Hemolysis is a well-documented complication in patients with mechanical heart pumps. When red blood cells are damaged as they pass through a device, hemoglobin is released into the bloodstream, which over time can contribute to kidney injury, anaemia and other organ complications. Despite the clinical relevance of hemolysis, no in vitro hemolysis data for the approved device have previously been published – making this the first head-to-head laboratory comparison of two total artificial hearts using fresh human blood.

The study was conducted using human whole blood which was circulated through each device in a circulation model mimicking half of the human cardiovascular system (left side, or systemic, circulation). The results show that Realheart® TAH produced a significantly lower normalised hemolysis index (mgNIH), 18.11 ± 3.53 mg/100 L, compared with 37.15 ± 12.42 mg/100 L, than the comparator (p < 0.05). Further, plasma free hemoglobin, a direct marker of red blood cell destruction, was nearly twice as high in the comparator samples after six hours, and only the comparator significantly reduced the number of intact red blood cells relative to both the Realheart® TAH and the static control. In summary, Realheart® TAH causes significantly less harm to red blood cells than the market-approved alternative.

These results add to a growing body of experimental preclinical evidence, as well as computational modelling, indicating a favourable hemolysis profile for the Realheart® TAH design. The current study confirms that pattern in human blood, which is roughly twice as sensitive to mechanical damage as alternative experimental options (e.g. bovine blood). The tests in this study were limited to systemic circulation, and in the next step full-body circulation testing will bring the preclinical evaluation closer to the conditions the device will face in patients.

"This was our first study on human blood, and these data show that the Realheart® TAH causes significantly less blood damage than the only market-approved alternative, which is a critical biomarker evaluated by regulatory agencies. With this piece of the puzzle in place, we have moved on to more comprehensive evaluations, including full-body circulation testing, as part of our stepwise preparation for late-stage testing of our product. We have chosen to use human blood as this is more easily damaged than animal blood, which is typically used, thus giving a more clinically relevant risk assessment" says Ina Laura Perkins, CEO, Realheart.

Read the full study: http://doi.org/10.1111/aor.70149

Cardiovascular disease remains the leading cause of death in Sweden, and tens of millions of people globally suffer from heart failure. In the three-part documentary series, SVT science journalist and presenter Victoria Dyring shares her personal story of living with a congenital heart valve defect and the life-changing open-heart surgery that ultimately becomes unavoidable. The series provides a rare behind-the-scenes look at Swedish cardiac care, the existential realities of heart disease, and the medical advances that save lives every day.

The documentary features an interview with Dr. Azad Najar, founder and inventor of Realheart® TAH, who shares his personal journey and the motivation that drove him to dedicate over two decades to developing a better treatment for heart failure patients. Additionally, a prototype of Realheart® TAH is showcased in the documentary, illustrating the innovative four-chamber design that mimics the structure and function of the natural human heart.

Further, the series features Professor Göran Dellgren, Chief Physician at the Transplantation Center and Thorax Clinic at Sahlgrenska University Hospital in Gothenburg, and Realheart’s clinical research collaborator, as he is followed in his daily work behind the scenes. Viewers gain insight into the challenges he faces as a heart surgeon – including heart transplantation procedures – and hear him describe the role of mechanical heart pump therapy for patients with severe heart failure.

“Realheart® TAH is the only total artificial heart device in the world that mimics the structure and physiology of the natural human heart. We are very proud that our long-standing clinical collaborator Professor Dellgren’s vital work in cardiac care and our founder Azad Najar’s inspiring innovation journey are part of this important documentary. The series provides a powerful platform to raise awareness about the challenges facing heart failure patients and the urgent need for new treatment options,” says Ina Laura Perkins, CEO, Realheart.

The documentary is available for public viewing* on SVT Play from April 9, 2026.

* The documentary can only be viewed in Sweden.

Realheart is developing Realheart® TAH, the first total artificial heart that mimics the structure and function of the native human heart. The patent (IN580752) covers a control method and system configuration for an artificial heart, featuring integrated feedback mechanisms for real-time regulation of cardiac output. In detail, the system is designed to ensure precise and safe control of pump performance in medical environments.

By enabling continuous monitoring and adaptive adjustment of key parameters such as pressure, flow, and pump speed, the method supports automated control of artificial hearts and circulatory support systems, such as Realheart® TAH. This contributes to optimized hemodynamic stability and has a potential positive effect on treatment outcomes. The method and configuration are engineered for seamless integration into the company’s existing and future pump devices but can also be transferred and used in other total artificial heart suppliers’ hardware within the field of artificial hearts and circulatory support.

Country: India
Patent number: IN580752
Expiration date: March, 2041

Realheart is developing Realheart® TAH, the first total artificial heart that mimics the structure and function of the native human heart. The recently approved patent covers a core technology of Realheart® TAH, producing accurate and safe pressure measurements. By enabling real-time monitoring, the patented sensor enables automated control of artificial hearts and circulatory support systems, such as Realheart® TAH. The feature is designed to provide a meaningful treatment alternative for patients awaiting a heart transplant while providing benefits that may increase the quality of life. The structural design of Realheart® TAH aims to decrease risk factors commonly associated with currently approved artificial heart treatment devices, e.g., stroke, internal bleeding, and anaemia.

Region: European Patent Office (EPO)
Patent number: 4120893
Expiration date: March 18, 2041

In the presentation, CEO Ina Laura Perkins gives an overview of the company's operations, technology platform, and strategic direction going forward. Parts of the presentation also touch on the rights issue that the company has previously communicated, the subscription period for which began yesterday, January 13, 2026. The rights issue closes on January 27.

Ina Laura also demonstrates today's existing artificial heart systems and highlights their limitations from a patient perspective. She compares these with Realheart's patient-centered solution—a heart designed to mimic the natural blood flow of the human heart and an external patient unit that is quiet, lightweight, and has a long battery life. All this is done to create the best conditions for long-term treatment of patients with severe heart failure.

As previously announced, the purpose of the issue is to finance the continued development of Realheart's artificial heart Realheart® TAH and to strengthen the company's financial position ahead of upcoming development and regulatory steps. Full terms and conditions for the issue, including the subscription period, use of issue proceeds, and other details, are set out in previous press releases.

Read more and subscribe here: https://realheart.se/preferential-rights-issue-realheart/

A recording of the presentation* is available on the Company's YouTube channel: https://youtu.be/AaaZkgmn4GM

* The presentation is in Swedish.

Scandinavian Real Heart AB ("Realheart" or the "Company") announces that the subscription period in the previously resolved rights issue has commenced today, January 13, 2026. The issue is carried out with the aim of strengthening the Company's financial position and enabling continued development and commercialization of RealHeart TAH – the world's first artificial heart with a four-chamber principle.

The company's two main shareholders have already shown their strong commitment by announcing that they will exercise all received subscription rights under the preferential right to subscribe for new shares:

• Claes Mellgren intends to subscribe for 928,757 shares
• Per Olov Andersson intends to subscribe for 884,148 shares

The company's two main owners also announce that they stand behind the previously communicated guarantee commitment that guarantees the issue up to 70%.

The Board of Directors and management will also participate in the issue by exercising all received subscription rights in accordance with the preferential rights and have expressed interest in further subscription:

• Oskar Mellgren, Chairman of the Board, intends to subscribe for a total of 14,400 shares
• Ina Laura Perkins, CEO, intends to subscribe for a total of 7,143 shares
• Mia Tomczak, member of the Board of Directors, intends to subscribe for a total of 3,400 shares

Summary of the Rights Issue

On December 16, 2025, the General Meeting of Realheart resolved to carry out a rights issue of a maximum of 4,998,704 shares with preferential rights for existing shareholders (the "Rights Issue").

Complete terms and conditions of the issue and information on how to subscribe to the issue are available on the Company's website, https://realheart.se/preferential-rights-issue-realheart/

• Upon full subscription in the Rights Issue, Realheart will receive approximately SEK 70 million before issue costs.
• The Rights Issue is covered to approximately 70 percent by subscription and guarantee commitments.
• The subscription period for the Rights Issue runs from 13 January 2026 up to and including 27 January 2026.
• Shareholders who, on the record date of 9 January 2026, were registered as shareholders in accordance with the share register maintained by Euroclear Sweden AB ("Euroclear Sweden") on behalf of Scandinavian Real Heart AB have preferential rights to subscribe for new shares in relation to their existing shareholdings in the Company on the record date. Holding one (1) share as of the record date entitles the holder to one (1) subscription right, whereby one (1) subscription right entitles the holder to subscribe for one (1) share.
• The subscription price is SEK 14.00 per new share.

Reasons for the issue and use of the proceeds

Scandinavian Real Heart AB carries out the Rights Issue of approximately SEK 70 million in order to secure continued financing of the company's development work with Realheart® TAH – a totally artificial heart designed to mimic the structure and function of the human heart. The product is intended to become a permanent solution for patients with severe heart failure. Previous study results support that Realheart TAH has good potential to replace the human heart in the future.

Of the approximately 22 million patients suffering from heart failure in the EU and the US, the company estimates that a patient base of approximately 160 thousand patients suffering from advanced (NYHA class IV), biventricular heart failure includes the target group for TAH treatment. Furthermore, this is estimated to translate into an annual number of patients in need of TAH treatment to about 25 thousand, and is expected to follow the same increase as heart failure in general to about 35 thousand by 2030. The average market price for one TAH is $220 kUSD, which means a market potential of $34 billion USD. The US and EU are the largest markets, of which Germany is the largest European market and therefore of great interest to the company. A collaboration with a German hospital has been initiated for future clinical trials.

In 2025, the company has deepened its collaboration with Sahlgrenska University Hospital in Gothenburg, where surgical methodology and processes have been further developed based on experiences from previous animal studies. The studies are led by cardiac surgeon Professor Göran Dellgren together with a clinical team with extensive experience in heart transplants.

The aim is to first optimize the surgical methodology, then conduct survival studies to gather regulatory data, and finally apply to initiate clinical trials.

In 2025, the company has also increased its focus on product development. The company has produced a number of units of TAH with improved quality and simplified manufacturing processes compared to before.

The company will continue to develop production processes and product quality, both through internal initiatives and in close collaboration with carefully selected partners. As part of this work, there will be a move to more appropriate premises in 2026.

The units of TAH that the company manufactures will be used on an ongoing basis in both endurance tests that run continuously for up to six months and animal studies as well as blood tests. Endurance tests of the membrane, the most critical component has reached more than 20 months in ongoing tests.

To enable the transition to clinical studies, further design improvements to the product are required, which must be validated through endurance tests, animal studies and blood tests. This work has already begun and will continue in 2026. Several studies have been conducted with previous versions compared to market-leading competitors that show superior results in blood tests and in patient simulator studies (cardiovascular simulator, so-called hybrid simulator).

At full subscription, the proceeds (after issue costs of approximately SEK 300,000) are planned to be used as follows:

TAH unit – 60%

• Production of TAH units
• Product development
• Product quality
• Production Process
• Suitable premises

Preclinical studies – 28%

• Endurance tests
• Animal studies
• Blood tests

Regulatory work – 2%

Company costs – 10%

The liquidity is estimated to be sufficient to finance the working capital requirement for 12 months.

Terms and conditions for the Rights Issue

• Upon full subscription in the Rights Issue, the Company will receive issue proceeds of approximately SEK 70 million before issue costs.
• Shareholders who, on the record date of 9 January 2026, were registered as shareholders in accordance with the share register maintained by Euroclear Sweden AB ("Euroclear Sweden") on behalf of Scandinavian Real Heart AB have preferential rights to subscribe for new shares in relation to their existing shareholdings in the Company on the record date. Holding one (1) share as of the record date entitles the holder to one (1) subscription right, whereby one (1) subscription right entitles the holder to subscribe for one (1) share.
• The subscription price is SEK 14.00 per new share. No commission is charged.
• The Rights Issue entails an issue of a maximum of 4,998,704 shares.

Change in number of shares and share capital and dilution

• Upon full subscription in the Rights Issue, the number of shares in the Company will increase by a maximum of 4,998,704 shares, from 4,998,704 shares to a maximum of 9,997,408 shares.
• The share capital will increase by a maximum of SEK 25,043,507.040, from SEK 25,043,507.040 to a maximum of SEK 50,087,014.080, calculated based on a quota value of SEK 5.01 per share.
• The dilution effect amounts to a maximum of 50 percent of the total number of shares and votes in the Company.

The information document

In connection with the Rights Issue, the Company has prepared an information document (the "Information Document") in accordance with Article 1.4 db of Regulation (EU) 2017/1129 of the European Parliament and of the Council of 14 June 2017 on the prospectus to be published when securities are offered to the public or admitted to trading on a regulated market, and repealing Directive 2003/71/EC, as amended (the "Prospectus Regulation"). The information document has been prepared in accordance with the requirements of Annex IX to the Prospectus Regulation.

Full terms and conditions of the issue can be found in the Information Document.

The information document has been registered with the FIN-FSA and
is available on the Company's website, https://realheart.se/preferential-rights-issue-realheart/

Application forms for subscription without preferential rights will be available on Nordic Issuing AB's website.

Subscription commitments and guarantee commitments

The company has received subscription commitments from existing shareholders, the Board of Directors and senior executives of approximately SEK 25.6 million. Which in total corresponds to approximately 36.5% of the rights issue. Furthermore, the Company has received guarantee commitments from existing shareholders of approximately SEK 23.4 million. Which in total corresponds to approximately 33.5% of the rights issue. In total, the rights issue is thus covered to approximately 70% of subscription and guarantee commitments. The guarantee commitments only cover the part of the issue that is not covered by subscription commitments and subscription with subscription rights, up to a total coverage ratio of 70 percent of the issue amount. If the issue is subscribed to 70 percent or more without the need to use the guarantee, the guarantee obligations lapse. No compensation will be paid for subscription and guarantee commitments. Neither the subscription nor the guarantee commitments are secured by bank guarantees, escrow funds, pledging or similar arrangements.

Preliminary timetable for the Rights Issue

Issuing Institute

Nordic Issuing AB is the issuing agent in connection with the Rights Issue.

For further information, please contact:

Ina Laura Perkins, VD

Phone: +46(0)70 406 49 21

E-post: inalaura.perkins@realheart.se

About Scandinavian Real Heart AB

Scandinavian Real Heart AB is developing a complete artificial heart (Total Artificial Heart – TAH) for implantation in patients with life-threatening heart failure. The company's TAH has a patented design that includes a replica of the natural human heart. Realheart TAH incorporates a four-chamber® system (two atria, two chambers) which provides the opportunity to generate a physiologically adapted blood flow that mimics the body's natural circulation. A concept that is unique in the world of medical devices.

Important information

The publication, publication or distribution of this press release may be subject to restrictions by law in certain jurisdictions and persons in the jurisdictions in which this press release has been published or distributed should inform themselves of and comply with such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with applicable regulations in their respective jurisdictions. This press release does not constitute an offer, or a solicitation of any offer, to acquire or subscribe for any securities in Realheart in any jurisdiction, neither from Realheart nor from anyone else.

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 (the "Prospectus Regulation") and has not been approved by any regulatory authority in any jurisdiction. No prospectus will be prepared in connection with the Rights Issue. The Company will prepare and publish an information document in the form prescribed in Annex IX to the Prospectus Regulation.

This press release does not identify or purport to identify risks (direct or indirect) that may be attributable to an investment in the Company. The information in this press release is only to describe the background to the Rights Issue and does not claim to be complete or exhaustive. No assurance should be made in relation to the information in this press release regarding its accuracy or completeness.

This press release does not constitute an offer, or a solicitation of any offer, to buy or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration, or without the application of an exemption from registration, under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration, an exemption from, or in a transaction not subject to the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States, or to make a public offer of such securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into the United States, Australia, Belarus, Hong Kong, Japan, Canada, New Zealand, Russia, Switzerland, Singapore, South Africa, South Korea or any other jurisdiction where such announcement, publication or distribution of this information would be contrary to applicable regulations or where such action is subject to legal restrictions or would require additional registration or other measures than what follows from Swedish law. Actions in violation of this instruction may constitute a violation of applicable securities legislation.

Forward-Looking Statements

This press release may contain forward-looking statements that reflect the Company's intentions, beliefs or current expectations and goals for the Company's future operations, financial condition, liquidity, performance, prospects, expected growth, strategies and opportunities, and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and can be identified by words such as "believe", "expect", "anticipate", "intend", "may", "plan", "estimate", "will", "should", "could", "aim" or "may" or, in each case, their negative, or similar, expressions. The forward-looking statements in this press release are based on various assumptions, many of which are based on additional assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it cannot give any assurance that they will occur or prove to be accurate. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, actual results or results could differ materially from those expressed in the forward-looking statements, which are the result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this press release by such forward-looking statements. The Company does not warrant that the assumptions behind the forward-looking statements in this press release are free from errors and does not accept any responsibility for the future accuracy of the opinions expressed in this press release or any obligation to update or revise the statements in this press release to reflect subsequent events. The information, opinions and forward-looking statements contained in this press release relate only to the situation as of the date hereof and are subject to change without notice. The Company undertakes no obligation to review, update, confirm or publish any revisions to any forward-looking statements to reflect events that arise or circumstances that arise in relation to the content of this press release.

Information for distributors

In order to comply with the product governance requirements set out in: (a) Directive 2014/65/EU of the European Parliament and of the Council on markets in financial instruments, as amended, ("MiFID II"); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593, supplementing MiFID II; and (c) local implementing measures (collectively, the "MiFID II Product Governance Requirements"), and disclaiming any and all liability, whether arising in tort, contract or otherwise, which any "manufacturer" (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares offered have been subject to a product approval process, which has determined that such securities are: (i) suitable for an end target market of retail investors, and investors who meet the criteria of professional clients and eligible counterparties, as defined in MiFID II; and (ii) suitable for distribution through all distribution channels permitted under MiFID II (the "Target Market Assessment"). Notwithstanding the Target Market Assessment, distributors should note that: the price of the Company's shares may decrease and investors may lose all or part of their investment, that the Company's shares are not accompanied by any guarantee of return or capital protection, and that an investment in the Company's shares is only suitable for investors who are not in need of guaranteed returns or capital protection and who (alone or with the assistance of appropriate financial or other advisors) are capable of evaluating the benefits and risks of such investment and which has sufficient resources to bear the losses that such investment may result in. The target market assessment is without prejudice to other requirements regarding contractual, legal or regulatory sales restrictions due to the Rights Issue. For the avoidance of doubt, the Target Market Assessment does not constitute (a) an appropriateness or suitability assessment within the meaning of MiFID II or (b) a recommendation to any investor or group of investors to invest in, acquire, or take any other action in respect of the Company's shares. Each distributor is responsible for conducting its own Target Market Assessment in respect of the Company's shares and for deciding on appropriate distribution channels.

The shares were purchased at a price of SEK 14 each, corresponding to a total transaction amount of SEK 100,800. The transaction was carried out on Nasdaq First North Growth Market and is listed in the Swedish Financial Supervisory Authority's transparency register.
After the purchase, Oskar now holds a total of 7,200 shares in the company.

Patent 1: patent in China covering a pressure sensor for Realheart® TAH
Realheart is developing Realheart® TAH, the first total artificial heart that mimics the structure and function of the native human heart. The recently approved patent covers a core technology of Realheart® TAH, namely an accurate and safe pressure measurements in medical environments. By enabling real-time monitoring, the patented sensor enables automated control of artificial hearts and circulatory support systems, such as Realheart® TAH, that is designed to provide a meaningful treatment alternative for patients awaiting a heart transplant, while providing benefits that may increase the quality of life. The structural design of Realheart® TAH aims to decrease risk factors commonly associated with currently approved artificial heart treatment devices, e.g., stroke, internal bleeding, and anaemia.

Country: China
Patent number: ZL2021800364839
Expiration date: March 18, 2041

Patent 2: patent in Japan covering realtime regulation of Realheart® TAH
The patent encompasses a control method and system setup for artificial heart devices that incorporates feedback mechanisms to manage cardiac output in real time. Through continuous tracking and automatic adjustment of essential factors like pressure, flow, and pump speed, the technology enables fully automated regulation of artificial hearts and circulatory support systems, including the Realheart® TAH. This ensures stable and optimized blood flow. The design is intended to integrate smoothly with both current and upcoming versions of the Realheart® TAH but can also be applied to other comparable devices.

Country: Japan
Patent number: JP7731894B2
Expiration date: March 18, 2041

Realheart is developing Realheart® TAH, the first total artificial heart that mimics the structure and function of the native human heart. The recently approved patent (JP patent no. 7731894) covers a key technology of Realheart® TAH, entailing the automated control function of the device. The feature is an important part of the product’s value proposition, designed to provide a meaningful treatment alternative for patients awaiting a heart transplant, while providing benefits that may increase the quality of life. The structural design of Realheart® TAH aims to decrease risk factors commonly associated with currently approved artificial heart treatment devices, e.g., stroke, internal bleeding, and anemia.

The patent approval confers market protection for the device in Japan until 2041.