Bulletin from the Annual General Meeting in IRRAS AB (publ) on 30 June 2023

The Annual General Meeting in IRRAS AB (publ) has been held on 30 June 2023 and in particular the following resolutions were made.

Adoption of the annual report and the auditor’s report, resolution regarding appropriation of the Company’s results and discharge of liability for the Board of Directors and CEO

The Annual General Meeting resolved to adopt the balance sheet, income statement, consolidated income statement and consolidated balance sheet for 2022. Furthermore, it was resolved that no dividend will be distributed and disposable profits as of 31 December 2022 are carried forward. The Annual General Meeting also resolved to discharge the board members and the CEO from liability for 2022.

Determination of fees to the Board of Directors and election of the Board of Directors and auditor

The Annual General Meeting resolved that the total Board remuneration shall amount to SEK 1,786,000 of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 265,000 shall be paid to each of the other Board members elected by the General Meeting and who are not employees of the group. Board members who are residents in the United States shall be paid an additional amount of SEK 106,000. For work in the Audit Committee, the remuneration to the Chairman of the Committee amounts to SEK 130,000 and SEK 65,000 to the other member of the Committee. For work in the Remuneration Committee, the remuneration to the Chairman of the Committee amounts to SEK 100,000 and SEK 50,000 to the other member of the Committee. No extra compensation will be paid for participating in other committees. The Annual General Meeting also resolved that the remuneration to the auditor, as previous, shall be paid in accordance with approved invoices.

The Annual General Meeting resolved that the Board until the end of the next Annual General Meeting will consist of the members Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius and Catherine Gilmore-Lawless. Eva Nilsagård has declined re-election. Marios Fotiadis was elected Chairman of the Board. KPMG AB was re-elected as the company’s auditor, with Stefan Lundberg as auditor in charge, until the end of the Annual General Meeting of 2024.

Resolution on guidelines for remuneration to senior executives and approval of remuneration Report

The Annual General Meeting approved the Board’s report on remunerations.

Resolution to implement a long-term incentive scheme

The Annual General Meeting resolved, in accordance with the Board’s proposal, to introduce a multiyear incentive program (“Program 9”) consisting of employee stock options to be transferred to employees and consultants within the IRRAS Group (the “Employee Stock Options”). The Employee Stock Options are granted free of charge to the participants no later than 36 months after the Annual General Meeting. The Employee Stock Options shall vest one-third annually from the grant date.

The Employee Stock Options, after being vested in accordance with the above, can be exercised for acquisition of ordinary shares from the third anniversary of the grant date up until the seventh anniversary of the grant date.

Each Employee Stock Option granted entitles the holder to acquire one ordinary share in the Company at a strike price corresponding to 110 percent of the average of the volume-weighted share price of the Company’s share measured over ten trading days prior to the grant date.

The principle for allocation is that each participant is granted a yearly allocation as a percentage of the base salary. Allocation is limited to not more than 500 per cent of the yearly base salary for the CEO, not more than 200 per cent of the yearly base salary to members of global senior management and not more than 100 per cent of the yearly base salary for other employees and consultants.

The number of Employee Stock Options under the Programs, including any options outstanding according to previous incentive programs, shall be limited in such way that the options at full dilution at any given time shall not exceed a dilution of 10 per cent of the total number of shares in the Company calculated on a fully diluted basis.

The Annual General Meeting resolved to authorize the Board to resolve on a directed issue and repurchase of a maximum of 88,312,600 class C shares in order to secure the Company’s commitments according to all of the Company’s outstanding incentive programs. The Annual General Meeting also resolved on the transfer of ordinary shares to the participants within the framework of Program 9.

Resolution on a reverse share split

The Annual General Meeting resolved on a reverse share split 1:100, whereby one hundred (100) existing shares becoming one (1) share. The resolution by the Annual General Meeting regarding the reverse share split is conditional upon the registration of the proposed amendments of the Articles of Association below with the Swedish Companies Registration Office. The resolution to implement a reverse share split shall furthermore be conditional upon the acceptance of Bacara Holdings Limited, one of the largest shareholders of the Company, to transfer shares for no consideration to shareholders of the Company whose number of shares is not evenly divided by 100. The Board of Directors proposes that the Board of Directors shall be authorised to determine the record date for the reverse share split.

Resolution on an amendment of the articles of association

The Annual General Meeting resolved to amend the articles of association whereby the share capital shall amount to not less than SEK 20,000,000 kroner and not more than SEK 80,000,000 and the number of shares shall be not less than 7,000,000 and not more than 28,000,000. The resolution is conditional on the Annual General Meeting’s resolution on the reverse share split above.

Resolution in respect of authorisation for the Board of Directors to resolve to issue shares, warrants and/or convertible bonds

The Annual General Meeting resolved to authorise the Board of Director’s to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholders’ preferential rights, resolve on the issue of new shares, warrants and/or convertibles.                                                             

Complete proposals regarding the Annual General Meeting’s resolutions are available on IRRAS AB:s website www.irras.com. 

 Release

Comment from the Independent Bid Committee of IRRAS regarding the public offer from IR Holding Bidco

On 30 June 2023, Legacy Capital, Spetses, Bacara, Lexington, Kleanthis G. Xanthopoulos, Panormos, Philippe Audi, and Nicolas Murat (the “Bid Consortium”), through IR Holding Bidco Inc. (the “Offeror”), announced a public offer of SEK 0.18 in cash per share to the shareholders of IRRAS AB (publ) (”IRRAS”) (the “Offer”).

Marios Fotiadis, chairman of the board of IRRAS, and Kleanthis G. Xanthopoulos, board member and former CEO of IRRAS, are shareholders of IRRAS and are participating in the Offer as part of the Bid Consortium. They will contribute their shares in IRRAS to the Offeror upon completion of the Offer.

Further information regarding the Offer is available in the Offeror’s press release issued today, 30 June 2023. An offer document is expected to be published by the Offeror on or around 6 July 2023. See also https://medical-solutions-offer.com/. The acceptance period for the Offer is expected to end on or around 11 August 2023.

The Independent Bid Committee of IRRAS[1] has appointed Carnegie Investment Bank AB (publ) as financial advisor and Setterwalls Advokatbyrå as legal advisor in connection with the Offer. The Independent Bid Committee has also engaged Grant Thornton to provide a fairness opinion regarding the Offer. The Independent Bid Committee, together with its advisors, will evaluate the Offer and will publish its opinion on the Offer at the latest two weeks prior to the end of the acceptance period.

IRRAS intends to publish its January-June 2023 interim report before the end of the acceptance period for the Offer. IRRAS will update its financial calendar once a new date for the report has been set.

Stockholm, 30 June 2023

IRRAS AB (publ)

The Independent Bid Committee

 

For further information, please contact:

Anita Tollstadius, chairperson of the Independent Bid Committee of IRRAS

By phone: +46 70 337 30 26

By e-mail: ir@irras.com

 

[1] The Independent Bid Committee consists of Anita Tollstadius (chairperson), Catherine Gilmore-Lawless and Eva Nilsagård. Board members Marios Fotiadis and Kleanthis G. Xanthopoulos have not participated and will not participate in the handling of or decisions regarding the Offer.

 

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).

 

The information was submitted for publication, through the agency of the contact person set out above, on 30 June 2023, 08:40 CEST.

 Comment from the Independent Bid Committee of IRRAS regarding the public offer from IR Holding Bidco

IRRAS Shifts Commercial Strategy to Focus Resources on United States Market Opportunity and Publishes Financial Update

Due to the extended impact of COVID-19 pandemic restrictions and the evolving regulatory landscape, the commercial launch of IRRAS’ products in Europe has developed more slowly than in the United States, and the US market today accounts for more than 80 percent of the Company’s revenue. As a result, IRRAS will now focus its commercial investments on the US market, which has a shorter path to profitability due to the advanced nature of the product launch, the ongoing commercial partnership with Medtronic, and the market’s more attractive price points.

 

In relation to the restructuring, IRRAS will incur non-recurring one-time costs of SEK 3 million, which will impact the Company during the third quarter of this year. The restructuring is projected to result in cost savings amounting to approximately SEK 17 million on an annual basis.  

 

The table below summarizes the financial performance of IRRAS from 1 April to 31 May 2023. IRRAS estimates that net sales for Q2 will amount to approximately SEK 8.5 – 11.5 million.

 

 

1 April – 30 April

1 May – 31 May

Net sales (US)

0

2.9

Net sales (Europe)

0

0.2

Total net sales

0

3.1

Gross profit

(neg)

(neg)

Operating profit (EBIT)

-16.1

-13.9

 

“The commercial adoption of our IRRAflow system continues to increase with key neurosurgical centers in the United States, and clinical data confirms that the use of IRRAflow positively impacts patients with intracranial bleeding,” said Will Martin, President and Chief Executive Officer of IRRAS.  “At the same time, though, the financial environment remains challenging for early-stage commercial companies, and we must make the difficult decisions that are necessary to extend IRRAS’ cash runway and secure our path forward to profitability.”

 

The Company will continue to serve physicians and patients across the world via its network of distribution partners and will also ensure that its current regulatory activities remain active, including the transition of the IRRAflow system’s CE mark to Europe’s upgraded Medical Device Regulations (MDR).

 

IRRAS plans to begin the process of closing its wholly owned commercial subsidiaries in Europe to focus its commercial investments on the US market.  IRRAS will continue to strengthen its direct sales and education team in the United States, but, as part of this shift in commercial strategy, IRRAS plans to no longer employ a direct sales and education team in Europe and will prioritize key markets where it currently has active and engaged distribution partners in place.  With the Company’s focus now prioritized on US operations, IRRAS also plans to not draw upon its 10 million EUR loan facility with the European Investment Bank (EIB).  IRRAS is still actively exploring alternatives to secure the long-term financing of the Company.

 

"The planned decision to close down our commercial operations in Europe is difficult, but, after extended consideration, we believe that this is the best path forward for our patients, our employees, and our shareholders," said Martin. "In the near term, the Company plans to focus its resources on the US market, but this decision does not mean that we are abandoning our other markets.  Instead, this is a necessary realignment of our resources and operations to best serve the worldwide need for IRRAS’ products in the most cost-efficient manner possible.”

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:

Will Martin
President and Chief Executive Officer
ir@irras.com

 

 

 

 

 

 

 

 

 


This information is information that IRRAS is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 29-06-2023 23:30 CET.

 IRRAS Shifts Commercial Strategy to Focus Resources on United States Market Opportunity and Publishes Financial Update

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

The shareholders of IRRAS AB (publ), org.nr 556872-7134 (”the Company”), are hereby invited to the Annual General Meeting to be held on Friday 30 June 2023 at 1.00 p.m at the premises of Setterwalls Advokatbyrå at Sturegatan 10 in Stockholm.

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 Wednesday 21 June 2023; and
  2. notify the Company of their intention to attend the Annual General Meeting no later than than Monday 26 June 2023.

Notification of participation shall 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. The notification shall state name, personal registration number/company registration number, address and telephone number, number of shares held and proxies if applicable.

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, must temporarily request that their shares be registered in their own name so the shareholder is entered into the register of shareholders by 21 June 2023. 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 26 June 2023, will be considered when preparing the shareholder register.

Proxies

Shareholders represented by proxy shall issue a written and dated power of attorney. The power of attorney may not be older than one year unless indicated that it is valid for a longer period, not exceeding five years. If the proxy is issued by a legal person, a certified copy of the registration certificate or similar papers of authorisation are also required. Power of attorney, registration certificates and other authorisation documents must be available for the Meeting and, in order to facilitate entry to the Meeting, sent to the Company at the above address, no later than 26 June 2023. Proxy forms for shareholders who wish to participate in the Meeting by proxy will be made available on the Company's website www.irras.com.

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 guidelines for remuneration to senior executives
  15. Resolution on approval of remuneration report
  16. Resolution to implement a long-term incentive scheme
  17. Resolution on a reverse share split
  18. Resolution on an amendment of the articles of association
  19. Resolution in respect of authorisation for the Board of Directors to resolve to issue shares, warrants and/or convertible bonds
  20. Closing of the Meeting

Proposals

Proposals by the Nomination Committee

Election of Chairman of the Meeting (item 1)

The Nomination Committee has consisted of Christer Hellström, Chairman of the Nomination Committee, appointed by Bacara Holdings Limited, Philippe Audi, appointed by Spetses Investments Limited, Yana Vlasova, appointed by Lexington Holding Assets Limited, and Marios Fotiadis, Chairman of the Board of Directors of IRRAS AB.

The Nomination Committee proposes that Advokat Axel Helle be elected Chairman at the Annual General Meeting.

Determination of the number of Board members and auditors (item 10)

The Nomination Committee proposes that the Board of Directors shall consist of four Board members elected by the General Meeting. The Nomination Committee also proposes that the Company shall have one registered auditing company as auditor.

Determination of fees for Board members and auditors (item 11)

The Nomination Committee proposes that the total remuneration for the Board of Directors shall remain the same and amount to SEK 1,786,000 of which SEK 540,000 shall be paid to the Chairman of the Board of Directors and SEK 265,000 shall be paid to each of the other Board members elected by the General Meeting and who are not employees of the Group. Board members who are residents in the United States shall be paid an additional amount of SEK 106,000.

For work in the Audit Committee, the Nomination Committee proposes that, the remuneration shall be paid by SEK 130,000 to the Chairman of the Committee and 65,000 to each of the other members of the Committee. For work in the Remuneration Committee, the Nomination Committee proposes that, the remuneration shall be paid by SEK 100,000 to the Chairman of the Committee and 50,000 to each of the other members of the Committee. No extra compensation will be paid for taking part in other committees.

The Nomination Committee proposes that the remuneration for the auditors shall be paid in accordance with approved invoices.

Election of Board members and Chairman of the Board of Directors (item 12)

As members of the Board of Directors until the end of the next Annual General Meeting, the Nomination Committee proposes re-election of Kleanthis G. Xanthopoulos, Marios Fotiadis, Anita Tollstadius and Catherine Gilmore-Lawless. Eva Nilsagård has declined re-election.

The Nomination Committee also proposes election of Marios Fotiadis as the Chairman of the Board of Director.

Election of auditor (item 13)

The Nomination Committee proposes that the registered auditing company KPMG AB shall be re-elected as auditor for the period until the end of next Annual General Meeting. KPMG AB has informed that, if KPMG AB is re-elected as auditor, Stefan Lundberg will continue as the responsible auditor. The Nomination Committee’s proposal is recommended by the Company’s Audit Committee.

Proposals by the Board of Directors

Dividend (item 8)

The Board of Directors proposes that the Annual General Meeting shall resolve not to distribute any dividends for the financial year 2022.

Resolution on guidelines for remuneration to senior executives (item 14)

The Board of Directors proposes that the Annual General Meeting resolves that the following guidelines for remuneration and other terms of employment for senior executives shall apply until the 2027 Annual General Meeting, unless circumstances requiring a change occur. 

The guidelines apply to the CEO and other senior executives. Remuneration that is included in the guidelines shall include salary and other remuneration to senior executives. Remuneration is equated with transfers of securities and the concession of the right to acquire securities from the Company in the future. The guidelines do not apply to the Company’s incentive programs where senior executives in Company management retain the right to acquire shares in the Company in the future. To give an understanding of the Company’s total remuneration package, the salary and other remuneration to senior executives in Company management is provided in the Annual Report in Note 10.

The guidelines contribute to the Company’s business strategy, long-term interests and sustainability

The Company’s business strategy is to develop medical devices that create a new standard of care for haemorrhagic stroke and traumatic brain injuries. Management’s task is to commercialize these new innovative devices that are based on a unique technology and make IRRAS a globally acknowledged company. The goal of the remuneration package is to enable the Group to attract and retain qualified senior executives at a reasonable cost to the Company.

Different forms of remuneration

To retain and attract competent employees as senior executives in Company management, the remuneration must be competitive and based on prevailing market conditions. Remuneration consists of a fixed salary, variable remuneration and pension and other benefits. Beyond this, the Annual General Meeting can decide on long-term incentive programs such as share-based or share price-based incentive programs. The incentive program will contribute to long-term value growth.

In order to avoid encouraging the Company’s senior executives to take unnecessary risks, there must be a fundamental balance between fixed and variable remuneration. Each senior executive is to be offered a market level fixed salary based on the degree of difficulty of the work as well as the individual’s experience, responsibilities, qualifications and performance. In addition, each senior executive may, from time to time, be offered variable remuneration (bonuses) to be paid in cash. The variable remuneration is to be based on clear, predetermined, and measurable criteria and financial performance, and on business objectives that are defined in advance. Variable remuneration should also be used to promote the Company’s long-term value creation. Variable remuneration may not exceed 24 months’ fixed salary for the CEO and 9 months’ fixed salary for other senior executives in Company management.

The standard age of retirement is to be 65. Pension terms are to be in accordance with market practice and based on fee-based pension schemes. Other benefits that can be provided include a company car, health programs, health insurance, life insurance and memberships.

Termination of employment

The period of notice should normally be 6 months if the termination has been on the initiative of the Company and 6 months if the termination has been on the initiative of the senior executive in Company management. With reference to foreign senior executives, adjustments may be made to comply with local regulations and market conditions. Following a potential termination of the CEO, the sum of the total remuneration consisting of, but not limited to, salary, severance pay, bonus, or other benefits, shall not exceed 24 fixed monthly salaries. Correspondingly, the total remuneration for other Senior Executives shall not exceed 12 fixed monthly salaries.

Salary and terms of employment

In the preparation of these guidelines for remuneration to senior executives in Company management, salary and terms of employment for the Company’s employees have been observed by including information about the employee’s total remuneration. Additionally, the various components of the remuneration, the increase in remuneration and the rate of increase over time have been a part of the Remuneration Committee’s and the Board’s basis of decision when evaluating whether the guidelines for remuneration and the limitations set out herein are reasonable. In the remuneration report, which will be prepared and presented in conjunction with the 2024 Annual General Meeting, with respect to paid remuneration as well as remuneration in arrears covered by these guidelines, the development of the disparity between the remuneration for senior executives in Company management and remuneration for other employees will be reported.

The decision-making process to determine, review, and implement the guidelines

The Board of Directors has established a Remuneration Committee whose primary tasks are to make preparations for the Board of Directors’ decision to propose guidelines for remuneration for the CEO, evaluate variable remuneration for senior executives in Company management, and evaluate the application of guidelines for remuneration and provisions for key individuals, as resolved on by the Annual General Meeting. The Remuneration Committee shall also monitor and evaluate the application of the guidelines for the remuneration of senior executives in Company management, which the Annual General Meeting must resolve on by law, as well as the current remuneration structures and remuneration levels in the Company.

The Board of Directors shall prepare a proposal for new guidelines at least every fourth year and submit it to the Annual General Meeting for decision. The CEO and other senior executives in Company management do not participate in the Board of Directors’ processing of and resolutions regarding remuneration-related matters in so far as they are affected by such matters.

Derogation from the guidelines

The Board of Directors may temporarily resolve to derogate from the guidelines, in whole or in part, if, in a specific case, there is special cause for the derogation and the derogation is necessary to serve the Company’s long-term interests, including its sustainability or to ensure the Company’s financial viability.

Resolution on approval of remuneration report (item 15)

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).

Resolution to implement a long term incentive scheme (item 16)

The Board of Directors proposes that the Annual General Meeting resolves to introduce a multi-year incentive program ("Program 9"). This proposal is divided into three items:

  1. Terms of the Programs.
  2. Hedging regarding the Programs shall be implemented through a direct issue of Class C shares.
  3. Other matters related to the Programs.

A Terms of the Programs

A.1 Introduction

The Company currently has four active programs: program 1 (introduced 2016), program 6 (introduced 2020), program 7 (introduced 2021) and program 8 (introduced 2022). Full subscription of all programs would increase the total number of shares in the Company by 1.8 per cent. The Board of Directors proposes that the Annual General Meeting resolves to introduce Program 9 which is intended to be a multi-year program. 

A.2 Rationale

The Board wishes to introduce Program 9 to employees in order to provide incentives for employees to exert maximum effort for the success of the Company and any affiliate and provide means by which the employees may benefit from the increase in value of the Company’s share. In addition, Program 9 is introduced to make it easier for the Company to recruit new employees and to retain the Company’s key employees.

A.3 Other share-related incentive programs

Information about IRRAS’s current incentive programs is available in the annual report for the financial year 2022, note 2 and 10, and on the Company’s website, www.irras.com.

A.4 Basic terms of the Programs

Program 9 consists of employee stock options to be transferred to employees and consultants within the IRRAS Group (the “Employee Stock Options”). The Employee Stock Options entitles the holder to acquire shares in IRRAS in accordance with the following main conditions. Participants in the Group's option programs 1, 6 and 7, shall only be able to receive new Stock Options if previous stock options according to program 1, 6 and 7 are returned to the Company which accounts for for 0.4% of potential dilution if the programs are fully subscribed. Program 8 will not be affected. The Board proposes the swap since the price for acquiring shares in the programs is significantly higher than the market value of the shares and no longer constitutes an incentive for the participants.

  • The Employee Stock Options are granted free of charge to the participants no later than 36 months after the Annual General Meeting 2023 as the proposed Program 9 is intended to be a multi-year program that is proposed to cover the Company's needs for up to 36 months. Employee Stock Options that fall due according to the terms must be returned unless otherwise decided on the Boards discretion with the exceptions presented below and can be granted again within the framework of the mentioned 36-month period.
  • The Employee Stock Options shall vest one-third annually from the grant date.
  • The Employee Stock Options, after being vested in accordance with the above, can be exercised for acquisition of ordinary shares from the third anniversary of the grant date up until the seventh anniversary of the grant date (the “Exercise Period”).
  • Each Employee Stock Option granted entitles the holder to acquire one ordinary share in the Company at a strike price corresponding to 110 percent of the average of the volume-weighted share price of the Company’s share measured over ten trading days prior to the grant date.
  • The Employee Stock Options may not be transferred or pledged.
  • The Employee Stock Options may only be exercised if the holder is still employed by, or active as a consultant in, the Group or within a certain time after the last day of employment or the day on which the consulting assignment is terminated. For the avoidance of doubt, if a participant ceases to be an employee of any member of the Group for any of the reasons set out below, the Employee Stock Options will, unless the Board decides otherwise, be reduced pro rata to reflect acceleration of vesting. The Board may, however, decide that the Option should vest either immediately or on any other date not beyond the normal vesting period. The reasons are:
    • death;
    • ill-health, injury or disability, as established to the satisfaction of the Company;
    • retirement at normal retirement age;
    • early retirement with the written agreement of the participant’s employing company;
    • redundancy, at the discretion of the Company;
    • the Participant’s employing company ceasing to be under the control of the Company, or, as a result of a transfer of the undertaking in which the Participant works, transfer to a company which is neither under the control of the Company nor a Member of the Group; and
    • any other reason, if the Board so decides in any particular case.
  • In the event of a change of control of 50 per cent or more of the shares in the Company, asset sale of a substantial part of the business, liquidation, merger or any other such transaction materially affecting the Company, the Employee Stock Options shall be considered vested in their entirety.
  • The number of Employee Stock Options shall  be subject to recalculation as a result of a bonus issue, split, reversed split, rights issue and/or other similar measures.
  • The Employee Stock Options shall otherwise be subject to the terms set forth in the separate agreements with the participants and the detailed terms for the Programs designed by the Board of Directors.

A.5 Allocation

The right to receive Employee Stock Options shall apply to current and future employees and consultants.

The principle for allocation is that each participant is granted a yearly allocation as a percentage of the base salary. In preparation of the proposal, market practice for peer companies has been reviewed and based on such review, the proposal in Program 9 is that the allocation is limited to not more than 500 per cent for the CEO, not more than 200 per cent to members of global senior management and not more than 100 per cent for other employees and consultants, of the yearly base salary. In addition, newly employed and consultants may be awarded an allocation of up to 1.5 times the yearly allocation for newly employed and new consultants.

The number of Employee Stock Options under the Programs, including any options outstanding according to previous incentive programs, shall be limited in such way that the options at full dilution at any given time shall not exceed a dilution of 10 per cent of the total number of shares in the Company calculated on a fully diluted basis.

A.6 Implementation and administration and the right to amend the terms of the Employee Stock Options etc.

The Board of Directors is responsible for preparing the detailed terms and conditions of Program 9, in accordance with the above-mentioned terms and guidelines. To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for IRRAS based on foreign tax regulations. The Board of Directors may also make other adjustments if significant changes in IRRAS or its environment would result in a situation where the adopted terms and conditions of Program 9 no longer serve their purpose.

The intention is that the Board of Directors shall launch Program 9 as soon as practically possible after the Annual General Meeting. The Board will administer Program 9, but the Board may delegate all or part of the administration of the Program 9 to one or more committees or external service providers.

B. Hedge of the Programs via issuance of Class C shares

B.1 Resolution to authorise the Board to issue redeemable and convertible Class C shares

The Board shall be authorised to resolve on the directed issue of Class C shares on the following terms and conditions:

  1. The maximum number of Class C-shares to be issued are 88,312,600, corresponding to a dilution of approximately 10 percent of the number of shares and votes in the Company.
  2. With a deviation from the shareholders’ preferential rights, the new shares may only be subscribed for by one external party after arrangement in advance.
  3. The amount to be paid for each new share (the subscription price) shall equal the share’s quota value at the time of subscription.
  4. The authorisation may be exercised on one or several occasions until the Annual General Meeting 2024.
  5. The new Class C shares shall be subject to Chapter 4, Section 6 of the Swedish Companies Act (conversion restriction) and Chapter 20, Section 31 of the Swedish Companies Act (redemption restriction).

The purpose of the authorisation is to hedge the undertakings of the company according to all of the Company’s outstanding incentive programs, including the Programs.

B.2 Resolution to authorise the Board to decide on repurchase of Class C shares

The Board shall be authorised to decide on the repurchase of Class C shares in the Company on the following terms:

  1. Repurchase may be made through an acquisition offer addressed to all owners of Class C shares in the Company.
  2. The number of Class C shares that may be repurchased may not exceed 88,312,600 shares.
  3. Repurchases shall be made at a cash price per share corresponding to the quota value applicable at the time of repurchase.
  4. The Board shall have the right to determine remaining conditions for the repurchase.
  5. It shall be possible to repurchase so-called interim shares regarding Class C shares, from Euroclear Sweden AB designated Paid Subscribed Shares (BTAs).
  6. The authorisation may be exercised on one or more occasions until the Annual General Meeting 2024.

The purpose of the authorisation is to secure the Company’s commitments in accordance with all of the Company’s outstanding incentive programs, including the Programs.

B.3 Resolution on transfer of ordinary shares

The Annual General Meeting is proposed to decide on the transfer of ordinary shares to participants in all of the Company’s at each time outstanding incentive programs, including the Programs, on the following terms and conditions.

  1. Ordinary shares may be transferred to the participants.
  2. The terms for these transfers, the number of shares in each transaction and the time of the transactions shall follow the terms of each outstanding incentive program at each time, including the Programs.
  3. The number of ordinary shares that may be transferred within each incentive program may be subject to customary recalculations as a result of cash dividends, bonus issue, split, rights issue and/or similar events.

C. Other matters in relation to the Programs

C.1 Costs

Costs related to the Employee Stock Options will be accounted for in accordance with IFRS 2 which stipulates that the Employee Stock Options should be recorded as personnel expense in the income statement during the vesting period. A preliminary calculation, using a volatility of 77 percent, indicates an option value of approximately SEK 0.06 per employee stock option. Under the assumption of a share price of SEK 0.126 at the start of the Program, a share price at the end of the three year period of SEK 0.252 (corresponding to a total share price increase of 100 percent during the vesting period), the total cost for the Employee Stock Options amount to MSEK 5.7 which corresponds to an annual cost of about MSEK 1.9 before tax, provided that earnings take place over a 3-year period.

C.2 Effect on important key ratios

The annual costs for Programs are calculated to amount to approximately 4.7 percent of IRRAS’s revenues for the financial year 2022 and approximately 2.0 percent of IRRAS’s salary costs for the financial year 2022.

C.3 Adjustment authorisation

The Board, or a person appointed by the Board, shall be authorised to make any minor adjustments to the above resolutions that may be necessary in connection with the registration with the Swedish Companies Registration Office and Euroclear Sweden AB respectively.

C.4 Preparation of the proposal

The basis for the Programs has been prepared by the Board of Directors of the Company. The work has been supported by external advisors and has been made in consultation with shareholders. The Board has thereafter decided to present this proposal for the Annual General Meeting. Except for the staff that have prepared the matter upon instruction from the Board, no employee that may be a participant of the Programs has participated in the preparations of the program’s terms.

C.5 Majority requirements

The resolution by the Annual General Meeting regarding the implementation of the Programs according to item A above shall be conditional on the Annual General Meeting resolving in accordance with the Board’s proposal under item B above.

The resolution according to item A above shall require a majority of more than half of the votes cast at the Meeting. A valid resolution under item B above requires that shareholders representing not less than nine-tenths of the votes cast as well as the shares represented at the Meeting approve the resolution.

Resolution on a reverse share split (item 17)

The Board of Directors proposes that the Annual General Meeting resolves on a reverse share split 1:100, whereby one hundred (100) existing shares becoming one (1) share. The resolution by the Annual General Meeting regarding the reverse share split is conditional upon the registration of the proposed amendments of the Articles of Association in accordance with item 18 below with the Swedish Companies Registration Office.

The resolution to implement a reverse share split shall furthermore be conditional upon the acceptance of Bacara Holdings Limited, one of the largest shareholder of the Company, to transfer shares for no consideration to shareholders of the Company whose number of shares is not evenly divided by 100. Bacara Holdings Limited has also undertaken to round down its remaining shareholding in the Company to the nearest number evenly divided by 100.

The Board of Directors proposes that the Board of Directors shall be authorised to determine the record date for the reverse share split. Further information regarding the reverse share split, including the record date and details regarding the trading of the IRRAS share on Nasdaq Stockholm, will be announced as soon as the Board of Directors has resolved on the record date for the reverse split.

The Board of Directors as well as the CEO shall be authorised to make such minor adjustments to the decision that may prove necessary for registration of the decision with the Swedish Companies Registration Office. For a valid resolution in accordance with this item, it is required that the resolution is supported by shareholders who represent at least two thirds of both the votes cast and the shares represented at the Meeting.

Resolution on an amendment of the articles of association (item 18)

The Board of Directors proposes that the Annual General Meeting resolves to amend the Articles of Association in accordance with the following:         

Current wording: Proposed wording
§ 4 Share Capital The share capital of the company shall amount to not less than SEK 15,000,000 and not more than SEK 60,000,000. § 4 Share Capital The share capital of the company shall amount to not less than SEK 20,000,000 and not more than SEK 80,000,000.
§ 5 Number of shares and class of shares The number of shares in the company shall be not less than 500,000,000 and not more than 2,000,000,000 shares. § 5 Number of shares and class of sharesThe number of shares in the company shall be not less than 7,000,000 and not more than 28,000,000 shares.

The resolution shall be conditional on the Annual General Meeting approving the Board's decision on a reverse share split in accordance with item 17 above.

The Board of Directors as well as the CEO shall be authorised to make such minor adjustments to the decision that may prove necessary for registration of the decision with the Swedish Companies Registration Office. For a valid resolution in accordance with this item, it is required that the resolution is supported by shareholders who represent at least two thirds of both the votes cast and the shares represented at the Meeting.

Resolution in respect of authorisation for the Board of Directors to resolve to issue shares, warrants and/or convertible bonds (item 19)

The Board of Directors proposes that the Annual General Meeting authorises the Board of Directors to, on one or several occasions during the period until the next Annual General Meeting, with or without deviation from the shareholders’ preferential rights, resolve on share issues, issues of warrants and/or issues of convertible bonds.

The purpose of the authorisation and the reason for the deviation from the shareholders’ preferential rights, if any, is to enable the Company to carry out issues in a time-efficient way to finance acquisitions or investments in new or existing businesses. The issuance of shares, warrants and/or convertible bonds under the authorisation shall, in case of deviation from the shareholders’ preferential rights, be made at a subscription price according to the prevailing market conditions at the time of the issuance of the shares, warrants and/or convertible bonds. Payment for subscribed shares, warrants and/or convertible bonds shall be made in cash, in kind or by way of set-off.

A valid resolution by the General Meeting pursuant to the proposal above requires that the resolution be supported by shareholders representing at least two-thirds of both the votes cast and the shares represented at the General Meeting.

The shareholders’ right to submit questions

The shareholders are reminded of their right, in accordance with Chapter 7 Section 32 of the Swedish Companies Act, to request information from the Board and the CEO at the Meeting.

Other information

As per 31 May 2023 the total number of shares and votes in the Company amounts to 794,813,400. 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 May 2023

The Board of Directors

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

The information was released for public disclosure, through the agency of the contact person above, on June 1, 2023, at 09:00 (CET).

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

IRRAS AB publishes Interim Report for the period January to March 2023

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

Q1 Report 2023 – invitation to conference call and audiocast

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 publishes Annual Report for 2022

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

IRRAS Secures Short-term Financing Agreement of MSEK 40

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

IRRAS AB publishes Year End Report for the period January to December 2022

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

IRRAflow System Confirmed to More Effectively Remove Collected Blood and Reduce Catheter Infection Rates than Passive Drainage in Head-to-Head Analysis

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).

[1] Rauhala M, Luoto TM, Huhtala H, Iverson GL, Niskakangas T, Öhman J, Helén P. The incidence of chronic subdural hematomas from 1990 to 2015 in a defined Finnish population. J Neurosurg. 2019 Mar 22:1-11. doi: 10.3171/2018.12.JNS183035. [Epub ahead of print] PubMed PMID: 30901751.

[2] Yang W, Huang J. Chronic Subdural Hematoma: Epidemiology and Natural History. Neurosurg Clin N Am. 2017 Apr;28(2):205-210. doi: 10.1016/j.nec.2016.11.002. Epub 2017 Feb 1. Review. PubMed PMID: 28325454

[3] Balser D, Farooq S, Mehmood T, Reyes M, Samadani U. Actual and projected incidence rates for chronic subdural hematomas in United States Veterans Administration and civilian populations. J Neurosurg. 2015 Mar 20:1-7. [Epub ahead of print] PubMed PMID: 25794342; PubMed Central PMCID: PMC4575892.

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