Arkiv

Realheart receives EUR 750,000 in second grant payment from the European Innovation Council

Västerås, Sweden, December 29, 2023 – Scandinavian Real Heart AB (publ) today announces that the company has received its second payment from the European Innovation Council (EIC) grant that was awarded in December 2021, aimed at supporting the development of the artificial heart Realheart TAH. The payment of EUR 750,000 equals 30% of the total grant sum of EUR 2.5 million.

The company was awarded the grant within the framework of the European Innovation Council Accelerator program, which main purpose is to support the development of European innovations that have the potential to create new markets or disrupt existing ones. With the current payment, Realheart has received 80% of the total grant sum and will receive the final EUR 500,000 as the product development advances.

"We are very happy to receive the second payment of the innovation grant for the continued development of Realheart TAH. We have had a fruitful dialogue with the European Innovation Council during the reporting period and see its continued support as proof of the innovation height in our unique artificial heart. The payment will be used to finance the last part of our preclinical development of Realheart TAH, which will enable us to then move into the next phase," says Realheart's CEO, Ina Laura Perkins.
 

Today, more than 8,300 patients with advanced heart failure in Europe and the U.S. are waiting to undergo a heart transplant, and unfortunately many pass away while on a waiting list. Realheart develops Realheart TAH, an artificial heart that mimics the structure, function, and blood flow of the human heart, and which unique attributes create completely new opportunities to save lives and offer patients an improved quality of life while waiting for a transplant.  

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.

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.

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.

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

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.

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

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 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.

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.

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.

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

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.

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

Press Release July 5, 2023

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

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

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

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

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

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

Press Release July 4, 2023

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

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

The Rights Issue in summary:

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

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

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

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

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

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

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

Subscription with preferential rights

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

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

Subscription without preferential rights

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

Advisers

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

Important information

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

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

The information in this press release may not be published, released or distributed, directly or indirectly, in or to the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such action would be unlawful, subject to legal restrictions or require other actions than those following from Swedish law. Actions in violation of this instruction may constitute violations of applicable securities laws. No shares, warrants or other securities in Realheart have been registered, and no shares, warrants or other securities will be registered, under the then-applicable United States Securities Act of 1933 (the "Securities Act") or securities legislation in any state or other jurisdiction in the United States, and may not be offered, sold or otherwise transferred, directly or indirectly, in or to the United States except in accordance with an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and in accordance with securities legislation in the relevant state or other jurisdiction in the United States.

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

Link to the prospectus.

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

Press Release July 3, 2023

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

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

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

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

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

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

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

Realheart Enters Into Collaboration With Sahlgrenska for Clinical Studies

Press Release July 3, 2023

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

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

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

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

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

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

Realheart Gets Go-Ahead for International Trademark Protection

Press Release, 28 June 2023

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

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

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

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

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

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

Press Release, 21 June, 2023

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

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

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

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

Link to the interview on YouTube (Swedish).

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

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

Press Release, 15 June 2023

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

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

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

Determination of fees for Board members and auditor

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

Election of Board of Directors and auditor

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

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

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

Nomination Committee

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

Amendment of the Articles of Association

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

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

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

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

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

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

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

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

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

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

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

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

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

Press Release, 15 June 2023

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

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

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

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

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

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

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

Press Release, 14 June 2023

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

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

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

Determination of fees for Board members and auditor

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

Election of Board of Directors and auditor

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

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

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

Nomination Committee

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

Amendment of the Articles of Association

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

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

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

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

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

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

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

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

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

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

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

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

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

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