Stockholm, July 21, 2021 – IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, announced today that it has successfully completed an in-person verification audit of its Quality Management System (QMS) by DEKRA, the company’s notified body. Earlier this year, IRRAS announced that the company had received certification of its QMS under the Medical Device Single Audit Program (MDSAP). As a result of this verification audit, the company’s MDSAP certification that covers both its IRRAflow and Hummingbird ICP Monitoring product lines will now be extended for two additional years and will remain valid until July 2024.
This DEKRA audit also included a thorough inspection and validation of IRRAS’ new manufacturing facility, IRRAS South, Inc. After this successful audit, IRRAS’ corporate ISO 13485:2016 certification will be expanded to also cover this facility, which has now been audited with no major findings by both the United States Food and Drug Administration (FDA) and DEKRA, IRRAS’ European regulatory representative. IRRAS can now manufacture and globally ship medical devices from this facility based on these positive audit outcomes.
MDSAP is a stringent audit process that was established to enable medical device manufacturers to undergo one single audit of their QMS that covers the requirements of participating regulatory jurisdictions in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan(MHLW) and the United States (FDA). This extended MDSAP certification will support IRRAS’ efforts to secure product regulatory clearance in these new markets.
“This recently completed audit is another strong confirmation of the meaningful progress made by our IRRAS team,” said Will Martin, President and CEO of IRRAS. “Not only does the extension of our MDSAP certificate allow us to pursue meaningful regulatory approvals over the next three years, but it is an important milestone to receive ISO certification for IRRAS’ first in-house manufacturing facility. This accomplishment validates our team’s collective commitment to quality and also secures necessary supply of IRRAflow capital equipment for our growing number of customers around the globe.”
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).
At the Extraordinary General Meeting (the "EGM") held on July 15, 2021 it was resolved in accordance with the proposal by the Board of Directors to authorize the Board of Directors to resolve on entry into a credit facility with the European Investment Bank (EIB), where the interest rate or the amount to be repaid is raised should the result of the Company or dividend paid to shareholders of the Company, if any, increase.
The complete proposal by the Board of Directors is included in the notice to convene the EGM, which is 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).
Stockholm, July 1, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that Will Martin has formally assumed the role of President and Chief Executive Officer (CEO), which comes as part of a planned succession process first announced in April 2021. Kleanthis G. Xanthopoulos, Ph.D., will step down as CEO and will remain on the Company’s Board of Directors.
Will Martin joined IRRAS as Chief Commercial Officer in 2018. Prior to IRRAS, he most recently 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 leadership roles at other life science companies. He holds 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.
“It has been a tremendous honor to serve as the CEO of IRRAS, and I am incredibly proud of the team and what we have accomplished together,” said Dr. Xanthopoulos. “We have made meaningful progress to strengthen all elements of the company, and now, we are solely focused on commercial execution and acceleration. Will is the right leader to lead IRRAS into this next phase of growth.”
“I am incredibly excited and humbled to lead IRRAS during this important period,” said Martin. “We have now treated more than 200 patients with our IRRAflow system at more than 30 leading institutions, and we now have IRRAflow systems in place in 18 countries across 4 continents. As COVID restrictions lessen globally, our products are helping more critically ill patients each day, and I look forward to positioning the company to best support hospitals and investors around the world.”
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).
Stockholm, June 30, 2021– IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that as of 30 June 2021, the total number of shares and votes in IRRAS AB amounts to 79,481,340.
The number of shares and votes in IRRAS AB has increased as a result of the registration of 13,200,000 ordinary shares, which i accordance with previously announced information was issued in connection with the directed share issue carried out by the company on 10 June 2021.
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).
This information is published in accordance with Chapter 4, Section 9 of the Swedish Financial Instruments Trading Act (SFS 1991:980). This press release was made public, through the agency of the person above on 30 June 2021, at 8.30 a.m. CEST.
The shareholders of IRRAS AB (publ), org.nr 556872-7134 (”the Company”), are hereby invited to the Extraordinary General Meeting to be held on Thursday 15 July 2021. Due to the spread of the COVID-19, the Board of Directors has resolved that the Extraordinary General Meeting should be conducted without the psysical presence of shareholders, representatives or third parties and that the shareholders before the General Meeting should be able to exercise their voting right only by absentee ballot.
Notice of Attendance
A shareholder who would like to participate in the General Meeting shall:
be entered in the register of shareholders maintained by Euroclear Sweden AB by the record date Wednesday 7 July 2021; and
announce their intention to attend the General Meeting, by having submitted an absentee ballot in accordance with the instructions under the heading ”Absentee Ballot” below such that the Company has received the advance vote no later than Wednesday 14 July 2021.
In order to be entitled to participate in the General Meeting, a shareholder who has registered their shares in the name of a nominee, in addition to announcing their intention to participate by submit its absentee ballot, must temporarily request that their shares be registered in their own name so the shareholder is entered into the register of shareholders by 7 July 2021.This registration may be temporary (so-called voting right registration) and is requested with the nominee in accordance with the nominee’s procedures and in advace as determined by the nominee. Voting right registrations completed no later than the 9 July 2021, will be considered when preparing the shareholder register.
Absentee Ballot
Shareholders may exercise their voting right at the General Meeting only by voting in advance, a so-called absentee ballot pursuant to section 22 of the Temporary Exemptions to Facilitate the Execution of General Meeting in Companies and Associations Act (2020:198).
A special form must be used for the absentee ballot. This is available on the Company’s website www.irras.com. Terms and conditions for the absentee ballot are included in the form. The completed and signed form for the absentee ballot must be sent by mail to IRRAS AB (publ), Attn: CFO, P.O Box 160, 101 23 Stockholm or by e-mail to EGM@irras.com no later than 14 July 2021. The Shareholder may not add special instructions or conditions to the absentee ballot. If this occurs the vote (i.e. the absentee ballot in its entirety) will be invalid. If the shareholder submits an absentee ballot via proxy, the power of attorney must be attached to the form. The proxy form is available on the Company’s website, www.irras.com. If the shareholder is a legal person, the certificate of registration or other authorization document must be attached to the form.
Matters to be dealt with at the Meeting and proposed agenda
Election of Chairman of the Meeting
Election of at least one person to certify the minutes
Preparation and approval of the voting list
Approval of the agenda
Establishment of whether the Meeting has been duly convened
Resolution in respect of authorization for the the Board of Directors to resolve on the issue of participating debentures
Proposals
Resolution in respect of authorization for the the Board of Directors to resolve on the issue of participating debentures (item 6)
The Board of Directors proposes that the General Meeting authorizes the Board of Directors to, on one or more occasions, during the period up to the next Annual General Meeting, resolve on entry into a credit facility with the European Investment Bank (EIB), where the interest rate or the amount to be repaid is raised should the result of the Company or dividend paid to shareholders of the Company, if any, increase.
The shareholders’ right to submit questions
The Board of Directors and the CEO shall, if any shareholder so requests and the Board of Directors believes that it may be done without significantly harming the Company, provide information regarding circumstances that may affect the assessment of an item on the agenda. A request for such information shall be made in writing to the Company via mail to IRRAS AB (publ), Attn: CFO, Box 160, 101 23 Stockholm or by e-mail to EGM@irras.com, no later than 5 July 2021. The information shall be available on the Company’s website www.irras.com and on the Company’s head office as stated above no later than 10 July 2021.
Other information
As per the date of this notice, the total number of shares and votes in the Company amounts to 79,481,340. The Company holds no shares in the Company. For information about how your personal data will be processed, see
https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.
Documents
The proxy form and other documents in accordance with the Swedish Companies Act will be available at the Company’s office at the address set out above and will be sent free of charge to shareholders who so request and provide their postal address or e-mail address. The documents will also be available at the Company’s website, www.irras.com.
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).
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 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.
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).
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.”
1Rajjoub 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).
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