IRRAS´ 2021 annual report has today been published on the company´s website.

The report is available on the Investor Relations page of the IRRAS company website at https://investors.irras.com/en/reports-presentations.

The financial year covers the period from 1 January to 31 December 2021.

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
CEO
ir@irras.com 

Europe
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com

+46 (0) 10 211 51 72
 

The information was released for public disclosure, through the agency of the contact persons above, on April 29, 2022 at 15:00 p.m. (CET).

 IRRAS AB Annual Report 2021

Commercial Activity Normalizes, Resulting in Seventh Consecutive Quarter of Revenue Growth

” After two challenging years of pandemic-related challenges, the 1st quarter of 2022 confirmed what is possible for IRRAS moving forward.”

” Q1 2022 confirmed our organization’s clear progress, and we look forward to what lies ahead during the rest of this year. During the second quarter, our focus shifts toward completing a needed fundraising, and the process is underway to secure financing that will allow our team to build upon our recent progress for 18 months or more.”

Will Martin, CEO of IRRAS

First quarter, January – March 2021

• Net revenue amounted to SEK 8.6 million (4.0).
• Operating loss (EBIT) amounted to SEK -33.7 million (-39.3).
• Loss after tax amounted to SEK -33.3 million (-38.8).
• Earnings per share before and after dilution amounted to SEK -0.46 (-0.59).
   

Important events during the quarter

Largest dataset with IRRAflow system to date is presented at neurosurgical conference and documents improved outcomes

• West Virginia University Hospital (WVUH) presented data from 45 IRRAflow patients with a 0% catheter occlusion rate, decreased vasospasm, and reduced shunt placement.

Next-generation IRRAflow system launched in the United States

• The first global patient treatments with the next-generation IRRAflow control unit occurred at WVUH. 

Regulatory clearance for IRRAflow received in Australia

• The Australian Therapeutic Goods Administration (TGA) granted regulatory clearance for the IRRAflow control unit and tube set, allowing commercial shipments to Australia.

First patients enrolled in ACTIVE clinical study

• Aarhus University Hospital enrolled the first patients in the ACTIVE clinical study to compare outcomes of IRRAflow versus traditional drainage across 120 patients.

Additional patent issued for IRRAflow system in the U.S.

• A third patent was issued in the US that provides coverage of IRRAflow’s ability to administer therapeutic drugs.

Process to secure long-term financing ongoing

• Financial advisors have been retained to evaluate a potential financing of IRRAS. The target is for the financing to provide the company with sufficient funds to support 18 months or more of growth.

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

Q1 Report 2022 – conference call and audiocast
IRRAS will host a conference call and an online presentation of its Q1 2022 interim report on April 27 at 16.30 CET. The presentation will be held in English.

The dial-in numbers for the conference call are:
Sweden: +46 8 50 55 83 73
UK: +44 33 33 00 92 61
US: +1 631 913 1422
PIN: 33 44 24 60

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

https://tv.streamfabriken.com/irras-q1-2022

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 April 27, 2022, at 8:00 a.m. (CET).

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

The shareholders of IRRAS AB (publ), org.nr 556872-7134 (”the Company”), are hereby invited to the Annual General Meeting to be held on Tuesday 24 May 2022. The Board of Directors has, in accordance with the Swedish Act on temporary exceptions to facilitate the execution of general meetings in companies and other associations (Sw. lagen (2022:121) om tillfälliga undantag för att underlätta genomförandet av bolags- och föreningsstämmor), resolved that the Annual General Meeting should be conducted without the psysical presence of shareholders, representatives or third parties and that the shareholders before the Annual 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 Annual General Meeting shall:

1. be entered in the register of shareholders maintained by Euroclear Sweden AB by the record date Monday 16 May 2022; and
2. announce their intention to attend the Annual 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 Monday 23 May 2022.

In order to be entitled to participate in the Annual 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 16 May 2022. 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 made no later than the 18 May 2022, will be considered when preparing the shareholder register.

Absentee Ballot

Shareholders may exercise their voting right at the Annual 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 Annual General Meeting in Companies and Associations Act (2022:121).

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: Sten Gustafsson, P.O Box 160, 101 23 Stockholm or by e-mail to AGM@irras.com no later than 23 May 2022. 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

1. Election of Chairman of the Meeting
2. Election of one person or two persons to certify the minutes
3. Preparation and approval of the voting list
4. Approval of the agenda
5. Establishment of whether the Meeting has been duly convened
6. Presentation of the Annual Report and the Auditor’s Report and the Consolidated Financial Statement and the Group Auditor’s Report
7. Resolution regarding adoption of the profit and loss statement and the balance sheet and the consolidated profit and loss statement and consolidated balance sheet
8. Resolution regarding appropriation of the Company’s profit according to the adopted balance sheet
9. Resolution regarding discharge from liability for the members of the Board of Directors and the Managing Director
10. Determination of the number of board members and auditors
11. Determination of fees for the Board of Directors and the Auditors
12. Election of board members and chairman of the board
13. Election of Auditor
14. Resolution on approval of remuneration report
15. Closing of the Meeting

Proposals

Proposals by the Nomination Committee

The Nomination Committee’s proposal regarding election of Chairman of the Meeting (item 1), determination of number of board members and auditors (item 10), determination of fees for board members and auditors (item 11) election of board members and Chairman of the Board of Directors (item 12) and election of auditor (item 13) will be presented on the Company's website www.irras.com well in advance of the Meeting, and thereafter included in the postal voting forms that the Company will provide.

Proposals by the Board of Directors

Election of one or two persons to verify the minutes of the General Meeting together with the Chairman (item 2)

The Board of Directors proposes that Carl-Mikael Lindholm, or in the event he is unable to participate, the individual appointed by the Board of Directors, be elected to verify the minutes. The role of the certifier also includes checking the voting list and ensuring that all postal votes received are correctly recorded in the minutes of the Meeting.

Preparation and approval of the voting list (item 3)

It is suggested that the voting list be used as prepared by the Company based on the register as of 16 May 2022, presented to the General Meeting and the received postal votes and controlled by the persons verifying the minutes.

Dividend (item 8)

The Board of Directors proposes that the Annual General Meeting shall resolve not to distribute any dividends for the financial year 2021.

Resolution on approval of remuneration report (item 14)

The Board of Directors proposes that the Annual General Meeting resolves to approve the Board's report on remuneration in accordance with Chapter 8, Section 53 a of the Swedish Companies Act (2005:551).

The shareholders’ right to submit questions

The Board of Directors and the CEO shall, if any shareholder so requests and the board 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: Sten Gustafsson, Box 160, 101 23 Stockholm or by e-mail to AGM@irras.com, no later than 14 May 2022. 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 19 May 2022.

Other information

As per 25 April 2022 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 in April 2022

The Board of Directors

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 April 25, 2022, at 8:30 (CET).

 NOTICE TO ATTEND THE ANNUAL GENERAL MEETING OF IRRAS AB (PUBL)

Stockholm, Sweden (April 25, 2022) – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that the publication of the company’s interim report for the period from January to March 2022 (“Q1 2022 Interim Report”) will be published on Wednesday, 27 April 2022.

Financial calendar for 2022

Report	Previously Announced Date	New Date
Q1 2022 interim report	10 May 2022	27 April 2022
Q2 2022 interim report	22 July 2022	Unchanged
Q3 2022 interim report	10 November 2022	Unchanged

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 April 25, 2022, at 8:30 (CET).

Stockholm, March 11, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it received the initial regulatory approvals for its flagship product, IRRAflow, from the Australian Department of Health and Therapeutic Goods Administration (TGA) for commercial distribution in Australia.  As a result of this approval, IRRAS is now listed on the Australian Register of Therapeutic Goods (ARTG), allowing the company to expand its global commercialization and begin to market IRRAflow to Australian customers.

TGA clearance has been received for both the class II IRRAflow control unit and digital pump and tube set, while clearance for the class III IRRAflow dual-lumen catheter is expected in the near future.  The successful TGA certification process is the culmination of in-depth assessment of the quality and safety of IRRAS products, which began with last year’s Medical Device Single Audit Program (MDSAP) certification.

In 2018, an estimated 387,000 Australian residents had suffered a stroke at some time in their lives, according to the Australian Bureau of Statistics 2018 Survey of Disability, Ageing, and Carers.  Stroke also accounted for 5.3% of all deaths in Australia during the same survey.

“As the world’s population continues to age, there is an increased risk of stroke,” said Will Martin, President and Chief Executive Officer of IRRAS. “The recent regulatory approval of IRRAflow in Australia is a clear sign that our global regulatory strategy is progressing as planned.  We are thrilled to offer IRRAflow’s cutting-edge technology to neurosurgeons in Australia, so they can provide advanced treatment options for their patients suffering from intracranial bleeding.”

“With this new regulatory clearance, IRRAS will now be able to offer Australian caregivers the most innovative solution for intracranial bleeding,” said Coenraad Tamse, MD, VP of International Sales of IRRAS. “We will now continue the commercial momentum that we’ve seen in both the United States and Europe by building relationships with key Australian surgeons in the near future.”

About the Australian Register of Therapeutic Goods (ARTG)
The Australian Register of Therapeutic Goods (ARTG) is the central point of control for the legal supply of therapeutic goods in Australia. The ARTG is a database of information about therapeutic goods for human use approved for supply in, or exported from, Australia. It is the reference database of the Therapeutic Goods Administration (TGA).

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 March 11, 2022, at 8:30 (CET).

Stockholm, March 3, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the first global patient treatment with its next-generation IRRAflow system, the company’s lead product that uses active fluid exchange to treat patients with intracranial bleeding. 

Dr. Nicholas Brandmeir, a neurosurgeon from the Rockefeller Neuroscience Institute at West Virginia University and WVU Medicine Ruby Memorial Hospital (WVUH), successfully treated the first global patient suffering from a hemorrhagic stroke with the next-generation IRRAflow system.

“Over the last year, our team has been utilizing IRRAflow’s active fluid exchange technology to therapeutically treat our hemorrhagic stroke patients,” said Dr. Brandmeir. “We are excited to have the opportunity to be the first in the world to be able to utilize the next-generation IRRAflow system. The new IRRAflow control unit has welcomed improvements from a procedural workflow standpoint, which will benefit our team and patients.” 

“The first patient treatment with our next-generation IRRAflow system is a critical next step in our company’s accelerating commercial launch,” said Will Martin, President and Chief Executive Officer of IRRAS. “Dr. Nicholas Brandmeir and the team at WVUH have been wonderful partners as we jointly work to transform how critically ill patients with intracranial bleeding are treated and provide them and their families hope for improved outcomes from this debilitating disease.” 

Earlier last month, the surgeons from WVUH presented clinical data from the hospital’s treatment of its first 45 patients using the IRRAflow system across multiple intracranial pathologies. The data presented demonstrated that the use of IRRAflow resulted in a 0% catheter occlusion rate, a decreased percentage of observed vasospasm, and a reduced need for shunt placement after treatment.  All of WVUH’s published data compared favorably to historic published rates. 

The presentation can be viewed at the following link: https://youtu.be/GsNeYLvUuk8

The IRRAflow system offers an advanced approach to fluid management by actively exchanging intracranial fluids through recurring irrigation that dilutes collected toxic material, making it easier to remove, and prevents solid particles from blocking drainage holes, ensuring that fluid can continuously be drained throughout the entire treatment. In clinical data that has been published to date, IRRAflow’s combination of automated irrigation and controlled drainage has been shown to result in fewer complications, more thorough drainage, and reduced required treatment time. 

This next-generation IRRAflow control unit will serve as the foundation of IRRAS’ commercial efforts moving forward.  The system has been enhanced based on early user feedback and will improve the overall user experience with:

• Step-by-step interactive tutorials to guide system setup,
• Additional data tracking to help nursing better assess the patient’s condition each hour of treatment,
• An intuitive graphical user interface that simplifies treatment workflow and adjustment of treatment parameters, and
• A new drainage collection design that provides additional options to optimize fluid drainage. 

Click here to experience the next-generation IRRAflow system.

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 March 3, 2022, at 8:00 (CET).

Stockholm, February 22, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the commercial launch of its next-generation IRRAflow system, the company’s latest innovation to advance the treatment of intracranial bleeding, in the United States. This next-generation technology is continued validation of the company’s commitment to providing an enhanced user experience while treating critically ill patients.

The IRRAflow system offers advanced fluid management to therapeutically treat critically ill patients with intracranial bleeding by incorporating recurring irrigation that dilutes collected toxic material, making it easier to remove, and prevents solid particles from blocking drainage holes, ensuring that fluid can continuously be drained throughout the entire treatment. IRRAflow’s combination of automated irrigation and controlled drainage results in fewer complications and more through drainage. 

The launch of the next-generation IRRAflow control unit will now enhance the user experience by providing:

• Step-by-step interactive tutorials to guide system setup,
• Additional data tracking to help nursing better assess the patient’s condition each hour of treatment,
• An intuitive graphical user interface that simplifies treatment workflow and adjustment of treatment parameters, and
• A new drainage collection design that provides additional options to optimize fluid drainage. 

Click on the link https://www.youtube.com/watch?v=2P7aV4-b4XI to experience the next-generation IRRAflow system

The first next-generation IRRAflow systems have been shipped to initial customer locations in the US, and staff training is now underway, with first patient treatments expected in the near future.

"Since our IRRAflow system was launched in the US, our team has worked closely with our customers to assess how we can further improve our products to improve the outcomes for our critically ill patients,” said Will Martin, President and Chief Executive Officer of IRRAS. “Our team has taken that feedback and has incorporated it into the next generation of our IRRAflow system. The customer response thus far confirms that the upgrades that have been made to the system will enhance the user experience, shorten training time required, and improve our ability to support patient treatments remotely.  Each of these factors will continue to significantly improve patient outcomes and contribute to continued sales growth.”

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 February 22, 2022, at 8:30 (CET).

“The 4th quarter of 2021 served as an encouraging end to an eventful year for our IRRAS team.  Each consecutive quarter of 2021 showed the progress that IRRAS is making toward becoming a leader in neurocritical care, and we are poised to continue this progress into 2022.”

“All told, we are pleased with our accomplishments throughout all of 2021.  During the year, our team progressed across all aspects of our business, and these accomplishments resulted in revenue growth of more than 200% during 2021.”

Will Martin, President and CEO of IRRAS

Fourth Quarter, October – December 2021

• Net revenue amounted to SEK 7.2 million (2.5)
• Operating loss (EBIT) amounted to SEK -43.5 million (-36.8)
• Loss after tax amounted to SEK -43.4 million (-38.1)
• Earnings per share before and after dilution amounted to SEK -0.55 (-0.57)

Period, January – December 2021

• Net revenue amounted to SEK 22.4 million (7.4)
• Operating loss (EBIT) amounted to SEK -136.5 million (-134.3)
• Loss after tax amounted to SEK -136.3 million (-135.9)
• Earnings per share before and after dilution amounted to SEK -1.89 (-2.46)

Important events during the quarter

CE Mark received for enhanced IRRAflow Drainage Catheter

• Enhanced catheter with improved kink resistance and drainage capabilities approved for use in European Union.

ACTIVE clinical study initiated by Aarhus University Hospital

• Aarhus University Hospital, a leading hospital in Denmark, began commercial patient treatments with IRRAflow and will capture its results in the ACTIVE clinical trial to prove the system’s superiority versus traditional drainage systems.

First patients enrolled in ARCH clinical study

• Dr. Behnam Rezai Jahromi from Helsinki University Hospital enrolled the first patient in the ARCH clinical study, which compares use of IRRAflow with clot-busting medication versus traditional drainage systems in IVH patients.
• Study will further document ability and safety of using IRRAflow to safely deliver intracranial medication.

Partnership with Lovell Government Services (LGS) Announced to Accelerate Launch into US Military and Veterans’ Hospitals

• IRRAS signed an agreement with LGS, a Service-Disabled Veteran-Owned Small Business, to serve as its vendor for product orders and contract from US government facilities.

The Board of Directors proposes no dividend

Important events after the end of the quarter

Expanded Intellectual Property Portfolio with Issuance of Additional Patent for IRRAflow System

• The third patent issued for the IRRAflow system provides coverage of the system’s ability to administer therapeutic drugs using its catheter’s dual-lumen design and controlled irrigation capabilities into targeted areas of treatment.

First patients enrolled in ACTIVE clinical study

• Dr. Anders Korshøj from Aarhus University Hospital, a leading hospital in Denmark, enrolled the first patient in the ACTIVE clinical study to evaluate the efficacy and safety of IRRAflow compared to traditional drainage systems

Largest IRRAflow dataset to date presented, confirming improved patient outcomes

• Surgeons from West Virginia University Hospital presented data from their first 45 IRRAflow patient treatments at the Neurosurgical Society of the Virginias annual meeting.  Data showed 0% occlusion rate and reduced incidence of infection, vasospasm, and shunt dependence compared to traditional passive drainage.

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

About IRRAS

IRRAS is a global medical care company focused on 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 February 16, 2022, at 8:00 a.m. (CET).

 IRRAS AB (publ) Year end report for January to December 2021

Stockholm, February 10, 2022 – On Wednesday, February 16, at 09.00 CET, IRRAS will host a conference call and an online presentation of its Q4 2021 interim report (which will have been published earlier on February 16 at 08.00 CET). The presentation will be held in English.

The dial-in numbers for the conference call are:

Sweden: +46 8 50 55 83 56
UK: +44 33 33 00 92 66
US: +1 646 722 4957

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

https://tv.streamfabriken.com/irras-q4-2021

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 February 10, 2022 at 8:30 (CET).

Stockholm, February 10, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the presentation of the largest dataset to date to document clinical outcomes using its IRRAflow system.  The neurosurgery team from the Rockefeller Neuroscience Institute at West Virginia University and WVU Medicine Ruby Memorial Hospital (WVUH), led by Dr. Nicholas Brandmeir, tracked the outcomes from the first 45 patients that they treated with IRRAflow across a variety of intracranial pathologies, and their positive initial results were presented by Dr. Babar Khan at the Neurosurgical Society of the Virginias annual meeting in White Sulphur Springs, West Virginia, on January 27, 2022. 

The presented data confirmed the effectiveness of the IRRAflow system’s automated irrigation by showing a 0% occlusion rate during the entire course of treatment.  Traditional passive drainage solutions, on the other hand, have catheter occlusion rates up to 47% documented in clinical literature.  Additionally, IRRAflow’s mechanism of action was also shown to more effectively remove collected blood after intracranial bleeding.  Average treatment time with IRRAflow was 6.8 days, and only 13% of patients required the placement of a shunt after IRRAflow treatment.  This percentage of shunt dependence with IRRAflow compares favorably to data from the CLEAR-III where 18% of patients required shunt placement after treatment with a passive ventricular drain. 

The WVUH data also highlighted a reduction of vasospasm observed after ruptured cerebral aneurysms compared to higher historic published rates.  After intracranial bleeding occurs, the collected blood induces an inflammatory response, which can cause the vessels in the brain to spasm or narrow, limiting blood flow, and putting the patient at risk for a secondary stroke. IRRAflow’s more efficient removal of collected blood resulted in decreased observation of this deadly vasospasm phenomenon.

These positive outcomes that highlight the IRRAflow system’s effectiveness were collected across a wide range of intracranial pathologies, including intraventricular hemorrhage (IVH), ventriculitis, subarachnoid hemorrhage, and subdural hematomas. This data set also serves to further expand the available clinical evidence to document IRRAflow’s ability to safely perform targeted drug delivery with positive results.  The WVUH team has delivered medication with IRRAflow to treat 24.4% of their patients to date.

“This data presented by the surgeons from the Rockefeller Neuroscience Institute at West Virginia University further confirms the positive impact that our IRRAflow system is having on a growing number of patients around the world,’ said Will Martin, President and Chief Executive Officer of IRRAS. “Our key corporate objective in 2022 is to document the superiority of our products with robust clinical data, and this early data shows that the use of IRRAflow can result in better patient outcomes, decreased length of hospitalization, and reduced overall cost of care.”

The presentation can be viewed at the following link:

https://youtu.be/GsNeYLvUuk8

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 February 10, 2022, at 8:30 (CET).