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).

Stockholm, January 28, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient enrollments in the ACTIVE (Use of Active Fluid Exchange to Treat Intraventricular Hemorrhage (IVH)) clinical study. The objective of the ACTIVE study is to evaluate the efficacy and safety of the IRRAflow system’s active irrigation and drainage compared to passive external ventricular drainage (EVD) alone. 

The ACTIVE study is a randomized, prospective clinical trial that consists of two arms. The first arm will assess the treatment of 60 IVH patients using IRRAflow and will compare the results to a second arm of 58 patients that will be treated with traditional passive EVDs. The study will compare overall effectiveness of the two treatment arms by looking at overall blood clearance, treatment time required, and long-term patient outcomes. Additionally, the safety of each treatment arm will be compared by assessing treatment complications, including catheter occlusions and infection. The clinical trial has also been designed for endpoint comparisons to be conducted at multiple interim checkpoints throughout enrollment.

“We are pleased to enroll our first patient in the ACTIVE study,” said Dr. Anders Korshøj. “We believe that the use of active irrigation may enhance outcomes for IVH patients, and we look forward to presenting our data from ACTIVE to confirm that IRRAflow’s unique mechanism of action reduces complications and treatment times.”

The Department of Neurosurgery at Aarhus University Hospital is one of the leading neurosurgical departments in Denmark. The department is responsible for general neurosurgery and highly specialized neurosurgical procedures in the central Denmark Region. Moreover, the department is responsible for diagnostics, treatment, and care of patients with certain neurosurgical conditions in the entire country.

“The first patient enrollment of the ACTIVE study is a critical step forward for our company,” said Will Martin, President and CEO of IRRAS. “The most important step to accelerate the commercial adoption of IRRAflow is to confirm its superiority to traditional drainage, and the ACTIVE trial will provide comparative data that demonstrates how IRRAflow is a better choice for patients suffering from IVH.”

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).

About Aarhus University and Aarhus University Hospital

Aarhus University Hospital belongs to the elite of university hospitals. Aarhus University Hospital develops and provides highly specialized medical treatment, research, and education at an international level. Aarhus University Hospital serves the citizens from across the Central Denmark Region in need of highly specialized treatment. For the last 13 years, Aarhus University Hospital has been appointed Denmark’s best hospital, and it currently ranks #32 on the Newsweek ranking of the world’s best hospitals.

Aarhus University (AU) is a dynamic, modern and highly international university. Since its founding in 1928, it has grown to become a leading public university with international impact and reach across the entire research spectrum. Out of over 17,000 universities worldwide, AU ranks among the top 100 universities in the world in several research areas and is considered among the top 25 universities in the European Union. AU stands out in particular in terms of research quality and the quality of degree programs. Regarding internationalization, AU is ranked in the top as well as no. 45 on THE’s ranking “Most International Universities in the World”.

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 January 28, 2022, at 8:30 (CET).

Stockholm, January 12, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the issuance of United States (U.S.) Patent Number 11,123,483, “Fluid Exchange Catheter System.”  This latest patent is the third US patent that provides intellectual property protection for the company’s lead product, IRRAflow, and it provides expanded coverage regarding the system’s ability to facilitate the targeted delivery of therapeutic medication into targeted areas of treatment.

The recently issued patent includes two key method claims regarding the IRRAflow system’s active fluid exchange mechanism of action.  The patent’s protection covers:

1. The administration of at least one drug to a patient through the catheter; and
2. The irrigation mechanism for unblocking the fluid exchange pores at the distal end of the catheter. 

The issuance of the latest patent adds to the existing intellectual property protection for the IRRAflow system and builds upon the previously issued US patents, U.S. Patent No. 8,398,581, issued on March 19, 2013, and U.S. Patent No. 9,623,177, issued on April 18, 2017.  IRRAS’ IRRAflow and Hummingbird ICP Monitoring product families now contain 12 total patents nationalized globally across 13 key countries.

“Strengthening our intellectual property portfolio with the addition of this patent further confirms the innovative technology contained with the IRRAflow system,” said Will Martin, President and Chief Executive Officer of IRRAS.  “Over the past year, global thought leaders in neurosurgery from Helsinki University Hospital and Buffalo General Medical Center centers have published cutting-edge clinical experience using IRRAflow to deliver both thrombolytic and antibiotic medication.  Moving forward, IRRAS is committed to capitalizing upon this sizable opportunity in intracranial drug delivery, and this patent is an important foundational element of our company’s long-term growth plans.”

IRRAflow, the company's initial commercial product, is a transformative medical device system that combines controlled irrigation with ongoing fluid drainage to better manage patients with intracranial bleedings.  The system's automated use of irrigation addresses challenges associated with traditional passive fluid drainage, such as catheter blockages and infection. In addition, IRRAflow's irrigating fluid helps to dilute toxic material, such as blood or bacteria, that is collected within the intracranial space and makes it easier to remove.

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 January 12, 2022, at 8:30 (CET).

Stockholm, December 23, 2021 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it has entered into a non-exclusive distribution agreement with Lovell Government Services, a Service-Disabled Veteran-Owned Small Business (“SDVOSB”), to serve as the company’s vendor for product orders and contract awards from United States government facilities.  This partnership will help IRRAS accelerate the launch of its IRRAflow and Hummingbird ICP product lines by utilizing Lovell’s position as a contracted vendor at Veterans Affairs (VA) hospitals and other United States government and military medical facilities.

“The IRRAS commercial team is excited to partner with the Lovell Government Services team as their deep experience and established contracts with VA and military medical facilities will provide guidance and strategic advantages as we expand within this important group of customers,” said Will Martin, President and CEO of IRRAS. “Our IRRAS team is dedicated to offering innovative, life-saving technology for all patients, but it is especially meaningful that this partnership will allow us to positively impact the lives of more patients that have volunteered to serve their country.”

Lovell, a Service-Disabled Veteran-Owned Small Business, is ranked as 2021’s fastest-growing privately held company in Government Services by Inc. 5000. They partner with medical and pharmaceutical companies looking to serve veteran and military patient populations and to compete for government contracts. With this partnership, Federal, State, and Local Government Agencies will be able to place orders for the IRRAflow or Hummingbird ICP product lines through appropriate contract vehicles, such as the Defense Logistics Agency’s ECAT system, the Federal Supply Schedule (FSS), the Distribution and Pricing Agreement (DAPA), and GSA Advantage for direct purchase.  Partnering with an SDVOSB also benefits government agencies by helping them meet their SDVOSB procurement goals and requirements.

“IRRAS has developed innovative devices dedicated to treating intracranial bleeding and traumatic brain injury, which unfortunately affect the communities that we serve in a disproportionate manner. The IRRAflow and Hummingbird devices will save and improve the lives of thousands of Veterans, active-duty service members, and their dependents. We’re honored that IRRAS is partnering with us,” says Chris Lovell, Major, USMC (Ret.), and CEO of Lovell Government Services.

About Lovell Government Services

Lovell Government Services was established by Chris Lovell, Major USMC Retired, in 2013. Lovell’s mission is to serve the Veterans Administration Hospital System, the U.S. Military Medical Networks, other Federal Healthcare Systems, and the communities they support. Lovell partners with Medical and Pharmaceutical Suppliers to fast track and distribute the latest in life-saving technologies to the Federal Government. Learn more at www.lovellgov.com

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 December 23, 2021, at 8:30 (CET).

Stockholm, December 3, 2021 – According to the principles for the appointment of the Nomination Committee in IRRAS AB (publ), the Nomination Committee for the annual general meeting 2022 shall be composed of members that represent the three largest shareholders after the end of the third quarter of the year before the AGM is held, together with the chairman of the company’s Board of Directors. The largest shareholders refer to the registered shareholders or otherwise known shareholders after the end of the third quarter.

The composition of the Nomination Committee has now been established, and IRRAS today announced that the Nomination Committee for the annual general meeting 2022 consists of the following persons:

• Christer Hellström, chairman of the nomination committee, representing Bacara Holdings Limited
• Arne Lööw, representing Fourth National Pension Fund
• Carl-Mikael Lindholm, representing Carl-Olof och Jenz Hamrins Stiftelse
• Marios Fotiadis, Chairman of the Board of IRRAS AB

The Nomination Committee’s proposals will be presented in the Notice to the annual general meeting 2022 and on IRRAS’ website, www.irras.com.

Shareholders who wish to submit proposals to the Nomination Committee can do so by sending an e-mail to nomination@irras.com (subject “Nomination Committee”) or by letter posted to IRRAS AB, Attn: IRRAS Nomination Committee, Vasagatan 16, 111 20 Stockholm, Sweden.

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 December 3, 2021 at 8:30 (CET).

Fifth Consecutive Quarter of Revenue Growth

“Q3 marked our company’s 5th consecutive quarter of growth, even with increased impact during the quarter from the COVID-19 Delta variant. This growth and the strengthening foundation of our business show that IRRAS is well positioned to continue this positive growth trajectory.”

“We are pleased with our accomplishments during the third quarter of 2021, and our continued progress across the key elements of our business – revenue growth, operational efficiency, and clinical data generation – confirms our forward momentum.”

Will Martin, President and CEO of IRRAS

Third Quarter, July – September 2021, Results

• Net revenue amounted to SEK 6.1 million (2.1)
• Operating loss (EBIT) amounted to SEK -27.0 million (-31.0)
• Loss after tax amounted to SEK -26.9 million (-31.0)
• Earnings per share before and after dilution amounted to SEK -0.34 (-0.47)

Period, January – September 2021, Results

• Net revenue amounted to SEK 15.2 million (4.9)
• Operating loss (EBIT) amounted to SEK -93.0 million (-97.5)
• Loss after tax amounted to SEK -92.9 million (-97.8)
• Earnings per share before and after dilution amounted to SEK -1.30 (-1.90)

Important events during the quarter

Company Leadership Transition Completed

• On July 1, Will Martin assumed the role of IRRAS President & Chief Executive Officer.  Kleanthis G. Xanthopoulos, Ph.D. remains on the company’s Board of Directors.

Loan Financing Completed via European Investment Bank

• IRRAS signed a 10M EUR loan agreement that provides non-dilutive financing for IRRAS to fund product development and clinical data generation activities being performed in the EU.

Ventriculitis Case Study Published

• Helsinki University Hospital published a case series that confirmed the ability of IRRAflow to treat patients with pyogenic ventriculitis, an aggressive brain infection.
• Publication documents the ability of IRRAflow to directly deliver antibiotics into the intracranial space for the first time in peer-reviewed literature.

Expanded Quality System Certifications Received after Onsite Inspection

• IRRAS’ in-house manufacturing facility for IRRAflow capital equipment was added to its ISO 13485:2016 certification, and the company’s MDSAP certificate was extended for 3 years.

Important events after the end of the quarter

CE Mark certification received for enhanced IRRAflow Drainage Catheter

• Enhanced catheter with improved kink resistance and increased drainage capabilities now available for patient treatments in Europe.

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 investigator-initiated 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 patients in the ARCH clinical study, which compares use of IRRAflow with clot-busting medication versus traditional drainage systems in patients with intraventricular hemorrhage.

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 November 9, 2021 at 8:00 a.m. (CET).

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