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EIC has Subscribed for 600,000 Shares in the Directed Share Issue Resolved by the Board of Directors of Realheart on 27 April 2025

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, UNITED STATES OR ANY OTHER JURISDICTION IN WHICH THE PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL, BE SUBJECT TO LEGAL RESTRICTIONS OR WOULD REQUIRE REGISTRATION OR OTHER ACTIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY SECURITIES IN SCANDINAVIAN REAL HEART AB (PUBL). SEE ALSO THE SECTION “IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE.

Scandinavian Real Heart AB (publ) ("Realheart" or the "Company") hereby announces an update regarding the directed share issue resolved by the Board of Directors on 27 March 2025 (the "Directed Share Issue"). As previously communicated, the European Investment Council ("EIC") required a certain period to make an investment decision regarding potential participation in the Directed Share Issue in accordance with its regulations and internal processes. EIC has now subscribed for 600,000 shares in the Directed Share Issue. The subscription price in the Directed Share Issue amounts to SEK 11.13 per share. Consequently, the Company will be provided with SEK 6,678,000.

As previously communicated, EIC's subscription in the Directed Share Issue is conditional upon the Inspectorate of Strategic Products (Sw. Inspektionen för strategiska produkter) leaving the notifications regarding the Directed Share Issue pursuant to the Screening of Foreign Direct Investments Act (Sw. lagen (2023:560) om granskning av utländska direktinvesteringar) without action or approving the notifications after review.

As a result of EIC's decision to participate in the Directed Share Issue, the Company's share capital will increase by SEK 3,006,000, from SEK 22,037,507.04 to SEK 25,043,507.04, through the issuance of an additional 600,000 shares. This means that the total number of shares will increase from 4,398,704 shares to 4,998,704 shares. EIC's subscription of shares in the Directed Share Issue will result in a dilution of approximately 12.0 percent of the capital and votes for existing shareholders, based on the total number of shares and votes in the Company after the Directed Share Issue.

Advisers

Setterwalls Advokatbyrå AB acts as legal advisor to the Company in connection with the Directed Share Issue.

Important Information

This announcement is not for publication, release or distribution, in whole or in part, directly or indirectly, in or into the United States of America (including its territories and possessions, any State of the United States and the District of Columbia), United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other jurisdiction in which publication, release or distribution would be unlawful. This announcement is for information purposes only and does not constitute an offer to sell or issue, or the solicitation of an offer to buy, acquire or subscribe for shares in the capital of the Company in the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other state or jurisdiction in which such offer or solicitation is not authorised or to any person to whom it is unlawful to make such offer or solicitation. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions.

This announcement is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorized any offer to the public of shares or other securities in any member state of the EEA and no prospectus has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”), who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933 (the “Securities Act”) or with any securities regulatory authority of any state or other jurisdiction of the United States and may not be offered, sold or transferred, directly or indirectly, in or into the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. No public offering of the Directed Share Issue is being made in the United States, Sweden or elsewhere.

This announcement has been issued by, and is the sole responsibility of, the Company.

The distribution of this announcement and the offering of the securities referred to herein in certain jurisdictions may be restricted by law. No action has been taken by the Company or any of its respective affiliates that would, or which is intended to, permit an offering of the securities in any jurisdiction or result in the possession or distribution of this announcement or any other offering or publicity material relating to the securities in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required by the Company to inform themselves about, and to observe, such restrictions.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the Directed Share Issue. Any investment decision to buy shares in the Directed Share Issue must be made solely on the basis of publicly available information.

This announcement does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any securities in any jurisdiction. This announcement does not constitute a recommendation concerning any investor’s option with respect to the Directed Share Issue. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

This announcement contains (or may contain) certain forward-looking statements with respect to certain of the Company's current expectations and projections about future events. These statements, which sometimes use words such as “aim”, “anticipate”, “believe”, “intend”, “plan”, “estimate”, “expect” and words of similar meaning, reflect the directors' beliefs and expectations and involve a number of risks, uncertainties and assumptions which could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement. Statements contained in this announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. The information contained in this announcement is subject to change without notice and, except as required by applicable law or the Nasdaq First North Growth Market Rulebook for Issuers of shares, the Company does not assume any responsibility or obligation to update publicly or review any of the forward-looking statements contained in it and nor do they intend to. You should not place undue reliance on forward-looking statements, which speak only as of the date of this announcement. No statement in this announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial years will necessarily match or exceed the historical or published earnings of the Company. As a result of these risks, uncertainties and assumptions, the recipient should not place undue reliance on these forward-looking statements as a prediction of actual results or otherwise.

Realheart Receives Patent Approval in Japan

Västerås, Sweden, April 29, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has been granted a patent approval by the Japan Patent Office (JPO) concerning a pressure sensor device for artificial hearts and circulatory support systems such as Realheart® TAH. The patent is a supportive measure to ensure market protection of the company’s device on the Japanese market and is valid until 2041.

Realheart develops Realheart® TAH, the world’s first total artificial heart mimicking the shape, function, and blood flow pattern of the human heart. The patent (JP7656624B2) covers a pressure sensor with a biocompatible housing with integrated pressure-sensitive components used in the device. The sensor is designed to ensure accurate and safe pressure measurements in medical environments. By enabling real-time monitoring, the sensor supports automated control of artificial hearts and circulatory support systems, such as Realheart® TAH, contributes to optimized blood flow and has a potential positive effect on treatment outcomes. The design is engineered for integration into advanced medical systems, particularly within the field of artificial hearts and circulatory support.

The granted patent confers protection for the device in Japan until 2041.

Scandianvian Real Heart AB Announces Outcome of Exercise of Warrants of Series TO 3

NOT FOR RELEASE, DISTRIBUTION OR PUBLICATION, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA OR ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE ADDITIONAL REGISTRATION OR OTHER MEASURES.

Scandinavian Real Heart AB (publ) (“Realheart” or the “Company”) today announces the outcome of the subscription period for the warrants of series TO 3 (“Warrants”) issued in connection with the rights issue of units carried out by the Company during the period June 12, 2024 – July 5, 2024. In total, 31,998,400 Warrants were exercised for subscription of 159,992 shares, corresponding to a subscription rate of approximately 58 percent of the total 54,910,406 issued Warrants. Through the exercise, Realheart will receive approximately SEK 2.1 million before issue costs.

Overview of the Final Outcome
The exercise period for the Warrants ran from March 3, 2025 to March 31, 2025. The final outcome shows that 159,992 shares were subscribed for through the exercise of Warrants, corresponding to an exercise rate of approximately 58 percent. The subscription price for one share subscribed for through the exercise of the Warrants was SEK 12.98, which, in accordance with the terms of the Warrants, corresponds to 70 percent of the volume weighted average price (VWAP) of the Company's share on Nasdaq First North Growth Market during the measurement period. Through the exercise, Realheart will receive approximately SEK 2.1 million before issue costs.

Shares and Share Capital
By exercising the Warrants, the total number of shares in Realheart increases by 159,992, resulting in the total number of outstanding shares in the Company increasing from 2,153,330 to 2,313,322. The share capital of the Company increases by SEK 801,559.92 from SEK 10,788,183.30 to SEK 11,589,743.22, in accordance with the terms of the issue. For existing shareholders who have not exercised any Warrants, the dilution amounts to approximately 7 percent of the total number of shares and votes in the Company after the exercise of the Warrants.

Exercised Warrants are replaced with interim shares until registration with the Swedish Companies Registration Office, after which the interim shares are automatically converted into ordinary shares. The interim shares are expected to be converted into shares approximately two banking days after registration with the Swedish Companies Registration Office.

IMPORTANT INFORMATION
The information in this press release may not be announced, published or distributed, directly or indirectly, within or into the United States, Australia, Belarus, Canada, Hong Kong, Japan, New Zealand, Russia, Singapore, South Africa, South Korea, Switzerland or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require measures other than those required by Swedish law. Any action in contravention of this announcement may constitute a violation of applicable securities laws. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in Realheart in any jurisdiction, neither from Realheart nor from anyone else.

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction.

This press release does not identify or purport to identify any risks (direct or indirect) that may be associated with an investment in the Company. The information contained in this press release is for the purpose of describing the background to the exercise of the Warrants only and does not purport to be complete or exhaustive. No representation is made as to the accuracy or completeness of the information contained in this announcement.

This press release does not constitute an offer or invitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an applicable exemption from registration under the U.S. Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of such securities in the United States.

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

Realheart Has Resolved on a Directed Share Issue of a Maximum of 2,881,115 Shares Which Will Provide the Company With Approximately SEK 32.6 Million Upon Full Subscription

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO AUSTRALIA, CANADA, HONG KONG, JAPAN, NEW ZEALAND, SINGAPORE, SOUTH AFRICA, UNITED STATES OR ANY OTHER JURISDICTION IN WHICH THE PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL, BE SUBJECT TO LEGAL RESTRICTIONS OR WOULD REQUIRE REGISTRATION OR OTHER ACTIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER TO BUY SECURITIES IN SCANDINAVIAN REAL HEART AB (PUBL). SEE ALSO THE SECTION “IMPORTANT INFORMATION” AT THE END OF THIS PRESS RELEASE.

Scandinavian Real Heart AB (publ) (”Realheart” or the ”Company”) has today, based on an authorisation from the annual general meeting 2024, resolved to carry out a directed share issue of a maximum of 2,881,115 shares at a subscription price of SEK 11.31 per share (the “Directed Share Issue”). The investors in the Directed Share Issue comprise a limited number of qualified and other professional investors, including both new and existing shareholders, among others Claes Mellgren and Per Olof Andersson. The Company has received subscription for 2,085,382 shares, which means that the Company will receive approximately SEK 23.6 million before deduction of transaction costs. Furthermore, the existing shareholder, the European Investment Council (“EIC”), shall, in accordance with the Board of Directors’ issue resolution, have the opportunity to decide on participation in the Directed Share Issue with subscription of a maximum of 795,733 shares which, upon full subscription, will provide the Company with approximately SEK 9.0 million.

The Directed Share Issue

The Board of Directors has, based on the issue authorisation granted by the Annual General Meeting on 7 June 2024, resolved on a directed share issue of a maximum of 2,881,115 shares at a subscription price of SEK 11.31 per share. The Company has received subscription for 2,085,382 shares, which means that the Company will receive approximately SEK 23.6 million before deduction of transaction costs. The investors in the Directed Share Issue comprise the existing shareholders Claes Mellgren, Christer Jönsson, Objective Point Sweden AB and Abbe Dikmen as well as the new shareholders Per Olof Andersson and Vellenova AB. Furthermore, the existing shareholder EIC, shall, in accordance with the Board of Directors’ issue resolution, have the opportunity to decide on participation in the Directed New Share Issue with subscription of a maximum of 795,733 shares which, upon full subscription, will provide the Company with approximately SEK 9.0 million. The reason for including certain existing shareholders among those entitled to subscribe is that these shareholders have expressed and demonstrated an interest in long-term ownership in the Company. The board believes this creates security, stability, and favorable conditions for the Company's development, which is deemed to be beneficial for both the Company and all its shareholders. Additionally, through Claes Mellgren and Per Olov Andersson, the Company is strengthened by two new principal owners with experience in building AQ Group AB into one of Scandinavia’s leading industrial companies.

The subscription price in the Directed Share Issue has been determined through arm’s length negotiations between the subscribers and the Company. The subscription price represents a discount of approximately 20 percent in relation to the average volume-weighted price for the Company’s share on Nasdaq First North Growth Market during the period from March 14 to March 27, 2025 (the last ten trading days prior to the announcement of the Directed Share Issue). The Board of Directors therefore assesses that the subscription price has been determined in such a manner that market fairness has been ensured and that the subscription price reflects prevailing market conditions and demand.

According to the issue made by the Board of Directors, EIC shall have the opportunity to subscribe for a maximum of 795,733 shares in the Directed Share Issue which, upon full subscription, will provide the Company with approximately SEK 9.0 million. However, EIC requires a certain period of time to make an investment decision in accordance with its regulations and internal processes. With respect to the shares that may potentially be subscribed for by EIC depending on EIC's decision to participate in the Directed Share Issue or not, subscription and payment must be completed no later than April 24, 2025.

Subscription by the Directed Share Issue is conditional upon the Inspectorate of Strategic Products leaving the notifications regarding the Directed Share Issue pursuant to the Screening of Foreign Direct Investments Act (Sw. lagen (2023:560) om granskning av utländska direktinvesteringar) without action or approving the notifications after review.

Through the Directed Share Issue, the Company’s share capital will increase by SEK 10,447,763.82, from SEK 10,788,183.30 to SEK 21,235,947.12, by new issue of 2,085,382 shares, resulting in the total number of shares increasing from 2,153,330 shares to 4,238,712 shares. The Directed Share Issue results in a dilution of approximately 49.2 percent of the capital and votes for existing shareholders based on the total number of shares and votes in the Company after the Directed Share Issue.

If EIC decides to participate in the Directed Share Issue, the Company's share capital will increase by an additional SEK 3,986,622.33, from SEK 21,235,947.12 to SEK 25,222,569.45, through the issuance of an additional 795,733 shares. Consequently, the total number of shares will increase from 4,238,712 shares to 5,034,445 shares. In such a case, the Directed Share Issue will result in a total dilution of approximately 57.2 percent of the capital and votes for existing shareholders, based on the total number of shares and votes in the Company after the Directed Share Issue. However, as described above, EIC has not made any investment decision regarding participation in the Directed Share Issue.

Background and Reasons

Realheart is developing a complete artificial heart (Total Artificial Heart – TAH) for implantation in patients suffering from life-threatening heart failure. The Company's TAH features a patented design that incorporates a four-chamber system (two atria, two ventricles) to generate a physiologically adapted blood flow that mimics the body's natural circulation.

Realheart has conducted several animal studies as part of the preclinical program, which will form the basis for the first clinical study in humans. The results indicate that the Realheart® TAH provides good heart function and a low level of harmful blood impact, while the survival time of the implanted animals exceeded previous attempts. Overall, the results support the potential of the Realheart® TAH to replace the human heart in the future. Parallel blood studies also show that the Realheart® TAH induces approximately 80 percent less blood damage (hemolysis) compared to the market leader's artificial heart.

Realheart is also focused on strengthening collaboration with strategic national and international suppliers and partners to ensure the development and production of the TAH. To finance the preclinical studies and ensure successful outcomes ahead of clinical trials, the Company now intends to carry out the Directed Share Issue.

The net proceeds from the Directed Share Issue are intended to be used for further preclinical studies, development, production and regulatory work, and corporate costs.

Deviation From the Shareholders’ Pre-emptive Rights

The board of directors has made an overall assessment and carefully considered the possibility to raise capital through a rights issue with preferential right for the Company’s existing shareholders. The board of directors considers that the reasons for deviating from the shareholders’ preferential right are: (i) that a rights issue would take a significantly longer time to complete and entail a higher risk for an adverse effect on the share price, particularly in light of the current market volatility and the challenging market conditions, (ii) to carry out a directed share issue can be made at lower costs and with less complexity than a rights issue, and (iii) with background of the current market conditions and as the rights issues carried out by the Company in recent years have not been fully subscribed, the board of directors has assessed that a rights issue would also require external underwriting from a guarantor syndicate that would entail additional significant costs. Considering the above, the board of directors has made the assessment that a directed share issue with deviation from the shareholders’ preferential right is the most favourable alternative for the Company to finance its operations, create value for the Company and is in the best interest of the Company’s shareholders. The board of directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.

Advisers

Setterwalls Advokatbyrå AB acts as legal advisor to the Company in connection with the Directed Share Issue.

Important Information

This announcement is not for publication, release or distribution, in whole or in part, directly or indirectly, in or into the United States of America (including its territories and possessions, any State of the United States and the District of Columbia), United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other jurisdiction in which publication, release or distribution would be unlawful. This announcement is for information purposes only and does not constitute an offer to sell or issue, or the solicitation of an offer to buy, acquire or subscribe for shares in the capital of the Company in the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other state or jurisdiction in which such offer or solicitation is not authorised or to any person to whom it is unlawful to make such offer or solicitation. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions.

This announcement is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorized any offer to the public of shares or other securities in any member state of the EEA and no prospectus has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”), who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933 (the “Securities Act”) or with any securities regulatory authority of any state or other jurisdiction of the United States and may not be offered, sold or transferred, directly or indirectly, in or into the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. No public offering of the Directed Share Issue is being made in the United States, Sweden or elsewhere.

This announcement has been issued by, and is the sole responsibility of, the Company.

The distribution of this announcement and the offering of the securities referred to herein in certain jurisdictions may be restricted by law. No action has been taken by the Company or any of its respective affiliates that would, or which is intended to, permit an offering of the securities in any jurisdiction or result in the possession or distribution of this announcement or any other offering or publicity material relating to the securities in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required by the Company to inform themselves about, and to observe, such restrictions.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the Directed Share Issue. Any investment decision to buy shares in the Directed Share Issue must be made solely on the basis of publicly available information.

This announcement does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any securities in any jurisdiction. This announcement does not constitute a recommendation concerning any investor’s option with respect to the Directed Share Issue. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

This announcement contains (or may contain) certain forward-looking statements with respect to certain of the Company's current expectations and projections about future events. These statements, which sometimes use words such as “aim”, “anticipate”, “believe”, “intend”, “plan”, “estimate”, “expect” and words of similar meaning, reflect the directors' beliefs and expectations and involve a number of risks, uncertainties and assumptions which could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement. Statements contained in this announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. The information contained in this announcement is subject to change without notice and, except as required by applicable law or the Nasdaq First North Growth Market Rulebook for Issuers of shares, the Company does not assume any responsibility or obligation to update publicly or review any of the forward-looking statements contained in it and nor do they intend to. You should not place undue reliance on forward-looking statements, which speak only as of the date of this announcement. No statement in this announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial years will necessarily match or exceed the historical or published earnings of the Company. As a result of these risks, uncertainties and assumptions, the recipient should not place undue reliance on these forward-looking statements as a prediction of actual results or otherwise.

Realheart Announces Intention to Carry out a Directed Share Issue of up to Approximately SEK 32 Million

Scandinavian Real Heart AB (publ) (”Realheart” or the ”Company”) hereby announces its intention to carry out a directed share issue, of up to approximately SEK 32 million, to a limited number of qualified and other professional investors (the “Directed Share Issue”).

The Directed Share Issue

The share issue is intended to be carried out with deviation from the shareholders’ pre-emptive rights and is resolved upon by the Board of Directors, pursuant to the authorisation granted by the annual general meeting on 7 June 2024. The Company may at any time shorten, extend or terminate, and wholly or partially refrain from carrying out the Directed Share Issue. The Company will announce the outcome of the Directed Share Issue through a press release after the negotiations with the subscribers have been completed.

Background and Reasons

Realheart is developing a complete artificial heart (Total Artificial Heart – TAH) for implantation in patients suffering from life-threatening heart failure. The Company's TAH features a patented design that incorporates a four-chamber system (two atria, two ventricles) to generate a physiologically adapted blood flow that mimics the body's natural circulation.

Realheart has conducted several animal studies as part of the preclinical program, which will form the basis for the first clinical study in humans. The results indicate that the Realheart® TAH provides good heart function and a low level of harmful blood impact, while the survival time of the implanted animals exceeded previous attempts. Overall, the results support the potential of the Realheart® TAH to replace the human heart in the future. Parallel blood studies also show that the Realheart® TAH induces approximately 80 percent less blood damage (hemolysis) compared to the market leader's artificial heart.

Realheart is also focused on strengthening collaboration with strategic national and international suppliers and partners to ensure the development and production of the TAH. To finance the preclinical studies and ensure successful outcomes ahead of clinical trials, the Company now intends to carry out the Directed Share Issue.

The net proceeds from the Directed Share Issue are intended to be used for further preclinical studies, development, production and regulatory work, and corporate costs.

Deviation From the Shareholders’ Pre-emptive Rights

The Board of Directors has made an overall assessment and carefully considered the possibility to raise capital through a rights issue with preferential right for the Company’s existing shareholders. The Board of Directors considers that the reasons for deviating from the shareholders’ preferential right are: (i) that a rights issue would take a significantly longer time to complete and entail a higher risk for an adverse effect on the share price, particularly in light of the current market volatility and the challenging market conditions, (ii) to carry out a directed share issue can be made at lower costs and with less complexity than a rights issue, and (iii) with background of the current market conditions and as the rights issues carried out by the Company in recent years have not been fully subscribed, the Board of Directors has assessed that a rights issue would also require external underwriting from a guarantor syndicate that would entail additional significant costs. Considering the above, the Board of Directors has made the assessment that a directed share issue with deviation from the shareholders’ preferential right is the most favourable alternative for the Company to finance its operations, create value for the Company and is in the best interest of the Company’s shareholders. The Board of Directors thus considers that the reasons outweigh the main rule that new share issues are to be carried out with preferential rights for the shareholders.

Advisers

Setterwalls Advokatbyrå AB acts as legal advisor to the Company in connection with the Directed Share Issue.

Important information

This announcement is not for publication, release or distribution, in whole or in part, directly or indirectly, in or into the United States of America (including its territories and possessions, any State of the United States and the District of Columbia), United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other jurisdiction in which publication, release or distribution would be unlawful. This announcement is for information purposes only and does not constitute an offer to sell or issue, or the solicitation of an offer to buy, acquire or subscribe for shares in the capital of the Company in the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Singapore, South Africa or any other state or jurisdiction in which such offer or solicitation is not authorised or to any person to whom it is unlawful to make such offer or solicitation. Any failure to comply with these restrictions may constitute a violation of the securities laws of such jurisdictions.

This announcement is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorized any offer to the public of shares or other securities in any member state of the EEA and no prospectus has been or will be prepared in connection with the Directed Share Issue. In any EEA Member State, this communication is only addressed to and is only directed at qualified investors in that Member State within the meaning of the Prospectus Regulation.

In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” (within the meaning of the Prospectus Regulation as it forms part of domestic law in the United Kingdom by virtue of the European Union (Withdrawal) Act 2018 (the “UK Prospectus Regulation”), who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it.

The securities referred to herein have not been and will not be registered under the U.S. Securities Act of 1933 (the “Securities Act”) or with any securities regulatory authority of any state or other jurisdiction of the United States and may not be offered, sold or transferred, directly or indirectly, in or into the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in compliance with any applicable securities laws of any state or other jurisdiction of the United States. No public offering of the Directed Share Issue is being made in the United States, Sweden or elsewhere.

This announcement has been issued by, and is the sole responsibility of, the Company.

The distribution of this announcement and the offering of the securities referred to herein in certain jurisdictions may be restricted by law. No action has been taken by the Company or any of its respective affiliates that would, or which is intended to, permit an offering of the securities in any jurisdiction or result in the possession or distribution of this announcement or any other offering or publicity material relating to the securities in any jurisdiction where action for that purpose is required. Persons into whose possession this announcement comes are required by the Company to inform themselves about, and to observe, such restrictions.

This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the Directed Share Issue. Any investment decision to buy shares in the Directed Share Issue must be made solely on the basis of publicly available information.

This announcement does not constitute an invitation to underwrite, subscribe for or otherwise acquire or dispose of any securities in any jurisdiction. This announcement does not constitute a recommendation concerning any investor’s option with respect to the Directed Share Issue. Each investor or prospective investor should conduct his, her or its own investigation, analysis and evaluation of the business and data described in this announcement and publicly available information. The price and value of securities can go down as well as up. Past performance is not a guide to future performance.

This announcement contains (or may contain) certain forward-looking statements with respect to certain of the Company's current expectations and projections about future events. These statements, which sometimes use words such as “aim”, “anticipate”, “believe”, “intend”, “plan”, “estimate”, “expect” and words of similar meaning, reflect the directors' beliefs and expectations and involve a number of risks, uncertainties and assumptions which could cause actual results and performance to differ materially from any expected future results or performance expressed or implied by the forward-looking statement. Statements contained in this announcement regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. The information contained in this announcement is subject to change without notice and, except as required by applicable law or the Nasdaq First North Growth Market Rulebook for Issuers of shares, the Company does not assume any responsibility or obligation to update publicly or review any of the forward-looking statements contained in it and nor do they intend to. You should not place undue reliance on forward-looking statements, which speak only as of the date of this announcement. No statement in this announcement is or is intended to be a profit forecast or profit estimate or to imply that the earnings of the Company for the current or future financial years will necessarily match or exceed the historical or published earnings of the Company. As a result of these risks, uncertainties and assumptions, the recipient should not place undue reliance on these forward-looking statements as a prediction of actual results or otherwise.

Subscription Price Determined for the Exercise of Series TO3 Warrants in Scandinavian Real Heart AB

Scandinavian Real Heart AB ("Realheart" or the "Company") hereby announces that the subscription price for the exercise of Series TO3 warrants (the "Warrants") has been set at SEK 12.98. The exercise period for the Warrants commences on March 3, 2025, and ends on March 31, 2025. The last day for trading in the Warrants is March 27, 2025.

During the period from June 12, 2024, to July 5, 2024, Realheart conducted a rights issue of units (the "Rights Issue"). Each unit issued in the Rights Issue consisted of two (2) shares and one (1) Series TO3 Warrant. Two (2) Series TO3 Warrants entitle the holder to subscribe for one (1) new share in the Company.

At an extraordinary general meeting on November 5, 2024, a reverse share split was resolved in the ratio of 1:100, meaning that one hundred (100) existing shares were consolidated into one (1) share. In connection with this, the subscription price and the number of shares that each Series TO3 Warrant entitles its holder to subscribe for were adjusted, in accordance with the terms, to neutralize the effect of the reverse share split. After the adjustment, two hundred (200) Series TO3 Warrants are required to subscribe for one (1) new share in the Company.

The reverse share split does not affect the total number of outstanding Warrants or their ISIN code (SE0022240214). Other terms of the Warrants, such as the subscription period, remain unchanged.

Following the recalculation, one (1) Series TO3 Warrant entitles the holder to subscribe for 0.005 shares (previously 0.5 shares). Since the subscription of fractional shares is not possible, two hundred (200) Warrants are now required to subscribe for one (1) new share in the Company.

If all Series TO3 Warrants are exercised in full, Realheart will receive approximately SEK 3.6 million before issuance costs.

The subscription price for the Series TO3 Warrants has been determined at 70 percent of the volume-weighted average price of the Company’s shares on Nasdaq First North Growth Market during the period from February 17 to February 28, 2025, i.e., during the ten trading days immediately preceding the start of the subscription period. 70 percent of the volume-weighted average price during the measurement period amounted to SEK 12.98.

Summary of Instructions and Key Dates
Holders of Warrants who wish to exercise them to subscribe for shares must submit their application no later than March 31, 2025. Warrants that are not exercised by this date will expire worthless. Holders who do not wish to exercise their Warrants have the opportunity to sell them. Trading in the Warrants will continue until March 27, 2025.

Detailed Information and Subscription Instructions
Exercise of Nominee-Registered Warrants
Holders whose Warrants are nominee-registered (held in a securities account, ISK, or capital insurance) must apply for the exercise of the Warrants by contacting their nominee and following the nominee’s instructions regarding subscription and payment. This should be done well in advance of March 31, 2025, as different nominees have different processing times.

Exercise of Directly Registered Warrants
Holders whose Warrants are directly registered (held in a VP account) must apply for the exercise of the Warrants by completing and submitting a subscription form so that it is received by the issuing institution, Nordic Issuing, no later than March 31, 2025.

The subscription form is available on the Company's and Nordic Issuing’s respective websites. Please note that payment for the new shares must be received by Nordic Issuing no later than March 31, 2025, in accordance with the instructions on the subscription form.

Trading of TO3 Warrants
Holders who do not wish to exercise their Warrants have the opportunity to sell them on Nasdaq Stockholm. The Warrants will be traded until March 27, 2025, under the ticker HEART TO3 and with ISIN code SE0022240214. Warrants that are not exercised by March 31, 2025, will expire worthless.

Outcome and Delivery of New Shares
The outcome of the Warrant exercise will be announced via a press release around April 3, 2025. Subscribed and paid shares may be registered in the subscriber’s securities account as interim shares (IA) until the registration of the issue is completed with the Swedish Companies Registration Office, at which point the interim shares will automatically be converted into shares in Realheart.

Number of Warrants and Potential Proceeds from Exercise
If all 54,910,406 Series TO3 Warrants are fully exercised, the share capital will increase by up to SEK 1,375,505.67 to SEK 12,163,688.97 through the issuance of up to 274,552 new shares, resulting in the total number of outstanding shares in the Company increasing from 2,153,330 to 2,427,882.

Upon full exercise of all Series TO3 Warrants, the dilution of shares will amount to approximately 11 percent. If all Warrants are exercised in full, Realheart will receive approximately SEK 3.6 million before issuance costs.

Complete Terms of the Warrants
The complete terms and conditions of the Warrants are available on the Company's website, https://realheart.se/

Advisors
Skills Corporate Finance AB is acting as financial advisor to the Company, and Setterwalls Advokatbyrå AB is acting as legal advisor. Nordic Issuing is acting as the issuing agent in connection with the exercise of the Warrants.

Year-End Report Q4, 2024

Summary of Year-End Report October – December 2024

Group Overview 2024-10-01 2023-10-01 2024-01-01 2023-01-01
2024-12-31 2023-12-31 2024-12-31 2023-12-31
3 mon 3 mon 12 mon 12 mon
Operating income 5 024 798 047 50 054 902 882
Earnings after financial items -10 329 017 -52 895 973 -34 350 238 -67 977 292
Balance sheet total 83 279 673 102 638 279 83 279 673 102 638 279
Equity / assets ratio 81% 80% 81% 80%
Earnings per share -4,99 -0,55 -16,61 -0,70
Earnings per share after dilution -4,24 -0,39 -14,08 -0,51
Number of shares* 2 068 152 96 994 446 2 068 152 96 994 446
Number of shares after full exercise of warrents  2 438 927   134 071 898   2 438 927   134 071 898 
Parent Company Overview 2024-10-01 2023-10-01 2024-01-01 2023-01-01
2024-12-31 2023-12-31 2024-12-31 2023-12-31
3 mon 3 mon 12 mon 12 mon
Operating income 5 024 798 047 50 054 902 882
Earnings after financial items -12 583 526 -52 865 323 -32 409 725 -67 678 901
Balance sheet total 85 837 128 103 221 678 85 837 128 103 221 678
Equity / assets ratio 82% 80% 82% 80%
Earnings per share -6,08 -0,55 -15,67 -0,70
Earnings per share after dilution -5,16 -0,39 -13,29 -0,50
Number of shares* 2 068 152 96 994 446 2 068 152 96 994 446
Number of shares after full exercise of warrants  2 438 927   134 071 898   2 438 927   134 071 898 

* In November 2024, a share reverse split was carried out, which meant that 100 shares were merged into 1 share.

Revenue and Result
Scandinavian Real Heart AB is currently engaged in research and development and currently has no sales of its own products. The revenue recognized for the period consists mainly of grants received for research and development. Research and development costs incurred for Realheart® TAH were capitalized during the period October 1 – December 31, 2024, in the amount of SEK 10 million. 

Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees and 2 hourly employees.

Transactions With Related Parties
No significant transactions with related parties have taken place during the period.

Significant Risks and Uncertainties
Realheart’s focus is on getting through the preclinical phase (hemolysis, GLP studies in animals and endurance tests) to be able to start clinical studies. This means that the company must finalize the version of both the controller and the heart pump to be included in these tests. Realheart must also hold parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route for the product to market.

The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can can secure funding in both the short and long term. The board is continuously working on different scenarios to ensure the company’s future operations.

Financial Position
At the end of the period, the Group’s cash and cash equivalents amounted to SEK 23.7 million. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the company.

CEO Comment
The last three months have seen important progress in the development of our artificial heart, Realheart® TAH. At the end of January, we were pleased to announce new successes in the ongoing preclinical safety studies evaluating the treatment safety and function of our artificial heart. Shortly before this, we received the news that the U.S. Food and Drug Administration (FDA) approved the company’s application for Humanitarian Use Device (HUD) status for Realheart® TAH, which could potentially have a positive impact on the future clinical development of our technology.

Significant Events During the Fourth Quarter 2024
On the first day of the period, the Company announced the publication of a preclinical study describing a new method to simulate hemolysis in artificial hearts using pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative approach, the study was awarded the ESAO-SAGE research prize at the 50th Congress of the European Society for Artificial Organs 2024.

Ten days into the period, Realheart announces that it has initiated a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplant and Vascular Surgery at Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplant surgeons with Realheart® TAH and gain valuable professional input for the clinical trials. Realheart® TAH is intended for use in patients awaiting heart transplantation or as an alternative to transplantation.

A few days into November, a decision was taken on a 1:100 reverse share split, whereby one hundred (100) existing shares were consolidated into one (1) share. The reverse share split was registered with the Swedish Companies Registration Office in November.

Halfway through the period, the Company communicates that it has been granted an approval by the Patent Office of India for its patent application (no. 202117045813) for a technical application related to the clinical use of Realheart® TAH.

Midway through the period, updated safety data from a preclinical study with Realheart® TAH is also presented at the 30th Annual Meeting of ISMCS 2024. At the meeting, the company’s R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award, a prestigious award that rewards groundbreaking innovation.

On the very last day of the period, Realheart announces that the subscription price for warrants series TO 2 (the “Warrants”) has been set to SEK 8.47. The exercise period for the warrants commences on January 2, 2025 and runs until January 31, 2025. The last day of trading in the warrants is January 29, 2025.

Significant Events After the End of the Fourth Quarter
The first event after the end of the period is that the Company’s total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation by the US Food and Drug Administration (FDA). The HUD designation makes Realheart® TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product special market rights.

January concludes with successful results from a 7-day animal study of Realheart® TAH, showing that the device provides adequate cardiac function, automatically adjusts to rest and exercise, and maintains good blood biochemistry.

A few days into February, the outcome of the subscription period for the warrants of series TO 2 (“Warrants”) issued in connection with the rights issue of units carried out by the Company during the period June 20, 2023 – July 7, 2023 is announced. A total of 17,035,600 Warrants were exercised for subscription of 85,178 shares, corresponding to a subscription rate of approximately 51 percent of the total 33,495,885 issued Warrants. Through the exercise, Realheart will receive approximately SEK 721 thousand before issue costs.

Scandinavian Real Heart AB Announces Outcome of the Exercise of Series TO 2 Warrants

NOT FOR RELEASE, DISTRIBUTION, OR PUBLICATION, DIRECTLY OR INDIRECTLY, WITHIN OR TO THE UNITED STATES, AUSTRALIA, BELARUS, HONG KONG, JAPAN, CANADA, NEW ZEALAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION WHERE SUCH ACTION WOULD BE UNLAWFUL OR REQUIRE ADDITIONAL REGISTRATION OR OTHER MEASURES.

Scandinavian Real Heart AB (publ) ("Realheart" or the "Company") today announces the outcome of the subscription period for the series TO 2 warrants ("Warrants"), which were issued in connection with the rights issue of units carried out by the Company between June 20, 2023, and July 7, 2023. A total of 17,035,600 Warrants were exercised for the subscription of 85,178 shares, corresponding to a subscription rate of approximately 51 percent of the total 33,495,885 issued Warrants. Through this exercise, Realheart will receive approximately SEK 721,000 before issuance costs.

Overview of Final Outcome

The exercise period for the Warrants ran from January 2, 2025, to January 31, 2025. The final outcome shows that 85,178 shares were subscribed through the exercise of Warrants, corresponding to an exercise rate of approximately 51 percent. The subscription price per share subscribed via the exercise of Warrants was SEK 8.47, which, in accordance with the terms of the Warrants, corresponds to 70 percent of the volume-weighted average price (VWAP) of the Company's shares on Nasdaq First North Growth Market during the measurement period. Through this exercise, Realheart will receive approximately SEK 721,000 before issuance costs.

Shares and Share Capital

As a result of the exercise of Warrants, the total number of shares in Realheart increases by 85,178, bringing the total number of outstanding shares in the Company from 2,068,152 to 2,153,330. The number of votes increases accordingly. The share capital of the Company increases by SEK 426,741.78 from SEK 10,361,441.52 to SEK 10,788,183.30, in accordance with the terms of the issuance. For existing shareholders who did not exercise any Warrants, the dilution amounts to approximately 4 percent of the total number of shares and votes in the Company after the exercise of Warrants.

Exercised Warrants will be replaced with interim shares until registration with the Swedish Companies Registration Office is completed, after which the interim shares will automatically be converted into ordinary shares. The interim shares are expected to be converted into ordinary shares approximately two banking days after registration with the Swedish Companies Registration Office.

IMPORTANT INFORMATION

The information in this press release may not be disclosed, published, or distributed, directly or indirectly, within or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea, or any other jurisdiction where such action would be unlawful, subject to legal restrictions, or require actions beyond those required under Swedish law. Any actions in violation of this directive may constitute a breach of applicable securities laws. This press release does not constitute an offer to acquire or subscribe for securities in Realheart in any jurisdiction, either from Realheart or from any other party.

This press release is not a prospectus under the meaning of Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction.

This press release does not identify or purport to identify risks (direct or indirect) associated with an investment in the Company. The information in this press release is solely intended to describe the background to the exercise of the Warrants and does not claim to be comprehensive or exhaustive. No representations are made regarding the accuracy or completeness of the information in this press release.

This press release does not constitute an offer to sell or an invitation to purchase securities in the United States. The securities mentioned herein may not be sold in the United States without registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States without registration, an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities mentioned herein in the United States or to conduct a public offering of such securities in the United States.

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

Realheart Presents Successful Results From a Preclinical Implantation Using Its Total Artificial Heart

Västerås, Sweden, January 30, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has successfully completed a 7-day animal study with its total artificial heart Realheart® TAH. The results show that the device provided adequate cardiac function, automatically adapted to rest and movement and maintained good blood biochemistry.

“We are very pleased to share this positive update. Results from the implantation test show that Realheart® TAH achieved the targeted cardiac output, resulting in adequate perfusion of the body with low mechanical stress and damage to red blood cells” says Ina Laura Perkins, CEO of Realheart.

Throughout the study the device functioned as intended. At one week the study was terminated as there had been some signs of bleeding which is a common complication of large cardiac surgery.

“A 7-day chronic implantation is a meaningful milestone for our development as this duration affords the assessment of the device performance in an animal that is awake and ambulatory and under various cardiac loads and allows for the elimination of many post-surgical effects”, says CEO Ina Laura Perkins.

The company is currently conducting a preclinical program to evaluate the safety and function of Realheart® TAH prior to conducting clinical studies in heart failure patients. The results from this test will guide further preclinical testing of Realheart® TAH and serve as an integral part of the data set used in dialogue with regulatory agencies.

Realheart® TAH Receives Humanitarian Use Device Designation by the U.S. Food and Drug Administration (FDA)

Västerås, Sweden, January 29, 2025 – Scandinavian Real Heart AB (publ) today announces that its total artificial heart, Realheart® TAH, has been granted Humanitarian Use Device (HUD) designation by the U.S. Food and Drug Administration (FDA). The HUD designation makes Realheart® TAH eligible to apply for Humanitarian Device Exemption (HDE), an expedited regulatory pathway that can grant the product limited marketing rights.

Realheart® TAH is a total artificial heart that mimics the structure and physiological function of the human heart. Following multiple rounds of communication with the FDA, the device has been granted Humanitarian Use Device status which paves the way for Realheart® TAH to treat patients with advanced biventricular heart failure who have few other options and need to be supported by a total artificial heart.

HDE is approved if the sponsor can demonstrate data indicating probable safety and benefit to the intended patient group.

Realheart will continue communications with the FDA to develop a clinical investigation strategy to support a Humanitarian Device Exemption premarket approval.

“We are extremely pleased that Realheart® TAH has been granted Humanitarian Use Device designation by the FDA. It is gratifying to look forward to our efforts culminating in such humanitarian benefit. We look forward to updating the market on further clinical and regulatory activities and meanwhile continue our preclinical development which will be important for a potential future full market approval,” says Ina Laura Perkins, CEO of Realheart.

Last Day for Exercise of Warrants TO 2 in Scandinavian Real Heart AB

Scandinavian Real Heart AB (“Realheart” or the “Company”) reminds holders of warrants of series TO 2 (the “warrants”) that the last day for exercise is January 31, 2025. Holders who do not exercise their warrants risk that they expire without value.

Upon full exercise of all warrants, the Company will receive approximately SEK 1.4 million before issue costs. To avoid the warrants expiring without value, the holder must either trade or subscribe.

Important Dates

  • Last day of trading: January 29, 2025
  • Last day to exercise: January 31, 2025

Summarized Terms and Conditions

  • Subscription price: SEK 8.47 per share (corresponding to 70 percent of the volume weighted average price during the measurement period).
  • Exercise ratio: 200 warrants entitle the holder to subscribe for one (1) new share in the Company.
  • ISIN code for the warrants: SE0020358166.
  • Total number of warrants: 33,495,885 warrants series TO 2. Upon full exercise, 167,479 new shares will be issued.
  • Dilution effect at full exercise: Approximately 7.5 percent.
  • Trading venue: The warrants are admitted to trading on Nasdaq First North under the ticker “HEART TO2”.

Instructions for use

Nominee-Registered Holdings
Holders with warrants in a share depository account, ISK account or endowment insurance should contact their bank or nominee well in advance of January 31, 2025, to ensure that the application is processed correctly.

Directly Registered Holdings
Holders with warrants in a securities account must complete and submit the application form for exercise, so that it is received by the issuing institution Nordic Issuing no later than January 31, 2025. The application form is available on the Company's and Nordic Issuing's respective websites.

Subscribed and paid shares may be registered in the subscriber's securities depository account as interim shares (IA) until the issue has been registered with the Swedish Companies Registration Office, whereupon interim shares are automatically converted into shares in Realheart.

Full Terms and Conditions of the Warrants
Full terms and conditions of the warrants are available on the Company's website, https://realheart.se/

Advisors
Skills Corporate Finance AB is the financial advisor to the Company and Setterwalls Advokatbyrå AB is the legal advisor. Nordic Issuing acts as issuing agent in connection with the exercise of the warrants.

Subscription Price Set for the Exercise of Series TO 2 Warrants in Scandinavian Real Heart AB

Scandinavian Real Heart AB ("Realheart" or the "Company") hereby announces that the subscription price for series TO 2 warrants (the "warrants") has been set at SEK 8.47. The exercise period for the warrants begins on January 2, 2025, and runs until January 31, 2025. The last day for trading the warrants is January 29, 2025.

Realheart conducted a rights issue of units (the "Rights Issue") during the period June 20, 2023 – July 7, 2023. Each unit issued in the Rights Issue consisted of two (2) shares and one (1) series TO 2 warrant. Two (2) series TO 2 warrants entitle the holder to subscribe for one (1) new share in the Company.

At an extraordinary general meeting on November 5, 2024, a consolidation of shares in the ratio of 1:100 was resolved, meaning that one hundred (100) existing shares were consolidated into one (1) share. In connection herewith, the subscription price and the number of shares that each series TO 2 warrant entitles to were adjusted, in accordance with the terms, to neutralize the effect of the consolidation. After the adjustment, two hundred (200) warrants are required to subscribe for one (1) new share in the Company. The Rights Issue announced on May 7, 2024, resulted in the cap for the subscription price upon exercising TO 2 being adjusted from SEK 200 after the consolidation to SEK 134 per share.

The consolidation does not affect the total number of outstanding warrants or their ISIN code (SE0020358166). Other terms for the warrants, such as the subscription period, remain unchanged.

After the recalculation, one (1) series TO 2 warrant entitles the holder to subscribe for 0.005 shares (previously 0.5 shares). Since it is not possible to subscribe for a fraction of a share, two hundred (200) warrants are now required to subscribe for one (1) new share in the Company. A corresponding recalculation has been made regarding series TO 3 warrants.

Upon full exercise of all series TO 2 warrants, Realheart will receive approximately SEK 1.4 million before issuance costs.

The subscription price for the series TO 2 warrants is set at 70 percent of the volume-weighted average price of the Company's shares on Nasdaq First North Growth Market during the period December 12 – 30, 2024, i.e., during the 10 trading days immediately preceding the start of the subscription period. 70 percent of the volume-weighted average price during the measurement period amounted to SEK 8.47.

Summary Instructions and Important Dates
Holders of warrants who wish to exercise them to subscribe for shares must notify this no later than January 31, 2025. Warrants that are not exercised before then will expire without value. Holders who do not wish to exercise their warrants have the opportunity to sell them. Trading in the warrants will continue until January 29, 2025.

Detailed Information and Instructions for Subscription
Exercise of Custodian-Registered Warrants
Holders who have their warrants custodian-registered (held in a securities account, ISK account, or capital insurance) should notify the exercise of the warrants by contacting their custodian and following the custodian's instructions regarding subscription and payment. This should be done well in advance of January 31, 2025, as different custodians have different processing times.

Exercise of Directly Registered Warrants
Holders who have their warrants directly registered (held in a VP account) should notify the exercise of the warrants by filling in and sending in the subscription form for the exercise, so that the subscription form is received by the issuing agent Nordic Issuing no later than January 31, 2025.

The subscription form is available on the Company's and Nordic Issuing's respective websites. Note that payment for the new shares must be received by Nordic Issuing no later than January 31, 2025, in accordance with the instructions on the subscription form.

Trading with TO 2
Holders who do not wish to exercise their warrants have the opportunity to sell them on Nasdaq Stockholm. The warrants are traded until January 29, 2025, under the ticker HEART TO2 and with ISIN code SE0020358166. Warrants that are not exercised by January 31, 2025, will expire without value.

Outcome and Delivery of New Shares
The outcome of the exercise of the warrants will be announced via a press release around February 3, 2025. Subscribed and paid shares may be registered in the subscriber's securities account as interim shares (IA) until the registration of the issue is completed with the Swedish Companies Registration Office, whereupon the interim shares will automatically be converted into shares in Realheart.

Number of Warrants and Potential Proceeds from Exercise
Upon full exercise of all 33,495,885 series TO 2 warrants, the share capital will increase by a maximum of SEK 839,069.79 to SEK 11,200,511.31 through the issuance of a maximum of 167,479 new shares, resulting in the total number of outstanding shares in the Company increasing from 2,068,152 to 2,235,631.

Dilution Effect
Upon full exercise of all series TO 2 warrants, the dilution of the shares will amount to approximately 7.5 percent. Upon full exercise of all warrants, Realheart will receive approximately SEK 1.4 million before issuance costs.

Complete Terms for the Warrants
Complete terms for the warrants are available on the Company's website, https://realheart.se/

Advisors
Skills Corporate Finance AB is the financial advisor to the Company, and Setterwalls Advokatbyrå AB is the legal advisor. Nordic Issuing acts as the issuing agent in connection with the exercise of the warrants.

New Preclinical Simulation Data Shows Superior Effect of Realheart® TAH in Regulating Cardiovascular Function During Sleep

Västerås, Sweden, November 21, 2024 – Scandinavian Real Heart AB (publ) announces today that the company presented updated safety data from a preclinical study with Realheart® TAH at the 30th Annual Meeting of ISMCS 2024. At the meeting, the company’s R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award, a prestigious award that recognizes ground-breaking innovation.

Besides presenting positive results from two preclinical studies, earlier communicated in a press release on September 5, Realheart now presented promising results concerning cardiac output during sleep and exercise.

In the current studies, the performance of Realheart® TAH was compared to a market-leading product. Simulation results show that Realheart TAH's automatically regulated cardiac output is superior to the market-leading product in adapting to patient needs, both during sleep and exercise.

“This is very promising data as it is likely that patients will have a better quality of life if the artificial heart can automatically adapt to the body's activity level. We are committed to developing an artificial heart that mimics the physiological heart as closely as possible, and the research results presented at the ISMCS meeting reveal yet another aspect in which we are successful in this ambition,” said Ina Laura Perkins, CEO of Realheart.

During ISMCS, Realheart R&D engineer Faisal Zaman was nominated for the Helmut Reul Young Investigator Award for his contributions to the research and development of Realheart® TAH. The nomination meant that the research results were presented in the opening session of the conference and thus to a packed auditorium.

Realheart Is Granted Patent Approval in India for Its Device Used in the Surgical Implantation of Realheart® TAH

Västerås, Sweden, November 20, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has been granted an approval by Intellectual Property India for its patent application (no. 202117045813) concerning a technical application related to the clinical use of Realheart® TAH.

The approved patent pertains to a vascular coupling device, which is used to connect Realheart® TAH to the major vessels of the circulatory system. The duration of the patent (no. 552361) is 20 years, which will thus expire in April 2042.

“We are very happy that the patent authority in India has granted us a patent approval that complements and further strengthens our IP portfolio in India, which is a valuable as fast-growing market. While the U.S. remains our most prioritized market in the short term, we see great potential in the Indian market to realize the company’s long term growth potential,” says Ina Laura Perkins, CEO of Realheart.

Interim Report Q3 2024

Summary of Interim Report July – September 2024

(SEK)
Group Overview 2024-07-01 2023-07-01 2024-01-01 2023-01-01
2024-09-30 2023-09-30 2024-09-30 2023-09-30
3 month 3 month 9 month 9 month
Operating income 4 650 878 45 030 104 835
Profit/loss after financial items -9 914 833 -8 016 849 -24 021 221 -15 081 319
Balance Sheet total assets 92 709 939 150 142 414 92 709 939 150 142 414
Equity / Assets ratio 84% 90% 84% 90%
Earnings per share -0,05 -0.08 -0,12 -0.16
Number of shares 206 815 258 96 994 446 206 815 258 96 994 446
Earnings per share after dilution* -0.04  -0.06  -0.10  -0.11 
Parent Company Overview 2024-07-01 2023-07-01 2024-01-01 2023-01-01
2024-09-30 2023-09-30 2024-09-30 2023-09-30
3 month 3 month 9 month 9 month
Operating income 4 650 878 45 030 104 835
Profit/loss after financial items -5 903 757 -8 064 889 -19 826 199 -14 813 578
Balance Sheet total assets 96 750 454 148 435 929 96 750 454 148 435 929
Equity / Assets ratio 85% 92% 85% 92%
Earnings per share -0,03 -0.08 -0,10 -0.15
Number of shares 206 815 258 96 994 446 206 815 258 96 994 446
Earnings per share after dilution* -0.02  -0.06  -0.08  -0.11 

* Upon full exercise of all options in TO2, TO3 and Option Program 2022/2027.

Revenue and Result
Scandinavian Real Heart AB is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of received de minimis grants. Research and development costs of Realheart® TAH were capitalized during Q4 with 5.7 MSEK. During the period, capitalized research and development costs were written down by 6.3 MSEK.

Employees
The number of employees in the Group at the end of the quarter was 11 full-time employees.

Related Party Transactions
No significant related party transactions have taken place during the period.

Significant Risks and Uncertainties
Realheart's focus is on getting through the pre-clinical phase (Hemolysis, GLP studies on animals and endurance tests) to be able to start clinical studies. This means that the company must finalize the version of both the controller and the heart pump that will be included in these tests. Realheart must also conduct parallel discussions with the Notified Body in the EU and with the FDA in the US to ensure the fastest and safest route to market for the product. The company is continuously working on measures to minimize delays. Furthermore, the continued product development requires that the company can solve its financing. The board is continuously working with different scenarios to ensure the company's future operations. 

Financial Position
At the end of the period, the Group's cash and cash equivalents amounted to 31.7  MSEK. At present, the Group does not generate its own positive cash flow and is thus dependent on external financing. In order to solve the longer-term financing needs, the Board of Directors is continuously evaluating options for further capitalization of the company.

CEO Comment
During the third quarter, we have taken further steps in the preclinical validation of Realheart® TAH. As a result of the high innovation standard in our device, we have successfully established new important collaborations with the University of Gothenburg and the Hannover Medical School. These collaborations aim to accelerate the preclinical testing of Realheart® TAH, as well as familiarize leading transplantation surgeons with the device ahead of clinical studies. Further, we have proudly announced positive results from three separate studies reaffirming the promising hematological profile as well as the physiological control functions of Realheart® TAH. In parallel, our ongoing activities to optimize the preclinical safety study protocol are moving ahead. Collectively, our step-wise successes reflect the company’s work in moving toward the clinical evaluation of our artificial heart. 

Significant Events During the Third Quarter of the Year
At the beginning of the period, the outcome of the Company's rights issue is published. The outcome shows that 38,083,456 units were subscribed for with unit rights, corresponding to approximately 39.3 percent of the Rights Issue. In addition, the Company has received subscription applications for 5,527,237 units, corresponding to approximately 5.7 percent of the Rights Issue, for subscription without unit rights. Through the Rights Issue, the Company will initially receive approximately SEK 24.3 million before issue costs.

Halfway into July, Realheat carries out a directed issue of units to guarantors in connection with the completed rights issue. The Company's Board of Directors, based on the authorization from the Annual General Meeting on June 7, 2024, has decided to issue 6,300,000 units as guarantee compensation directed to a number of the guarantors who provided guarantee commitments in the rights issue of units carried out by the Company during the period June 12 through July 5, 2024, in accordance with the guarantee agreements entered into. Through the directed issue to the underwriters, 6,300,000 warrants of series TO3 are also issued, which entitle to subscribe for a maximum of 3,150,000 shares in the Company. Upon full exercise of the Warrants, the share capital will increase by a maximum of SEK 126,000.00.

July ends with Realheart announcing the last day of trading in BTUs and the first day of trading in warrants of series TO3. The number of warrants of series TO3 amounts to 54,910,406. Upon full exercise of all warrants of series TO3, the Company can be provided with a maximum of 27,455,203 new shares, which corresponds to a dilution of 11.7 percent.

During the first half of August, the Company announces the appointment of Jimmy Nybom as new interim CFO, during the ongoing recruitment process of a permanent CFO. Jimmy has had extensive contacts with Realheart as the company's auditor during the years 2019-2022 and is therefore well versed in the company's finances and operations.

In the second half of August, Realheart announces that it has entered into a collaboration with a leading veterinary large animal unit at the University of Gothenburg in Sweden for the continued preclinical safety evaluation of the Realheart® TAH artificial heart. The purpose is to conduct high-quality animal experimental large animal experiments required to ultimately conduct a clinical study. This will also facilitate the preparation of the clinical trial planned to be conducted in Sweden.

The final event of the period is an announcement that the company will present new data from two successful preclinical studies evaluating the treatment safety of the company's total artificial heart Realheart® TAH, at the 30th Annual Meeting of the International Society for Mechanical Circulatory Support (ISMCS) 2024, on November 13-15 in Utsunomiya, Japan.

Significant Events After the End of the Period
The first event after the end of the period is an announcement that the Company has published a preclinical study describing a new method to simulate hemolysis in artificial hearts using pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative approach, the study was awarded the ESAO-SAGE research prize at the 50th Congress of the European Society for Artificial Organs 2024.

Closer to mid-October, the company announces a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplantation and Vascular Surgery at Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplant surgeons with Realheart® TAH and gain valuable professional input for the clinical trials. Realheart® TAH is intended for use in patients awaiting heart transplantation or as an alternative to transplantation.

November begins with the publication of the communiqué from Realheart's extraordinary general meeting. At the same time, the record date for the reverse share split in the Company is announced as November 22. The reverse share split will take place according to the ratio 1:100, whereby one hundred (100) existing shares will be consolidated into one (1) share.

Record Date for Reverse Share Split in Scandinavian Real Heart AB

At the Extraordinary General Meeting in Scandinavian Real Heart AB (“Realheart” or the “Company”) held on 5 November 2024 a reverse share split of 1:100 was resolved upon, whereby one hundred (100) existing shares become one (1) share. Further, the Extraordinary General Meeting resolved to authorize the Board of Directors to determine the record date for the reverse share split. The Board of Directors of Realheart has today resolved that the record date for the reverse split shall be 22 November 2024.

Reverse share split

At the Extraordinary General Meeting in Realheart held on 5 November 2024 a reverse share split of 1:100 was resolved upon, whereby one hundred (100) existing shares become one (1) share. Further, the Extraordinary General Meeting resolved to authorize the Board of Directors to determine the record date for the reverse share split. The Board of Directors of Realheart has today resolved that the record date for the reverse split shall be 22 November 2024.

No action is required by shareholders to participate in the reverse split.

As a consequence of the reverse split, the ISIN Code for the Realheart share will be changed. As from 21 November 2024, the shares will be traded with the new ISIN Code SE0023286836.

The reverse split means that the total number of shares in the Company will be reduced from 206,815,200 shares to 2,068,152 shares, each with a quota value of approximately SEK 5.01. The reverse split will result in a corresponding re-calculation of the outstanding warrants and incentive scheme in Realheart. Shareholders, whose number of shares on the record date is not evenly divided by 100, will for no consideration receive shares from Najar Medical and Invention AB, so that their respective shareholding will be evenly divided by 100. The transfer of these rounding shares will be administrated by Euroclear Sweden AB and without shareholders being required to take any further actions.

Time table for the reverse split

  • The last trading date in Realheart’s share before the reverse split shall be 20 November 2024.
  • The first trading date in Realheart’s share after the reverse split shall be 21 November 2024, which means that the share price as from this date will reflect the effects of the reverse split.
  • The record date for the reverse split shall be Friday 22 November 2024.

Bulletin From the Extraordinary General Meeting in Scandinavian Real Heart AB on 5 November 2024

An Extraordinary General Meeting in Scandinavian Real Heart AB (the “Company”) has been held on 5 November 2024 and in particular the following resolutions were made.

Reduction of the Company’s share capital through redemption of shares

The Meeting resolved to reduce the Company’s share capital by SEK 2.9 through a redemption of shares. The reduction is carried out in order to achieve a number of shares in the Company evenly divisible by 100, for the purpose of enabling the reverse share split in accordance with the below. The reduction of the share capital shall be effected through the redemption of all own shares that the Company will hold by the Board member Azad Najar, through Najar Medical and Invention AB, returning a total of 58 shares without consideration, whereby the number of shares will be evenly divisible by 100. The reduction of the share capital is made for allocation to the Company’s unrestricted equity.

Bonus issue without the issue of new shares

The Meeting resolved to restore the Company's share capital by increasing the share capital by SEK 20,681.52 through a bonus issue without issuance of new shares. The bonus issue is carried out in order to achieve a time-efficient procedure with the redemption of shares in accordance with the above, without requiring permission from the Swedish Companies Registration Office or a general court. The bonus issue is carried out through a transfer from the Company's non-restricted equity to the Company's share capital.

After completion of the bonus issue and reduction of the share capital in accordance with the above, the Company's share capital will amount to SEK 10,361,441.52 divided into 206,815,200 shares, each with a quota value of SEK 0.0501.

Amendment of the Articles of Association

The Meeting resolved on an amendment of the Articles of Association, whereby the limits for the number of shares in the Articles of Association (§ 5) is changed to not less than 2,000,000 and not more than 8,000,000, and the limits for the share capital (§ 4) is changed to not less than SEK 10,020,000 and not more than SEK 40,080,000.

The amendment is made in order to enable the reverse share split in accordance with the below.

Reverse share split

In order to achieve an appropriate number of shares for the Company, the Meeting resolved on a reverse share split of the Company's shares (1:100), whereby the number of shares in the Company is reduced by combining one hundred (100) shares into one (1) share. It was resolved to authorize the Board of Directors to determine the record date for the reverse share split (to occur after the resolution has been registered with the Swedish Companies Registration Office) and to otherwise take the measures required for the implementation of the reverse share split.

If a shareholder’s holding of shares does not correspond to a full number of new shares, i.e. is not evenly divisible by one hundred (100), this shareholder will, free of charge, receive such number of shares from Najar Medical and Invention AB so that his/her holding, after addition of the provided shares, is evenly divisible by one hundred (100). Further information on the procedure for the reverse share split will be announced when the Board of Directors resolves on the record date.

Complete resolutions as above are available on the Company's website, www.realheart.se/sv/investerare/agarinformation/bolagsstammor/

Realheart Initiates Collaboration With Hannover Medical School Ahead of Clinical Studies and Potential Launch of Realheart® TAH

Västerås, Sweden, October 10, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has entered a collaboration with Professors Arjang Ruhparwar and Jan Schmitto, at the Department of Cardiothoracic, Transplantation and Vascular Surgery at the Hannover Medical School, Hannover, Germany. The collaboration aims to familiarize leading transplantation surgeons with Realheart® TAH and gain valuable professional input ahead of clinical studies. Realheart® TAH is intended for use in patients awaiting heart transplant treatment or as an alternative to transplantation.

Department of Cardiothoracic, Transplantation and Vascular Surgery (HTTG) at Hannover Medical School is considered one of the leading medical centers in the world, specializing in the treatment of complex cardiac indications and diseases. Within the framework of the agreement, HTTG will function as an advisor and, in due time, potentially take part in the company’s clinical evaluation of Realheart® TAH.

“We are delighted to enter this partnership with Hannover Medical School, through which we will be able to gain further valuable input from leading cardiac surgeons on the therapeutic use of Realheart® TAH. Further, it provides an opportunity for Prof. Dr. Jan Schmitto and his team to get familiarized with our artificial heart ahead of its potential implementation in clinical practice,” says Ina Laura Perkins, CEO of Realheart.

Realheart’s partners at HTTG are Dr. Arjang Ruhparwar, professor in Cardiac Surgery and director of the Department of Cardiothoracic, Transplantation and Vascular Surgery, and Dr. Jan Schmitto, Professor in Cardiac Surgery, and director of the Mechanical Circulatory Support (MCS) program, Surgical Head of the Interdisciplinary Heart Failure Unit, and the director of the newly implemented Innovation-Division “Cardiac Device Technologies” at Hannover Medical School. As academic surgeons with long-standing experience in the development of novel medical devices, innovative cardiac surgery and experimental research, Professors Ruhparwar and Schmitto are recognized as global key opinion leaders in the mechanical circulatory support field.

“Total artificial hearts constitute a new and important class of devices that will help to fulfill the large unmet medical need for patients awaiting a heart transplant. My team and I look forward to getting familiarized with the Realheart® TAH in detail, with the aim to provide new insights to its development and, hopefully, evaluate the device in an upcoming clinical study,” comments Jan Schmitto, Professor, Department of Cardiothoracic, Transplantation and Vascular Surgery, at the Hannover Medical School.

Realheart’s Preclinical Study Presenting a Unique Computational Model Recognized With the ESAO-SAGE Research Award

Västerås, October 1, 2024 – Scandinavian Real Heart AB (publ) announces today that the company has published a preclinical study describing a novel method to simulate hemolysis in artificial heart devices that utilize pumping mechanisms. This unique method will be important in the further development of Realheart® TAH. Based on its innovative height, the study was recognized with the ESAO-SAGE Research Award at the 50th European Society for Artificial Organs Congress 2024.

The breakdown of red blood cells (hemolysis) in mechanical devices that circulate blood (MCS) is still a safety issue due to consequential side effects, e.g., thrombosis. It is therefore important to reduce the risk of hemolysis from devices that seek regulatory approval for clinical use. In a recent study, Realheart, and its academic partner University of Bath, describe a newly-developed simulation model for MCSs that utilize back-and-forth (positive-displacement) pumping mechanisms. Such simulations have historically been based on devices that spin to pump blood, thus limiting the applicability to Realheart® TAH. This novel method, and the study results, will be important in further improving the hemolytic profile of Realheart® TAH and in providing essential safety information to regulatory agencies.

The study was recognized with the ESAO-SAGE Research Award at the 50th European Society for Artificial Organs Congress, earlier in September. The awardee is selected by a Special Committee based on a manuscript published in the International Journal for Artificial Organs, which is presented at the Annual ESAO Congress.

“The insight from this study is unique as it is the first time an artificial heart with four valves, of which two are also moving, has been simulated. It has been a challenging study that our academic partner University of Bath have taken on and excelled at. The results provide an excellent basis for further understanding of functional valve movements in Realheart® TAH to further optimize the control of the heart and the scale of the product components when developing new devices of varying sizes, such as MINIheart,” says Ina Laura Perkins, CEO of Realheart.

Read the full article: www.journals.sagepub.com/doi/pdf/10.1177/03913988241267797

NOTICE TO ATTEND THE EXTRAORDINARY GENERAL MEETING IN SCANDINAVIAN REAL HEART AB

The shareholders of Scandinavian Real Heart AB, reg. no. 556729–5588 (the "Company"), are hereby invited to an Extraordinary General Meeting on Tuesday, 5 November 2024 at 10.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, SE-722 13 Västerås, Sweden. Registration for the Meeting begins at 09.30.

Right to participate in the Meeting, etc.

Shareholders who wish to participate in the Meeting must:

  • be recorded in the share register kept by Euroclear Sweden AB no later than Monday, 28 October 2024; and
  • notify the Company of their intention to participate no later than Wednesday, 30 October 2024 by post to Setterwalls Advokatbyrå AB, attn: Anna af Petersens, P.O. Box 1050, 101 39 Stockholm or by e-mail to anna.afpetersens@setterwalls.se. The notification shall state full name, personal identification number/company registration number, shareholding, address, daytime telephone number and, if applicable, information about proxies or assistants (maximum two).

To be entitled to participate in the Meeting, shareholders whose shares are held in the name of a nominee must, in addition to providing notification of their participation in the Meeting, re-register the shares in their own name so that the shareholders are registered in the share register on the record date on Monday, 28 October 2024. This re-registration may be temporary (so-called “voting right registration”) and is carried out through the nominee according to their procedures at a time predetermined by the nominee. Voting rights registration that has been completed by the nominee no later than Wednesday, 30 October 2024, are considered when preparing the share register.

Proxies etc.

If a Shareholders shall be represented by proxy, the proxy shall bring a written, dated and by the shareholder signed, power of attorney to the Meeting. 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, the proxy shall bring a current copy of the registration certificate and similar papers of authorisation. In order to facilitate entry to the Meeting, a copy of the power of attorney and other authorisation documents should be attached to the notification to the Meeting. Proxy forms will be available on the Company's website www.realheart.se and will be sent by post to shareholders who contact the Company and state their address.

Processing of personal data

For information on how personal data is processed in connection with the Meeting, please refer to the privacy policy available on Euroclear Sweden AB's website: https://www.euroclear.com/dam/ESw/Legal/Privacy-notice-bolagsstammor-engelska.pdf.

Proposal for agenda

  1. Election of chairman of the Meeting
  2. Election of one or two persons to verify the minutes
  3. Preparation and approval of the voting list
  4. Approval of the agenda
  5. Determination as to whether the Meeting has been duly convened
  6. Resolution regarding reduction of the Company’s share capital through redemption of shares
  7. Resolution regarding bonus issue without the issue of new shares
  8. Resolution on amendment of the Articles of Association
  9. Resolution on a reverse share split
  10. Closing of Meeting

Item 1 – Election of chairman of the Meeting

The Board of Directors proposes that Magnus Öhman is elected chairman of the Meeting.

Item 6 – Resolution regarding reduction of the Company’s share capital through redemption of shares

In order to achieve a number of shares in the Company evenly divisible by 100, for the purpose of enabling the reverse share split pursuant to item 9 below, the Board of Directors proposes that the Meeting resolves to reduce the share capital of the Company through a redemption of shares. As of the date of this notice, there are 206,815,258 shares in the Company. Through a redemption of 58 shares, the number of shares will be evenly divisible by 100. The Board member Azad Najar, through Najar Medical and Invention AB, who currently holds 3,487,905 shares in the Company, has undertaken to, without consideration, return 58 shares to the Company.

In light of the above, the Board of Directors has decided that the shares so returned shall be redeemed. The Board of Directors therefore proposes that the General Meeting resolves to reduce the share capital by SEK 2.9, without repayment to Najar Medical and Invention AB. The reduction of the share capital shall be effected through the redemption of all own shares that the Company will hold by Najar Medical and Invention AB returning a total of 58 shares without consideration. The reduction of the share capital is made for allocation to the Company’s unrestricted equity.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 7–9 of the notice.

Item 7 – Resolution regarding bonus issue without the issue of new shares

In order to achieve a time-efficient procedure with the redemption of shares in accordance with item 6 above and without requiring permission from the Swedish Companies Registration Office or a general court, the Board of Directors proposes that the General Meeting resolves to restore the Company's share capital by increasing the share capital by SEK 20,681.52 through a bonus issue without issuance of new shares. The bonus issue is carried out through a transfer from the Company's non-restricted equity to the Company's share capital.

After completion of the bonus issue and reduction of the share capital in accordance with item 6 above, the Company's share capital will amount to SEK 10,361,441.52 divided into 206,815,200 shares, each with a quota value of SEK 0.0501.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6 and 8–9 of the notice.

Item 8 – Resolution on amendment of the Articles of Association

In order to resolve on the reverse share split as proposed under item 9 below, the Board of Directors proposes that the General Meeting resolves to change the limits for the number of shares in the Articles of Association (§ 5) from “not less than 96,000,000 and not more than 384,000,000 shares” to “not less than 2,000,000 and not more than 8,000,000 shares”.

The Board of Directors furthermore proposes that the General Meeting resolves to change the limits for the share capital in the Articles of Association (§ 4) from “not less than SEK 3,840,000 and not more than SEK 15,360,000” to “not less than SEK 10,020,000 and not more than SEK 40,080,000”.

The Board of Directors furthermore proposes that the General Meeting resolves to amend the Articles of Association to be bilingual and thus be written both in Swedish and in English.

The proposed Articles of Association in its entirety will be set out in the Board of Directors’ compete proposal.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6–7 and 9 of the notice.

Item 9 – Resolution on a reverse share split

In order to achieve an appropriate number of shares for the Company, the Board of Directors proposes that the General Meeting resolves on a reverse share split of the Company’s shares (1:100), whereby the number of shares in the Company is reduced by combining one hundred (100) shares into one (1) share. The Board of Directors shall be authorized to determine the record date for the reverse share split (to occur after the resolution has been registered with the Swedish Companies Registration Office) and to otherwise take the measures required for the implementation of the reverse share split.

If a shareholder’s holding of shares does not correspond to a full number of new shares, i.e. is not evenly divisible by one hundred (100), this shareholder will, free of charge, receive such number of shares from Najar Medical and Invention AB so that his/her holding, after addition of the provided shares, is evenly divisible by one hundred (100). Further information on the procedure for the reverse share split will be announced when the Board of Directors resolves on the record date.

The Board of Directors, the CEO, or the person appointed by the Board of Directors or the CEO, are authorized to make such minor amendments to the resolution as may be required in connection with the registration or execution of the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution is conditional upon the Meeting passing resolutions in accordance with items 6–8 of the notice.

Majority requirements

For resolutions according to items 6–9 to be valid, it is required that the resolutions are supported by shareholders who represent at least two-thirds of both the votes cast and the shares represented at the Meeting.

Information on the number of shares and votes

At the time of issue of this notice, the total number of shares and votes in the Company amounts to 206,815,258.

Shareholders’ right to request information

The shareholders are reminded of their right, in accordance with Chapter 7 Section 32 of the Swedish Companies Act (2005:551), to request information from the Board of Directors and the CEO.

Provision of documents

Required documents according to the Swedish Companies Act, including the Articles of Association in their complete proposed new wording, will be available at the Company’s office no later than two weeks before the Meeting and will be sent free of charge to shareholders who request it and state their postal address. The documents will also be available on the Company’s website www.realheart.se from this date at the latest. All the above documents will also be presented at the Meeting.

Västerås in September 2024

Scandinavian Real Heart AB

THE BOARD OF DIRECTORS