Stockholm, June 17, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that Sabina Berlin will step down as Chief Financial Officer (CFO) due to personal reasons. Griffen Stapp, who currently serves as the company’s Group Financial Controller, will act as interim CFO until the search for a permanent replacement is complete. Mrs. Berlin will continue to work closely with company leadership to provide needed guidance and support during the transition period.

“Since Sabina joined IRRAS in 2014, she has been instrumental in building IRRAS into a company that is positioned for commercial acceleration,” said Kleanthis G. Xanthopoulos, Ph.D., Chief Executive Officer of IRRAS. “Working across two continents with a 9-hour time difference is very demanding, and we understand and accept her decision. We are fortunate that we have an experienced internal resource in Griffen, who has the necessary expertise to capably fill the role.”

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

Sten Gustafsson
IR
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on June 18, 2021 at 12:00 (CET). 

 IRRAS announces changes to management team

IRRAS AB (“IRRAS” or the “Company”) (Nasdaq: IRRAS) has completed a directed share issue of 13,200,000 shares at a subscription price of SEK 5 per share (the “Directed Issue”), through which the Company receives approx. SEK 66 million before transaction costs.

The Board of Directors of IRRAS has, based on the authorization to issue shares granted by the annual general meeting on April 28, 2021 and as announced by the Company through press release earlier today, resolved on a directed issue of 13,200,000 shares at a subscription price of SEK 5 per share, consequently raising gross proceeds of approx. SEK 66 million. The subscription price in the Directed Issue was determined through an accelerated bookbuilding procedure lead by Carnegie Investment Bank AB (publ), and was, accordingly, in the assessment of the Board of Directors set on market terms and conditions.

A number of Swedish and international new and existing shareholders participated in the Directed Issue, including the Fourth Swedish National Pension Fund, Bacara Holdings Limited, Lexington Holding Assets Ltd and the Xanthopoulos family trust.

The reason for deviating from the shareholders’ preferential rights in the Directed Issue is to raise capital in a time- and cost-effective manner and to diversify the shareholder base with Swedish and international institutional investors.

The net proceeds from the Directed Issue is intended to be used to ensure continued and successful implementation of the Company’s growth strategy, including:

• accelerate commercialization of the product portfolio in the US and EU to maximize equipment footprint to drive disposable revenue;
• convert evaluation phase IRRAflow systems into revenue-generating commercial centers; and
• general corporate purposes

The Directed Issue entails a dilution of approximately 16.6 percent of the number of shares and votes in the Company (calculated as the number of newly issued shares divided by the total number of shares in the Company after the Directed Issue). Through the Directed Issue, the number of shares and votes in the Company will increase by 13,200,000 from 66,281,340 to 79,481,340. The share capital will increase by SEK 396,000.00 from approx. SEK 1,988,440.20 to approx. SEK 2,384,440.20.

In connection with the Directed 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 of the Directed Issue. In addition, the members of the Board of Directors and certain members of the senior management of the Company, have agreed to not sell any shares in IRRAS for a period of 180 calendar days after the settlement date of the Directed Issue, subject to customary exceptions.

Advisers

Carnegie Investment Bank AB (publ) is acting as Sole Global Coordinator and Bookrunner in connection with the Directed Issue. Setterwalls Advokatbyrå is legal adviser to the Company in connection with the Directed Issue.

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

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

Europe

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 June 10, 2021 at 23:00 (CEST). 

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 IRRAS in any jurisdiction, neither from IRRAS or anyone else.

This press release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exception from registration, according to the applicable U.S. Securities Act from 1933 (“Securities Act”), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States. The information in this press release shall not be published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa, the United States of America or any other jurisdiction in which the release, publication or distribution of this information would be unlawful or where such action is subject to legal restrictions or would demand additional registration or other actions than those required according to Swedish law. Acts in contrary to this instruction can constitute a crime according to applicable securities laws.

This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the “Prospectus Regulation”) 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 Regulation.

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 document and should not act or rely on it.

To the extent this press release contains forward-looking statements, such statements does not constitute facts and are characterized by words such as “shall”, “expect”, “believe” “assess”, “intend”, “estimate” and similar expressions. Such statements reflect IRRAS’ intentions, views or present expectations or assumptions. Such forward-looking statements are based on IRRAS’ current plans, estimates and projections, which have been made to the best of IRRAS’ ability. However, IRRAS does not assert that these statements will be correct in the future. Forward-looking statements are associated with risks and uncertainties which are difficult to predict and which generally cannot be affected by IRRAS. It should be contemplated that actual events or outcomes may differ materially from what is included or expressed in such forward-looking statements.

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 new shares in the Issue have been subject to a product approval process, which has determined that the these 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 may decline and investors could lose all or part of their investment; the shares offer no guaranteed income and no capital protection; and an investment in the shares 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. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Carnegie Investment Bank will only procure investors who meet the criteria of professional clients and eligible counterparties.

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.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the shares and determining appropriate distribution channels.

 IRRAS has carried out a directed share issue of 13,200,00 shares at a subscription price of SEK 5 per share

IRRAS AB (“IRRAS” or the “Company”) (Nasdaq: IRRAS) intends to carry out a new issue of shares of up to 20 percent, corresponding to approximately 13 million shares, of the total number of outstanding shares in the Company to Swedish and international institutional investors (the “Directed Issue”). IRRAS has appointed Carnegie Investment Bank AB (publ) (“Carnegie”) to act as Sole Global Coordinator and Bookrunner in connection with the Directed Issue.

IRRAS intends to carry out the Directed Issue based on the authorization to issue shares granted by the annual general meeting on April 28, 2021. The subscription price and the total number of new shares in the Directed Issue will be determined through an accelerated bookbuilding procedure, which will commence immediately following the publication of this press release. Pricing and allocation of the new shares are expected to take place before the commencement of trading on Nasdaq Stockholm at 09:00 CEST on June 11, 2021. By establishing the subscription price in the Directed Issue through an accelerated bookbuilding procedure, it is the assessment of the Board of Directors that the subscription price will be set on market terms and conditions. The closing, pricing and allocation in the bookbuilding procedure are determined at the discretion of the Company and may be cancelled at any time, meaning the Company may refrain from carrying out the Directed Issue. The Company will announce the outcome of the Directed Issue in a subsequent press release after the bookbuilding procedure has been completed.

Current shareholders Bacara Holdings Limited, Lexington Holding Assets Ltd and the Xanthopoulos family trust have committed to subscribe for shares in the Directed Issue corresponding to approx. SEK 21 million. There will be no compensation or preferential treatment in the event of allocation in exchange for the subscription commitments.

The reason for deviating from the shareholders’ preferential rights in the Directed Issue is to raise capital in a time- and cost-effective manner and to diversify the shareholder base with Swedish and international institutional investors.

The net proceeds from the Directed Issue is intended to be used to ensure continued and successful implementation of the Company’s growth strategy, including:

• accelerate commercialization of the product portfolio in the US and EU to maximize equipment footprint to drive disposable revenue;
• convert evaluation phase IRRAflow systems into revenue-generating commercial centers; and
• general corporate purposes

In connection with the Directed 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 of the Directed Issue. In addition, the members of the Board of Directors and certain members of the senior management of the Company, have agreed to not sell any shares in IRRAS for a period of 180 calendar days after the settlement date of the Directed Issue, subject to customary exceptions.

Advisers

Carnegie Investment Bank AB (publ) is acting as Sole Global Coordinator and Bookrunner in connection with the Directed Issue. Setterwalls Advokatbyrå is legal adviser to the Company in connection with the Directed Issue.

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

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

Europe
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 June 10, 2021 at 17:31 (CEST). 

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 IRRAS in any jurisdiction, neither from IRRAS or anyone else.

This press release is not an offer or invitation to acquire or subscribe for shares or other securities in the United States. The securities that have been mentioned in this release are not allowed to be sold in the United States without registration, or without application of an exception from registration, according to the applicable U.S. Securities Act from 1933 (“Securities Act”), or as a part of a transaction that is not covered by the registration requirements according to the Securities Act. There is no intention to register any shares or securities mentioned herein in the United States or to announce a public offering of such securities in the United States. The information in this press release shall not be published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into Australia, Canada, Hong Kong, Japan, New Zealand, Switzerland, Singapore, South Africa, the United States of America or any other jurisdiction in which the release, publication or distribution of this information would be unlawful or where such action is subject to legal restrictions or would demand additional registration or other actions than those required according to Swedish law. Acts in contrary to this instruction can constitute a crime according to applicable securities laws.

This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 (the “Prospectus Regulation”) 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 Regulation.

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 document and should not act or rely on it.

To the extent this press release contains forward-looking statements, such statements does not constitute facts and are characterized by words such as “shall”, “expect”, “believe” “assess”, “intend”, “estimate” and similar expressions. Such statements reflect IRRAS’ intentions, views or present expectations or assumptions. Such forward-looking statements are based on IRRAS’ current plans, estimates and projections, which have been made to the best of IRRAS’ ability. However, IRRAS does not assert that these statements will be correct in the future. Forward-looking statements are associated with risks and uncertainties which are difficult to predict and which generally cannot be affected by IRRAS. It should be contemplated that actual events or outcomes may differ materially from what is included or expressed in such forward-looking statements.

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 new shares in the Issue have been subject to a product approval process, which has determined that the these 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 may decline and investors could lose all or part of their investment; the shares offer no guaranteed income and no capital protection; and an investment in the shares 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. Furthermore, it is noted that, notwithstanding the Target Market Assessment, Carnegie Investment Bank will only procure investors who meet the criteria of professional clients and eligible counterparties.

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.

Each distributor is responsible for undertaking its own Target Market Assessment in respect of the shares and determining appropriate distribution channels.

 IRRAS intends to carry out a directed issue of shares

Stockholm, June 8, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it has received certification of its Quality Management System (QMS) under the EU Medical Device Regulation (MDR) 2017/745 and the Medical Device Single Audit Program (MDSAP).  MDR and MDSAP are considered the highest audit standards in the medical device industry, and it is a substantial achievement to document IRRAS’ compliance. These added certifications serve as a significant validation of the company’s approach to delivering high-quality products to key countries around the globe.

MDSAP is a stringent audit process that was established to enable medical device manufacturers to undergo one single regulatory audit of their quality management system that covers the requirements of participating regulatory jurisdictions in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW) and the United States (FDA).  By successfully completing the MDSAP audit, IRRAS has demonstrated that it satisfies strict requirements related to the design, development, production, deployment, and sale of its solutions.  IRRAS now plans to use this MDSAP certification as the starting point to secure product regulatory clearance in these markets, starting with Brazil and Australia.

Also, by confirming that its QMS meets the new EU MDR guidelines, IRRAS can now move forward with seeking CE Mark for its IRRAflow and Hummingbird ICP Monitoring product lines under MDR.  As of May 26, 2021, all products that seek regulatory clearance in Europe must conform to the new EU Medical Device Regulation (MDR) 2017/745, which replaces the prior Medical Device Directive.  Successfully certifying its QMS to the more stringent MDR standards is an important step in completing the ongoing MDR CE Mark for Hummingbird.  The existing CE Mark for IRRAflow remains valid until May 2024, and this certification will help facilitate an extension under MDR at the appropriate time.

“At IRRAS, a commitment to quality underscores everything that we do,” said Kleanthis, G. Xanthopoulos, Ph.D., CEO of IRRAS.  “By certifying our QMS under both MDR and MDSAP, we have validated that commitment and confirmed our ability to maintain the highest quality standards within the medical device industry.”

"This achievement is the result of our team working closely with our new notified body, DEKRA, to successfully complete multiple audits across many months,” said Will Martin, IRRAS’ President and Chief Commercial Officer.  “Finalizing these important quality certifications is a significant early milestone in this partnership with DEKRA, and it also serves as an important building block for future revenue growth.  With these certificates in place, we can now ensure continued product availability in Europe, while also pursuing final regulatory clearance for our products in our next wave of targeted growth markets, such as Brazil and Australia.”

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 is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

Sten Gustafsson
IR
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on June 8, 2021 at 10:00 (CET).

 Stockholm, May 28, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the publication of a clinical case report entitled, “Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow Self-Irrigating Catheter” in the Cureus Journal of Medical Science.¹

The publication concluded that the use of IRRAflow is a “safe and effective way to avoid complications related to standard EVD placement, such as clotting and replacement.” Also, it was noted that “our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD.”     

This manuscript reports the use of IRRAflow to treat intraventricular hemorrhage (IVH) for the first time in peer-reviewed literature. In addition, the case report also documents the initial published clinical experience using the IRRAflow system to deliver medication that dissolves blood collected within the ventricles after a hemorrhagic stroke. Previously, targeted delivery of anti-spasm medication using an earlier generation of the IRRAflow system was reported in the Asian Journal of Neurosurgery.²

“Documenting the treatment of an IVH with IRRAflow for the first time in a peer-reviewed journal is a meaningful step forward in our efforts to build clinical evidence to support the system’s front-line use,” said Kleanthis G. Xanthopoulos, Ph.D., Chief Executive Officer of IRRAS. “Even more importantly, when a world-leading institution such as Buffalo General Medical Center highlights clearly superior performance of IRRAflow compared to passive drainage techniques, it validates the system’s impact and sets the stage for broadened adoption.”

The corresponding author on the report is Dr. Adnan Siddiqui, MD, Vice Chairman and Professor of Neurosurgery at the State University of New York at Buffalo (UB) Jacobs School of Medicine and Biomedical Sciences. Dr. Siddiqui is also the director of neurosurgical stroke service at Kaleida Health’s Gates Vascular Institute (GVI), director of the neuroendovascular fellowship program at UB, director of the UB Canon Stroke and Vascular Research Center, and the Chief Executive Officer & Chief Medical Officer of the Jacobs Institute (JI), a non-profit medical device innovation center.

Dr. Elad Levy, MD, Chairman of the Department of Neurosurgical Surgery at the UB Jacobs School of Medicine and Biomedical Sciences and Secretary of the Congress of Neurological Surgeons (CNS) Executive Committee, served as a co-author on the case report, along with Dr. Timothy O’Connor, MD, Dr. Ryan Hess, MD, Dr. Asham Khan, MD, and Dr. Kenan Rajjoub, MD.

The case report highlights treatment using the IRRAflow fluid management system for a patient suffering from IVH at Buffalo General Medical Center in Buffalo, NY. IVH is a devastating form of intracranial bleeding “with an expected mortality rate between 50 and 80%,” according to the case report.

During this patient treatment, an IRRAflow catheter was placed into the patient’s right ventricle and provided drainage without interruption throughout patient treatment. A traditional external ventricular drain (EVD) was placed in the patient’s left ventricle, but, “by the following day, the left-sided EVD catheter had become clotted and stopped draining.” The occluded EVD was subsequently replaced with a second IRRAflow catheter, and the decision was made to deliver a thrombolytic medication, alteplase, through the IRRAflow catheter to dissolve the collected blood. After this decision to convert treatment completely to IRRAflow, follow-up scans clearly showed a decrease in the volume of blood present and the size of the patient’s enlarged ventricles, which was not possible before with an occluded EVD.

“Our long-term strategy is to expand the use of IRRAflow toward targeted drug delivery,” said Will Martin, President and Chief Commercial Officer of IRRAS. “With traditional IV administration, it is difficult for many of these medications to cross into the brain and reach therapeutic levels, but IRRAflow’s recurring irrigation can potentially offer this capability in a controlled manner. Documenting this early experience in published literature sets the stage for future conversations with regulatory agencies.”

¹ Rajjoub K, Hess R M, O'Connor T E, et al. (May 22, 2021) Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow® Self-Irrigating Catheter. Cureus 13(5): e15167. doi:10.7759/cureus.15167

² Venkataramana NK, Rao SA, Naik AL, Shetty K, Murthy P, Bansal A, Panotopoulos C. Innovative approach for prevention and treatment of post subarachnoid hemorrhage vasospasm: A preliminary report. Asian J Neurosurg 2012; 7: 78-80.

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

Sten Gustafsson
IR
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on May 28, 2021 at 08:30 (CET). 

Stockholm, May 25, 2021 – IRRAS, a global medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that its unsecured promissory note under the Paycheck Protection Program (the “PPP”) for a principal amount of USD 832,055 (approximately SEK 6.9 million) has been forgiven and will be reported as revenue in May. IRRAS is considered to have lived up to the requirements for foregivness based on the use of the loan according to the terms of the PPP.

The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) that was approved by the United States Congress to provide a USD 2.2 trillion package that allocates funding to small businesses to stimulate the economy and help businesses recover from the COVID-19 restrictions more quickly.

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).
  

For more information, please contact:

Sten Gustafsson
IR
+46 10 211 5172
sten.gustafsson@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 May 25, 2021 at 17:30 CET.

 Release

Stockholm, May 11, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the CE Mark certificates for its IRRAflow system and the company’s ISO13485:2016 certification have been transferred to a new notified body, DEKRA. After the successful completion of a recent audit by DEKRA, these CE Mark certificates for IRRAflow will remain valid until May 2024.

“With DEKRA, we are building a relationship with one of the largest, most respected notified bodies in the world,” said Will Martin, President and Chief Commercial Officer of IRRAS. “DEKRA has resources in place near our US headquarters in Southern California, so important regulatory work has continued despite Covid-19. We believe that this transition can shorten our approval timelines and allow us to consistently plan our European product introductions moving forward.”

“Consolidating our regulatory relationships with DEKRA, a global leader in the space, as our notified body is an important step in the long-term growth of IRRAS,” said Kleanthis G. Xanthopoulos, PhD., Chief Executive Officer of IRRAS. “Regulatory requirements have changed dramatically in Europe, and, as guidelines evolve, it is critical that we take needed steps to ensure that our life-saving products remain available to patients in Europe.”

Founded more than 95 years ago, DEKRA is the leading expert organization and largest notified body in Europe. DEKRA is one of the five largest notified bodies globally and was also one of the first notified bodies to be approved under Europe’s new Medical Device Regulations. The company currently employs more than 43,000 people in approximately 60 countries on six continents.

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 is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
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 May 11, 2021 at 08:30 (CET).

Meaningful Commercial Acceleration Seen Globally

”During Q1, the global installed base for IRRAS products increased; the total number of IRRAflow systems increased from 73 to 84 and Hummingbird systems grew from 5 to 9.  An increase in the number of systems shipped is important, but it is more critical to convert evaluations into revenue-generating commercial customers. During the quarter, two influential US comprehensive stroke centers, Buffalo General Medical Center and West Virginia University, placed commercial disposable stocking orders for IRRAflow. The contracts signed by these customers more than doubled the number of commercial IRRAflow control units (from 9 to 19) and will generate recurring revenue as usage continues.

The patient impact was further confirmed as the team at Buffalo General also published an initial chronic subdural hematoma case series in a peer-reviewed journal that showed a 25% reduction in treatment time when using IRRAflow from 6 to 4.5 days. Such data and recent successful evaluations have provided our team with important tools to help successfully navigate the approval process for a growing list of centers interested in acquiring the IRRAflow system.

To date, more than 200 patients have been treated with IRRAflow at over 30 leading institutions globally. These treatments continue to show compelling results with zero catheter occlusions or major complications observed.”

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

First quarter, January – March 2021

• Net revenue amounted to SEK 4.0 million (1.6).
• Operating loss (EBIT) amounted to SEK -39.3 million (-35.2).
• Loss after tax amounted to SEK -39.3 million (-34.3).
• Earnings per share before and after dilution amounted to SEK -0.59 (-1.19).
   

Important events during the quarter

During Q1, the IRRAS manufacturing facility was successfully inspected by the US Food and Drug Administration (FDA) and the California Department of Public Health (CDPH) and received its manufacturing license. The IRRAflow control unit can now be manufactured in-house.

In Q1, two comprehensive stroke centers in the US, Buffalo General Medical Center and West Virginia University, analyzed the outcomes from their IRRAflow evaluations, placed disposable stocking orders, and began commercial use of the system.

During the quarter, IRRAS began to transfer its international regulatory activities to a new notified body, DEKRA. DEKRA completed audits of IRRAS quality system under ISO, MDR, and MDSAP guidelines, and in the near future, will assume the existing CE Mark certificates for IRRAflow.

IRRAS is in negotiations with the European Investment Bank (EIB) regarding a financial partnership that could provide non-dilutive financing that will allow IRRAS to borrow 7-9M € over the coming years based upon the achievement of agreed-upon performance criteria. The negotiations are in advanced stages; however, final approval is still subject to EIB’s internal review.

Important events after the end of the quarter

In April, the Board of Directors appointed Will Martin as President and Chief Executive Officer (CEO) of the Company. Will Martin, currently the company’s President and Chief Commercial Officer, will assume his new role on July 1, 2021. He will succeed current CEO, Kleanthis G. Xanthopoulos, Ph.D., who will remain on IRRAS’ Board of Directors.

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

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
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 May 4, 2021 at 8:00 a.m. (CET).

 IRRAS AB (publ) interim report for January to March 2021

The Annual General Meeting (the "AGM") on April 28, 2021 resolved to adopt the balance sheet, income statement, consolidated income statement and consolidated balance sheet for 2020. Furthermore, it was resolved that no dividend will be distributed and disposable profits as of December 31, 2020 are carried forward.

The AGM also resolved to discharge the board members and the CEO from liability for 2020.

The AGM approved the nominating committee's proposal that the board shall consist of five board members. The AGM resolved that the total board remuneration shall amount to SEK 1,786,000 of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 265,000 shall be paid to each of the other board members elected by the General Meeting and who are not employees of the group. Board members who are residents in the Unitied States shall be paid an additional amount of SEK 106,000. For work in the Audit Committee, the remuneration to the Chairman of the Committee amounts to SEK 130,000 and SEK 65,000 to the other member of the Committee. For work in the Remuneration Committee, the remuneration to the Chairman of the Committee amounts to SEK 100,000 and SEK 50,000 to the other member of the Committee. No extra compensation will be paid for participating in other committees. The total remuneration on a total of SEK 1,786,000 as stated above requires that the Audit Committee consists of two members and that the Renumeration Committe consists of two members. The AGM also resolved that the remuneration to the auditor, as previous, shall be paid in accordance with approved invoices.

The AGM resolved that the board until the end of the next AGM meeting will consist of the members Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius, Eva Nilsagård and Catherine Gilmore-Lawless. Marios Fotiadis was 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 2022.

The AGM approved the board's report on remunerations.

The AGM approved the board's proposal regarding a long-term incentive program 2021 (LTIP 2021) in accordance with items A and B of the proposal.

The AGM approved the board's proposal to be authorized to increase share capital through the issue of new shares, warrants and/or convertibles.                                                              

Complete proposals regarding the AGM's decisions are available on IRRAS AB:s website www.irras.com.

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

USA
Kleanthis G. Xanthopoulos, Ph.D.
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 persons above, on April 28, 2021 at 19:30 (CET).

 Bulletin from Annual General Meeting in IRRAS on April 28, 2021

Stockholm, April 21, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that its Board of Directors has appointed Will Martin as President and Chief Executive Officer (CEO) of the Company. Will Martin, currently the company’s President and Chief Commercial Officer, will assume his new role on July 1, 2021, He will succeed current CEO, Kleanthis G. Xanthopoulos, Ph.D., who will remain on IRRAS’ Board of Directors and will serve as a company advisor during a transition period.

Will Martin joined IRRAS in 2018. Prior to IRRAS, he served as General Manager of the Peripheral Vascular devices business for Philips Healthcare, Vice President of Commercial Operations at AtheroMed, Inc. prior to its acquisition by Volcano Corporation, and held other key commercial roles at other life science companies. He received a BA degree from The University of Notre Dame and an MBA from Johns Hopkins University and also served as a Lieutenant in the United States Navy.

“Dr. Xanthopoulos has built a strong medical and technical foundation for IRRAS within the expanding market for neurocritical care. Critical fundamental elements, such as establishing in-house manufacturing, strengthening our organization, securing key regulatory approvals, and growing sales, are now in place,” said Marios Fotiadis, Chairman of IRRAS’ Board of Directors. “We have been planning for a potential transition since Will Martin was promoted to President in June. With IRRAS now positioned for faster commercial expansion, the timing is right.”

“During my time at IRRAS, we’ve made meaningful progress in building a strong foundation for future expansion across all areas of our business,“ said Will Martin. “I am incredibly excited to lead our Company through its next phase of growth and will work closely with our team members to become a global leader in neurocritical care.”

“We have now treated over 200 patients with IRRAflow at more than 30 leading institutions in 18 countries across 3 continents with extremely positive treatment outcomes. Our other product line, Hummingbird, is well positioned to increase market share globally in the established market for intracranial pressure monitoring,” said Dr. Xanthopoulos. “During Q1, we more than doubled the number of commercial capital systems in the US, and sales are growing faster than ever before. The stage is set, and the time is right for Will to take over as IRRAS’ President and CEO. With his strong commercial skills and my continued engagement, IRRAS will have the right set up for the next step of growth and financial value creation.”

About IRRAS

IRRAS is a global medical care company focused on 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 Stockholm (ticker: IRRAS).

For more information, please contact:

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

Europe
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 April 21, 2021 at 20:00 (CET). 

 IRRAS Promotes Will Martin to Chief Executive Officer