First quarter, January – March 2023

• Net revenue amounted to SEK 11.2 million (8.6).
• Operating loss (EBIT) amounted to SEK -59.2 million (-33.7).
• Loss after tax amounted to SEK -59.2 million (-33.3).
• Earnings per share before and after dilution amounted to SEK -0.07 (-0.46).
   

CEO Statement

The first quarter served as an encouraging start to 2023 for IRRAS as our total revenue of MSEK 11.2 marked the highest quarterly revenue total in the company’s history. 

During last quarter’s year-end report, we referenced that the US was expected to drive a higher percentage of the company’s revenue in future quarters due to two reasons:  (1) increased utilization from existing customers as account penetration grows, and (2) revenue contribution as a result of our commercial partnership with Medtronic.  During Q1, the US market accounted for 83% of our total revenue, and 95% of our US revenue was generated by existing customers that had previously ordered.  Although all revenue during Q1 was generated from IRRAS-driven accounts, customer interest driven by our partners at Medtronic was encouraging, and a robust funnel has been created during the early stages of their sales activity.

Beyond sales activity, a number of other important growth drivers also occurred during Q1 2023.  World-renowned surgeons from the University of Buffalo published the first comparative clinical data to confirm the superiority of IRRAflow versus traditional passive drainage.  Such clinical data and support from leading physicians continues to drive the product approval process for IRRAflow at other leading US facilities.

Finally, we made meaningful, needed progress regarding the company’s next needed financing.  Our existing investors remain supportive as we’ve signed a short-term bridge financing with Bacara Holdings, and, in the near future, we plan to finalize and announce plans to provide the company capital to support our continued growth and expansion.

Thank you for your continued interest and support.

Will Martin, CEO

Important events during the quarter

Superiority of IRRAflow system confirmed in head-to-head clinical study performed by Neurosurgeons at University of Buffalo and published in the Operative Neurosurgery Journal. The study concluded that IRRAflow system, when used for the treatment of chronic subdural hematomas (cSDH), results in favorable clinical outcomes, low complication and revision rates, faster clearance of collected blood, and reduced rates of catheter infections compared to passive drainage using an external ventricular drain (EVD).

Important events after the end of the quarter

Secured bridge financing agreement through a loan providing up to MSEK 40 in funding to cover working capital needs until the completion of the ongoing financing process.

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

Q1 Report 2023 – conference call and audiocast
IRRAS will host a conference call and an online presentation of its Q1 2023 interim report on May 17 at 16.00 CET. The presentation will be held in English.

Dial-in number to the teleconference will be received by registering on the link below. After the registration you will be provided phone numbers and a conference ID to access the conference:

https://conference.financialhearings.com/teleconference/?id=5003756

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

https://ir.financialhearings.com/irras-q1-2023

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 May 17, 2023, at 8:00 a.m. (CET).

 IRRAS AB (publ) Interim report for January to March 2023

Stockholm, May 15, 2023 – On Wednesday, May 17, at 16.00 CET, IRRAS will host a conference call and an online presentation of its Q1 2023 interim report (which will have been published earlier on May 17 at 08.00 CET). The presentation will be held in English.

Dial-in number to the teleconference will be received by registering on the link below. After the registration you will be provided phone numbers and a conference ID to access the conference:

https://conference.financialhearings.com/teleconference/?id=5003756

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

https://ir.financialhearings.com/irras-q1-2023

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 May 15, 2023 at 8:30 (CET).

IRRAS´ 2022 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 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
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 27, 2023 at 08:30 a.m. (CET).

 Annual Report 2022 English

Stockholm, Sweden (April 20, 2023) – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced a short-term financing agreement with Bacara Holdings, its second largest shareholder, which is led by Marios Fotiadis, the company’s Chairman of the Board of Directors.  This bridge loan agreement provides IRRAS up to MSEK 40 in funding to cover its working capital needs until the completion of the company’s ongoing financing process.  The short-term loan is a secured credit facility with an interest rate of 6.0% on an annual basis.

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 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 20, 2023, at 21:25 (CET).

 IRRAS Secures Short-term Financing Agreement of MSEK 40

Fourth quarter, October – December 2022

• Net revenue amounted to SEK 10.6 million (7.2).
• Operating loss (EBIT) amounted to SEK -46.7 million (-43.5).
• Loss after tax amounted to SEK -46.3 million (-43.4).
• Earnings per share before and after dilution amounted to SEK -0.06 (-0.55).
   

Period, January – December 2022

• Net revenue amounted to SEK 40.0 million (22.4).
• Operating loss (EBIT) amounted to SEK -168.1 million (-136.5).
• Loss after tax amounted to SEK -166.6 million (-136.3).
• Earnings per share before and after dilution amounted to SEK -0.52 (-1.89).
• The Board proposes that no dividend be paid
   

Significant events during the quarter

IRRAS initiates commercial partnership with Medtronic

• A sales agency agreement was initiated with Medtronic, the world’s largest medical device company, which gives Medtronic exclusive right to promote IRRAflow in a select number of territories in the United States. Training for Medtronic team members and first customer engagement also occurred during Q4.

IRRAS receives US FDA 510(k) clearance for its next-generation IRRAflow control unit

• Regulatory approval was received in the US for the latest system, which incorporates enhancements driven by user feedback such as interactive tutorials, software with upgraded graphics, a new drainage collection design, and added functionality that permits data transmission to the hospital’s bedside monitor and central nursing station.

Significant events after the quarter

Superiority of IRRAflow system confirmed in head-to-head clinical study

• Neurosurgeons from the University at Buffalo published results of their comparative clinical study in the Operative Neurosurgery journal, which that compared outcomes when treating chronic subdural hematoma patients with IRRAflow against passive drainage alone.
• The study demonstrated that IRRAflow treatment resulted in faster hematoma clearance and a reduction in catheter-related infections, which led to favorable clinical outcomes and lower complication and revision rates.

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, 2023, at 8:00 a.m. (CET).

 IRRAS AB (publ) Year End report for January to December 2022

Stockholm, February 13, 2023 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that the publication of the first comparative study detailing the use of the company’s novel IRRAflow system.  This study, which was conducted under the guidance of Dr. Adnan Siddiqui and the team from the Department of Neurosurgery, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, one of the world’s leading centers for neurosurgical innovation, was published in the peer-reviewed Operative Neurosurgery medical journal.  The manuscript concludes that IRRAS’ IRRAflow system when used for the treatment of chronic subdural hematomas (cSDH) results in favorable clinical outcomes, low complication and revision rates, faster clearance of collected blood, and reduced rates of catheter infections compared to passive drainage using an external ventricular drain (EVD).

The manuscript, titled “Use of Novel Automated Active Irrigation With Drainage Versus Passive Drainage Alone for Chronic Subdural Hematoma—A Propensity Score-Matched Comparative Study With Volumetric Analysis,” retrospectively analyzed the treatment of 55 patients, 21 treated with IRRAflow and 34 treated with passive drainage, that underwent propensity score matching to ensure appropriate similarities in patient demographics, baseline comorbidities, and hematoma volume.

After the completion of the analysis, the surgeons found that the use of IRRAflow resulted in a statistically significant higher rate of hematoma clearance (0.5 ± 0.4 mL/day with IRRAflow vs. 0.4 ± 0.5 mL/day with passive drainage) and a statistically significant reduction in catheter-related infections.  Additionally, in the subgroup analysis that looked procedures that were performed using a burrhole alone, treatment with IRRAflow also resulted in significantly lower hematoma expansion at discharge and significantly improved brain expansion.

Furthermore, the data from this clinical study showed that the use of IRRAflow resulted in a nonsignificant reduction in duration of catheter placement (3.7 ± 2.2 with IRRAflow vs. 4.4 ± 4.1 with passive drainage), total hospital length of stay (6.8 ± 3.0 with IRRAflow vs. 10.6 ± 16.2  with passive drainage), and rate of seizure activity (0 patients with IRRAflow vs. 3 patients with passive drainage), each suggesting a trend that may have shown significance with a larger sample size.

A chronic subdural hematoma is a collection of blood and blood breakdown products between the surface of the brain and its outer layer that generally occurs after head trauma in an older patient.  As the world’s population progressively ages, the increasing incidence of cSDH will be a burden to patients and a future challenge for neurosurgical clinics.[1] The incidence of chronic subdural hematomas (CSDH) ranges from 1.72 to 20.6 per 100,000 persons per year and is projected to become the most common cranial neurosurgical condition among adults by the year 2030.[2]^,[3]

"This recently published clinical data confirms the positive impact that IRRAflow can have on the lives of patients suffering from intracranial bleeding," said Will Martin, President and Chief Executive Officer of IRRAS. "This study is a critical next step in the growing pool of clinical evidence that demonstrates the impact of IRRAflow by providing head-to-head data that confirms that IRRAflow's combination of irrigation and drainage results in both more effective blood removal and safer clinical outcomes than traditional treatment methods."

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 13, 2023, at 8:30 (CET).

Stockholm, February 9, 2023 – On Thursday, February 16, at 16.00 CET, IRRAS will host a conference call and an online presentation of its Q4 2022 interim report (which will have been published earlier on February 16 at 08.00 CET). The presentation will be held in English.

Dial-in number to the teleconference will be received by registering on the link below. After the registration you will be provided phone numbers and a conference ID to access the conference:

https://conference.financialhearings.com/teleconference/?id=5005418

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

https://ir.financialhearings.com/irras-q4-2022

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 February 9, 2023 at 8:30 (CET).

Stockholm, Sweden, February 1, 2023 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that the publication of the interim report for the period from October to December 2022 (“Q4 2022 Interim Report”) will be published on Thursday, 16 February 2023.

Report	Previously Announced Date	New Date
Q4 2023 interim report	22 February 2023	16 February 2023

                                                       Financial calendar for 2023

Annual report 2022	27 April 2023
Q1 2023 interim report	17 May 2023
Annual General Meeting	7 June 2023
Q2 2023 interim report	24 August 2023
Q3 2023 interim report	9 November 2023
Q4 2023 interim report	21 February 2024

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 1, 2023, at 8:30 (CET).

Stockholm, December 12, 2022 – IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced that it received regulatory clearance from the United States Food, Drug, and Administration (FDA) to active all of the functionality on the next generation control unit for its flagship product, IRRAflow, the world’s first and only active fluid exchange system.

Earlier this year, IRRAS introduced this next-generation IRRAflow system, which included embedded interactive tutorials, intuitive software with upgraded graphics, refined treatment workflow, and a new drainage collection design, to its customers in the US.  This most recent FDA 510(k) clearance extends the system’s previous FDA clearances and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station.

The IRRAflow system advances treatment options for patients suffering from intracranial bleeding as the first irrigating drainage system that enables active fluid exchange. IRRAflow combines automated irrigation, controlled drainage, and continuous monitoring of the patient’s intracranial pressure (ICP) into one intelligent system.  Its unique mechanism of action uses recurring irrigation to prevent solid particles from blocking the drainage holes on the catheter tip and to also dilute collected toxic material, making it easier to remove.

“IRRAS prides itself on consistently upgrading its products to better meet the needs of its customers, and the US regulatory clearance of the next generation IRRAflow control unit is the latest example of our team delivering upon that promise,” said Will Martin, President and Chief Executive Officer of IRRAS.  “Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize care for their critically ill patients.  Being able to introduce the latest IRRAflow functionality is the exciting next step toward accomplishing our mission to becoming a global leader in the neurocritical space.”

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 12, 2022, at 8:00 (CET).

Stockholm, December 6, 2022 – According to the principles for the appointment of the Nomination Committee in IRRAS AB (publ), the Nomination Committee for the annual general meeting 2023 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 2023 consists of the following persons:

• Christer Hellström, chairman of the nomination committee, representing Bacara Holdings Limited
• Philippe Audi, representing Spetses Investments Limited
• Yana Vlasova, representing Lexington Holding Assets Limited
• 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 2023 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 6, 2022 at 8:30 (CET).