Arkiv

Interim Report 230701-230930

Press Release November 16, 2023

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Revenue and Result

Scandinavian Real Heart AB is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of foreign currency exchange gains. Research and development costs of Realheart® TAH were capitalized during Q3 with 4.2 MSEK. 1.9 MSEK for purchased services and other external costs and 2.3 MSEK for personnel. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.

Other external costs of 8.9 MSEK includes cost for guarantors of 3.4 MSEK and issuing costs of 2.3 MSEK.

Financial Position

During the period, the company has received cash of 42.2 MSEK after issuing costs from a preferred and directed share issue, 7.2 MSEK from R&D Tax credit in Australia and 0.5 MSEK from received Grants. With a cash balance of 44 MSEK at the end of the period the company has funding that will last into the third quarter of 2024. 

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 Second Quarter of the Year

The period begins with Realheart initiating a collaboration with Chief Physician and Professor Göran Dellgren at the Transplantation Centre and Thorax Clinic at Sahlgrenska University Hospital in Gothenburg. The collaboration is part of the preparations for the clinical studies with the company's artificial heart.

During the first week of July, it was announced that Realheart, after Almi's evaluation, has received business development support totalling SEK 0.850 million. Realheart submitted four applications, all of which have now been approved.

Halfway through July, Realheart publishes the outcome of the company's rights issue. A total of 21,214,649 units were subscribed, corresponding to 60.6 per cent of the Rights Issue. The Rights Issue provides the Company with approximately SEK 33.9 million before issue costs.

The last days of July, Realheart communicates that it carries out a directed new issue of units to guarantors in connection with the completed rights issue. The decision means that it issues 642,950 units as guarantee compensation directed to a number of the guarantors who provided guarantee commitments in the rights issue of units that the Company carried out during the period 20 June to 7 July 2023, in accordance with the guarantee agreements entered into.

On the same day, the company also announces that it carries out a directed issue to EIC in connection with the completed rights issue. The Company's Board of Directors, pursuant to the authorisation granted by the Annual General Meeting on 14 June 2023, decided to issue 9,150,000 units to the European Innovation Council ("EIC") Accelerator, in accordance with the investment agreement published on 15 May 2023. Realheart thus receives an additional SEK 14,640,000 before transaction costs.

During the first part of August, Realheart announces that the Nomination Committee of the company proposes that Magnus Öhman be elected to the Board at the next general meeting. Until then, he is co-opted to the board. Magnus Öhman has extensive experience from the medical technology industry, including as CEO of St Jude Medical's Swedish subsidiary within Cardiac Rhythm Management.  

In the second half of August, the company announced three upcoming presentations regarding different parts of the achieved research results. The presentations take place at three different scientific conferences in Europe – ESAO in Bergamo, BDW in Rostock and EUMS in Paris – where many future customers and partners participate. Among other things, the company highlights its experience with animal-free methods in its development work and challenges the industry to take the step away from animals.

In a press release at the end of August, Realheart announced that CEO Ina Laura Perkins has been invited to speak about the company's artificial heart at the China Heart Congress in Beijing in September 2023. The conference is one of the largest in cardiovascular diseases in the Asia-Pacific region with over 8,000 participants. Ina Laura Perkins has been invited by one of China's leading heart surgeons, Mr Shenshou Hu, President of Fuwai Hospital in Beijing.

The last thing that happens in August is that Realheart decides to co-opt Stuart McConchie to the board, after the nomination committee informs that it intends to propose him as a new board member at the next general meeting. Stuart McConchie has held top positions in global medical technology companies for more than 25 years, guiding companies from research to product commercialisation.

September begins with the news that Realheart has been selected for Business Sweden's scale-up programme Catalyst, which aims to create international growth. In the programme, which is aimed at Sweden's most innovative and promising companies, participants receive a tailored project plan for market entry valued at SEK 250,000 and opportunities to build networks in the market, among investors and other experts.

Significant Events After the End of the Period

On the penultimate day of October, Realheart announces another addition to the board, Giovanni Lauricella, after the nomination committee announced that it intends to propose him as a new board member at the next general meeting. Giovanni Lauricella is currently Managing Partner at Lifeblood Inc, a company specialising in recruitment and fundraising for medical device companies.

November begins with the press release announcing that Realheart has successfully established a new test model for evaluating the impact of artificial hearts on the blood. Initial test results show that the company's artificial heart, Realheart TAH, induces 80% lower degree of haemolysis compared to today's market-dominant heart pump system. The company will shortly start haemolysis testing with the clinical version of the product.

In mid-November, Realheart provides an update on the development and commercialisation of Realheart TAH based on a thorough analysis conducted under the guidance of the company's Board of Directors, including the new co-opted members. Realheart will focus more clearly on the use of the product as a bridging treatment before organ transplantation and now assesses that the product can receive reimbursement in the US already when used in clinical trials.

CEO Ina Laura Perkins Has the Word 

Since last summer, we have been able to attract three new people who will be proposed for election to the Board at an
Extraordinary General Meeting on November 24. They have already contributed significant knowledge and experience from the cardiac medical device industry as adjunct members. After the end of the reporting period, we could announce that initial tests show that Realheart TAH induces 80% less hemolysis than today's market-dominant artificial heart, and a few days ago we presented an updated development and commercialization plan. Although our timetable has been slightly postponed, we now see an opportunity for revenue already during the upcoming clinical trials. 

New Specialist Expertise to the Board

In August, Magnus Öhman, former CEO of Cardiac Rhythm Management, and Stuart McConchie, with a background as CEO and COO of three international heart pump companies, were added to the company's board. At the end of October, Giovanni Lauricella, who has a solid network among international specialist investors, was also added.

Updated Development and Commercialization Plan

After thorough work under the leadership of our strengthened board, we were able to present an updated development and commercialization plan earlier this week. We will now focus more clearly on the use of Realheart TAH as a bridging treatment while waiting for organ transplantation – a sub-market where each percentage point of the patients currently on the waiting list for heart transplantation in Europe and the US corresponds to a potential sales revenue of 150 MSEK. At the same time, we have identified an opportunity to obtain reimbursement for Realheart TAH in the US already in the clinical trial phase, which would result in an earlier revenue flow than previously planned. In light of, among other things, delayed deliveries of components, we have updated the schedule for the remaining steps before the first clinical study and we now estimate that a trial application can be submitted at the turn of the year 2024/25.

Additional Puzzle Pieces in Place for the First Clinical Study

We have now succeeded in establishing a preclinical test system that makes it possible to mimic the blood flow throughout the body and more comprehensively evaluate damage to red blood cells (hemolysis). Initial test results show that Realheart TAH induces 80% lower degree of hemolysis compared to today's market-dominant artificial heart. It is also gratifying that for the first clinical study in humans, we have a well-functioning collaboration in place with Professor Göran Dellgren, chief physician at the Transplantation Center and Thoracic Clinic at Sahlgrenska University Hospital. 

International Attention for Realheart TAH

In late August, we participated in ESAO in Italy and EUMS in Paris, two important European meetings that bring together experts in interventional cardiology. During the quarter, we were awarded Business Sweden's CATALYST grant of 250,000 SEK to map the addressable market for Realheart TAH in China. 

Business Sweden also sponsored our presence at the Chinese International Import Expo (CIIE) in Shanghai where we participated on November 5-10. The visit followed closely on the heels of the China Heart Congress in early September, where the company was invited to present Realheart TAH to China's top cardiologists. 

We have also attended scientific meetings and investor conferences in Finland, Malta, USA, China and Turkey and had the opportunity to demonstrate a prototype of the product's controller. In October, I was invited by the Heart Failure Policy Network to attend the launch of the Heart Failure Mission at the European Parliament in Brussels. Today, approximately 15 million individuals in Europe suffer from heart failure, a figure that is expected to increase by 90% by 2040. The Parliament's initiative aims to highlight the clinical need for new heart failure treatments and promote European investment in the field.

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 September 30, 2023, the number of shares in Scandinavian Real Heart was 96 994 446.

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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

Year-end Report 2023 2024-02-15

Interim Report Q1 2024 2024-05-11

Annual Report 2023 2024-05-23

Annual General Meeting

The company's annual general meeting is planned to be held Thursday, June13th, 2024.

Submission of Interim Report

Västerås, November 16, 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/

Interim Report 230401-230630

Press Release, August 24, 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 Q2 with 3.5 MSEK. 1.2 MSEK for purchased services and other external costs and 2.3 MSEK for personnel. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.

The item other external costs of 2.9 MSEK consists of costs for purchased services of 0,7 MSEK and various other costs of 2.2 MSEK.

Financial Position

During the period, the company has received cash of 3.8 MSEK from an extended loan from ALMI and 0,6 MSEK from received Grants. With a cash balance of 7,3 MSEK at the end of the period together with the recently finalized share issue of 42.2 MSEK and the received R&D Tax credit from Australia of 7.2 MSEK, the companty has funding that will last into the third quarter of 2024.

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 Second Quarter of the Year

In April, it is announced that industry players and Realheart estimate the market potential for total artificial hearts (TAHs) to be 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.

During April, the company announces that Joseph Bornoff's simulations of Realheart have been published in the Springer Nature journal Scientific Reports. Bornoff has developed an advanced CFD (Computational Fluid Dynamics) model of the Realheart® TAH (Total Artificial Heart) to study the blood flow in the pump and optimize its function.

Furthermore, it is communicated that results of Scandinavian Realheart's total artificial heart showing lower hemolysis are published in the journal Artificial Organs. The article summarizes the work done by an international research team led by Dr Ina Laura Perkins and Dr Azad Najar from Realheart, in collaboration with researchers at Swansea University Medical School in the UK.

May begins with researchers at Scandinavian Real Heart and the University of Bath publishing the world's first computer simulation method for dual mechanical heart valves in series. The article is the result of an international collaboration between researchers at Realheart and researchers at the University of Bath (UK) and was published in the scientific journal "Computer Methods in Biomechanics and Biomedical Engineering".

In mid-May, Realheart communicates decisions on new issues of up to 73 MSEK. May also includes a confirmation that Scandinavian Real Heart AB receives an initial investment from EIC Fund of up to 3.5 MEUR.

June begins with a board member resigning from Scandinavian Real Heart AB at his own request. After careful consideration, Patrick NJ Schnegelsberg took the decision to resign from the board of Realheart, as his work situation required his undivided attention and time.

In the beginning of June, Realheart announces that the company participates in a Vinnova collaboration for wireless TAH technology. The company Invivopower has been awarded a grant of 0.9 MSEK from Vinnova to further develop its patented technology for wireless energy transfer through the skin in collaboration with Scandinavian Real Heart AB. The project runs from June 2023 to May 2024.

In mid-June, cardiac surgeon Dilek Gürsoy speaks about Realheart's artificial heart at Impact LECH. Gürsoy, who is one of several first-class speakers, talks about artificial hearts in general and about Realheart's artificial heart specifically. She also participates in a panel discussion on "Man and machine in medicine".

During the second half of June, Realheart publishes a prospectus in connection with a rights issue of units of approximately 56 MSEK. The subscription period in the Rights Issue runs from June 20, 2023 to July 7, 2023.

At the end of June, Realheart communicates that the Company's Chief Medical Officer Dr. Ulf Kjellman has been interviewed by Trading Direkt Healthcare, on the theme of artificial hearts.

Among the last things to happen in June is the approved trademark registration of Realheart in key international markets, in addition to the protection that the brand already has in Sweden. This allows the brand to be developed to exclusively support the company's artificial heart.

Significant Events After the End of the Period

In the first days of July, the Company communicates that 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 with the Company's artificial heart.

July also begins with the German heart surgeon Professor Jan Schmitto, via a press release, estimating the market for companies that can provide a sufficiently good artificial heart is huge. He assesses Realheart's TAH as very promising, partly due to the pulsating blood flow similar to the human heart.

In the first week of July, after Almi's evaluation, it was announced that Scandinavian Real Heart AB would receive business development support totaling 0.85 MSEK. Realheart submitted four applications and all have been approved.

Further into July, Scandinavian Real Heart AB announces the outcome of the Company's rights issue.

At the end of July, a press release is published that Realheart conducts a directed new issue of units to guarantors and a directed issue to EIC in connection with the completed rights issue.

A few days into August, Realheart announces the last day of trading with BTU and the first day of trading with warrants of series TO2.

In the second week of August, Realheart communicates that Magnus Öhman is elected to the company's board of directors. Magnus Öhman has extensive experience from the medical technology industry, including as CEO of St. Jude Medical's Swedish subsidiary within Cardiac Rhythm Management.

CEO Ina Laura Perkins has the Word

A look back at the first quarter provides confidence in the development going forward, including the achievement of a significant milestone of four-day survival in animals. Confidence in the product and the company was strengthened, resulting in two prominent cardiac surgeons deciding to join our team; Professor Bart Meyns in our Medical Council and Dr. Ulf Kjellman as Medical Director.

During the second quarter, the initial focus was on intensified marketing towards the medical community via three articles on Realheart® TAH, approved for publication in scientific journals. Later in the quarter, we increased awareness of our heart among our collaborating cardiac surgeons and the general public through a news broadcast at Trading Direkt Healthcare and through a conference presentation in Austria. As knowledge about artificial hearts as an alternative to heart transplants needs to be spread globally, these international articles and presentations play a key role.

As we establish an internationally recognized brand, it is of course important to ensure its protection. We are therefore delighted to announce that Realheart is registered in several key target markets, including the EU, US, Canada, Japan and Australia.

On the financing side, we got the go-ahead from the European Innovation Council to invest via a directed issue. This is a major success factor as few companies are privileged to be nominated for this type of investment of up to 15 MEUR. At the same time, we started a new share issue with a closing date of July 7, as the development of artificial hearts needs continuous financing, and the closer we get to the clinic, the more financing opportunities open up.

Another exciting news is the collaboration with the Swedish Invivopower for the development of wireless charging instead of power supply via a cable through the skin, which is the norm for all heart pump manufacturers today. The Vinnova funding enables Invivopower to develop a first prototype for wireless charging completely tailored to our wishes. This is a great opportunity for us to start a future project in the present and thus potentially offer wireless charging earlier than planned. This would benefit both patients and doctors.

Our request to Sahlgrenska for collaboration to conduct the first clinical trial received a very positive response from Professor Göran Dellgren, an internationally recognized heart surgeon. The hospital is one of only two in Sweden authorized to perform heart transplants, so we are now working together towards the goal of offering our artificial heart to Swedish patients via the first clinical trial in Sweden.

Ina Laura Perkins

VD, 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 June 30, 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

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 Thursday, June13th, 2024.

Submission of Interim Report

Västerås, August 24, 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/

Scandinavian Real Heart AB announces outcome in the Company’s rights issue

Pressrelease, 2023-07-12

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 completed the rights issue of units, consisting of shares and warrants of series TO2, which the board of directors decided on May 15, 2023, with authorization from the annual general meeting on June 14, 2023 (the “Rights Issue”). The outcome concludes that 13 532 749 units have been subscribed through use of unit rights, corresponding to approximately 38.7 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 2 332 251 units without unit rights, corresponding to approximately 6.7  percent of the Rights Issue. A total of 15 865 000 units were subscribed with the support of unit rights and applications for subscription without unit rights, corresponding to 45.4 percent of the Rights Issue. Hence, underwriting commitments of 5 349 649 units, corresponding to 15.3 percent of the Rights Issue, will be exercised. In total, 21 214 649 units were subscribed, corresponding to 60.6 percent of the Rights Issue. Through the Rights Issue, the Company will receive approximately SEK 33.9 million before issue costs.

On May 15, 2023, Realheart announced that the board of directors of the Company had resolved on a rights issue of approximately SEK 56 million. The subscription price in the Rights Issue was SEK 1.60 per unit, consisting of two (2) newly issued shares and one (1) warrant of series TO2. The total number of units offered in the Rights Issue amounted to 34,979,248.

Outcome in the Rights Issue

The subscription period in the Rights Issue ended on July 7, 2023. The final outcome shows that 13 532 749 units has been subscribed for with support of unit rights, corresponding to approximately 38.7 percent of the Rights Issue. Additionally, the Company has received applications for subscription of 2 332 251 units without support of unit rights, corresponding to approximately 6.7 percent of the Rights Issue. Consequently, 15 865 000 units were subscribed with and without unit rights, corresponding to approximately 45.3 percent of the Rights Issue. Underwriting commitments of 5 349 649 units will be exercised by the Company, corresponding to 15.3 percent of the Rights Issue. In total, 21 214 649 units were subscribed, corresponding to 42 429 298 newly issued shares and 21 214 649 warrants of series TO2.

Through the Rights Issue, the Company will initially receive approximately SEK 33.9 million before deduction of issue costs.

Comment from Ina Laura Perkins, CEO

”We are delighted that so many shareholders have chosen to subscribe for units in Realheart and we welcome all new shareholders to join us on our journey. Your support is critical for us to continue our current trajectory of successes and to effectively progress the development of the Realheart ® TAH into the clinic towards product approval. With the valuable contributions from the Rights Issue we are looking forward to completing our pre-clinical studies.”, commented Ina Laura Perkins, CEO at Realheart.

Allocation of units subscribed for without the support of unit rights

Allocation of units subscribed for without the support of unit rights has taken place in accordance with the principles set out in the prospectus that the Company published on June 19, 2023, due to the Rights Issue (the “Prospectus”). Notification of such allocation is announced separately through settlement notes. Nominee-registered shareholders receive notification of allotment in accordance with instructions from the respective nominee.

Shares, share capital, and dilution

Through the Rights Issue, the total number of shares in the Company increase by 42 429 298 shares, from 34,979,248 shares to 77 408 546 shares, and the share capital increase by SEK 4 242 929.80, from SEK 3,497,924.8 to SEK 7 740 854.60, corresponding to a dilution effect of 54.8 percent of the total number of shares and votes in the Company. If all warrants of series TO2 are fully exercised for subscription of new shares in the Company, the total number of shares in the Company will increase with an additional 10 607 324 shares, from 77 408 546 shares to 88 015 870 shares, and the share capital will increase with an additional SEK 1 060 732.4, from SEK 7 740 854.60 to SEK 8 801 587.0, corresponding to a dilution effect of 12.1 percent of the total number of shares and votes in the Company.

Trading in paid subscribed units ("BTU”)

Trading in BTU takes place until the conversion of BTU into shares and warrants of series TO2 after the Rights Issue has been registered with the Swedish Companies Registration Office. Registration with the Swedish Companies Registration Office is expected to take place during week 30, 2023.

Warrants of series TO2

Two (2) warrants of series TO2 entitles the holder to subscribe for one (1) new share in the Company at an exercise price corresponding to seventy (70) percent of the volume-weighted average price (VWAP) paid for the Company’s shares ten (10) days prior to the subscription period, but not more than SEK 2. Subscription of new shares through warrants of series TO2 shall be carried out in accordance with the terms and conditions of the warrants during the period from and including January 2, 2025, up to and including January 31, 2025. Trading in warrants of series TO2 shall take place from and in conjunction with the conversion of BTU into shares and warrants of series TO2, which is expected to take place during week 30, 2023.

Compensation to underwriters

In connection with the Rights Issue, a number of investors have entered underwriting commitments. For underwriting commitments made, an underwriting compensation of 15 percent of the underwritten amount is paid if the underwriters choose compensation in the form of cash or alternatively 17.5 percent of the underwritten amount if the underwriters choose compensation in the form of newly issued units. Underwriters who wish to receive underwriting compensation in the form of units must notify Skills no later than two days after having been notified.

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.

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.

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.

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 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.

Year-end Report 22-01-01 until 22-12-31

Press Release 24 February, 2023

Summary of the Year-end Report

* Equity ratio: equity divided by total capital.

** Earnings per share: profit for the period divided by 33 183 461.

Proposed Treatment of the Company's Retained Earnings

The Board of Directors propose that the company's earnings be carried forward in the amount of 5 873 671.

No dividends will be paid to shareholders.

Revenue and Results

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 21.2 MSEK. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.

The item other external costs of 24.5 MSEK consists of costs for purchased services of 10.2 MSEK and various other costs of 14.3 MSEK. Of these costs, 21.2 MSEK has been capitalized.

Financial Position

With a cash balance of 11.3 MSEK, the companty has funding that will last into second 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 Fourth Quarter of the Year

• In early October, Realheart's CEO Ina Laura Perkins will appear at the Transplantation Forum organised by Focus Patient in collaboration with The Gift of Life and the European Society of Organ Transplanta- tion, ESOT, at the City Conference Center in Stock- holm. Among the speakers will be Dr Bartley Griffith, an American surgeon who recently performed a high-profile pig heart transplant for a human.

• At the end of October, it is announced that Realheart's artificial heart is featured in a German TV documentary on heart disease and new scientific developments, broadcast on ZDF on 25 October. Both Realheart's founder Azad Najar and Dr Dilek Gürsoy, who is part of the company's surgical team for the ongoing animal studies, are interviewed in the programme.

• The last thing to happen in October is that the third implantation on animals is completed and trials continue. Once again, the implantation went quickly and progress was made, among other things, in the optimal placement of the pump.

Significant Events After the End of the Period

• A step into January, the company reaches a new milestone with Realheart TAH. Since the series of animal trials with the clinical version of the company's artificial heart began in 2022, Realheart has been able to progressively increase survival time from the previous milestone of one day to four days. After implantation, the animal has been able to stand up and eat. In addition, several key performance criteria were confirmed.

• In the second half of January, a press release announces that Realheart and KTH are optimising heart function in Sweden's first patient simulator. The collaboration between Realheart and KTH to develop the simulator (scientific term: "hybrid simulator") started in 2022 after a grant of SEK 4 million from Vinnova Smart Elektronik.

• At the end of January, it is announced that Dr. Ulf Kjellman strengthens Realheart's medical council. Ulf Kjellman has over 35 years of experience in cardiac and thoracic surgery and was involved in the introduction of HeartMate II, HeartMate 3, Centrimag, Maquet pumps, Berlin Excor and SynCardia TAH, among others.

• The last event of January is that the company is offering subscription right holders the right to subscribe to HEART TO1. The subscription period will run from 1-28 February 2023.

CEO Ina Laura Perkins "Our heart surgeons speak warmly about our artificial heart"

In the last three months of the year, we made progress in three areas: international marketing, soft funding and our animal studies. In October, our Realheart® TAH was featured in prime time on the German TV channel ZDF in a documentary on heart disease.

A German TV crew visited one of our surgeries to interview the company's founder Azad Najar and the heart surgeon Dilek Gürsoy who performs the operations. Interviewer was a German celebrity chef who has a heart condition himself, and the show followed a young woman with heart failure on her road to a successful heart transplant. The documentary highlights Realheart as a promising alternative solution to the organ shortage.

Germany is one of the largest markets in Europe for artificial hearts. To learn more, I visited the clinic that performs the most heart pump surgeries in the country: the Medical University of Hannover. There I interviewed heart surgeon Professor Jan Schmitto, who said that in Germany alone, 40,000-60,000 artificial hearts are needed each year. This means that we have underestimated the need.

Proof of the strong need is the sales forecast for 2023 from our European competitor. They started selling in November and expect to sell over 100 hearts in the first year at revenues of €10-13 million and scale up production to 1000 hearts by 2027. This is great news for heart failure patients in Europe, but it is only enough for a fraction of patients. Doctors are reminding us that even more artificial hearts are urgently needed.

The situation is similar in the rest of the world. In December, I spoke at the Critical Heart Disease Congress in China. The digital conference has so far been viewed by 24,000 viewers, including doctors and healthcare professionals from Australia, the UK, Austria, Italy, the US and China. I also gave an introduction to the International Society for Mechanical Circulatory Support (ISMCS), for which I have been on the Board since May. Through these networks, we can find the right partners and future customers faster, and raise awareness of artificial hearts as a cure for heart failure. The marketing has already had an impact as I have received enquiries from doctors in Brazil and elsewhere.

To start clinical trials, we need good results from animal studies in addition to blood and durability tests. During the year, we have worked on the surgical process and animal care, for example on the settings of the heart-lung machine. We have realized that this is not readily available knowledge but that we are building up valuable unique know-how within the team. Therefore, we decided not to communicate as frequently and in as much detail about our animal studies as we had done in the past. I understand that this may frustrate shareholders, but I can assure you that we have quietly made great progress: 4 days of survival without blood damage.

Developing an artificial heart requires excellence throughout the entire chain – from idea to marketing and sales. This chain is complete with us, we have all the pieces needed to get to market. Here, our international expertise from several artificial heart projects contributes greatly, as it is a challenge to find equivalent in Sweden. I am convinced that our diversity contributes strongly to our success. It is awesome that we have over 100 years of combined expertise.

In addition to a strong team and good results, continued funding is needed to reach the market. Therefore, we are working on the due diligence process for the European Innovation Council fund which has nominated us for €15 million investment, as well as on finding soft funding. We are very grateful that ALMI chose to continue supporting our work with an innovation loan of 7.6 million SEK. In the first quarter of 2023, our shareholders can further strengthen our cash position via the share option. The funding will be used for animal studies and to start the blood tests on the clinical version of Realheart TAH – we are proceeding nicely according to our plan in other words.

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, almost 3,500 people die of heart failure in Sweden alone. Today, the best treatment is a heart transplant, but the number of donated hearts is only enough for 2% of those in need.

The idea behind Realheart was born in 1999, when the doctor and innovator Azad Najar made the first sketch of an artificial heart that fully mimics the biological one. 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 with the aim to reduce 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, blood pressure, oxygen saturation, pump function 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 good quality 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 permanent 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 September 30, 2022, the number of shares in Scandinavian Real Heart was 33,183,461.

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

Submission of Interim Report

Västerås, Februari 24, 2023

The Board

Scandinavian Real Heart AB

For Further Information, Please Contact

Ina Laura Perkins

CEO Scandinavian Real Heart AB
Phone: +46 70 406 49 21
E-mail: inalaura.perkins@realheart.se

Jonas Caspari Bark

CFO Scandinavian Real Heart AB
Mobile +46 70 643 88 61
E-mail: jonas.bark@realheart.se

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

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

Realheart Reaches New Milestone With the World’s First Four Chamber Artificial Heart

Press Release, 10 January 2023

Scandinavian Real Heart AB, the company developing the world's first four-chamber total artificial heart (TAH), successfully extended the survival of animals implanted with Realheart’s TAH.

Since the series of animal trials with the clinical version of the company's TAH began in 2022, Realheart has been able to increase survival time from one to four days.

After implantation, the animal was able to stand up and eat. In addition, Scandinavian Real Heart was able to confirm key TAH performance criteria, including:

  • No haemolysis (damage to red blood cells): Haemolysis due to mechanical stress caused by artificial hearts on blood cells is a major cause of severe side effects impacting survival of artificial heart patients over time.
  • No thromboembolic events (blood clots): Good blood flow and low mechanical stress in the TAH minimise the risk of very serious, and life-threatening consequences for patients, including stroke. 
  • High pumping capacity and good right-left balance: The TAH can pump eight litres of blood per minute. This is significantly more capacity than what an adult human needs. The balance between blood flow from the right and left ventricles is crucial for survival.
  • Short procedure: A heart-lung machine used during the implantation of the TAH was disconnected after less than 2.5 hours. The extended use of a heart-lung machine during open heart surgeries poses considerable safety risks to patients. Realheart is developing its TAH to reduce time on a heart-lung machine and overall procedure times, therefore improving overall safety.

''I am incredibly pleased with how much we have been able to achieve after just a few implantations of our TAH. The fact that we see no signs of haemolysis or blood clots, combined with the fact that we can achieve good left-right balance, a pulsatile blood flow, and natural blood pressure, is extremely satisfying. We are now moving forward with the aim of continuing to further prolong survival time by optimising the surgical methodology,'' said Ina Laura Perkins, CEO of Realheart. The company plans to initiate human clinical trials 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.

Third Animal Implantation Completed – Trials Continue

Press Release 27 October, 2022

Realheart announces it has performed a third implantation in sheep to test the clinical version of Realheart TAH – the version that will also be used in clinical trials expected to start in 2024. 3-4 more implantations are now planned in the series.

The surgery was performed in an animal laboratory in Belgium by the same surgical team as in previous trials: Dr Dilek Gürsoy and Dr Joeri van Puyvelde, led by Professor Bart Meyns. Once again, the implantation went quickly and progress was made, including the optimal placement of the pump.

''I am very pleased to confirm that the series continues and that more implantations are now scheduled and I look forward to reporting the results once all the analyses are complete'' says Ina Laura Perkins, CEO of Realheart.

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 Successfully Completes Second Animal Implant of its Total Artificial Heart

Press Release, 8 July 2022

On July 6th, Scandinavian Realheart’s Total Artificial Heart (TAH) was successfully implanted in a sheep for the second time. This follows the first successful implantation of the Company’s TAH reported on June 1st. Both implantations were part of an ongoing animal study designed to assess the performance of the clinical version of Realheart® TAH before entering human clinical trials, expected to start in 2024.

The procedure was performed in Belgium by Drs. Dilek Gürsoy, Joeri van Puyvelde, and Professor Bart Meyns, three experienced cardiac surgeons. Overall, the surgery was rapid and went well. A key milestone of survival over 24 hours has been reached. On the second day following the implant, the animal moved a lot, dislocating some of the life support equipment and the decision was taken to end the study. Measures have been taken to avoid recurrence.

This time the implantation was performed on a slightly smaller sheep than the previous one. Thanks to the smaller pump in Realheart’s clinical TAH version, the device could still be implanted successfully. "The pump is really good, I really believe in it," commented heart surgeon Dr. Dilek Gürsoy after the implantation.

The Company plans to achieve longer survival times in future sheep studies. The next surgery is planned for early September 2022.

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.

First Animal Trial with Clinical Version Completed

Press release, 2 June 2022

Yesterday, the first in a series of sheep implantations to test the newly developed clinical version of the Realheart artificial heart was performed. Surgically, the trial was very successful, and the pump performance optimal. Nevertheless, the decision was made to end the trial today to make some adjustments for the next surgery which will take place later this month.

This was the first implantation of the clinical version of the Realheart® TAH – the version that will eventually be used in humans.

The operation was performed in an animal laboratory in Belgium by three very experienced heart surgeons: Dr Dilek Gürsoy, Dr Joeri van Puyvelde and Professor Bart Meyns.

''Dr Gürsoy and Professor Meyns are familiar with Realheart TAH since before, but Dr van Puyvelde, who worked on our heart for the first time, was impressed by how stable everything was running. Other international experts present during the operation had never seen a such a smooth implantation of a total artificial heart. These are aspects that could have a major impact on the future uptake of the Realheart® TAH in healthcare'' said Ina Laura Perkins, CEO of Realheart.

It took the surgical team 2 hours and 10 minutes to implant the pump. To reach a total time from starting the heart-lung machine until the pump is fully connected to the body of less than 3 hours is key for the animal to have a good chance of survival. This was achieved by good margins. It was also found that energy consumption was lower and pump performance higher compared to previous versions of the Realheart® TAH.

''I like that the device is controlled by the inflow pressure. It is operating in a very controlled, physiological manner, similar to the human heart, which is important for the exercise capacity and preventing suction'' said Professor Bart Meyns.

The data collected is now being evaluated as part of preparations for future operations.

''What our team has achieved is amazing and we are very close to achieving our goals. Heart surgery is one of the biggest procedures you can do and there is a lot going on, but we have seen that our pump always does what it is supposed to do. I'm looking forward to the next operation and coming back to let you know how it went,'' says Ina Laura Perkins.

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’s CEO Presents Blood Results at the ISMCS Conference in Hannover

Press release 27 May, 2022

Realheart's CEO Ina Laura Perkins is holding a presentation today at the annual meeting for the International Society for Mechanical Circulatory Support in Hannover, where she will give an update on the process of developing the world's first artificial four-chamber heart and will also share the results achieved so far through blood tests.

Blood testing is a key activity in Realheart's development work, as the aim is to achieve as low blood damage as possible to move away from the side effects that have so far hampered the use of artificial hearts as a treatment option. Certain parameters, such as hemolysis, i.e. the leakage of hemoglobin from red blood cells, also need to be reported to regulatory authorities.

The version of the Realheart TAH developed in 2018 – a manually controlled prototype – was initially tested with porcine blood in a German laboratory. The hemolysis values that were obtained then proved to be comparable to those of another artificial heart under development.

Similar tests were conducted with human blood in Realheart's own lab at the Karolinska University Hospital in Stockholm. Comparing the results between the old version and the next version of the pump – which had external pressure sensors and an automatic algorithm – an 18 percent reduction in the hemolysis value of the newer version was obtained.

In the following series of tests, this newer version of the pump was compared with SynCardia, the product that is currently the most widely used in the market, and preliminary results show that Realheart's hemolysis value was less than half of that of its competitor. The company is now preparing to test the newly developed clinical version of Realheart TAH against SynCardia.

In parallel, a blood-based study of the effect of heart pumps on the immune system has recently been initiated in collaboration with the Karolinska Institute in Stockholm.

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.

Improved controller for clinical trials results in six-month delay

Press release 28 April, 2022

Realheart has decided to equip patients in the first clinical trial with the full version of the controller – a kind of remote control – instead of a simpler version as previously envisaged. This will benefit patients and shorten the overall development time of the controller but will delay the human trial by six months, now set to begin in the first half of 2024 instead of the second half of 2023.

''Our goal is an artificial heart that allows the user to lead a good life with great freedom of movement. This also applies to the patients participating in our clinical trials. We want even the very first patient to be able to leave the hospital, and for this to work in practice, the external controller needs to be both safe and really easy to use'' said Ina Laura Perkins, CEO of Realheart.

The controller that Realheart has used so far to test and refine the design in bench and animal trials was developed in-house, but to move to humans, a more advanced one is needed as it will be used by the patient themselves without supervision from healthcare professionals or experts. During fall 2021, Realheart started a collaboration with the Australian company Hydrix, which specialises in the development of control systems for heart pumps. Their platform is characterised precisely by a strong focus on the needs of the end user.

''The controller is technically very advanced, but for those who will live with our artificial heart in the future, it must be extremely easy to use. We already have an updated electronic architecture in place and by not producing a special test version but going straight to the final version we can save time overall, while somewhat delaying the first implantation in a human,'' said Ina Laura Perkins, CEO of Realheart.

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 was submitted for publication, through the agency of the contact person, on 28-04-2022 12:00 CET.

Realheart provides clarification on UAE media reports

Scandinavian Real Heart AB would like to make the following comment regarding information in the Arabic media tonight:

It is correct that we are in discussions with a party in the United Arab Emirates (UAE) about a possible investment in Realheart and the opening of a representative office in Sharjah, but no agreement has been reached.

The founder, Dr Azad Najar, is currently in the UAE for participation in the International Conference of Pharmacy and Medicine.

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 was submitted for publication, through the agency of the contact person, on 18-01-2022 20:44 CET.

Realheart receives an EU grant of 2.5 million euros for its artificial heart

Realheart has been granted 2.5 million euros in as a grant from the European Innovation Council, EIC, to support the development of the world's first artificial four-chamber heart, which is scheduled to begin clinical trials as early as 2023.

Heart failure is one of the most common causes of death in the world. An artificial heart can save many lives, but the alternative that has been available so far gives many serious side effects and is therefore rarely used. Realheart's total artificial heart is designed to mimic the way the natural heart works to reduce the risk of side effects. It can be worn permanently or while waiting for a transplant.

The European Innovation Council (EIC) has been set up within the framework of the EU Horizon Europe program. The aim is to identify and support pioneering new technology and innovations all the way from early research to scaling up internationally. The EIC has now granted Realheart a grant of EUR 2.5 million, corresponding to approximately SEK 25.7 million. news alert announcing the EIC Accelerator’s successful companies.

– It is a very welcome contribution and that we have been awarded this grant confirms that our business plan is very well thought out. It also opens doors to future potential investments by the EIC up to 15 million euro, which we have the possibility to negotiate for as long as we reach our milestones in this project. We have left the prototype behind and are now working fully on the clinical version of our artificial heart. This money will take us a long way on the way to the market and the many patients who are waiting for a new heart, says Ina Laura Perkins, CEO of Realheart.

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 was submitted for publication, through the agency of the contact person, on 16-12-2021 15:01 CET.

Dr Ina Laura Perkins new CEO of Realheart

After 8 years as CEO of Realheart, founder Azad Najar hands over the leadership to Dr Ina Laura Perkins, who has been Chief Scientific Officer at the company since 2017.

On March 15, Dr Ina Laura Perkins will shoulder the role as CEO of Realheart, thus taking over the leadership of the Västerås company and its development of an artificial heart.

Ina Laura has two master's degrees, in biomedicine, and in innovation and entrepreneurship. In 2010, she won The Prince of Wales Innovation Scholarship for her stem cell work and received her PhD in 2015 from Swansea University Medical School. In 2019, Ina Laura completed an Executive MBA in financial management at The Stockholm School of Economics.

Ina Laura has worked with medical innovations throughout her career. Before joining Realheart in 2017, she was involved in the start-up of The Nobel Prize winner Sir Martin Evans' stem cell company Celixir and worked as Head of Research at Calon Cardio-Technology with the development of a new left-chamber assist device.

“Gaining the board's confidence to lead Realheart into the exciting times ahead is very honourable. Throughout my career, I have made a conscious decision to broaden my skills to be ready to take on a CEO role. Thanks to Azad's innovation and business abilities, it is now a fantastic company I am set to manage. My immediate focus will be to strengthen the organization with more employees so that we can keep a steady pace forward towards clinical trials ", says incoming CEO Ina Laura Perkins.

After the handover, Azad Najar will take on the role of Chief Medical and Innovation Officer and will be responsible for animal studies and the company's innovations.

“Already from being a company with few people, I have constantly worked to develop the competence in Realheart and recruit highly skilled people. Now I can look back and proudly say that we have a good organization with very competent staff. The work with preclinical animal testing is growing and requires great focus in the future. We also need to be at the forefront of innovations in heart failure treatment to achieve our vision “no one should have to die of heart failure". I therefore need to free up more time to work with these two important areas in the company. We have been planning for a long time for Ina Laura to take over the role of CEO. She will be an excellent CEO with her wise leadership, her enormous competence and her large industry network ", comments outgoing CEO Azad Najar.

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 was submitted for publication, through the agency of the contact person, on 08-03-2021 15:09 CET.

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