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The Subscription Period in Realheart’s Rights Issue Starts Today

Press Release 20 June, 2023

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, 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 RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Today, June 20, 2023, the subscription period for Scandinavian Real Heart AB (publ)’s (“Realheart” or the “Company”) rights issue of units, which was announced on May 15, 2023 (the “Rights Issue”), begins. The subscription period in the Rights Issue runs up to and including July 7, 2023. However, note that nominees may have a deadline for subscription in the Rights Issue that falls before July 7, 2023.

The Rights Issue in summary:

  • Subscription period: June 20, 2023 – July 7, 2023.

  • Trade in unit rights: June 20, 2023 – July 4, 2023.

  • Preferred rights: For every one (1) share held on the record date of June 16, 2023, one (1) unit right was received and one (1) unit right entitle to subscription of one (1) unit.

  • Unit: One (1) unit contains of two (2) newly issued shares and one (1) warrant of series TO2.

  • Subscription price: SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are received free of charge.

  • Issue proceeds: In the event of full subscription in the Rights Issue, the Company will receive approximately SEK 56 million before issue costs.

  • Underwritten level: The rights issue is covered to approximately 60.6 percent through subscription and underwriting commitments.

Subscription with preferential rights

The shareholders who, on the record date of June 16, 2023, were registered in the share register maintained by Euroclear Sweden AB (“Euroclear”) and on behalf of the Company, directly registered shareholders, receive a pre-printed issue report with attached payment advice from Euroclear. In the event that a different number of unit rights than those stated in the preprinted issue report are used for subscription the special application form, which is available on Nordic Issuing’s platform https://minasidor.nordic-issuing.se/, shall be used as a basis for subscription through cash payment.

Shareholders whose holdings of shares in the Company were nominee-registered with a bank or other nominee on the record date do not receive an issue report or a special application form from Euroclear. Subscription and payment must then instead take place in accordance with instructions from the respective trustee.

Subscription without preferential rights

Notification of subscription without preferential rights by a nominee is made in accordance with instructions from the respective nominee. For subscription through an endowment insurance or an investment savings account, please contact your nominee. Application to subscribe for units without preferential rights shall be made on Nordic Issuing's platform https://minasidor.nordic-issuing.se/.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2(k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in 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 other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

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” 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.

Link to the prospectus

Correction: Realheart Publishes Prospectus in Connection With Rights Issue of Units of Approximately SEK 56 Million

Press Release, 19 June 2023

The previous press release was inadvertently published with a MAR label. No information in the communiqué was of such a nature that it relates to MAR.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, 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 RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Scandinavian Real Heart AB (publ) (“Realheart” or the “Company”) has prepared an EU growth prospectus (the “Prospectus”) for the forthcoming issue of units consisting of shares and warrants with preferential rights for existing shareholders (the “Rights Issue”), which the board of directors decided on and announced on May 15, 2023. The Prospectus was approved and registered by the Swedish Financial Supervisory Authority on June 16, 2023 and has been made available on the Company’s website, www.realheart.se, together with all other information related to the Rights Issue. The Prospectus will also be made available on the Swedish Financial Supervisory Authority’s website, www.fi.se, and on Nordic Issuing’s website, www.nordic-issuing.se.

The record date for obtaining unit rights in the Rights Issue was June 16, 2023. The subscription period in the Rights Issue will run from June 20, 2023, to July 7, 2023.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2(k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in 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 other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

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” 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.

Link to the prospectus in PDF format.

Realheart Publishes Prospectus in Connection With Rights Issue of Units of Approximately SEK 56 Million

Press Release 19 June, 2023

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, 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 RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL OR WOULD REQUIRE FURTHER REGISTRATION OR ANY OTHER MEASURES.

Scandinavian Real Heart AB (publ) (“Realheart” or the “Company”) has prepared an EU growth prospectus (the “Prospectus”) for the forthcoming issue of units consisting of shares and warrants with preferential rights for existing shareholders (the “Rights Issue”), which the board of directors decided on and announced on May 15, 2023. The Prospectus was approved and registered by the Swedish Financial Supervisory Authority on June 16, 2023 and has been made available on the Company’s website, www.realheart.se (http://www.realheart.se), together with all other information related to the Rights Issue. The Prospectus will also be made available on the Swedish Financial Supervisory Authority’s website, www.fi.se, and on Nordic Issuing’s website, www.nordic-issuing.se.

The record date for obtaining unit rights in the Rights Issue was June 16, 2023. The subscription period in the Rights Issue will run from June 20, 2023, to July 7, 2023.

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

Publication, release, or distribution of this press release may in certain jurisdictions be subject to legal restrictions and persons in the jurisdictions where this press release has been made public or distributed should inform themselves of and follow such legal restrictions. The recipient of this press release is responsible for using this press release and the information herein in accordance with applicable rules in each jurisdiction.

The information in this press release neither contains nor constitutes an offer to acquire, subscribe for or otherwise trade shares, warrants or other securities in Realheart. No action has been taken and no action will be taken to allow an offer to the public in any jurisdiction other than Sweden. The Swedish Financial Supervisory Authority's approval of the Prospectus shall not be construed as an approval of the Company's shares, warrants or other securities. However, this press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 ("Prospectus Regulation"), and this press release neither identifies nor purports to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Realheart. The information in this press release is only intended to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance shall be given with respect to the accuracy or completeness of the information in this press release. Any investment decision should, in order for an investor to fully understand the potential risks and benefits associated with the decision to participate in the Rights Issue, be based solely on the information in the Prospectus. Therefore, an investor is recommended to read the entire Prospectus. This press release constitutes marketing in accordance with Article 2(k) of the Prospectus Regulation.

The information in this press release may not be published, released or distributed, directly or indirectly, in 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 other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

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” 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.

Link to the prospectus in PDF format.

This disclosure contains information that Realheart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB’s news distributor Cision upon publication of this press release.

Correction: Bulletin From the Annual General Meeting in Scandinavian Real Heart AB on 14 June 2023

The previous press release was inadvertently published with a MAR label. No information in the communiqué was of such a nature that it relates to MAR.

Press Release, 15 June 2023

The Annual General Meeting in Scandinavian Real Heart AB (the “Company”) has been held on 14 June 2023 and in particular the following resolutions were made.

Adoption of the profit and loss statement and the balance sheet, appropriation of the results and discharge of liability

The Annual General Meeting resolved to adopt the presented profit and loss statements and balance sheet for the financial year 2022. Furthermore, the Annual General Meeting resolved that no dividend will be paid for the financial year 2022 and that the results shall be carried forward into new account. The Annual General Meeting resolved to discharge the Board members and the CEO, active during the financial year 2022, from liability towards the Company.

Determination of fees for Board members and auditor

The Annual General Meeting resolved that a fee of SEK 150,000 shall be paid to the Chairman of the Board of Directors and SEK 72,500 to each of the other Board members who do not work operationally within the Company. It was resolved that fees to the auditor shall be paid according to approved invoices.

Election of Board of Directors and auditor

The Annual General Meeting resolved that the Board shall consist of five board members without deputies.

For the time until the end of the next Annual General Meeting, Christer Norström, Azad Najar, Ulf Grape, Oliver Voigt and Solveig Bergström were re-elected as Board members. Christer Norström was re-elected as Chairman of the Board.

The auditing company Grant Thornton Sweden AB was re-elected as auditor for the period until the Annual General Meeting 2024. The Company has been informed that Joakim Söderin will be appointed as auditor-in-charge.

Nomination Committee

The Annual General Meeting resolved that the Nomination Committee for the Annual General Meeting 2024 shall consist of Kim Norström and Azad Najar.

Amendment of the Articles of Association

The Annual General Meeting resolved on an amendment of the Articles of Association whereby the share capital in the Company shall amount to not less than SEK 7,000,000 and not more than SEK 28,000,000 and the number of shares shall amount to not less than 70,000,000 shares and not more than of 280,000,000 shares.

Furthermore, it was resolved to introduce a new section 11 in the Articles of Association which allows the General Meeting to be held in Västerås or Stockholm.

Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders

The Annual General Meeting resolved to approve the Board of Directors’ resolution of 15 May 2023, on issuance of units, in the form of new shares and warrants giving right to subscribe for new shares, with preferential rights for the shareholders. The issue comprises no more than 69,958,496 new shares and no more than 41,954,941 warrants of series TO2, which may be subscribed for and allotted together in the form of so called units where each unit consists of two (2) shares and one (1) warrant of series TO2. After the issue, the shares and the warrants will be separated. Two (2) warrants entitles to subscription of one (1) new share in the Company.

The shareholders of the Company shall have preferential rights to subscribe for units. For each share held on the record date, the shareholder receives one unit right, whereby one unit right entitles to subscribe for one unit. The record date for determining which shareholders shall be entitled to subscribe for units on a preferential basis shall be 16 June 2023.

In case not all units have been subscribed for, the Board of Directors shall decide that allotment of units subscribed for without unit rights shall take place up to the maximum amount of the issue, whereby the Board of Directors primarily will allot units to those who also subscribed for units based on unit rights, and in the event of over subscription, pro rata to their subscription based on unit rights. Secondly, the Board of Directors will allot units to those who subscribed for units without unit rights, and if full allotment cannot be made, pro rata to their subscription. To the extent not possible, allotment shall be made through drawing of lots, and finally, subject to such allocation being required in order for the issue to be fully subscribed, to the guarantors of the issue.

Warrants may also, with deviation from the shareholders’ preferential rights, be subscribed for by underwriters in the rights issue that have chosen to receive compensation in the form of newly issued units.

The subscription price is SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are issued free of charge. In the case of full subscription, this provides issuing proceeds of approximately MSEK 56.

Subscription for units with or without unit rights shall be made during the period from 20 June 2023 until, and including 7 July 2023. The Board of Directors shall be entitled to extend the subscription period. Trading with unit rights is expected to take place during the period from 20 June 2023 until, and including 4 July 2023. Trading in BTU (Paid Subscribed Units) is expected to take place from 20 June 2023 until, around week 30 2023.

Authorisation for the Board of Directors to resolve on a new share issue

The Annual General Meeting resolved on authorisation for the Board of Directors to, within the limits of the applicable Articles of Association, with or without deviating from the shareholders' preferential rights, on one or more occasions during the period until the next Annual General Meeting, resolve on an increase in the Company's share capital through a new issue of shares in the Company.

Complete proposals regarding the Annual General Meeting's resolutions as above are available on the Company's website, www.realheart.se

Cardiac Surgeon Dilek Gürsoy Speaks About Realheart’s Artificial Heart at Impact LECH

Press Release, 15 June 2023

Cardiac surgeon Dilek Gürsoy is one of several top-notch speakers at Impact LECH, taking place June 15-18 in Austria. Dr. Gürsoy speaks about artificial hearts in general and about the Realheart artificial heart specifically. She will also participate in a panel discussion on the theme "Man and machine in medicine".

Dr. Gürsoy was the first female surgeon in Europe to implant an artificial heart and is one of several prominent cardiac surgeons involved in Realheart's animal studies. Dr. Gürsoy has nearly 20 years of experience in cardiac surgery and also has expertise in the field of artificial hearts.

Realheart is at the forefront of developing a TAH solution that is expected to have significant advantages over the artificial hearts available today. Some of these expected advantages are that Realheart® TAH mimics the natural pulsating blood flow of the human heart with the aim of reducing the risks of blood-related side effects, and that the blood flow is automatically adapted to the body's needs. In addition, the product consists of two separate pumps, allowing for better placement in the chest. The energy-efficient pump principle provides a long battery life and allows for wireless charging via the skin in the future. An adequate TAH can save lives and provide a good quality of life while reducing healthcare costs.

"Artificial heart treatment and artificial heart research is important and therefore I am happy to share my long experience in this field at Impact Lech on 17 June 2023. Realheart's pump is very good, I really believe in it," says Dr. Dilek Gürsoy.

Impact LECH is a concept designed to highlight facts and shape opinion on current topics. The theme this time is human-machine interaction and how it can be designed in a successful and meaningful way.

"Realheart is a new generation of artificial hearts. We are developing our TAH to be the absolute best for the patients and to provide them with a continued good quality of life, but also to enable a fast surgery, which we have also shown in our animal studies. The fact that an experienced heart surgeon is talking about our product and highlighting its potential to become an alternative to heart transplantation for patients with life-threatening heart failure is extremely important," says Realheart's CEO Ina Laura Perkins.

Bulletin From the Annual General Meeting in Scandinavian Real Heart AB on 14 June 2023

Press Release, 14 June 2023

The Annual General Meeting in Scandinavian Real Heart AB (the “Company”) has been held on 14 June 2023 and in particular the following resolutions were made.

Adoption of the profit and loss statement and the balance sheet, appropriation of the results and discharge of liability

The Annual General Meeting resolved to adopt the presented profit and loss statements and balance sheet for the financial year 2022. Furthermore, the Annual General Meeting resolved that no dividend will be paid for the financial year 2022 and that the results shall be carried forward into new account. The Annual General Meeting resolved to discharge the Board members and the CEO, active during the financial year 2022, from liability towards the Company.

Determination of fees for Board members and auditor

The Annual General Meeting resolved that a fee of SEK 150,000 shall be paid to the Chairman of the Board of Directors and SEK 72,500 to each of the other Board members who do not work operationally within the Company. It was resolved that fees to the auditor shall be paid according to approved invoices.

Election of Board of Directors and auditor

The Annual General Meeting resolved that the Board shall consist of five board members without deputies.

For the time until the end of the next Annual General Meeting, Christer Norström, Azad Najar, Ulf Grape, Oliver Voigt and Solveig Bergström were re-elected as Board members. Christer Norström was re-elected as Chairman of the Board.

The auditing company Grant Thornton Sweden AB was re-elected as auditor for the period until the Annual General Meeting 2024. The Company has been informed that Joakim Söderin will be appointed as auditor-in-charge.

Nomination Committee

The Annual General Meeting resolved that the Nomination Committee for the Annual General Meeting 2024 shall consist of Kim Norström and Azad Najar.

Amendment of the Articles of Association

The Annual General Meeting resolved on an amendment of the Articles of Association whereby the share capital in the Company shall amount to not less than SEK 7,000,000 and not more than SEK 28,000,000 and the number of shares shall amount to not less than 70,000,000 shares and not more than of 280,000,000 shares.

Furthermore, it was resolved to introduce a new section 11 in the Articles of Association which allows the General Meeting to be held in Västerås or Stockholm.

Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders

The Annual General Meeting resolved to approve the Board of Directors’ resolution of 15 May 2023, on issuance of units, in the form of new shares and warrants giving right to subscribe for new shares, with preferential rights for the shareholders. The issue comprises no more than 69,958,496 new shares and no more than 41,954,941 warrants of series TO2, which may be subscribed for and allotted together in the form of so called units where each unit consists of two (2) shares and one (1) warrant of series TO2. After the issue, the shares and the warrants will be separated. Two (2) warrants entitles to subscription of one (1) new share in the Company.

The shareholders of the Company shall have preferential rights to subscribe for units. For each share held on the record date, the shareholder receives one unit right, whereby one unit right entitles to subscribe for one unit. The record date for determining which shareholders shall be entitled to subscribe for units on a preferential basis shall be 16 June 2023.

In case not all units have been subscribed for, the Board of Directors shall decide that allotment of units subscribed for without unit rights shall take place up to the maximum amount of the issue, whereby the Board of Directors primarily will allot units to those who also subscribed for units based on unit rights, and in the event of over subscription, pro rata to their subscription based on unit rights. Secondly, the Board of Directors will allot units to those who subscribed for units without unit rights, and if full allotment cannot be made, pro rata to their subscription. To the extent not possible, allotment shall be made through drawing of lots, and finally, subject to such allocation being required in order for the issue to be fully subscribed, to the guarantors of the issue.

Warrants may also, with deviation from the shareholders’ preferential rights, be subscribed for by underwriters in the rights issue that have chosen to receive compensation in the form of newly issued units.

The subscription price is SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are issued free of charge. In the case of full subscription, this provides issuing proceeds of approximately MSEK 56.

Subscription for units with or without unit rights shall be made during the period from 20 June 2023 until, and including 7 July 2023. The Board of Directors shall be entitled to extend the subscription period. Trading with unit rights is expected to take place during the period from 20 June 2023 until, and including 4 July 2023. Trading in BTU (Paid Subscribed Units) is expected to take place from 20 June 2023 until, around week 30 2023.

Authorisation for the Board of Directors to resolve on a new share issue

The Annual General Meeting resolved on authorisation for the Board of Directors to, within the limits of the applicable Articles of Association, with or without deviating from the shareholders' preferential rights, on one or more occasions during the period until the next Annual General Meeting, resolve on an increase in the Company's share capital through a new issue of shares in the Company.

Complete proposals regarding the Annual General Meeting's resolutions as above are available on the Company's website, www.realheart.se

This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB’s news distributor Cision upon publication of this press release.

Realheart Part of Vinnova Project for Cordless TAH Technology

Press Release, 8 June 2023

Invivopower has been granted EUR 80,000 from Vinnova to further develop its patented technology for transcutaneous energy transfer in collaboration with Scandinavian Real Heart. The project runs from June 2023 to May 2024.

''This does not affect our short-term timeline but gives us a great head start in a future development of the next generation of Realheart TAH. We remain on track with the goal of initiating clinical trials in 2024'', said Ina Laura Perkins, CEO of Realheart.

All of today's artificial hearts and other heart pumps are powered by a cable that connects the implanted pump to an energy source outside the body (driveline). Driveline infections are the most common type of heart pump-associated infections because the driveline exit point creates a conduit for bacteria. Invivopower's solution is instead based on an energy link that transfers energy without breaking the protective skin barrier.

Vinnova, Sweden's innovation agency, has awarded €80,000 in grant funding to Invivopower to develop a platform for the implementation of transcutaneous energy transfer technology (TET), that can be used by companies that develop heart pumps. Realheart will contribute with hardware and software development as well as market validation.

''Realheart is one of the most advanced companies in the world in developing an artificial heart. This project gives us a unique opportunity to put our technology in the hands of our customer early on, thereby gaining invaluable feedback that allows us to focus on the right things in developing a competitive product,'' Bengt Bern, CEO and founder of Invivopower, said.

''We are very grateful that Vinnova makes collaborations like this possible. Wireless transfer of energy/charging is certainly something that we want to implement in Realheart TAH in the future, and through this project we get access to a prototype that is also based on our own technology'', said Realheart's CEO Ina Laura Perkins.

Heart failure is one of the most common causes of death in the world, and the artificial hearts available have too many shortcomings to make a serious impact as a treatment option. Realheart TAH is being developed to overcome these obstacles while increasing the quality of life for patients. Realheart therefore already has a longer battery life and a thinner power cable. 

Board Member in Realheart Resigns at his own Request

Press Release, 7 June 2023

Scandinavian Real Heart AB announces today that board member Patrick NJ Schnegelsberg at his own request resigns from the Company's board. Schnegelsberg's last day will be today, June 7, 2023.

Patrick NJ Schnegelsberg has after careful consideration taken the decision to resign from the board of directors of Realheart, as his work situation requires his undivided attention and time.

“On behalf of the Board, the Company and the shareholders, I would like to thank Patrick for his contribution and commitment to the Board”, says Christer Norström, Chairman of the Board of Realheart.

The nomination committee will begin the work of finding a replacement for Patrick NJ Schnegelsberg.

Realheart Releases the Annual Report for 2022

Press Release, 24 May 2023

Today, Realheart publishes the annual report for 2022. In addition to the regular Swedish version, a designed version is also released containing reports, collaborations and milestones during the year.

The annual report including the auditor's report and the designed English version can be found at www.realheart.se and as attachments in this press release. 

Notice to Attend the Annual General Meeting in Scandinavian Real Heart AB

Press Release, 16 May 2023

The shareholders in Scandinavian Real Heart AB, reg. no. 556729–5588 (the "Company"), are hereby invited to the Annual General Meeting on Wednesday, 14 June 2023 at 15.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås. Registration for the Meeting begins at 14:30.

Right to participate in the Meeting, etc.

Shareholders who wish to participate in the Meeting shall

  • be recorded in the share register kept by Euroclear Sweden AB no later than Monday, 5 June 2023, and
  • notify the Company their intention to participate no later than Thursday, 8 June 2023 by post to Scandinavian Real Heart AB, Kopparbergsvägen 10, 722 13 Västerås, by phone +46 (0)70-643 88 61 or by e-mail jonas.bark@realheart.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, 5 June 2023. 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 Thursday, 8 June 2023, 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/Integritypolicy-bolagsstammor-svenska.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. Presentation of the annual report and the auditor’s report
  7. Resolution on
  1. adoption of the profit and loss statement and the balance sheet;
  2. appropriation of the Company’s profit or loss as set forth in the adopted balance sheet;
  3. discharge of the Board members and the CEO from liability
  1. Determination of number of Board members and auditors
  2. Determination of fees for Board members and auditor
  3. Election of Board members, Chairman of the Board and auditor
  4. Election of Nomination Committee
  5. Resolution on amendment of the Articles of Association
  6. Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders
  7. Resolution on authorisation for the Board of Directors to resolve on a new share issue
  8. Closing of meeting

The Nomination Committee’s proposals

The Nomination Committee's proposals regarding the election of Chairman of the Meeting (item 1), determination of number of Board members and auditors (item 8), determination of fees for Board members and auditor (item 9), election of Board members, Chairman of the Board and auditor (item 10) as well as the election of the Nomination Committee (item 11) will be presented on the Company's website www.realheart.se well in advance of the Meeting.

The Board of Directors’ proposals

Item 7 b – Resolution on appropriation of the Company’s profit or loss as set forth in the adopted balance sheet (item 8 b)

The Board of Directors proposes that the Annual General Meeting shall resolve that distributable profits are carried forward and not to distribute any dividends for the financial year 2022. 

Item 12 – Resolution on amendment of the Articles of Association

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

Current wording: Proposed wording:
§ 4 Share Capital The share capital of the company shall amount to not less than SEK 2,000,000 and not more than SEK 8,000,000. § 4 Share Capital The share capital of the company shall amount to not less than SEK 7,000,000 and not more than SEK 28,000,000.
§ 5 Number of shares The number of shares in the company shall be not less than 20,000,000 and not more than 80,000,000 shares. § 5 Number of sharesThe number of shares in the company shall be not less than 70,000,000 and not more than 280,000,000 shares.

Furthermore, the Board of Directors proposes that the Meeting resolve to introduce a new section 11 in the Articles of Association which allows the General Meeting to be held in Västerås or Stockholm as set out below.

Proposed wording:
§ 11 Location for the general meetingA general meeting may be held in Västerås or Stockholm.

Since it is proposed that the section be inserted as a new section 11, it is also proposed to renumber subsequent sections in the Articles of Association so that previous sections 11–13 become sections 12–14.

The resolution shall be conditional on the Meeting approving the Board's resolution on a new issue of units with preferential rights for the shareholders in accordance with item 13 below.

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

Item 13 – Approval of the resolution by the Board of Directors to issue new units consisting of shares and warrants with preferential rights for the shareholders

The Board of Directors proposes that the Meeting resolves to approve the Board of Directors’ resolution of 15 May 2023, on issuance of so called units, in the form of new shares and warrants giving right to subscribe for new shares, with preferential rights for the shareholders in accordance with below.

Number of units and share capital increase

The issue comprises no more than 69,958,496 new shares and no more than 34,979,248 warrants of series TO2, which may only be subscribed for and allotted together in the form of so called units where each unit consists of two (2) shares and one (1) warrant of series TO2. After the issue, the shares and the warrants will be separated. Two warrants entitles to subscription of one (1) new share in the Company.

The Company’s share capital may be increased through subscription of the new shares and through exercise of the warrants for subscription of new shares. The Company’s share capital may be increased by no more than SEK 8,744,812, out of which no more than SEK 6,995,849.6 is from the new shares and no more than SEK 1,748,962.4 is from the new shares that may be subscribed for through exercise of the warrants. The share capital increases have been calculated based on a quotient value of SEK 0.10 per share. 

Right to subscribe for units

The shareholders of the Company shall have preferential rights to subscribe for units. For each share held on the record date, the shareholder receives one unit right, whereby one unit right entitles to subscribe for one unit. The record date for determining which shareholders shall be entitled to subscribe for units on a preferential basis shall be 16 June 2023.

In case not all units have been subscribed for, the Board of Directors shall decide that allotment of units subscribed for without unit rights shall take place up to the maximum amount of the issue, whereby the Board of Directors primarily will allot units to those who also subscribed for units based on unit rights, and in the event of over subscription, pro rata to their subscription based on unit rights. Secondly, the Board of Directors will allot units to those who subscribed for units without unit rights, and if full allotment cannot be made, pro rata to their subscription. To the extent not possible, allotment shall be made through drawing of lots, and finally, subject to such allocation being required in order for the issue to be fully subscribed, to the guarantors of the issue.

Subscription price of units

The subscription price is SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are issued free of charge. In the case of full subscription, this provides issuing proceeds of approximately MSEK 56.

The share premium shall be transferred to the unrestricted premium reserve.

Subscription and payments of units

Subscription for units based on unit rights shall be made through payment in cash during the period from 20 June 2023 until, and including 7 July 2023. The Board of Directors shall be entitled to extend the subscription period.

Subscription without unit rights shall be made through notice on special application form during the period from 20 June 2023 until, and including 7 July 2023. The Board of Directors shall be entitled to extend the subscription period. Payment for units shall be made at the latest three business days following the date of the dispatch of a contract note to the subscriber, specifying allocation of units, or such later date as the Board of Directors may decide.

Trading with unit rights is expected to take place during the period from 20 June 2023 until, and including 4 July 2023. Trading in BTU (Paid Subscribed Units) is expected to take place from 20 June 2023 until, around week 30 2023. 

Subscription and subscription price of new shares subscribed for through exercise of warrants

Subscription of new shares through exercise of warrants may be made during the period from and including 2 January 2025 up to and including 31 January 2025.

Two (2) warrants entitle the holder to subscribe for one (1) new share in the Company at a subscription price per share (the “Exercise Price”) corresponding to the higher of (i) 70 percent of the volume weighted average trading price of the company’s share on Nasdaq First North Growth Market during a period of 10 trading days immediately preceding the subscription period, however no more than SEK 2 per share, and (ii) the quotient value of the share at the time of exercise of warrants. The part of the Exercise Price exceeding the quota value of the Company’s shares shall be allocated to the unrestricted share premium fund. If no trading price is recorded for a particular trading day within the specified period, such day shall not be taken into account, but the period shall instead be extended backwards in time with the number of previous trading days required for the period to comprise a total of 10 trading days with a recorded trading price. The Exercise Price calculated in accordance with above shall be rounded off to two decimals, where SEK 0.005 shall be rounded upwards.

Right to dividends of new shares

The new shares shall entitle to dividends as from the first record date for dividends following registration of the new shares with the Swedish Companies Registration Office.

Miscellaneous

The Board of Directors, or a person appointed by the Board of Directors, shall be authorised to make any minor adjustments required to register the resolution with the Swedish Companies Registration Office or Euroclear Sweden AB.

The resolution on a rights issue is conditional upon that the Articles of Association are amended according to item 12 above.

Item 14 – Resolution on authorisation for the Board of Directors to resolve on a new share issue

The Board of Directors proposes that the Annual General Meeting resolve on authorisation for the Board of Directors to, within the limits of the applicable Articles of Association, with or without deviating from the shareholders' preferential rights, on one or more occasions during the period until the next Annual General Meeting, resolve on an increase in the Company's share capital through a new issue of shares in the Company. The purpose of the authorisation and the reasons for any deviation from the shareholders' preferential rights is that new issues should be able to take place in order to increase the Company's financial flexibility and the Board's capacity for action, to be able to broaden the shareholder base in the Company and to be able to finance any business mergers and acquisitions of operations or businesses that the Company may carry out.

The total number of shares to be issued by in accordance with the authorisation shall not be limited in any other way than by the limits of the share capital and the number of shares included in the Company's Articles of Association registered at any time. The issues shall be carried out at a market-based subscription price, subject to a market-based issue discount where applicable, and payment shall be made through cash payment, with property in kind or by set-off, or with other conditions.

The Board of Directors or a person appointed by the Board of Directors shall authorised to make the minor adjustments required for the registration of the resolution at the Swedish Companies Registration Office. For a valid resolution in accordance with the Board's proposal, the resolution must be supported by shareholders with 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 34,979,248.

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 Directors and the CEO at the Meeting.

Provision of documents

The Company's annual report and audit report for the financial year 2022, the Board of Directors' complete proposals for resolutions as set out above as well as other documents according to the Swedish Companies Act will be kept available to the shareholders at the Company's head office; Kopparbergsvägen 10, 722 13 Västerås and on the Company's website www.realheart.se no later than Wednesday 24 May 2023. Copies of the documents will also be sent to shareholders who so request and who provide their postal address.

Västerås in May 2023

Scandinavian Real Heart AB

THE BOARD OF DIRECTORS

Realheart Carries out new Issues of Shares of Maximum SEK 73 Million

NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, JAPAN, SOUTH AFRICA OR AUSTRALIA OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

Press Release, 15 May, 2023

The board of directors of Scandinavian Real Heart AB (publ) ("Realheart" or the "Company") has, subject to approval from the annual general meeting, decided to carry out a rights issue of up to 34,979,248 units with preferential rights for existing shareholders (the "Rights Issue"). The date for the annual general meeting has been moved to 14 June 2023. The subscription period will take place from 20 June until and including 7 July  2023. In the event the Rights Issue is fully subscribed, the Company will be provided with approximately SEK 56 million before transaction costs. The Rights Issue is covered to approximately 60.6 percent through subscription commitments and underwriting commitments from current shareholders and external investors. In addition to the Rights Issue, the Board of Directors propose a directed issue (the “Directed Issue”) of approximately 1.5 million EUR to the European Innovation Council’s (“EIC”) Accelerator which, per today’s exchange rate of 11.3 SEK per EUR corresponds to approximately SEK 17 million.

Summary

  • In the event the Rights Issue is fully subscribed, Realheart will receive approximately SEK 56 million before transaction costs.
  • The Rights Issue is covered to approximately 9.5 percent through subscription commitments from existing shareholders and to approximately 51.2 percent through underwriting commitments. Thus, the Rights Issue is secured to 60.6 percent through subscription commitments and underwriting commitments.
  • The subscription period in the Rights Issue is set to take place from 20 June 2023 until and including 7 July 2023.
  • Existing shareholders will receive one (1) unit right for each share held in the Company on the record date on June 16, 2023. One (1) unit right entitles the holder to subscribe for one (1) unit in the Rights Issue. One (1) unit consists of two (2) newly issued shares and one (1) warrant of series TO2. The subscription price is SEK 1.6 per unit, corresponding to SEK 0.8 per share. The warrants are issued free of charge.

Background and motive to the Rights Issue

Realheart develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body’s natural circulation – a unique concept in the medical technology world.

The clinical version of Realheart TAH, i.e. the version that will eventually be used in humans, was fully developed in 2022 and began to be tested in preclinical studies. During the animal trials, Realheart was able to gradually increase survival time from one to four days. In addition, several other key TAH performance criteria were confirmed, including no signs of hemolysis (damage to red blood cells) or thromboembolic events (blood clots) in combination with a good left-right balance and a pulsatile blood flow and natural blood pressure. In 2023, the Company will continue to conduct animal trials as well as reliability studies and blood tests in order to meet the FDA’s requirements for starting clinical studies in humans. Realheart aims to start human clinical studies in 2024 and has regular dialog with both the FDA in the US and the Notified Body in the EU. Realheart also focuses on negotiating and signing agreements with strategically important national and international suppliers and partners who will contribute to the development and production of Realheart TAH.

To be able to further fund the preclinical studies and generate successful results, with the ambition to begin human clinical trials during 2024, Realheart is conducting a Rights Issue.

The capital from the Rights Issue of maximum approximately SEK 56 million will be allocated to the following areas of application, in order of priority:

  1. Preclinical studies: approximately 75 percent
  1. Blood tests and reliability tests: 25 percent
  2. Animal trials: 50 percent
  1. Regulatory work: Approximately 5 percent
  2. Operational costs: Approximately 20 percent

Terms for the Rights Issue

  • In the event of full subscription in the Rights Issue, the Company is provided approximately SEK 56 million before transaction costs.
  • The subscription period for units will take place from 20 June 2023 until and including 7 July 2023.
  • Existing shareholders will receive one (1) unit right for each share held in the Company on the record date 16 June 2023. One (1) unit right entitles the holder to subscribe for one (1) unit. One (1) unit consists of two (2) newly issued shares and one (1) warrant of series TO2.
  • The subscription price per unit is SEK 1.6, corresponding to SEK 0.8 per share. The warrants are issued free of charge.
  • In the Rights Issue, a maximum number of 34,979,248 units will be issued, corresponding to 69,958,496 shares and 34,979,248 warrants of series TO2.

Terms for the Warrants of series TO2

  • Two (2) warrants of series TO2 entitles the holder to subscribe for one (1) new share in the Company. The subscription price for shares through the exercise of warrants corresponds to 70 percent of the volume-weighted average price paid for the Company’s shares ten (10) days prior to the subscription period, but not more than SEK 2.
  • The exercise period for the warrants of series TO2 will take place during the period 2 January 2025-31 January 2025.
  • Upon full exercise of the warrants of series TO2, the number of shares will increase by a maximum of 17,489,624.
  • The warrants of series TO2 are expected to be admitted to trading on Nasdaq First North Growth Market in close connection to the Rights Issue’s registration at the Swedish Companies Registration Office and Euroclear and the BTU’s conversion to ordinary shares and warrants.

The Directed Issue

In addition to the Rights issue, the Board of Directors propose a Directed Issue of approximately 1.5 million EUR to the EIC Innovation Council’s (EIC) Accelerator on the same terms as in the Rights Issue. The Directed Issue is conditional on the implementation of the Rights Issue. Further information will be provided in a separate press release.

Change in number of shares and share capital as well as dilution

In the event of full subscription in the Rights Issue, the amount of shares in the Company may increase by 69,958,496, from 34,979,248 to maximum 104,937,744 and the share capital may increase by maximum SEK 6,995,849.6, from SEK 3,497,924.8 SEK to maximum SEK 10,493,774.4, corresponding to a maximum dilution effect of 66.7 percent of the number of shares and votes in the Company.

In the event of full exercise of the warrants of series TO2, the amount of shares in the Company may increase by maximum 17,489,624, from 104,937,744 to maximum 122,427,368 and the share capital by maximum SEK 1,748,962.4, from SEK 10,493,774.4 SEK to maximum SEK 12,242,736.8 corresponding to a maximum dilution effect of 14.3 percent of the number of shares and votes in the Company.

EU growth Prospectus

Full terms and conditions for the Rights Issue and other information about the Company will be available in the EU growth prospectus, which is expected to be published by June 19, 2023 (the “Prospectus”).

Subscription commitments and underwriting commitments

The Company has obtained subscription commitments of approximately SEK 5.3 million, corresponding to approximately 9.5 percent of the Rights Issue and approximately SEK 28.6 million of underwriting commitments, corresponding to approximately 51.2 percent of the Rights Issue. In total, the Rights Issue is covered to approximately 60.6 percent of subscription commitments and underwriting commitments.

Underwriting compensation of fifteen (15) percent of the guaranteed amount is paid if the underwriters choose compensation in the form of cash or seventeen point five (17.5) percent of the guaranteed amount if the underwriters choose compensation in the form of new issued units. If the underwriters choose to receive the underwriting compensation in new issued units, the board will decide to issue such new units with the authorization from the annual general meeting to be held on 14 June 2023. For remuneration in the form of Units, the issue price is the market price of the share minus a market discount (approximately 10%). The warrants are issued free of charge. No compensation is paid for the subscription commitments. Neither the subscription commitments nor the underwriting commitments are secured by bank guarantee, blocking measures, pledges, or similar arrangements.

Indicative time table for the Rights Issue

General meeting June 14, 2023
Last day of trading in the Company’s shares including the right to receive unit rights June 14, 2023
First day of trading in the Company’s shares excluding the right to receive unit rights June 15, 2023
Record date for participation in the Rights Issue June 16, 2023
Estimated date for publication of EU growth prospectus June 19, 2023
Subscription period for the Rights Issue June 20 – July 7, 2023
Trading with unit rights (UR) June 20 – July 4, 2023
Trading with BTU June 20 – approximately week 30, 2023
Estimated date for publication of Rights Issue results July 12, 2023

Advisers

Skills Corporate Finance Nordic AB is financial adviser and Setterwalls Advokatbyrå AB is legal adviser to Realheart in connection with the Rights Issue.

Important information

The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for any securities in the Company in any jurisdiction where such offer would be considered illegal. This press release does not constitute an offer to sell or an offer to buy or subscribe for shares issued by the Company in any jurisdiction where such offer or invitation would be illegal. In a member state within the European Economic Area ("EEA"), shares referred to in the press release may only be offered in accordance with applicable exemptions under the Prospectus Regulation.

This press release does not constitute or form part of an offer or solicitation 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 exemption from registration under the US Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold within 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 the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into the United States, Canada, Japan, South Africa or Australia, or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations.

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" 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.

A prospectus regarding the Rights Issue described in this release will be published by the Company on or about 19 June 2023. This release is however not a prospectus in accordance to the definition in the Prospectus Regulation. In accordance with article 2 k of the Prospectus Regulation this press release constitutes an advertisement. Complete information regarding the Rights Issue can only be obtained through the Prospectus. Realheart has not authorized any offer to the public of shares or rights in any other member state of the EEA. 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. 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 new shares. Any investment decision in connection with the Rights Issue must be made on the basis of all publicly available information relating to the Company and the Company's shares. Such information has not been independently verified by the Company’s financial adviser. The financial adviser is acting for the Company in connection with the transaction and no one else and will not be responsible to anyone other than the Company for providing the protections afforded to its clients nor for giving advice in relation to the transaction or any other matter referred to herein.

Information to distributors

Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the "MiFID II Product Governance Requirements"), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares in Realheart have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in Realheart may decline and investors could lose all or part of their investment; the shares in Realheart offer no guaranteed income and no capital protection; and an investment in the shares in Realheart is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Rights Issue.

For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in Realheart.

Each distributor is responsible for undertaking its own target market assessment in respect of the shares in Realheart and determining appropriate distribution channels.

This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB’s news distributor Cision upon publication of this press release.

EIC Fund to Invest in Scandinavian Real Heart AB

Press Release, 15 May 2023

Realheart receives confirmation of an initial investment from the EIC of up to 3.5 MEUR.

Today, we are pleased to announce that the European Innovation Council's (EIC) Accelerator intends to make an initial investment of up to 3.5 MEUR, equivalent to approximately 39 MSEK as part of Realheart’s next investment round. The investment means that the EIC considers Realheart's artificial heart to be groundbreaking and has the potential to reform healthcare for heart failure patients.  Formal confirmation is expected shortly.

EIC is one of Europe's leading financiers of innovative companies that are expected to become global leaders in their markets. The EIC Accelerator is a program that supports carefully selected companies with both funding and services to accelerate development and market entry. The selection of companies is based on the assessment of the pioneering nature of innovation, scaling up potential and with risk levels that are too high for private investors alone.

The investment in Realheart is conditional on:

– The investment being a co-investment with new and existing shareholders.

– That EIC's total ownership does not exceed 20 percent of the company after completion of the investment

Realheart has previously stated that it will need an additional approximately 40 MEUR to reach the market for its total artificial heart (TAH). Thus, going forward, the initial EIC investment of up to 3.5 MEUR together with follow-on investment, which, depending on future milestones achieved, can be maximum 15 MEUR (follow this link) will cover a significant share of that amount in future issues.

"For Realheart, it is a great honor to be selected by EIC as a recipient of investment. We are pleased that EIC sees our potential and that they want to be part of our continued growth and development" says Ina Laura Perkins, CEO of Realheart.

Realheart is currently in preclinical studies and expects to start clinical studies in 2024.

This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB’s news distributor Cision upon publication of this press release.

Realheart Returns to Communicating in Both Swedish and English

Press Release, 12 May 2023

Realheart's recently published decision to communicate only in English is reversed. Shareholders and other stakeholders have provided feedback and emphasized the value of having communication in Swedish.

Based on this, Realheart chooses to return to communicating in both languages, as the company wants to meet the needs and wishes of the market. This means that all press releases and reports will continue to be published in both Swedish and English.

Interim Report 230101-230331

Press Release 11 May, 2023

Revenue and Result

Scandinavian Real Heart is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of foreign currenty exhance gains. Research and development costs of Realheart® TAH were capitalized during the year with 4.1 MSEK. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.

The item other external costs of 4.2 MSEK consists of costs for purchased services of 1.0 MSEK and various other costs of 3.2 MSEK. Of these costs, 4.1 MSEK has been capitalized.

Financial Position

During the period, the company has received cash of 3.7 MSEK from an extended loan from ALMI and 4.1 MSEK from TO1. With a cash balance of 10.5 MSEK, the companty has funding that will last into third quarter of 2023.

In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.

Significant Events During the First Quarter of the Year

January starts with communicating increased survival time from one to four days, and also that several performance criteria were increased. All this was reached in the end of 2022, but was communicated in 2023, after collection of data including analysis. The main citieria were: no hemolysis, no thromboembolic events, high pumping capacity and good right-left balance, and short procedure.

In January, the company also communicates that they, together with KTH, developed Sweden's First Patient Simulator. The collaboration between Realheart and KTH to develop the simulator (scientific term: "hybrid simulator") began in 2022 after a contribution of SEK 4 million from Smart Elektronik, a joint initiative by Vinnova, Formas and the Swedish Energy Agency.

In Januari, the company also communicates that Dr. Ulf Kjellman Strengthens Realheart's Medical Advisory Board. Ulf Kjellman has over 35 years of experience in cardiothoracic surgery.

End of February, Professor Bart Meyns Strengthens Realheart's Advisory Board. Dr Meyns is a Professor at the University of Leuven in Belgium and is also leading Realheart's surgical team in the ongoing animal study.

In the beginning of March, Realheart announces the outcome of the exercise of warrants of series TO1. A total of 7 183 148 warrants of series TO1 were exercised, corresponding to approximately 70 percent of the total number of warrants, which brings the Company approximately SEK 4.2 million before issuing related costs.

Last days of March, cardiac surgeon Ulf Kjellman Takes over as Chief Medical Officer (CMO) at Realheart. Kjellman, who has many years of experience in advanced cardiac surgery, will be clinically responsible for the company's preclinical and clinical studies.

The first quarter ends with Realheart's CEO to Present at the Swiss Nordic Bio Zürich Healthcare Investor Conference. There is an increased interest in the possibilities of total artificial hearts (TAH) and the interest in Realheart is much higher this year compared to last year's conference. Artificial hearts open the door to a paradigm shift in the care of patients with severe heart failure. Here, saving lives and reducing healthcare costs go hand in hand.

Significant Events After the end of the Period

In the middle of April the company communicates that the market need in the US and Europe is estimated at 200,000 artificial hearts per year – equivalent to SEK 200 Billion – and the trend is accelerating. Industry players and Realheart estimate that the market potential for total artificial hearts (TAHs) is over 200,000 units per year in Europe and the US. Realheart believes it is well positioned to take significant market share with its four-chamber artificial heart.

In April, Joseph Bornoff’s Simulations of the Realheart is Published in the Springer Nature Journal Scientific Reports. It is an advanced computational fluid dynamics (CFD) model of the Realheart® TAH (Total Artificial Heart) to study blood flow in the pump and optimize its function. The work has been co-authored with colleagues at Realheart.

At the end of April, results of Scandinavian Realheart’s Total Artificial Heart demonstrating lower rates of hemolysis are published. The peer-reviewed study titled ”In Vitro Hemolytic Performance of the Realheart V11C TAH Prototype with Porcine Blood” was published in the journal of Artificial Organs.

During the first days in May, scientists at Scandinavian Real Heart and at the University of Bath publish the world’s first computer simulation method for dual mechanical heart valves in series. The article “Overset meshing in combination with novel blended weak-strong fluid-structure interactions for simulations of a translating valve in series with a second valve” was published in the scientific journal “Computer

CEO Ina Laura Perkins has the Word

I am pleased to look back at a busy and very successful first quarter of 2023 with several key achievements for Realheart.

First, and foremost, by reaching the four-day survival benchmark of animals implanted with our TAH, we have shown that the Company is on track towards obtaining approval for the first in human use of our implant. This is the result of significant efforts by our R&D team, surgeons, and others who continue to improve surgical methodology and study protocols to a level where the procedure is becoming routine.

Similarly, our R&D team together with researchers at KTH Royal Institute of Technology, successfully developed the first patient simulator (digital twin) that is used to test the Company’s TAH algorithm. Apart from this being a “first” in our space, having access to digital twin technology will improve and streamline our R&D processes for current and future products. The project was rewarded with a grant from the Strategic Innovation Program Smarter Electronic Systems – a joint initiative by Vinnova, Formas and the Swedish Energy Agency.

We have continued to expand our team with two world renowned cardiac surgeons: Dr. Ulf Kjellman has been appointed as the Company’s CMO, and Prof. Bart Meyns has joined our Medical Advisory Board. Both are Key Opinion leaders with extensive experience in cardiac surgery and from the field of developing and testing heart pumps.

With the support of our shareholders, we have successfully raised 4.2 MSEK from warrants of series TO1. In an increasingly competitive and rapidly evolving environment, this as well as future financing, are critical for us to continue our current trajectory of successes, to effectively progress the development of the Realheart® TAH into the clinic towards product approval, and to create shareholder value.

We have continued to promote Realheart on the international stage to both investors and the medical and scientific community. Dr Azad Najar, our founder and Chief Innovation Officer, was selected as keynote speaker at the Artificial

Intelligence (AI) Conference in Cairo and the Dubai Innovation Conference.

And I have, together with Dr Oliver Voigt, presented Realhart at the Healthcare Investor Conference, Swiss Nordic Bio, in Zürich. Creating awareness and an international footprint of our technology among investors and the medical and scientific communities is key to the future success of the Company.

Significant events after the end of the period is that Realheart has published three scientific articles, in Springer Nature journal Scientific Reports, the journal Artificial Organs, and Computer Methods in Biomechanics and Biomedical Engineering . This is really important work, done in international collaboration between scientists at Realheart and researchers at the University of Bath and Swansea University Medical School, both in the United Kingdom.

After an eventful start of the year, we are incredibly excited and full of confidence. Knowing that we are on the right track, we are looking forward to completing our pre-clinical studies. Again, I want to highlight that support from current and future shareholders is essential for us to continue on our path to success.

Ina Laura Perkins

CEO, Scandinavian Real Heart AB

Scandinavian Real Heart AB

Swedish innovation power has given the world medical technology inventions such as the heart and lung machine, the pacemaker and the dialysis machine. The next big innovation is Realheart's artificial heart. A Swedish patented innovation that will save the lives of heart failure patients. Every year, 3,500 people die of heart failure in Sweden alone. Today, the only rescue is a heart transplant, but the number of donated hearts is only enough for 2% of those in need.

The start-up of the company was initiated by the doctor Azad Najar in 1999 when he started sketching an artificial heart that completely mimics the biological. In 2007, Azad co-founded Scandinavian Real Heart with two partners. The original idea behind Realheart® TAH is based on flow analyzes made at KTH 2002-2005 and is based on constructing an artificial heart that mimics the biological. By imitating its basic principle, a pressure and flow is created that reduces the risk of blood clots and provides an energy-efficient blood flow. These factors are important to give the patient a good quality of life. The development of the product has progressed strongly over the years. Blood circulation, pump function, pressure, and pulse generation have been verified in ethically approved animal experiments. Today, research and development takes place in close collaboration with world-leading heart surgeons, researchers and engineers.

Patent Protection

Realheart has granted patents in Sweden, Germany, the United Kingdom, the United States, China and India that protect the original pump principle in TAH. This patent also provides protection for future products: RealVAD® and PulsePump®.

Patent protection is also available on the latest version of Realheart® TAH in Sweden, USA, UK, Australia and Japan. The patent application for it has also been filed for Germany and Canada. The patents provide protection in the markets that are largest and most important for artificial hearts right now, with the exception of China and India which are considered important emerging markets. In addition to the patent protection described above, Realheart has also approved patents in Sweden, the USA and the United Kingdom for the future Sternal prosthesis product. The application is also submitted in Germany and France. In 2018, a new connection was designed for a simple and secure connection between Realheart® TAH and the body's circulatory system. The patent application for this has also been filed.

Finally, the patent application has been filed in two parts for the use of pressure sensors for the automatic control. Given the existing patents together with the new patent applications, the Board believes that the company has a strong patent situation and strong intellectual property protection.

Mission and Goal

Realheart's mission is to use medical technology solutions to save as many heart failure patients as possible and to create the best conditions for a life-affirming continuation of life. The company's overall goal is for the artificial heart to be commercialized and become a full-fledged treatment alternative for patients with heart failure. The heart should have a better function than the solutions that are on the market today. It should be possible to use both as a bridge to transplantation and as final therapy.

The Stock

Scandinavian Real Heart AB was listed on the Nasdaq First North Growth Market in December 2021. Nasdaq First North GM is a registered SME marketplace for growth companies that enables Nordic and international entrepreneurs to gain access to growth capital to develop and expand their operations. As of March 31, 2023, the number of shares in Scandinavian Real Heart was 34 979 248.

Principles for the preparation of the Interim Report

The interim report has been prepared in accordance with the Annual Accounts Act and with the application of general advice, recommendations and statements from the Swedish Accounting Standards Board.

Audit Review

The interim report has not been reviewed by the Company's auditor.

Upcoming Financial Reports

Annual Report 2022 2023-05-26

Interim Report Q2, 2023 2022-08-24

Interim Report Q3, 2023 2022-11-16

Year-end Report, 2023 2023-02-15

Annual General Meeting

The company's annual general meeting is planned to be held Friday, June 16th.

Submission of Interim Report

Västerås, May11, 2023

The Board

Scandinavian Real Heart AB

For Further Information, Please Contact

Ina Laura Perkins

CEO Scandinavian Real Heart

Phone: +46 70 406 49 21

E-mail: inalaura.perkins@realheart.se

Jonas Caspari Bark

CFO Scandinavian Real Heart

Phone: +46 70 643 88 61 E-mail: jonas.bark@realheart.se

This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information in this press release has been published through the agency of the contact persons set out below, at the time stated by Scandinavian Real Heart AB’s news distributor Cision upon publication of this press release.

Link to archive for financial reports: https://realheart.se/sv/investerare/arkiv/

Realheart to Proceed With Communication in English Only

Press Release 9 May, 2023

Scandinavian Real Heart AB has decided to continue to communicate only in English from the publication of the Q1 report on May 11, 2023. This means that all regulatory, including Market Abuse Regulation press releases, will be published only in English.

The exception is annual reports, which according to current regulations must always be available in Swedish for Swedish-registered companies. An English version will also be available.

Scientists at Scandinavian Real Heart and at the University of Bath Publish the World’s First Computer Simulation Method for Dual Mechanical Heart Valves in Series

Press Release 3 May, 2023

Scandinavian Real Heart (the “Company”) today announced the publication of the world’s first combined computational fluid dynamics (CFD) and fluid-structure interaction (FSI) methodology for simulating positive displacement bileaflet valves in series. The article “Overset meshing in combination with novel blended weak-strong fluid-structure interactions for simulations of a translating valve in series with a second valve” is the result of an international collaboration of scientists at Scandinavian Real Heart and researchers at the University of Bath (UK) and was published in the scientific journal “Computer Methods in Biomechanics and Biomedical Engineering”.

The researcher group, led by K. Fraser, at the Department of Mechanical Engineering of the University of Bath, have created an efficient and accurate method for simulating two mechanical heart valves in series, a fundamental requirement for simulations of the Realheart® TAH (Total Artificial Heart). The team has achieved this by using sophisticated CFD tools (overset meshing together with a blend of weak and strong coupling) to generate accurate calculations of the fluid shear stress in critical regions during the opening and closing of mechanical heart valves. By doing so, the scientists were able to balance the computational efficiency needed to simulate the whole Realheart® TAH with the accuracy required to resolve the dynamics of blood flow.

“Heart valves are notoriously difficult to model. The Realheart® TAH contains a two valves in series design so that the up and down movement of the first valve creates the pressures that moves the second valve. This makes computational modelling more complex,” commented Ina Laura Perkins, CEO of Realheart and one of the co-authors of the study. “The model published here is the foundation for the Realheart® TAH computational modelling methodology developed by the Company that was recently published in Nature Scientific Reports (https://www.nature.com/articles/s41598-023-32141-2). Developing and using such breakthrough computational modelling tools enables us to learn more from simulations, thus saving significant development and testing time and resources,” Ina Laura Perkins, added.

Computer Methods in Biomechanics and Biomedical Engineering Publishes research on computational biomechanics and biomedical engineering, including cell mechanics, biofluids, hemodynamics, modeling, design and assessment. It is affiliated with the European Society of Biomechanics and published by Taylor & Francis. The article can be accessed here: https://www.tandfonline.com/doi/full/10.1080/10255842.2023.2199903

Results of Scandinavian Realheart’s Total Artificial Heart Demonstrating Lower Rates of Hemolysis, Published in the Journal Artificial Organs

Press Release 27 April, 2023

Scandinavian Real Heart (the “Company”) has published results demonstrating that the Company’s Realheart Total Artificial Heart (TAH) prototype V11C has lower rates of hemolysis compared to published data from studies of the Reinheart's large and small TAH. The peer-reviewed study titled ”In Vitro Hemolytic Performance of the Realheart V11C TAH Prototype with Porcine Blood” was published on-line, ahead of print, in the Journal of Artificial Organs.

The paper summarizes work performed by an international team of researchers led by Drs. Ina Laura Perkins and Azad Najar of Scandinavian Real Heart in collaboration with scientists at the Swansea University Medical School in the United Kingdom.

High rates of hemolysis requiring repeat and frequent blood transfusions are a key factor limiting the utility of currently available TAHs. Furthermore, hemolysis testing is a regulatory requirement for all new devices intended for the treatment of patients with heart failure. In this study, the so called “Aachen Rig” is used as a step towards creating a gold standard for testing pulsatile flow blood pumps.

In order to compare the outcomes of hemolysis testing with data published in the literature, the researchers utilized the Aachen Rig to test the Realheart V11C TAH prototype. By utilizing the continuous flow pump BPX-80 from Medtronic Inc. as a control, the authors demonstrated that the Realheart V11C TAH has a lower absolute and relative rate of hemolysis when compared to published results obtained with both the large and small ReinHeart TAH (ReinHeart TAH GmbH) devices.

"Developing a TAH is a technical and clinical challenge and ensuring that hemolysis is as low as possible is a key factor impacting the design of artificial hearts. It is against this background that we are developing the Realheart TAH with pulsatile blood flow. Thanks to the design of our artificial heart, with two atria, two chambers and an AV plane, we can generate natural blood flow which we expect will contribute to a reduced risk of hemolysis. The research published in this article is the foundation for the methodology we are using in our ongoing comparison with the market-leading pump SynCardia,” said Ina Laura Perkins, CEO of Realheart.

Artificial Organs is a peer-reviewed biomedical journal that publishes research in the field of artificial organs and medical technology. The journal was founded in 1977 and is published monthly. The publication can be accessed via: https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.14533

(Access fee may be required).

Realheart Moves the Date of the Annual General Meeting and Publication of the Annual Report for 2022

Press Release 19 April, 2023

Realheart's planned Annual General Meeting (AGM) will be moved from May 26 to June 16, 2023. The reason for this is that the company intends to arrange a physical meeting in Västerås and the previously communicated date conflicts with other planned activities. In connection with this, the publication of the annual report for 2022 is also moved forward to May 26, i.e. three weeks before the date of the meeting, in accordance with current regulations.

Notice of the AGM will be sent out as usual four weeks before the meeting, i.e. on May 19.

Joseph Bornoff’s Simulations of the Realheart Published in Scientific Reports

Press Release 18 April, 2023

Realheart has several international collaborations with researchers and PhD students to develop the world's first four-chamber heart. One of these is Joseph Bornoff, a PhD student at the University of Bath in the UK. Bornoff has developed an advanced Computational Fluid Dynamics (CFD) model of the Realheart® TAH (Total Artificial Heart) to study blood flow in the pump and optimize its function. The work, co-authored with colleagues at Realheart, has now been published in the Springer Nature journal Scientific Reports.

The Realheart model can be simulated across a wide range of operating conditions where variations in heart rate and stroke volume were investigated. The model was validated using Assistant Professor Libera Fresiello's hybrid simulator, a work published in the scientific journal Artificial Organs in 2022, and showed excellent agreement between simulation and experimental results. The computational model builds upon previous work by Joseph where he developed a fluid-structure interaction method to simulate complex valve motion.

Based on detailed descriptions of the background, methodology and results, Joseph concluded that the risk of blood damage was low, thanks to the low levels of shear stress in the pump. In addition, the excellent drainage of blood through the pump during operation was comparable to other similar devices examined, suggesting that the thrombogenic potential was low.

Bornoff holds a first class MEng (Hons) in Mechanical Engineering from the University of Bath, and is currently undertaking a PhD at the University of Bath, where he is researching a multiscale analysis of a novel total artificial heart, in collaboration with Scandinavian Real Heart since 2020. Bornoff is active in several research areas, such as fluid-structure interaction, artificial hearts, and numerical models and computational fluid dynamics.

“The use of computational modelling enables us to increase productivity in development of the Realheart TAH and future products by enabling reduced testing with simultaneous increased understanding of links between form and function. This puts us in the forefront of sophisticated preclinical testing methodology that saves resources and reduces the need for animal testing” said Ina Laura Perkins, CEO of Realheart.

Scientific Reports is a globally renowned peer-reviewed journal that covers all areas of the natural sciences, psychology, medicine, and engineering, and was the 5th most-cited journal in the world in 2021. Joseph Bornoff’s article: “Fluid-structure interaction modelling of a positive-displacement Total Artificial Heart” has been published in the Artificial Organs collection which covers new methods applicable to improving artificial organs, or studies assessing their function, and is online here: https://rdcu.be/c9T04

Market Need in the US and Europe is Estimated at 200,000 Artificial Hearts per Year – Equivalent to SEK 200 Billion – And the Trend is Accelerating

Press Release 12 April, 2023

Industry players and Realheart estimate that the market potential for total artificial hearts (TAHs) is over 200,000 units per year in Europe and the US. Realheart believes it is well positioned to take significant market share with its four-chamber artificial heart.

"Sales will likely only be limited by the number of artificial hearts we have the capacity to produce," said the company's CEO Ina Laura Perkins. "We have great advantages with our TAH because we have started to automate parts of the production process at an early stage of development. Having said that, we have no long-term limitations for volume production," Ina Laura continues.

An important factor in the production is the awarded Eurostars 3 grant of 10 MSEK that Realheart has received together with Berlin Heart to automate the process of membrane production. The membranes are a critical component of the company's artificial heart and must be manufactured with high precision and unwavering repeatability. The best way to achieve this is to automate the manufacturing process. This is why Realheart collaborates with Berlin Heart, who are experts in the field of developing and manufacturing membrane technologies that are successfully used in their external heart pumps.

According to WHO and several other actors, cardiovascular diseases are today the most common cause of death globally in high-income countries, and the number of people affected is only increasing, as well as the number of years the patient can live with their disease. All of this means a significant increase in the burden and cost of healthcare. According to research[1], the global bill will increase from USD 346 billion in 2012 to USD 400 billion in 2030. Heart failure is a type of cardiovascular disease where the heart is no longer able to pump the amount of blood the body needs. Around 300,000 Swedes[2] have heart failure and around 64 million[3] people are affected globally.

New treatment options are needed, and an artificial heart may be a near-term option for patients with severe heart failure. A sufficiently good TAH can help reduce the suffering of those affected and at the same time has the potential to reduce the cost of care for heart failure.

Realheart expects to initiate clinical trials in 2024 and a market launch in 2025/2026.

[1] Lippi, Giuseppe; Sanchis-Gomar, Fabian. 2020. Global epidemiology and future trends of heart failure. AME Medical Journal.

[2]https://janusinfo.se/lakemedelskommitte/lok/artiklar/lakemedelsbehandlingvidkroniskhjartsvikt.5.6b0cec9617a2d3d28f8699b5.html

[3] (1): Savarese G, Lund LH. Global Public Health Burden of Heart Failure a comprehensive and updated review of epidemiology, https://pubmed.ncbi.nlm.nih.gov/28785469/