Report from the extraordinary general meeting in Scandinavian Real Heart AB on November 24, 2023

Press release November 24th, 2023

Scandinavian Real Heart AB (the "Company") has on November 24, 2023, held an extraordinary general meeting where mainly the following decisions were made.

Determination of the number of board members.

The meeting resolved to approve the nomination committee's proposal that the number of members of the board of directors shall consist of eight ordinary board members without deputies.

Election of board members.

The meeting resolved to approve the nomination committee's proposal to elect Magnus Öhman, Stuart McConchie and Giovanni Lauricella to the board of directors. The other members remain on the Board of Directors as proposed by the Nomination Committee.

Determination of fees for the Board of Directors

The Meeting resolved, in accordance with the Nomination Committee's proposal, that fees to the Board of Directors shall be paid with SEK 72,500 to each of the new members.

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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/

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Realheart provides an update on the development and commercialization of its artificial heart

Västerås, Sweden, November 13, 2023 – Scandinavian Real Heart AB (publ) today provides a strategy update on the development and commercialization of its artificial heart, the Realheart TAH, which in initial testing has been shown to induce 80% lower levels of hemolysis compared to today's market-dominant artificial heart. This update is based on a thorough analysis conducted under the guidance of the company's Board of Directors, including the new adjunct board members. Realheart will increase its focus on the use of the product as a bridging treatment ahead of organ transplantation and now deems that the product is eligible for reimbursement in the US already when used in upcoming clinical trials. Because of significant supply chain issues and delays with development partners, the scheduled start of the first clinical study has been postponed from 2024 to 2025. This is in turn likely to impact the timing of a future market introduction.

"The Board and management, in consultation with external experts, have conducted a thorough review of the plans for the development and commercialization of the Realheart TAH. The updated plan includes a sharper focus on the use of the Realheart TAH as a bridging treatment for patients awaiting organ transplantation. Further, we have identified an opportunity to get the product reimbursed already for use in upcoming clinical trials in the US, which has the potential to generate early revenues for the company. The use of our artificial heart ahead of organ transplantation is the first important step towards our long-term vision – that no one should have to die from heart failure," says Realheart's CEO, Ina Laura Perkins.

A more precisely defined commercialization strategy

In total, more than 8,300 patients with severe heart failure are currently listed for a heart transplant in Europe and the US. Many of these unfortunately die during their time on the waiting list. Realheart aims to significantly reduce this mortality and increase the quality of life for those waiting for a donor organ. The company aims to provide the first artificial heart that mimics the human heart, and thus, has the potential to minimize the risk of side effects.

Following decades of research and development, the Realheart TAH is now undergoing functional and safety testing ahead of the first clinical study in humans. Realheart deems that the product is eligible for reimbursement in the US already for use in the upcoming clinical trials, which has the potential to generate early revenue streams for the company.

Future market approvals will create significant commercial potential – each one percent of the patients currently on waiting lists in Europe and the US for heart transplantation corresponds to a potential sales revenue of SEK 150 million. The use of the Realheart TAH in this setting is an important first step towards the company's long-term vision – that broader patient groups will have access to the product so that no one must die of heart failure.

Since the global number of transplant centers is limited, it will be possible to market Realheart TAH with relatively limited resources. The company's business model is based on direct sales of the product in the US and Europe, with the addition of necessary services and support for clinical staff and patients.

Updated timeline

Preparatory activities ahead of clinical studies

An application to initiate the first clinical study of Realheart TAH is expected to be submitted to the relevant authorities at the turn of 2024/2025. This requires a comprehensive preclinical data package based on safety studies, blood tests and reliability studies.

Safety studies are being conducted in preclinical models to meet regulatory requirements for the first study in patients. This work is progressing with very positive results to date.

The blood tests are carried out in a laboratory setting and the company has recently established a preclinical test system that mimics the natural blood flow throughout the body, thereby enabling a more reliable evaluation of red blood cell damage (hemolysis). Initial test results show that the Realheart TAH induces 80% lower levels of hemolysis compared to today's market-dominant heart pump systems.

Reliability studies of the individual components of the Realheart TAH have already been carried out with good results, and corresponding tests of the artificial heart as a complete system will start shortly.

First in human study

As part of the preparations for the first clinical study of the Realheart TAH, the company has established a collaboration with Professor Göran Dellgren, Chief Physician at the Transplantation Center and Thorax Clinic at Sahlgrenska University Hospital in Gothenburg, Sweden. Several experimental and clinical preparatory studies are conducted within the framework of this collaboration, including further evaluation of alternative surgical methods, and definition of the suitable patient pool for the clinical study.

The initial clinical study, which is expected to be initiated in 2025, will be conducted in 2 to 4 patients awaiting heart transplantation. Assuming positive results, an additional study in 10-20 patients will follow to confirm the performance and safety of the Realheart TAH in clinical use, prior to market authorization applications.

The process towards market authorization

A process has been initiated in Europe with a Notified Body (an independent organization that ensures that manufacturers comply with EU regulations), to establish the requirements for Market Approval in the EU.

In parallel, Realheart has had meetings with the US regulatory authority (the FDA) to determine what documentation will be required for Market Approval, and further meetings are anticipated to establish the specific application process that is most appropriate in the US.

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

Press Release November 8, 2023

The shareholders in Scandinavian Real Heart AB, reg. no. 556729-5588 (the "Company"), are hereby invited to the Annual General Meeting on Friday, 24 November 2023 at 10.00 at Best Western Plus Hotel Plaza, Kopparbergsvägen 10, 722 13 Västerås. Registration for the Meeting begins at 09:30.

Right to participate in the Meeting, etc.

Shareholders who wish to participate in the Meeting shall

be recorded in the share register kept by Euroclear Sweden AB no later than Thursday, 16 November 2023, and

notify the Company their intention to participate no later than Monday, 20 November 2023 by post to Scandinavian Real Heart AB, Kopparbergsvägen 6, 722 13 Västerås, by phone +46 (0)70-643 88 61 or by e-mail jonas.bark@realheart.se.The notification shall state full name, personal identification number/company registration number, shareholding, address, daytime telephone number and, if applicable, information about proxies or assistants (maximum two).

To be entitled to participate in the Meeting, shareholders whose shares are held in the name of a nominee must, in addition to providing notification of their participation in the Meeting, re-register the shares in their own name so that the shareholders are registered in the share register on the record date on Thursday, 16 November 2023. This re-registration may be temporary (so-called "voting right registration") and is carried out through the nominee according to their procedures at a time predetermined by the nominee. Voting rights registration that has been completed by the nominee no later than Monday, 20 November 2023, are considered when preparing the share register.

Proxies etc.

If a Shareholders shall be represented by proxy, the proxy shall bring a written, dated and by the shareholder signed, power of attorney to the Meeting. The power of attorney may not be older than one year unless indicated that it is valid for a longer period, not exceeding five years. If the proxy is issued by a legal person, the proxy shall bring a current copy of the registration certificate and similar papers of authorisation. In order to facilitate entry to the Meeting, a copy of the power of attorney and other authorisation documents should be attached to the notification to the Meeting. Proxy forms will be available on the Company's website www.realheart.se and will be sent by post to shareholders who contact the Company and state their address.

Processing of personal data

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

Proposal for agenda

1.
Election of Chairman of the Meeting

2.
Election of one or two persons to verify the minutes

3.
Preparation and approval of the voting list

4.
Approval of the agenda

5.
Determination as to whether the meeting has been duly convened

6.
Determination of number of Board members

7.
Election of Board members

8.
Determination of fees for Board members

9.
Closing of meeting

The Nomination Committee's proposals

Item 1 – Election of Chairman of the Meeting

The Nomination Committee consists, until the Annual General Meeting 2024, of Kim Norström and Azad Najar as decided by the Annual General Meeting 2023. The Nomination Committee proposes that Christer Norström, or the person appointed by the Nomination Committee if he is prevented from attending, is appointed as Chairman of the Extraordinary General Meeting.

Item 6 – Determination of number of Board members

The Nomination Committee proposes that the Board of Directors should consist of eight

ordinary Board members without deputies.

Item 7 -Election of Board members

The Nomination Committee proposes, for the period until the end of the next Annual General Meeting, that the current Board of Directors be supplemented with the following new members: Magnus Öhman, Stuart McConchie and Giovanni Lauricella. The board of directors otherwise consists of the members Christer Norström, also chairman of the board, Azad Najar, Ulf Grape, Oliver Voigt and Solveig Bergström as board members.

Magnus Öhman

Born: 1961
Education: MSc in Mechanical Engineering
Board of Director assignments: Magnus is currently Chairman of the board of Neosense Technologies, a Swedish medtech start-up company that develops invasive sensor based products where the first product significantly improves continuous oxygen monitoring for neonatal children to improve survival rate and Quality of Life. He has been a board member at Stockholms Tekniska Institut, an engineering school founded in 1924.

Experience: Magnus has over 30 years of experience from medtech including R&D leadership in both site and global responsibilities and as Managing Director for the St Jude Medical CRM subsidiary with R&D, manufacturing and distribution operations with over 600 employees and a revenue of 5.3 billion SEK. Magnus has managed or supervised 40+ product developments projects from start to regulatory approved and launched globally. Magnus previously served as CEO of Stockholms Tekniska Institut, an engineering school with 350+ students managing a turnaround operationally and strategically.

Stuart McConchie

Born: 1952
Education: Pharmacology – Monash University, Melbourne, Australia.
Board of Director assignments: Stuart has no current board positions.
Experience: Stuart has held senior positions in global medical device companies for more than 25 years, guiding companies from research to product commercialisation. Stuart has worked with several heart pump companies, most recently as CEO of UK-based Calon Cardio Technology, and previously with US-based Jarvik Heart and Australian HeartWare Inc where he also gained experience in a publicly traded environment before the company was acquired by Medtronic. Stuart has extensive regulatory experience, including FDA interaction with multiple products.

Giovanni Lauricella

Born: 1987

Education: Bachelor of Science (BSc) in Finance, a Master of Science (MSc) in Regulatory Affairs in Medical Devices, a Harvard University Certificate in Advanced Negotiation Strategy and a Universita Bocconi Certificate in Private Equity and Venture Capital.

Board of Director assignments: Managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.

Experience Giovanni has worked with over 500 startups worldwide and is currently member of several boards. He also organizes the conference Med-Tech World, which gathers around 3,000 participants, bringing together companies with investors, industry, and the media. He runs the podcast MedTech Money which focuses on demystifying raising and investing capital for Medtech startups.

Item 8 – Determination of fees for Board members

The Nomination Committee proposes that board fees for each of the new members according to item 7 above shall be paid with SEK 72,500.

Information on the number of shares and votes

At the time of issue of this notice, the total number of shares and votes in the Company amounts to 96,994,446.

Shareholders' right to request information

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

Provision of documents

Proxy forms as well as other documents required by the Companies Act will be kept available to the shareholders at the Company's head office; Kopparbergsvägen 6, 722 13 Västerås and on the Company's website www.realheart.se.

Copies of the documents will also be sent to shareholders who so request and who provide their postal address.

Västerås in November 2023
Scandinavian Real Heart AB
THE BOARD OF DIRECTORS

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Realheart has successfully established a novel test system to evaluate hemolysis of its total artificial heart

Västerås, November 1, 2023 – Scandinavian Real Heart AB (publ.) today announces that the company has successfully established a closed-loop preclinical test system that replicates the body's circulatory system and enables more precise evaluations of hemolytic events. Initial test results show that the company's artificial heart, Realheart TAH, induces 80% less hemolysis compared to the current market leader. The company will shortly start the evaluation of hemolytic events using a clinical version of the product.

Measurements of hemoglobin released from red blood cells (plasma free hemoglobin; pfHb) are performed to determine the risk of ruptured blood cells (hemolysis) during the use of total artificial hearts (TAH). Such analyses compose a cornerstone in the preclinical documentation required to obtain approval from regulatory authorities before conducting clinical trials. During the fall, Realheart successfully completed the construction of an exhaustive test system, which surpasses the regulatory standards of hemolysis testing in pulsating artificial hearts. The model has thereafter been used in initial tests to evaluate the impact of a Realheart TAH prototype on human blood.

The human circulatory system is composed of two halves. One that pumps blood from the heart to the lungs with low pressure, and the other that distributes blood to the organs using high pressure. To the company's knowledge, there are no similar test systems that combine both halves of the human circulatory system for pulsatile pump testing. Initial test results using the preclinical version of Realheart TAH in the test system show that it induces 80% less damage to red blood cells (hemolysis), compared to the current market-leading artificial heart. Furthermore, the tests have been performed using human blood, enabling the company to generate more clinically relevant data and optimize the product design, with the aim of avoiding side effects in future patients who receive treatment with Realheart TAH.

The new and more technically demanding test system was developed following a request from the U.S. Food and Drug Administration (FDA). The development has been time and resource consuming, but has created a positive setting for future regulatory interactions. The CEO of Realheart, Ina Laura Perkins, PhD, has been an active participant in the committee meetings arranged by the agency to develop the new standards for hemolysis testing.

Next, the company will evaluate its clinical product version of Realheart TAH in combination with the clinical control unit in development, to generate the preclinical documentation required in an application to initiate clinical studies in heart failure patients.

"We have succeeded in establishing a test system that opens completely new ways to replicating the function of the human circulatory system, thereby allowing us to compare the properties of our proprietary artificial heart with other cardiac pumps. The model strengthens us in our dialogues with heart specialists and investors who recognize its value in generating comparative performance data. Our initial results point toward a low grade of hemolysis originating from the use of Realheart TAH and we are now eager to test the clinical version of our unique artificial heart," comments Ina Laura Perkins, CEO of Realheart.

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Giovanni Lauricella is adjuncted to Realheart’s board of directors

Västerås, October 30 2023 – Scandinavian Real Heart AB (publ.) has today decided to adjunct Giovanni Lauricella to the board of directors, after being informed that the nomination committee intends to propose him as a new member of the board of directors at the next general meeting. Giovanni Lauricella is a managing partner at Lifeblood Inc., specializing in recruitment and fund raising for medtech companies.

Giovanni Lauricella has worked with over 500 startups worldwide and is currently member of several boards. He also organizes the conference Med-Tech World, which gathers around 3,000 participants, bringing together companies with investors, industry, and the media. He runs the podcast MedTech Money which focuses on demystifying raising and investing capital for Medtech startups.

Giovanni Lauricella holds a Bachelor of Science (BSc) in Finance, a Master of Science (MSc) in Regulatory Affairs in Medical Devices, a Harvard University Certificate in Advanced Negotiation Strategy and a Universita Bocconi Certificate in Private Equity and Venture Capital.

"We are happy to welcome Giovanni Lauricella to the board. He has a vast network in the industry and among specialist investors and has worked with a number of companies that have taken the step from innovation to the commercial market. He will make a strong contribution to the board's work," says Christer Norström, Chairman of the Board, Realheart.

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Realheart selected for Business Sweden’s Catalyst programme

Press release 2023-09-01

Scandinavian Real Heart AB has been selected for Business Sweden's scale-up programme Catalyst, which aims to create international growth. In the program targeting Sweden’s most innovative and promising companies, participants receive a customized project plan for market entry valued at 250,000 SEK and opportunities to build network in the market, among investors and other experts.

– Scandinavian Real Heart is one of Sweden’s most exciting and innovative medtech companies. With Scandinavian Real Heart, Sweden has the opportunity to develop into a leading Life Science nation. We are proud that Scandinavian Real Heart chooses to work with Business Sweden and look forward to supporting the company in their global growth, says Jonas Thulin, program manager at Business Sweden.

Through the program, Realheart receives for three months hands-on support in a selected market, as well as a customized market visit to increase understanding and to create networks.

– The program gives us a springboard towards international growth with tailored commercialization support, advice and coaching in a chosen market. Having been selected also shows that the expert jury sees great potential for our artificial heart. Realheart will take advantage of this opportunity, says CEO Ina Laura Perkins.

Realheart has been selected in the Asia/Pacific program, a region where the company intends to work with partners and distributors for marketing and sales of its artificial heart. Through the program, the company will be able to intensify the work of identifying possible partners in the region and creating initial contacts with key parties. As part of this effort, CEO Ina Laura Perkins speaks at one of the world's largest cardiovascular disease congresses, the China Heart Congress at the turn of August/September.

The market in the Asia Pacific region is of size. The number of patients with heart failure is estimated in China to be around 12 million and in Southeast Asia to 9 million, which can be compared with 15 million in Europe and 6 million in the USA.

Release

Stuart McConchie Appointed Adjunct Board Member to Realheart

Press release 2023-08-30

Scandinavian Real Heart AB has decided to adjunct Stuart McConchie to the board of directors, after the nomination committee informed that it intends to propose him as new board member at the next general meeting. Stuart McConchie has held top positions at global medical technology companies for 25 years, guiding companies from research phase to commercialization of products.

McConchie has worked with several mechanical circulatory assist device companies, most recently as CEO of UK based Calon Cardio Technology, and previously U.S. Jarvik Heart and Australian HeartWare Inc, where he gained public company experience before the company’s acquisition by Medtronic. Moreover, Stuart McConchie has extensive experience of clinical evaluation and regulatory affairs, including FDA interaction with numerous cardiac products.

– We are excited to welcome Stuart McConchie to the board of directors. His strong track record from successfully guiding MedTech companies from research stage through approval and commercialization, especially with his strong experience in regulatory matters will be very valuable to Realheart in the period ahead, says Chairman of the Board Christer Norström.

“Inevitably the spectrum of mechanical cardiac assist will include effective four chamber support.
The RealHeart® TAH is likely to be that device, and I am delighted to join the Realheart team”.
– says Stuart McConchie

Stuart McConchie Appointed Adjunct Board Member to Realheart

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

Patent Protection

Mission and Goal

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/

Interim Report 230401-230630

Realheart Interim Report 230401-230630

Realheart’s CEO to Speak at China Heart Congress

Press Release August 23, 2023

Scandinavian Realheart’s CEO Ina Laura Perkins has been invited to speak at the China Heart Congress, which will be held in Beijing on September 1-3, 2023. Ina Laura Perkins will speak about the company’s total artificial heart that is being developed for patients with heart failure.

The conference, which is one of the largest in cardiovascular disease in the Asia/Pacific region, is expected to gather 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. With an annual caseload of 15,000 cardiac surgeries and 50,000 interventional procedures, Fuwai Hospital is one of the world's largest cardiovascular clinics.

“CHC is an extraordinary opportunity for Realheart to create contacts and build awareness of our artificial heart in China and Southeast Asia. A better introduction to these markets is hard to imagine," says Ina Laura Perkins.

In markets outside Europe and the US, such as China and Southeast Asia, Realheart intends to work with partners and distributors for marketing and sales of its total artificial heart. The markets are sizeable and comprise advanced treatments. The number of patients with heart failure is estimated at approximately 12 million in China and 9 million in Southeast Asia, which can be compared with 15 million in Europe and 6 million in the USA.

During the autumn, Realheart intends to continue the work of identifying possible partners in the region and creating initial contacts with important parties.

Realheart’s CEO to Speak at China Heart Congress

Realheart to Present at Three Scientific Conferences in Europe

Press Release August 22, 2023

Realheart will be presenting its research results at three different scientific conferences in Europe over the next month – the ESAO in Bergamo, the BDW in Rostock and the EUMS in Paris – where many future customers and partners will also be attending. At ESAO, the company will highlight its experiences with animal-free methods and challenge the industry to take the step away from animals.

The annual conference of the European Society for Artificial Organs, which this time takes place in Bergamo, Italy, between 29 August and 1 September, brings together scientists, engineers, clinicians, and companies working with artificial organs to share their research results, technological advances and clinical experiences in order to improve quality of life of patients. It is therefore an important context for Realheart to be seen in.

Presenting at scientific conferences like ESAO requires either an invitation or submitting an abstract that is heavily scrutinised – and far from all are accepted. This year, three abstracts from Realheart have been accepted and will be presented in Bergamo.

Research and development engineer, Faisal Zaman, and Joe Bornoff, a mechanical engineer at the University of Bath, are presenting two, and the third is a longer talk entitled "Is it time to rethink the role of chronic animal studies in MSC development?" by the company's technical director Thomas Finocchiaro, which he has written together with Ina Laura Perkins.

In this talk, he presents Realheart's experiences with animal-free methods – such as in the lab and digitally – and challenges the industry to move away from animal testing.

''Despite the FDA Modernisation Act 2.0, passed last year, which frees the pharmaceutical industry from animal testing requirements, there is still a strong focus on chronic animal studies in medical technology development. We believe that a modernisation of our industry is needed and want to highlight non-animal methods and present our experience with them. We encourage collaboration within our field to develop more lab tests based on available clinical data from already approved products, to reduce animal testing in the development of new heart pumps'' said Ina Laura Perkins, CEO of Realheart.

Faisal Zaman will also participate in the International Workshop on Flow-induced Blood Damage in Rotating Systems at the University of Rostock on 24-25 August, where he will present the company's work in blood testing.

At the European Mechanical Circulatory Support Summit in Paris on 3-6 September, also an important conference where the leading cardiologists gather, CEO Ina Laura Perkins will give an update on Realheart's preclinical results and development.

Realheart to Present at Three Scientific Conferences in Europe

Magnus Öhman Appointed Adjunct Board Member to Realheart

Press Release August 10, 2023

The nomination committee in Scandinavian Real Heart AB proposes that Magnus Öhman is elected to the board at the next general meeting. Until then, he will be an adjunct 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.

The Swedish subsidiary in Cardiac Rhythm Management (CRM) had at the end of Magnus Öhman's time as CEO over 620 employees, of which 200 in research and development, and sales of over SEK 5 billion, of which SEK 900 million from own production. CRM includes products such as pacemakers and defibrillators.

Magnus Öhman currently runs his own consultancy business in leadership and life science and is also chairman of the medical technology company Neosense Technologies AB, focused on reducing mortality and permanent injuries in premature babies. In addition to several roles at St Jude, Magnus Öhman has also been CEO and board member of the Stockholm Technical Institute Foundation, and a mentor in leadership programs.

– "We look forward to welcoming Magnus Öhman to the Board of Directors and taking advantage of his broad expertise, not least on how to build successful growth companies in advanced medical technology for heart disease", says Chairman of the Board Christer Norström.

Scandinavian Real Heart AB utvecklar ett komplett artificiellt hjärta (Total Artificial Heart – TAH) för implantation i patienter med livshotande hjärtsvikt. Bolagets TAH har en patenterad design som innefattar en kopiering av det naturliga mänskliga hjärtat. Realheart® TAH införlivar ett fyrkammarsystem (två förmak, två kamrar) vilket ger möjlighet att generera ett fysiologiskt anpassat blodflöde som efterliknar kroppens naturliga cirkulation. Ett koncept som är unikt i den medicintekniska världen.

Magnus Öhman Appointed Adjunct Board Member to Realheart

Realheart Announces Last day of Trading With BTU and First day of Trading With Warrants of Series TO2

Press Release, August 2, 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)’s (“Realheart” or the “Company”) rights issue, in which the subscription period ended on July 7, 2023, has now been registered with the Swedish Companies Registration Office. Trading in BTU will therefore cease and BTU will be replaced with shares and warrants. Realheart’s warrants of series TO2 will, as a result of the registration of the rights issue with the Swedish Companies Registration Office, be admitted to trading on Nasdaq First North Growth Market on August 11, 2023 and traded under the ticker “HEART TO2”.

The last day for trading in BTU on Nasdaq First North Growth Market is August 7, 2023. Owners of BTU will thereafter receive shares and warrants, which are expected to be in place on each shareholder’s VP account/depositary on August 11, 2023.

Information for paid subscribed units (BTU):

Ticker: HEART BTU

ISIN-code: SE0020358182

Last trading day: August 7, 2023

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 to a subscription price corresponding 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 total number of warrants of series TO2 will amount to 31 007 599. Upon full exercise of all warrants of series TO2, the Company’s number of shares will increase by a maximum of 15 503 799 new shares and the Company may receive additional funding of up to a maximum of about SEK 31.0 million.

The exercise period for the warrants of series TO2 will take place during the period January 2, 2025-January 31, 2025. Warrants of series TO2 will be traded on Nasdaq First North Growth Market during the period from August 11, 2023 to January 29, 2025. The ISIN-code for warrants of series TO2 is SE0020358166.

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.

Realheart Announces Last day of Trading With BTU and First day of Trading With Warrants of Series TO2

Realheart Performs a Directed Issue to EIC in Connection With the Completed Rights Issue

Press Release July 26, 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 ("Realheart" or the "Company") announces that the Company's board of directors, based on the authorization from the annual general meeting on June 14, 2023, has resolved to issue 9 150 000 units to the European Innovation Council ("EIC") Accelerator, in accordance with the investment agreement announced on May 15, 2023. The directed issue consists of 9 150 000 units of the same type and on the same terms as the units in the rights issue announced on the same day and Realheart thus receives an additional SEK 14 640 000 before transaction costs. After the directed issue, the total number of shares will increase from 78 694 446 shares (after registration of the rights issue and the directed issue to underwriters) with 18 300 000 shares to a total of 96 994 446 shares. The EIC will then hold 18,9 of total shares and votes in the company.

The Company had received subscription commitments from EIC based on the following conditions:

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

– That the investment corresponds to one third of the total capital raising, i.e. the rights issue and the directed issue combined, but that EIC's total ownership does not exceed 20 percent of the company after the investment has been completed.

Through the directed issue to EIC the Company's share capital increases by SEK 1 830 000.0 from SEK 7 869 444.60 after the rights issue and the directed issue to underwriters to SEK 9 699 444.60. Through the directed issue to EIC 9 150 000 warrants of series TO2 are also issued, which entitle the holder to subscribe for 4 575 000 shares in the Company. Upon full exercise of the Warrants, the share capital will increase by a maximum of SEK 457 500.0 and the number of shares will increase by a maximum of 4 575 000 shares.

Total increase in number of shares and share capital

In total the number of shares in Realheart after the rights issue, the directed issue to the underwriters and the directed issue to EIC (jointly the "Issues") increases by 62 015 198 shares from 34 979 248 shares to 96 994 446 shares, and the share capital increases by SEK 6 201 519.80 from SEK 3 497 924.8 to SEK 9 699 444.60. This gives a dilution effect of approximately 63.9 percent of the votes and capital in the Company.

Through the Issues, a total of 31 007 599 warrants of series TO2 are issued, which entitle the holders to subscribe for a maximum of 15 503 799 shares in the Company. Upon full exercise of the warrants, the share capital will increase by an additional maximum of SEK 1 550 379.90. This corresponds to a dilution effect from the Warrants of an additional maximum of approximately 13.8 percent of the votes and capital in the Company.

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

Realheart Performs a Directed Issue to EIC in Connection With the Completed Rights Issue

Realheart Performs a Directed Issue of Units to Underwriters in Connection With the Completed Rights Issue

Scandinavian Real Heart AB ("Realheart" or the "Company") announces that the Company's board, with the support of the authorization from the annual general meeting on June 14, 2023, has resolved to issue 642 950 units as underwriting compensation directed to a number of the underwriters who provided underwriting commitments in the rights issue that the Company carried out during the period June 20 to July 7, 2023, in accordance with the underwriting agreements entered into.

The underwriters who provided underwriting commitments in the rights issue had the option of having the compensation paid out in cash or in the form of issued units in the Company, which was previously communicated in connection with the rights issue. In total, eight underwriters have chosen to have the underwriting compensation paid out in units. The Company's board has therefore resolved, with the support of the authorization from the annual general meeting on June 14, 2023, to issue 642 950 units as compensation to these underwriters, which will increase the company's number of shares by 1 285 900 shares and the company’s share capital by approximately 128 590.00 SEK. The purpose of the directed issue and the reason for the deviation from the shareholders’ preferential rights is thus to fulfill the Company’s commitments to the underwriters in accordance with the underwriting agreements.

Units are issued at a price of 1.6 SEK per unit, corresponding to 0.80 SEK per share, which corresponds to the pricing of shares and units in the rights issue. The board has resolved that payment for units shall be made by offsetting the respective underwriter's claim on the Company. The underwriters’ total claim amounts to 1 028 726,72 SEK. When these 642 950 units together with the 21 214 649 units that were issued in the rights issue have been registered with the Swedish Companies Registration Office, the number of shares in the Company will amount to 78 694 446 shares, and the Company's share capital to approximately 7 869 444,60 SEK. The dilution that accrues as a result of the directed issue to the underwriters amounts to approximately 1.6 percent after the rights issue has been registered.

Through the directed issue to the underwriters, 642 950 warrants of series TO2 are issued, which entitle the holder to subscribe for a maximum of 321 475 shares in the Company. Upon full exercise of the warrants, the share capital will increase by an additional maximum of SEK 32 147.50.

The Company has had no specific costs related to the directed issue as this takes place as part of the work with the rights issue.

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

Realheart Performs a Directed Issue of Units to Underwriters in Connection With the Completed Rights Issue

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

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.

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

The Subscription Period in Realheart’s Rights Issue Ends Today

Press Release, July 7, 2023

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

Today, July 7, 2023, is the last day to subscribe for units in Scandinavian Real Heart AB (publ)’s (“Realheart” or the “Company”) rights issue, which was announced on May 15, 2023 (the “Rights Issue”), begins. However, note that nominees may have a deadline for subscription in the Rights Issue that falls before July 7, 2023.

The Rights Issue in summary:

Subscription period: June 20, 2023 – July 7, 2023.
Trade in unit rights: June 20, 2023 – July 4, 2023.
Preferred rights: For every one (1) share held on the record date of June 16, 2023, one (1) unit right was received and one (1) unit right entitle to subscription of one (1) unit.
Unit: One (1) unit contains of two (2) newly issued shares and one (1) warrant of series TO2.
Subscription price: SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are received free of charge.
Issue proceeds: In the event of full subscription in the Rights Issue, the Company will receive approximately SEK 56 million before issue costs.
Underwritten level: The rights issue is covered to approximately 60.6 percent through subscription and underwriting commitments.

Subscription with preferential rights

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

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

Subscription without preferential rights

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

Advisers

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

Important information

Link to the prospectus.

The Subscription Period in Realheart’s Rights Issue Ends Today

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

Press Release July 5, 2023

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

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

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

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

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

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

Realheart's total artificial heart (TAH)

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

Press Release July 4, 2023

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

On friday, July 7, 2023, the subscription period for Scandinavian Real Heart AB (publ)’s (“Realheart” or the “Company”) rights issue of units, which was announced on May 15, 2023 (the “Rights Issue”), ends. Note that nominees may have a deadline for subscription in the Rights Issue that falls before July 7, 2023.

The Rights Issue in summary:

Subscription period: June 20, 2023 – July 7, 2023.
Trade in unit rights: June 20, 2023 – July 4, 2023.
Preferred rights: For every one (1) share held on the record date of June 16, 2023, one (1) unit right was received and one (1) unit right entitle to subscription of one (1) unit.
Unit: One (1) unit contains of two (2) newly issued shares and one (1) warrant of series TO2.
Subscription price: SEK 1.60 per unit, corresponding to SEK 0.80 per share. The warrants are received free of charge.
Issue proceeds: In the event of full subscription in the Rights Issue, the Company will receive approximately SEK 56 million before issue costs.
Underwritten level: The rights issue is covered to approximately 60.6 percent through subscription and underwriting commitments.

Subscription with preferential rights

Subscription without preferential rights

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

Link to the prospectus.

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

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

Press Release July 3, 2023

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

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

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

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

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

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

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

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

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CEO Ina Laura Perkins has the Word

Scandinavian Real Heart AB

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