IRRAS Announces Commercial Partnership with Medtronic in the United States for its IRRAflow[®] System

Stockholm, November 14, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced it has signed a Sales Agency Agreement to promote its IRRAflow system in the United States with Medtronic, a global leader in healthcare technology.

During the initial pilot phase of the agreement, Medtronic shall have the exclusive right to promote IRRAflow in a select number of its territories in the United States.  The IRRAS neurocritical education team will closely support the Medtronic sales professionals to train new customers, fulfill customer orders, and support patient treatments within these designated territories. 

In areas of the United States that are not governed by this Sales Agency Agreement, IRRAS’ team of sales professionals will continue to directly promote IRRAflow to stroke center customers. 

“Medtronic is a company that is unsurpassed in its focus on therapies that extend life, restore health, and improve patient outcomes,” said Will Martin, President and Chief Executive Officer of IRRAS. “As the largest medical device company in the world, Medtronic is the ideal partner to accelerate the commercial launch of our IRRAflow system in the world’s largest market.  This partnership will build broader awareness of IRRAS’ cutting-edge technology and will ensure that more patients with intracranial bleeding can receive the latest available advances in treatment.”

At the current time, IRRAS’ previously stated financial targets remain unchanged.  As the partnership with Medtronic matures, IRRAS will assess the impact of the shift in its sales strategy on these targets and will provide all needed updates in a timely fashion.

About the IRRAflow Active Fluid Exchange System

Patients that suffer from intracranial bleeding historically have suffered from subpar clinical outcomes due to the inherent shortcomings of passive drainage catheters that are used to drain excess fluid and remove collected blood within the brain.  Traditional drainage catheters experience unacceptably high rates of complications, such as catheter occlusions, insufficient drainage, and infection, that are well documented in clinical evidence, and the IRRAflow system has been designed to address such shortcomings and advance treatment options for these critically ill patients 

As the only system that enables active exchange of intracranial fluids, IRRAflow combines automated irrigation, controlled drainage, and continuous monitoring of the patient’s intracranial pressure (ICP) within one intelligent system.  IRRAflow’s unique mechanism of action uses recurring irrigation to prevent solid particles from blocking the drainage holes on the catheter tip and also to dilute collected toxic material, making it easier to remove.  This enhanced treatment has been shown to improve patient outcomes and reduced required treatment time across a variety of intracranial pathologies in more than 15 manuscripts published in peer-reviewed journals.

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

This information 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 November 14, 2022, at 18:00 (CET).

 IRRAS Announces Commercial Partnership with Medtronic in the United States for its IRRAflow System

IRRAS AB publishes Interim Report for the period January to September 2022

Third quarter, July – September 2022

  • Net revenue amounted to SEK 11.0 million (6.1).
  • Operating loss (EBIT) amounted to SEK -51.9 million (-27.0).
  • Loss after tax amounted to SEK -50.1 million (-26.9).
  • Earnings per share before and after dilution amounted to SEK -0.14 (-0.34).
     

Period, January – September 2022

  • Net revenue amounted to SEK 29.4 million (15.2).
  • Operating loss (EBIT) amounted to SEK -121.4 million (-93.0).
  • Loss after tax amounted to SEK -120.3 million (-92.9).
  • Earnings per share before and after dilution amounted to SEK -0.73 (-1.30).
     

Significant events during the quarter

Rights issue of MSEK 215 completed

  • IRRAS announced and completed a fully subscribed rights issue that raised MSEK 215 before deduction of costs related to the transaction.

Short-term financing agreement expanded

  • The extension of the bridge loan agreement that was initially signed during Q2 2022 provided an additional MSEK 10 to IRRAS. The entire MSEK 40 bridge loan was repaid with proceeds from the rights issue during Q3.

Enrollment begins in DIVE study as Mt. Sinai Health System in New York City treats its first patients

  • The DIVE study is a single-center clinical trial to evaluate the safety and radiographic outcomes associated with IRRAflow compared to Mt. Sinai’s historic experience with external ventricular drains.  

Significant events after the quarter

IRRAS participates in key neurosurgery conferences

  • IRRAS exhibited at the Congress of Neurological Surgeons (CNS) annual meeting in San Francisco, the Neurocritical Care Society (NCS) annual meeting in San Antonio, and at the European Congress of Neurosurgery in Belgrade, Serbia.

New educational webinar series announced in collaboration with Jacobs Institute and the University of Buffalo Department of Neurosurgery

  • IRRAS announced that Dr. Adnan Siddiqui and the leading neurosurgeons in Buffalo, NY, will host a series of webinars to discuss new treatments for intracranial hemorrhage, including the benefits of utilizing IRRAflow to more effectively clear collected blood from the brain.  This webinar series will enable further peer-to-peer discussion among top neurosurgeons to discuss how IRRAflow has impacted their patients.

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

Q3 Report 2022 – conference call and audiocast
IRRAS will host a conference call and an online presentation of its Q3 2022 interim report on November 10 at 09.00 CET. The presentation will be held in English.

The dial-in numbers for the conference call are:
Sweden: +46 8 50 51 63 86
UK: +44 203 198 4884
US: +1 412 317 6300
PIN code: 8057017#

The presentation will be webcast and can be accessed from the following web address:

https://ir.financialhearings.com/irras-q3-2022

About IRRAS

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

IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com

IRRAS AB (publ) is listed on Nasdaq Stockholm (ticker: IRRAS).

For more information, please contact:

USA
Will Martin
President and CEO

ir@irras.com

Europe

Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

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 November 10, 2022, at 8:00 a.m. (CET).

 IRRAS AB (publ) Interim report for January to Sep 2022

Q3 Report 2022 – invitation to conference call and audiocast

Stockholm, November 3, 2022 – On Thursday, November 10, at 09.00 CET, IRRAS will host a conference call and an online presentation of its Q3 2022 interim report (which will have been published earlier on November 10 at 08.00 CET). The presentation will be held in English.

The dial-in numbers for the conference call are:
Sweden: +46 8 50 51 63 86
UK: +44 203 198 4884
US: +1 412 317 6300
Pin code: 8057017#

The presentation will be webcast and can be accessed from the following web address:

https://tv.streamfabriken.com/irras-q3-2022

Speakers: President and CEO Will Martin, Interim CFO Griffen Stapp, and Head of Investor Relations Sten Gustafsson

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on November 3, 2022 at 8:30 (CET).

IRRAS Announces Participation and Data Presentation at the 22nd European Congress of Neurosurgery

Stockholm, October 13, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced it will be exhibiting at EANS 2022, the 22nd European Congress of Neurosurgery, hosted by the European Association of Neurological Societies. After two consecutive years in which the Congress was impacted by the Covid-19 pandemic, the EANS Annual Congress is again being held in person in Belgrade, Serbia, on 16 to 20 October 2022. Attendees of EANS 2022 are encouraged to learn more about IRRAS’ products, including its IRRAflow Active Fluid Exchange system, by visiting IRRAS’ booth #10.

In addition to exhibiting its products for conference participants, clinical data regarding the use of the IRRAflow system to treat intracerebral hemorrhage (ICH) and intraventricular hemorrhage (IVH) will be presented in a case series poster by Dr. Behnam Rezai Jahromi, a neurosurgeon from Helsinki University Hospital. The poster presentation, titled “Active CSF Exchange System for IVH Treatment,” will be available for review, in-person and virtually, for registered participants of EANS.

“My experience utilizing IRRAflow has shown impressive results in clearing out toxic blood in ventricles after patients have experienced ruptured aneurysms and the associated intracranial hemorrhage,” said Dr. Rezai Jahromi. “The combination of the IRRAflow system’s recurring irrigation, when combined with thrombolytic medication, can change the composition of cerebrospinal fluid, accelerate the ability to remove the toxic materials, and improve the clinical outcomes of these critically ill patients.”  

Dr. Rezai Jahromi will also lead an educational session on Tuesday, October 18th, at 1000 CET within the IRRAS booth. During the session, Dr. Rezai Jahromi will present his clinical experience utilizing IRRAflow to treat IVH patients and will also provide an update on the ARCH (Active Removal of Intracerebral Hematoma via active irrigation of ventricular system) clinical trial. 

To learn more about the ARCH clinical trial, click here: https://clinicaltrials.gov/ct2/show/NCT05118997?cond=active+removal&draw=2&rank=1.

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on October 13, 2022, at 8:30 (CET).

IRRAS Announces New Educational Webinar Series in Collaboration with the Jacobs Institute and the University of Buffalo Department of Neurosurgery

Stockholm, October 11, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the launch of a new educational webinar series, “Exploring the Impact of IRRAflow’s Active Fluid Exchange: Our Early Experience Utilizing IRRAflow for Intracranial Hemorrhage”, with the Jacobs Institute.

During each live webinar, Dr. Adnan Siddiqui, Chief Executive Officer and Chief Medical Officer of the Jacobs Institute, will moderate a panel of neurosurgeon experts in a 60-minute interactive discussion around new treatments for intracranial hemorrhage. Physician panelists and topics will vary with each webinar, but the overall subject will focus on the benefits of utilizing IRRAflow’s active fluid exchange to quickly and efficiently clear blood from the intraventricular space.

During each episode of the webinar series, Dr. Siddiqui and an esteemed group of expert panelists will discuss the historical shortcomings of traditional treatment for patients with intracranial bleeding and how new technological advances, such as IRRAS’ IRRAflow system, expand the options available to treat this challenging patient population. In addition, each physician panelist will discuss their experience incorporating IRRAflow into their clinical practice and share their recently published IRRAflow case reviews and ongoing clinical studies.  

“We are excited to partner with the Jacobs Institute, Dr. Siddiqui, and the University of Buffalo Department of Neurosurgery to bring together leading experts to discuss the evolution in treatment for intracranial bleeding,” said Will Martin, President and CEO of IRRAS. “Dr. Siddiqui and his peers in Buffalo are world-renowned for their contribution to advancing innovation in the treatment of stroke, and we feel that this webinar series will create an ideal learning environment where experts share advice with their peers regarding cutting-edge technology, and lessons learned during clinical practice.”

The IRRAflow Webinar Series
Title: Exploring the Impact of IRRAflow’s Active Fluid Exchange: Our Early Experience Utilizing IRRAflow for Intracranial Hemorrhage
Date: Tuesday, October 25th
Time: 5 pm EST

Moderator: Adnan H. Siddiqui, MD, Ph.D., CEO/CMO of the Jacobs Institute, Professor and Vice Chairman of the University of Buffalo Department of Neurosurgery (UBNS), and Director of Neurosurgical Stroke Service for Kaleida Health

Panelists:

  • Elad Levy, MD, Professor and Chairman of the University of Buffalo Department of Neurosurgery (UBNS), President-Elect of the Congress of Neurological Surgeons, and Co-Director, Gates Stroke Center at Kaleida Health 
  • Jason Davies, MD, Ph.D., Director of Cerebrovascular Microsurgery, Director of Endoscopy, Kaleida Health
  • Ryan Hess, MD, Department of Neurosurgery, Jacobs School of Medicine & Biomedical Science
  • Will Martin, President and CEO of IRRAS

Register Here: https://jacobsinstitute-org.zoom.us/webinar/register/WN_HieJpGtATlO2Z7zfvhYTiQ

About The Jacobs Institute

The Jacobs Institute is a non-profit organization whose mission is to accelerate the development of next-generation technologies in vascular medicine through collisions of physicians, engineers, entrepreneurs, and industry. The JI's vision is to improve the treatment of vascular disease in Western New York and the world, while fostering local economic development. The JI fosters medical collaboration and innovation through partnerships with the University at Buffalo (UB), Kaleida Health, and industry, to be a fitting tribute to the work and memory of Lawrence D. Jacobs, M.D.

To learn more about the Jacobs Institute, please visit our website at: https://jacobsinstitute.org.

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on October 11, 2022, at 8:30 (CET).

IRRAS Announces Participation and Educational Symposium at Key Upcoming Neurosurgery Conferences

Stockholm, October 5, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced its plans to participate in the upcoming annual meetings of the Congress of Neurological Surgeons in San Francisco, CA, from October 8 – 12, 2022, and the Neurocritical Care Society in San Antonio, TX, from October 17 – 21, 2022.

Both meetings are well-respected and highly engaging conferences that bring together neurosurgeons, neurointensivists, and other healthcare professionals from around the world to enhance health and improve lives through the advancement of neurosurgical education and scientific exchange. 

During CNS, IRRAS will exhibit at booth #332, and, at NCS, IRRAS’ team will be available at booth #513 to meet with attendees and provide demonstrations of the IRRAflow and Hummingbird neuromonitoring product lines.  Attendees at both conferences are encouraged to visit the IRRAS booths to learn more.

Also at CNS, IRRAS will participate in an all-day symposium where international experts will present their unique perspectives on neurotrauma management to integrate best practices and emerging evidence to optimize outcomes. The symposium will include a product demonstration station, where IRRAflow, the world’s first active fluid exchange system, and the Hummingbird ICP advanced neuromonitoring product line will be showcased. Details are provided below.

Symposium Details

Title: “SYM11: Neurotrauma Across the Lifespan and Around the World”
Date: Sunday, October 9, 2022
Time: 0800 to 1615 PDT
Location: Moscone Center, Room 2009

In addition to the neurotrauma symposium participation at CNS, clinical data regarding the use of the IRRAflow system will also be presented. Dr. Behnam Rezai Jahromi, a neurosurgeon from Helsinki University Hospital, will present the poster, titled “Active CSF Exchange and Removal of SAH to Reduce Shunt Dependency,” which will be available for review, both in-person and online.

“October will be an exciting month for IRRAS, and we are excited for the opportunity to partner with the Congress of Neurological Surgeons and the Neurocritical Care Society to participate in their upcoming annual meetings,” said Will Martin, President and Chief Executive Officer of IRRAS. “Our team is looking forward to meeting with attendees in person at both of these important meetings to build brand awareness for our IRRAflow and Hummingbird product lines and highlight the growing commercial adoption and clinical evidence base.” 

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on October 5, 2022, at 8:30 (CET).

Change in the total number of shares and votes in IRRAS AB

2022-09-30

As of 30 September 2022, the total number of shares and votes in IRRAS AB (“IRRAS”) amounts to 794,813,400.

The number of shares and votes in IRRAS has increased as a result of the registration of 230,572,566 ordinary shares subscribed for without the support of subscription rights, which in accordance with previously announced information, was issued in connection with the rights issue that was resolved by the board of directors on 4 July 2022 and approved by the extraordinary general meeting held on 3 August 2022.

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 below on 30 September 2022, at 08.00 a.m. CEST.

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

 Change in the total number of shares and votes in IRRAS AB

Change in the total number of shares and votes in IRRAS AB

2022-08-31

As of 31 August 2022, the total number of shares and votes in IRRAS AB (“IRRAS”) amounts to 564,240,834.

The number of shares and votes in IRRAS has increased as a result of the registration of 484,759,494 ordinary shares subscribed for with subscription rights, which in accordance with previously announced information, was issued in connection with the rights issue that was resolved by the board of directors on 4 July 2022 and approved by the extraordinary general meeting held on 3 August 2022.

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 below on 31 August 2022, at 8.00 a.m. CEST.

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
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

 Change in the total number of shares and votes in IRRAS AB

IRRAS raises SEK 215 million in a rights issue

Stockholm, (24 August 2022) – The subscription period of the rights issue in IRRAS AB (publ) (“IRRAS” or the “Company”), (Nasdaq Stockholm: IRRAS), ended on 23 August 2022. 484,759,494 shares, corresponding to approximately 67.8 percent of the offered shares, were subscribed for by exercise of subscription rights. Additionally, subscription applications corresponding to 38,426,359 shares, equivalent of approximately 5.4 percent of the offered shares, have been received for subscription without the exercise of subscription rights. A guarantee commitment corresponding to 192,146,207 shares, approximately 26.9 percent of the shares in the rights issue, will thus be utilized. IRRAS will, through the rights issue, receive approximately SEK 215 million before deduction of costs related to the transaction.

The rights issue in brief

  • 67.8 percent of the rights issue was subscribed for by exercise of subscription rights and 5.4 percent of the rights issue was subscribed for without subscription rights.
  • A guarantee commitment corresponding in total to 192,146,207 shares, approximately 26.9 percent of the shares in the rights issue, will be utilized. The guarantee commitment was provided by Spetses Investments Limited, an investment vehicle managed by Levant Capital (in which Marios Fotiadis is a director of the board[1]).
  • The purpose of the rights Issue is to ensure a successful implementation of the Company’s growth strategy, including financing of its ongoing operations and the continued commercialization of its product portfolio.

Through the rights issue, the Company will receive approximately SEK 215 million before deduction of costs related to the transaction. The rights issue consists of 715,332,060 new shares. The subscription price was SEK 0.30 per new share and the subscription period ended on 23 August 2022. As described in the prospectus, the Board of Directors has approved that Bacara Holdings Ltd, in connection with the payment of the subscription price, may set off a loan amount of SEK 40 million in total plus accrued interest incurred in connection with the utilization of a short-term loan facility that Bacara Holdings Ltd has provided to IRRAS.

Through the rights issue, the share capital of the Company will be increased by SEK 21,459,961.80 to a total of SEK 23,844,402.00. The number of shares in the Company will be increased by 715,332,060 shares, from 79,481,340 shares to 794,813,400 shares. The dilution for shareholders not subscribing for shares in the rights issue will be approximately 90 percent following the rights issue. The new shares subscribed for in the rights issue are estimated to be registered with the Swedish Companies Registration Office around week 34-35. Allotment of shares subscribed for without subscription rights will be made in accordance with the principles outlined in the prospectus. Around 25 August 2022, a settlement note will be sent to those who have received allotment of shares as confirmation of the allotment of shares subscribed for without subscription rights. No confirmation will be sent to subscribers who received no allotment. Payment for subscribed and allocated shares is to be made in cash in accordance with the instructions on the settlement note sent to the subscriber.

The last day for trading in paid-up subscribed shares (“BTAs”) is 25 August 2022. Thereafter, BTAs will be converted to shares, which is expected to take place around 6 September 2022 without special notification from Euroclear.

Advisors

Carnegie Investment Bank AB (publ) acts as Sole Global Coordinator and Joint Bookrunner in connection with the Rights Issue. Vator Securities acts as Joint Bookrunner in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to IRRAS in connection with the Rights Issue.

For more information, please contact:
USA
Will Martin
President and CEO

ir@irras.com


Europe
Sten Gustafsson

Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172

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).


Important information
The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction where such offer would be considered illegal. This press release does not constitute an offer to sell or an offer to buy or subscribe for shares issued by the Company in any jurisdiction where such offer or invitation would be illegal. In a member state within the European Economic Area ("EEA"), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

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

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

A prospectus regarding the Rights Issue described in this release has been published by the Company on 5 August 2022. This release is however not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. IRRAS has not authorized any offer to the public of shares or rights in any other member state of the EEA. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation. This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company and the Company's shares. Such information has not been independently verified by the Joint Bookrunners. The Joint Bookrunners are acting for the Company in connection with the transaction and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the transaction or any other matter referred to herein.

Information to distributors

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

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

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

The information was released for public disclosure, through the agency of the contact person above, on August 24, 2022, at 22:15 (CET).

[1] Bacara Holdings Limited is indirectly a shareholder of Spetses Investments Ltd. Bacara Holdings Limited is the largest shareholder of IRRAS and is owned by a related party of Marios Fotiadis, the Chairman of the Board of IRRAS. Marios Fotiadis is also a director of Levant Capital and Bacara Holdings Limited.

 IRRAS raises SEK 215 million in a rights issue

IRRAS Announces First Patient Treatments at Mount Sinai Health System in New York as Part of the DIVE Study

Stockholm, August 23, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient treatments with the company’s IRRAflow system within Mount Sinai Health System in New York, NY, one of the United States’ largest and most respected hospital groups.  Thus far, two patients suffering from intraventricular hemorrhage (IVH) have been enrolled in the Deployment of Irrigating Intraventricular Catheter System (DIVE) clinical trial for patients. The DIVE study will assess the IRRAflow system’s ability to more effectively treat patients experiencing IVH than traditional treatment with an external ventricular drain (EVD).

The DIVE study is a retrospective and prospective cohort, controlled, single-center, phase 1 study with a primary objective of evaluating the safety and radiographic outcomes associated with using IRRAS’ IRRAflow system compared to the current standard of care with external ventricular drains.  Dr. Christopher Kellner, Assistant Professor of Neurosurgery and Director of the Intracerebral Hemorrhage program at Mount Sinai, is the Principal Investigator of the study, which will compare retrospective EVD data from Mount Sinai Hospital and Mount Sinai West Hospital to prospective data collected from future patients treated with IRRAflow in up to 140 patients (70 EVD versus 70 IRRAflow).

“We are excited to enroll our first patients in the DIVE study,” said Dr. Kellner. “We believe that the combination of irrigation and drainage has the potential to be a more efficient and cost-effective means to treat intraventricular hemorrhage than traditional passive drainage. Our first patient was successfully treated in just 67 hours, a significant reduction from our historic data for ICU and hospital length of stay.  This study will continue to enroll patients and assess outcomes.”

“Our growing partnership with Mount Sinai is another exciting step toward IRRAS becoming a leader in the treatment of intracranial bleeding,” said Will Martin, President and CEO of IRRAS.  “Working closely with such a prestigious institution and closely tracking the outcomes of their patients within the DIVE study will be an important piece of the growing pool of clinical evidence to support improved outcomes with IRRAflow for this critically ill group of patients.”

The Mount Sinai Health System is an internationally recognized leader in clinical neurosurgery, neurosurgery education, and neurosurgery research. For 2021-2022, Neurosurgery and Neurology at The Mount Sinai Hospital rank 9th in the United States, according to U.S. News and World Report.

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
Director, Investor Relations

sten.gustafsson@irras.com
+46 102 11 5172

The information was released for public disclosure, through the agency of the contact person above, on August 23, 2022, at 8:30 (CET).

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