hamrin’s Foundation SEK 10 million.

 

 Release

A Year of Accomplishments Laying the Foundation for Future Growth

” The fourth quarter of 2019 was an important period of progress for IRRAS. We accomplished the remaining corporate milestones for the year, highlighted by the renewed CE Mark for the IRRAflow® catheter in the European Union (EU) and the launch of our Hummingbird ICP Monitoring product line in the United States (US). Importantly, our impact to patients continues to broaden and deepen. Since the launch of IRRAflow, we have completed successful patient treatments in seven major markets, including the US, Germany, Finland, Austria, Hong Kong, Israel, and Kuwait.

We’ve been pleased with the interest in IRRAflow so far during our US launch, and we have just started the relaunch of IRRAflow in the EU and the Hummingbird line in the US, but at this point early in our products’ commercialization, it remains challenging to fully project the future adoption of our products. Based on this and a slower than projected initial revenue growth in the US, our current expectation is that our previously communicated financial targets will be delayed. We will communicate new financial targets as soon as we gain better clarity about our ramp up.”

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

 

Fourth quarter, October – December 2019

• Net revenue amounted to SEK 3.4 million (0.0).
• Operating loss (EBIT) amounted to SEK -35.7 million (-50.1).
• Loss after tax amounted to SEK -36.5 million (-50.1).
• Earnings per share before and after dilution amounted to SEK -1.27 (-2.09).

 

Period January – December 2019

• Net revenue amounted to SEK 5.3 million (6.0).
• Operating loss (EBIT) amounted to SEK -151.5 million (-143.3).
• Loss after tax amounted to SEK -151.1 million (-138.8).
• Earnings per share before and after dilution amounted to SEK -5.61 (-5.83).

 

Important events during the quarter

• IRRAS received renewed CE Mark for the IRRAflow catheter
  IRRAS received CE Mark approval for its IRRAflow catheter December 19, 2019. The CE Mark complements the two CE Marks previously obtained for the IRRAflow system´s tube set with digital pump and control unit and allows IRRAS to once again commercially market the IRRAflow system in the European Union.
• FDA Clearance of new 510(K) filing to expand the time of use of IRRAflow
  November 21, 2019 the US FDA cleared a new 510(K) for IRRAflow. The application provided the FDA with supporting data demonstrating that extending the time of use of the product is safe and has the potential to be beneficial for neurocritical care patients.

Other key accomplishments

• US Launch of Hummingbird Products for Neurocritical Care
  In mid-December IRRAS launched the Hummingbird ICP Monitoring product line in the US. The Hummingbird family of products helps clinicians diagnose and manage patients’ intracranial pressure after traumatic brain injury, a subarachnoid hemorrhage, and/or stroke. The product line includes proprietary single and multi-lumen cranial access bolts, parenchymal intracranial pressure ICP monitoring, and a cranial access kit.
• IRRAflow wins CONNECT´s “2019 Most Innovative New Product” Award
  In December 2019, CONNECT, a premier nonprofit helping entrepreneurs with innovative startups in technology and life science sectors, announced that IRRAS has been selected as the 2019 winner in the medical device category.
• Key hires to the company
  In November IRRAS announced the hiring of Dr. Coenraad Tamse as Vice President, International Sales. Dr. Tamse brings more than 20 years of commercial marketing, and executive experience in the medical device field to IRRAS.

Important events after the end of the quarter

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

The report is available on the company’s website: https://investors.irras.com/en/reports-presentations
 

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 currently markets and sells its IRRAflow and Hummingbird product lines 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 +46 8 121 576 90.

 

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
ir@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 February 14, 2020 at 8:00 a.m. (CET).

 Release

On Friday February 14, at 4.00 p.m. CET, IRRAS will host a conference call and an online presentation of its Q4 2019 interim report (which will have been published earlier on the 14^th at 08.00 a.m. CET). The presentation will be held in English.

The dial-in numbers for the conference call are:

Sweden: +46 8 56 64 27 03
Rest of the world: +44 33 33 00 92 67

The presentation will be webcast and can be accessed from the following web address:
https://tv.streamfabriken.com/irras-q4-2019

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

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 currently markets and sells its IRRAflow and Hummingbird product lines 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 +46 8 121 576 90.

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
ir@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 January 30, 2020 at 8:00 a.m. (CET).

Stockholm, January 7, 2020 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative solutions for neurocritical care, today provides an update on the launch of its products in the United States (US) and product portfolio objectives for 2020. 

“We are excited to report on the growth and expansion of IRRAS’ IRRAflow® and Hummingbird ICP monitoring product lines,” said Kleanthis G. Xanthopoulos, Ph.D., President & CEO of IRRAS. “The CE Mark recertification of IRRAflow and the US launches of IRRAflow and Hummingbird provide IRRAS with good opportunities to meet our  2020 goals and accelerate our  progress toward becoming a global leader in neurocritical care.”

IRRAflow Updates and 2020 Goals

IRRAflow, a commercially available medical device system for the treatment of intracranial bleeding, is the world’s first “irrigating ventricular drain,” and 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.

• In the US, the launch of IRRAflow continues to progress as planned, and IRRAS has now generated physician support at approximately 70 stroke centers in the US.  Of these 70, more than 15 have purchased IRRAflow components or are actively evaluating the system, including locations in the high-volume neurocritical care markets of Illinois, New York, and California.  Training is underway to introduce IRRAflow at approximately 10 additional hospitals early in 2020. As the IRRAS commercial team expands during 2020, resources will be in place to train the remaining 45+ US hospitals that have expressed interest in IRRAflow.

• During the 4th quarter of 2019, four new centers in the US placed orders for the company’s IRRAflow system.  Of these four new purchasing customers, three of the hospitals represent IRRAS’ first customers to successfully complete an IRRAflow product evaluation and stock the system’s capital equipment moving forward.  Additionally, three of these new US customers added have received certification as comprehensive stroke centers and treat the most complex stroke patients.
• Currently in the US, IRRAS has deployed seven direct sales professionals focused on building brand awareness and physician support and training new customers. They have generated physician support to evaluate IRRAflow at approximately 25 of the top 100 neurosurgical centers in the US, and, as the size of the company’s US team grows in 2020, the ability to train and generate revenue from a larger customer base is expected to increase. 
• In December 2019, IRRAS received CE Mark approval for its IRRAflow catheter, enabling IRRAS to commercially market the system in the European Union.  With this CE Mark back in place and additional regulatory approvals, IRRAS now markets IRRAflow in the United States, the European Union, Costa Rica, Argentina, Israel, Kuwait, and Hong Kong.  To date, patient treatments have been completed in the United States, Germany, Finland, Austria, Hong Kong, Israel, and Kuwait. 
• In the second half of 2019, IRRAS introduced the IRRAflow Laser Level, the IRRAflow Drainage Collection System, a software usability upgrade for the IRRAflow Control Unit, and the IRRAS Cranial Access Kit to enhance the user’s experience with the IRRAflow system.
• In 2020, IRRAS’ target is to commercially introduce IRRAflow in at least 4 additional  markets globally.
• In 2020, IRRAS’ target is to introduce at least three additional line extensions to the IRRAflow family of products.  These expected introductions include usability improvements to the IRRAflow Tube Set and performance enhancements to expand the line of IRRAflow catheters.

Hummingbird Product Updates and 2020 Goals

• IRRAS’ Hummingbird® ICP Monitoring product family is now commercially available in the US and includes a proprietary zero-drift Intracranial Pressure (ICP) monitoring system and both single and multi-lumen cranial access bolts and catheters to provide the most accurate parenchymal ICP monitoring on the market.
• With the US launch of Hummingbird accelerating in 2020, IRRAS’ target is to expand its customer base for the Hummingbird products to more than 25 customers during the year.
• With the CE Mark for IRRAflow back in place, in 2020, IRRAS plans to work closely with global regulatory agencies to expand the Hummingbird regulatory approval to additional markets outside the US.

“With our CE Mark in place again, our international sales team is excited to bring IRRAflow to customers globally in 2020,” said Will Martin, IRRAS’ Chief Commercial Officer.  “We are beginning to execute upon our product relaunch strategies, and we look forward to reintroducing IRRAflow initially to customers in Germany and initiating training in additional countries in the near future. The global introduction of IRRAflow, combined with the continued US launch of IRRAflow and the US product introduction of Hummingbird ICP Monitoring, sets the stage for an exciting 2020 for 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 +46 8 121 576 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 January 7, 2020 at 08:00 a.m. (CET).

 Release

Stockholm, Sweden, December 19, 2019 – IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it received CE Mark approval for its IRRAflow^® catheter. This CE Mark complements the two CE Marks previously obtained for the IRRAflow system’s tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union. The complete IRRAflow CNS System received approval for CE Mark today and will be ready for commercial launch in the EU.

IRRAflow, the company’s initial commercial product, is a transformative medical device system that combines controlled irrigation with ongoing fluid drainage to better manage patients with intracranial bleedings. In April 2018, IRRAS received an updated ISO 13485:2016 certificate and updated CE Mark approvals for both the control unit and tube set with digital pump in the IRRAflow system, both of which are Class II products. The proprietary IRRAflow catheter, however, is a Class III product, and required more time to review.

“We are pleased to receive the final CE Mark for IRRAflow in Europe, which is a strategically important geography for IRRAS,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “With this approval, we can now ramp up our marketing and sales efforts for the initiation of product sales in the key EU market.”

“In my previous patient treatment experience with IRRAflow, I found the system’s combination of irrigation and drainage to be a valuable tool in treating my critically ill patients with intracranial bleeding and brain infections,” said Dr. Behnam Rezai Jahromi, Neurosurgeon from Helsinki University Hospital in Helsinki, Finland. “Innovation in neurocritical care has been limited through the years, and I look forward to studying the potential impact of IRRAflow more closely in the future.”

“Over the past year, we have seen many successful case outcomes and significant customer interest across a variety of neurosurgery procedures with IRRAflow, therefore, we are thrilled to be able to continue our expansion to Europe,” said Will Martin, IRRAS’ Chief Commercial Officer. Based on this early experience, we are confident that IRRAflow will continue to significantly improve patient outcomes and result in sustained sales growth.”  

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 +46 8 121 576 90.
  

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
ir@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 December 19, 2019 at 8.30 p.m. (CET).

 Release