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Realheart Awarded Close to SEK 1 Million From Tillväxtverket and Region Västmanland

Press Release July 5, 2023

Following Almi's evaluation, Scandinavian Realheart AB has been granted business development support of a total of SEK 0.850 million. Realheart submitted a total of four applications, all of which have now been granted.

"That Realheart is able to supplement its funding with additional public funds is a sign of the strong interest of society in making our artificial heart a reality and bringing it to market. It is a product that could give many people around the world a new lease on life," said Realheart CEO Ina Laura Perkins.

The current support is given to companies to contribute to digitalization, green transition, internationalization, and verification. The support for digitalization refers to Realheart, in collaboration with Linköping University and the University of Bath, to use new digital methods to understand the blood flow in artificial hearts in more detail to further reduce the risk of blood-related side effects, and to develop more digital twins of heart failure patients together with German Virtonomy. The project in green transition is about evaluating solutions for the heart's batteries and chargers from an environmental perspective while providing optimal energy supply, while the third project aims to prepare a launch of the heart on an international market. In verification, Realheart intends to confirm the production technology for a sub-component that was previously performed by a supplier to instead ensure in-house production.

Almi alone decides on the verification support, while Almi Företagspartner handles the other three supports on behalf of the Swedish Agency for Economic and Regional Growth and Region Västmanland, which makes the final decision on support based on Almi's recommendation.

The company has previously been awarded a development grant from the European Innovation Council (EIC) Accelerator of EUR 2.5 million. Earlier in 2023, EIC announced that it intends to invest up to EUR 3.5 million (approx. SEK 39 million) in connection with the new share issue that the company is currently carrying out. EIC is one of Europe's leading financiers of innovative companies that are expected to become global leaders in their markets.

The Subscription Period in Realheart’s Rights Issue Ends on Friday

Press Release July 4, 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.

On friday, July 7, 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”), ends. 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.

German Cardiac Surgeon Estimates That the Market for a Company That can Provide a Good Enough Artificial Heart is Huge

Press Release July 3, 2023

Leading German cardiac surgeon Professor Jan Schmitto estimates that the number of end stage heart failure patients in Germany with a population of 82 million, is around 40-60,000 per year. Although not all these patients may meet the criteria for a total artificial heart (TAH), the market for a company that can provide a good one is huge.

Jan Schmitto is Professor of Cardiac Surgery in the Department of Cardiac, Thoracic, Transplant and Vascular Surgery at Hannover Medical School, Germany. He is head of the Mechanical Circulatory Support (MCS) program and of the innovation department "Active Device Technologies", as well as surgical director of the multidisciplinary heart failure unit. Professor Schmitto has contributed to Hannover being one of the leading and most innovative clinics for advanced heart failure in the world and performs 60-100 LVAD (Left Ventricle Assist Device) implantations annually. He has published more than 280 peer-reviewed scientific articles and has been involved in the International Society for Heart and Lung Transplantation (ISHLT) for many years, including the organization's committee and the advanced MCS Academy.

“In Germany alone with 82 million inhabitants, there are estimations existing that 40-60,000 patients with severe heart failure could potentially benefit from a new heart every year. However, organ donor shortage only allows for around 300 heart transplants per year in Germany. With a good TAH on the market, many of these patients' lives could potentially be saved, while providing them with a good quality of life. Better treatment options also could potentially contribute significantly to reducing healthcare costs for society," said Prof. Jan Schmitto.

In Germany, thousands of patients are waiting in line, but less than 300 heart transplants are performed annually. In high-income countries, cardiovascular disease is the most common cause of death globally and with the treatment methods used today, patients suffer from long-term health problems and hospitalization. This means personal suffering and a high burden and cost to the healthcare system.

“In theory, a patient can live a normal life for many years with a TAH, but it is too early to say exactly how long as there is limited data available. "Realheart's TAH is very promising because, among other things, it has a natural pulsating blood flow similar to that of the human heart," said Prof. Schmitto.

“It is very valuable that heart surgeon Jan Schmitto speaks so positively about TAH therapy in general and the opportunities Realheart does have on the market. We know that advanced heart failure contributes to other complications such as kidney and lung problems. A TAH can help restore blood circulation and other body functions in previously severely ill patients so that they can survive and live with improved quality of life," said Ina Laura Perkins, CEO of Realheart.

The meeting with Schmitto resulted in a filmed interview: https://youtu.be/GmiIBBApKWo

Realheart Enters Into Collaboration With Sahlgrenska for Clinical Studies

Press Release July 3, 2023

Scandinavian Real Heart AB initiates a collaboration with Chief Physician and Professor Göran Dellgren at the Transplantation Center and Thorax Clinic at Sahlgrenska University Hospital. The collaboration is part of the preparations for the clinical studies on patients with the company's artificial heart, which is planned to start when everything is ready. The intention is that Sahlgrenska University Hospital will eventually participate in the clinical study.

Several experimental and pre-clinical studies will be carried out within the framework of the collaboration, including a closer examination of surgical methods and patient selection.

Professor Göran Dellgren has a long history of working with patients with severe heart failure and has performed several heart transplants and implantations of mechanical pumps. Since 2016, in a Swedish research group, he has been running one of the largest studies in Sweden on patients with severe heart failure where drug treatment is compared with mechanical circulatory support for the heart, the study is called the SweVAD study.

 "In the SweVAD study, we have recruited 64 patients, so hopefully we will be done within a year with that study," says Göran Dellgren.

Realheart's artificial heart is the first to be developed to mimic the human heart with four chambers and a pulsating blood flow. The company's vision is to be able to replace heart transplants with total artificial hearts in the future, or at least be a full-fledged alternative with equally good results, fewer side effects and greater accessibility for patients. Today, about 60 heart transplants are performed annually in Sweden, but the company believes that the need is far greater than that.

"We see great potential and synergy in our collaboration with Professor Dellgren at Sahlgrenska Hospital. It is incredibly important for us to have a dedicated and clinically active heart surgeon with us and now we will work together to prepare to be able to conduct a clinical trial in Sweden", says Ina Laura Perkins, CEO of Realheart.

Realheart Gets Go-Ahead for International Trademark Protection

Press Release, 28 June 2023

Scandinavian Realheart AB’s trademark registration of Realheart has been approved in important international markets, in addition to the protection the trademark already enjoys in Sweden. The registration allows the company to develop the brand so that it exclusively supports the company's total artificial heart.

“We are developing something completely different from what is available on the market today, which is why trademark protection is particularly important to us. It provides us good opportunity to both build and defend the value of our products,” says Realheart’s CEO Ina Laura Perkins.

The Realheart trademark was registered in Sweden in 2019, and the following year an application was submitted for international trademark registration. This application has now been approved in several key markets, including Australia, Canada, EU, Japan, Norway, Switzerland, UK and USA.

Realheart’s artificial heart is the first to be developed to mimic the four-chambered human heart and provide pulsating blood flow. It is also protected by several different patents in several important markets.

“Our goals are set high. We want patients to be able to return to a normal life again, we want to reach out to a large market and of course we also want to provide returns to those who invest in us. Therefore, we must ensure that we protect what we create,” says Ina Laura Perkins.

Realheart’s Chief Medical Officer Dr. Ulf Kjellman in an Interview with Trading Direkt Healthcare, on the Topic of Artificial Hearts

Press Release, 21 June, 2023

Recently, Direkt Studios Trading Direkt Healthcare hosted Realheart's medical director Dr. Ulf Kjellman. This week's episode had the theme of artificial hearts and with more than 30 years of experience in heart surgery and artificial hearts, Dr. Kjellman gave a clear picture of why artificial hearts need to become available as an alternative to heart transplants.

The goal with Realheart's artificial heart is to provide a good enough permanent solution for the most severely affected patients. Those who for various reasons cannot have a heart transplant. An artificial heart does not require patients to take the heavy medications that a transplant requires. Medications that are known to cause serious side effects such as cancer and infections.

" Relheart, like BiVACOR, is now in an advanced stage of development and the first patient studies are likely to be conducted in the near future. One of the biggest challenges in growing this market is to inform all referring physicians that mechanical hearts are an option", says Dr. Ulf Kjellman.

During the interview, Dr. Kjellman took us back to 1969 – the year when the first artificial heart was implanted in a patient in the US – an important milestone where it was made clear that a very sick person can survive until transplantation thanks to the bridging of an artificial heart. He further explained what an artificial heart is and how it works. In particular, he highlighted the difference between a temporary and a permanent solution and stressed the importance of the patient's quality of life.

Link to the interview on YouTube (Swedish).

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/