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

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

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

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

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

Realheart's total artificial heart (TAH)

The 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.

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

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

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

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

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

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

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

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

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 Enters Into Collaboration With Sahlgrenska for Clinical Studies

“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 Gets Go-Ahead for International Trademark Protection

Realheart's total artificial heart

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).

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

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.

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

''This does not affect our short-term timeline but gives us a great head start in a future development of the next generation of Realheart TAH. We remain on track with the goal of initiating clinical trials in 2024'', said Ina Laura Perkins, CEO of Realheart.

All of today's artificial hearts and other heart pumps are powered by a cable that connects the implanted pump to an energy source outside the body (driveline). Driveline infections are the most common type of heart pump-associated infections because the driveline exit point creates a conduit for bacteria. Invivopower's solution is instead based on an energy link that transfers energy without breaking the protective skin barrier.

Vinnova, Sweden's innovation agency, has awarded €80,000 in grant funding to Invivopower to develop a platform for the implementation of transcutaneous energy transfer technology (TET), that can be used by companies that develop heart pumps. Realheart will contribute with hardware and software development as well as market validation.

''Realheart is one of the most advanced companies in the world in developing an artificial heart. This project gives us a unique opportunity to put our technology in the hands of our customer early on, thereby gaining invaluable feedback that allows us to focus on the right things in developing a competitive product,'' Bengt Bern, CEO and founder of Invivopower, said.

''We are very grateful that Vinnova makes collaborations like this possible. Wireless transfer of energy/charging is certainly something that we want to implement in Realheart TAH in the future, and through this project we get access to a prototype that is also based on our own technology'', said Realheart's CEO Ina Laura Perkins.

Heart failure is one of the most common causes of death in the world, and the artificial hearts available have too many shortcomings to make a serious impact as a treatment option. Realheart TAH is being developed to overcome these obstacles while increasing the quality of life for patients. Realheart therefore already has a longer battery life and a thinner power cable. 

Realheart Part of Vinnova Project for Cordless TAH Technology

Realheart's recently published decision to communicate only in English is reversed. Shareholders and other stakeholders have provided feedback and emphasized the value of having communication in Swedish.

Based on this, Realheart chooses to return to communicating in both languages, as the company wants to meet the needs and wishes of the market. This means that all press releases and reports will continue to be published in both Swedish and English.

Realheart Returns to Communicating in Both Swedish and English