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Interim Report 220701-220930

Press Release 18 November, 2022

Summery of Interim Report

Group Overview

Third Quarter 2022
(2022-07-01 – 2022-09-30)

• Operating income amounted to 14 365 624 SEK.

• Earnings after financial items amounted to

  2 998 939 SEK.

• Balance sheet total,122 003 532 SEK.

• Earnings per share * amounted to SEK 0.09.

• Equity / assets ratio was 95%.

Parent Company Overview

First to Third Quarter 2022
(2022-01-01 – 2022-09-30)

• Operating income amounted to 14 375 624 (545 146) SEK.

• Earnings after financial items amounted to 3 086 779  (- 5 418 826) SEK.

• Balance sheet total, 121 112 466 (140 666 993) SEK.

• Earnings per share * amounted to SEK 0.09 (-0.16) SEK.

• Equity / assets ratio was 94% (40%).

Third Quarter 2022
(2022-07-01 – 2022-09-30)

• Operating income amounted to 13 471 835 (16 445) SEK.

• Earnings after financial items amounted to 8 997 861 (-1 410 135) SEK.

• Balance sheet total, 121 112 466 (140 666 993) SEK.

• Earnings per share * amounted to SEK 0.27 (-0.04) SEK.

• Equity / assets ratio was 94% (40%).

* Earnings per share: Earnings for the period divided by 33 183 461.
** Equity ratio: Equity divided by total capital.
Amounts in parentheses refer to the corresponding period last year.

Significant Events During the Third Quarter of the Year

•   July begins with a successful second implantation of the clinical version of Realheart TAH in sheep. The important milestone of 24-hour survival is achieved.

•  At the end of August, one of Realheart's biomedical engineers presents the company's work on developing methods to measure blood damage in pulsatile pumps. This at a conference on blood damage caused by heart pumps, organised by the University of Rostock in Germany.

•  September begins with the Realheart team attending the European Society of Artificial Organs (ESAO) conference in Austria. Three of the company's engineers present their research while the CEO and CTO are on hand to make contacts and represent the company.

•  In the last days of September, the Company announces that the third implantation on animals is scheduled to take place in October.

Significant Events After the End of the Period

•   Three days into October, Realheart's CEO appears at FOKUS Patient, organised by Fokus Patient in collaboration with the Gift of Life and the European Society of Organ Transplantation, ESOT.  The presentation is entitled ''When organs are not enough'' in the block on the future of organs and organ donation. Another speaker in the same session was Dr Bartley Griffith, an American surgeon who recently performed a high profile pig heart transplant in a human heart failure patient.

•  Midway through October, Realheart is granted an additional loan from Almi of SEK 7.6 million, which will ensure continued rapid product development targeting clinical trials.

Revenue and Result

Scandinavian Real Heart is currently working with research and development and currently has no sales of any products. The turnover reported for the period consists of grants received. Research and development costs of Realheart® TAH were capitalized during Q3 with 15.9 million. During the period, write-downs of capitalized costs for research and development were made by 0 million.

The item other external costs of 19.9 million consists of costs for purchased services of 8.9 million and various other costs of SEK 11.0 million. Of these costs, 15.9 million has been capitalized.

Financial Position

Following the rights issue completed in 2021, the Company is now in a strong liquidity position with approx. SEK 22 million. Together with the grant of SEK 25.7 million that we have been granted from the EIC and which we will receive in 2022/2024, we have funding that will last into quarter 2, 2023.

In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.

CEO Ina Laura Perkins has the Word

The development of Realheart® TAH continued with a high level of activity throughout the summer. We continued to work on our virtual implantations where we have now increased the number of patients to 15, and the pump has proven to be compatible with all male patients' bodies. The virtual implantations have also enabled us to start defining the dimensions for our follow-up product MiniHeart, which is intended for female patients among others. Nice synergies, in other words.

In July, we performed the second implantation on sheep and reached the milestone of 24 hours survival, which was extremely satisfying for the whole team. The pump did what it was supposed to do and the implantation proceeded smoothly, again providing a beneficial short time on the heart-lung machine before the complicated aftercare of the animal took place. Now that we are past the first critical day, we aim to gradually increase the survival time of each operation – and in parallel fine-tune the software of the controller based on the data we collect.

Something else I carry with me from this quarter is our participation in the ESAO conference in Austria. It brought together many of those who could be our future key customers and partners, and we had many fruitful discussions with representatives of the international clinical community, where we were able to learn about their experiences in treating patients with the artificial hearts available today. Several cardiac surgeons expressed an interest in our work, and several offered to help in various ways, such as with clinical trials.

“Implanting a TAH is the easiest thing you can do, you press a button and the patient is stable”, said one doctor, and we found that the main obstacle to the use of artificial hearts is the risk of side effects and the need for continued care. There is no product that combines easy implantation with reduced blood damage and that gives the patient a high quality of life – but that is only a few years away now.

As we know, we have identified blood damage reduction as one of our key success factors, so it is particularly interesting to see how our competitors are working. During the conference, we were able to hear a presentation from a company that has chosen to have an external consultant perform their tests on blood from cows. We carry out our tests on human blood in our own laboratory – something few others have access to – and because human blood is three times more sensitive than that of cows, we expect to get more reliable answers on how the heart pump will perform in the human body.

In return, some of our engineers had the opportunity to present their work related to our testing activities to the conference participants. We have, as I often point out, a team with a unique collective expertise and I was really proud to see the great interest in Soteris Andreous, Joseph Bornoff and Faisal Zaman's methodology for durability, simulation and blood testing. We also received an award for our collaboration with the University of Bath.

The interest from students who want to collaborate with us is very high, and I see this as a channel for continued future recruitment of high-skilled talent. We currently have an MSc student from the University of Twente in the Netherlands who is working on making our blood testing rig more user-friendly. This will help tremendously as we perform tests every week and will continue to do so throughout the development process. Furthermore, our students from Uppsala University and the Royal Institute of Technology continue their work with us.

In August, our new CFO Jonas Caspari Bark joined us. Jonas will have a very important role as a unifying force at our headquarters in Västerås, as I am in the blood lab in Stockholm or abroad a lot of the time. We are building a good structure for the company so that I can focus on the right things as we continue our journey towards clinical trials and the market.

Ina Laura Perkins
CEO, Scandinavian Real Heart AB

Scandinavian Real Heart AB

Swedish innovation power has given the world medical technology inventions such as the heart and lung machine, the pacemaker and the dialysis machine. The next big innovation is Realheart's artificial heart. A Swedish patented innovation that will save the lives of heart failure patients. Every year, almost 3,500 people die of heart failure in Sweden alone. Today, the only rescue is a heart transplant, but the number of donated hearts is only enough for 2% of those in need.

The idea behind Realheart was born in 1999, when the doctor and innovator Azad Najar made the first sketch of an artificial heart that fully mimics the biological one. In 2007, Azad co-founded Scandinavian Real Heart with two partners. The original idea behind Realheart® TAH is based on flow analyzes made at KTH 2002- 2005 and is based on constructing an artificial heart that mimics the biological. By imitating its basic principle, a pressure and flow is created with the aim to reduce the risk of blood clots and provides an energy-efficient blood flow. These factors are important to give the patient a good quality of life. The development of the product has progressed strongly over the years. Blood circulation, blood pressure, oxygen saturation, pump function and pulse generation have been verified in ethically approved animal experiments. Today, research and development takes place in close collaboration with world-leading heart surgeons, researchers and engineers.

Patent Protection

Realheart has granted patents in Sweden, Germany, the United Kingdom, the United States, China and India that protect the original pump principle in TAH. This patent also provides protection for future products: RealVAD® and PulsePump®.

Patent protection is also available on the latest version of Realheart® TAH in Sweden, USA, UK, Australia and Japan. The patent application for it has also been filed for Germany and Canada. The patents provide protection in the markets that are largest and most important for artificial hearts right now, with the exception of China and India which are considered important emerging markets. In addition to the patent protection described above, Realheart has also approved patents in Sweden, the USA and the United Kingdom for the future Sternal prosthesis product. The application is also submitted in Germany and France. In 2018, a new connection was designed for a simple and secure connection between Realheart® TAH and the body's circulatory system. The patent application for this has also been filed.

Finally, the patent application has been filed in two parts for the use of pressure sensors for the automatic control. Given the existing patents together with the new patent applications, the Board believes that the company has a strong patent situation and strong intellectual property protection.

Mission and Goal

Realheart's mission is to use medical technology solutions to save as many heart failure patients as possible and to create the best conditions for a life-affirming continuation of life. The company's overall goal is for the artificial heart to be commercialized and become a full-fledged treatment alternative for patients with heart failure. The heart should have a better function than the solutions that are on the market today. It should be possible to use both as a bridge to transplantation and as final therapy.

The Stock

Scandinavian Real Heart AB was listed on the Nasdaq First North Growth Market in December 2021. Nasdaq First North GM is a registered SME marketplace for growth companies that enables Nordic and international entrepreneurs to gain access to growth capital to develop and expand their operations. As of September 30, 2022, the number of shares in Scandinavian Real Heart was 33,183,461.

Principles for the Preparation of the Interim Report

The interim report has been prepared in accordance with the Annual Accounts Act and with the application of general advice, recommendations and statements from the Swedish Accounting Standards Board.

Audit Review

The interim report has not been reviewed by the Company's auditor.

Upcoming Financial Reports

Year-end Report, 2022 2023-02-24

Interim Report Q1, 2023 2023-05-18

Submission of Interim Report

Västerås, November 18, 2022
The Board
Scandinavian Real Heart AB

For Further Information, Please Contact

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

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

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

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

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Interim Report 220701-220930
Realheart Interim Report 220701-220930

Third Animal Implantation Completed – Trials Continue

Press Release 27 October, 2022

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

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

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

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

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Third Animal Implantation Completed - Trials Continue
Animal Studies Realheart

Realheart Featured in German TV Documentary

Press Release 25 October, 2022

Realheart's artificial heart is featured in a German TV documentary about heart disease and new scientific developments that will be broadcast on ZDF tonight, 25 October, at 8.15 PM.

The documentary, entitled ''Horst Licther: Mein Herz, mein Motor'', follows a heart failure patient on the waiting list for a transplant. It also highlights the shortage of donor hearts and the need for new technology in artificial hearts.

Both Realheart's founder Dr Azad Najar and Dr Dilek Gürsoy, who is part of the company's surgical team for the ongoing animal studies, are interviewed in the programme.

''The general interest in our artificial heart is high among patients, doctors and investors alike, and this kind of media coverage further helps to raise awareness of the prevalence of heart failure today, as well as the need for better medical devices to treat patients. It's very important for us to be able to showcase our heart in this kind of context'' said Realheart CEO Ina Laura Perkins.

The documentary is 43 minutes long and the part about Realheart start at 29:20. Those unable to watch the broadcast live can view it via the following link:

https://www.zdf.de/dokumentation/zdfzeit/zdfzeit-horst-lichter-mein-herz-mein-motor-100.html  

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart Featured in German TV Documentary
Ina Laura Perkins, CEO at Realheart

Realheart Has Been Granted an Additional Loan From Almi

Press Release 10 October, 2022

Realheart has been granted an additional loan from Almi of SEK 7.6 million, which will aid in securing a continuos rapid product development targeting clinical trials.

”It is a realtively small sum considering our total financing need, but we always evaluate options for additional funding, in order to extend the duration for our investors capital. Not all companies qualify and we are very greatful for the support from Almi," said Realheart CEO Ina Laura Perkins.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart Has Been Granted an Additional Loan From Almi
Ina Laura Perkins, CEO at Realheart

Realheart’s CEO to Speak at the Fokus Patient Forum on October 5

Press Release 3 October, 2022

On 5 October, Realheart's CEO Ina Laura Perkins will be presenting at the ''Transplantation Forum'' organised by Fokus Patient in collaboration with Livet som Gåva and the European Society of Organ Transplantation, ESOT, at the City Conference Centre in Stockholm.

The Transplantation Forum is part of a three-day forum where healthcare professionals, patients, companies, and other interested parties can get an overview of developments and discuss current issues in the field of transplantation in Sweden and internationally.

Participants include Dr Bartley Griffith, an American surgeon who recently performed a high-profile pig heart transplant for a human.

Realheart's CEO Ina Laura Perkins has been invited to give a presentation entitled ''When organs are not enough'' in a section covering the future of organs and organ donation.

''I look forward to telling future clients, people in healthcare and patients about Realheart and all the benefits it can offer as a complement to other options in the future. An artificial heart can easily be stored and taken straight off the shelf, making it urgently available – both as a permanent solution and as a bridge between the human heart and other alternatives. The patient also does not need to take immunosuppressive drugs for the rest of their life, as is the case after a transplant'' said Ina Laura Perkins.

The full programme is available here.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart's CEO to Speak at the Fokus Patient Forum on October 5
Ina Laura Perkins

Third Implantation in Sheep Scheduled to Take Place in October

Press Release 26 September, 2022

During the first half of 2022, Realheart performed successful implantations of its total artificial heart in sheep. These implantations are part of a series of implants to test the clinical version of Realheart® TAH. The next implant has been scheduled to take place in October.

Preparations for this third implant of the clinical Realheart® TAH version are underway and the implantation will be carried out in an animal laboratory in Belgium by three experienced heart surgeons who have also performed the first two implantations: Dr Dilek Gürsoy, Dr Joeri van Puyvelde, and Professor Bart Meyns.

“We have chosen to work with the best surgeons, and I am pleased that we have been able to find a date when all three are available," said Ina Laura Perkins, CEO of Realheart.

The version of the TAH that is being tested is the same one that the company intends to use in human clinical trials expected to start in 2024.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Third Implantation in Sheep Scheduled to Take Place in October

Realheart Team Attends ESAO Conference in Austria

Press Release 6 September, 2022

Realheart has been invited to the annual conference of the European Society for Artificial Organs, which will take place in Krems, Austria, 6-10 September. Three of the company's engineers will present their research at the conference. CEO Ina Laura Perkins and CTO Thomas Finocchiaro will also be in attendance to make contacts and represent the company.

Soteris Andreou presents his work on developing methods for reliability testing while Joseph Bornoff at University of Bath and Faisal Zaman present their methodology for blood testing – all processes that will be used to produce the data that need to be included in applications to regulatory authorities to start clinical trials.

Joseph Bornoff and Faisal Zaman have also been awarded the 2022 yESAO Exchange Award and will receive this at the conference. yESAO Exchange Awards is a stipend for young researchers with the aim of building international networks and producing advancements in the field of research.

''Realheart is the world's first four-chamber artificial heart, so in much of the research we do and the methods we develop, we are breaking new ground. That's why we're increasingly invited to present our findings at international conferences. This time it's particularly exciting because it's some of our younger talents who get to talk about their work themselves, and receive an award for it,'' said Ina Laura Perkins, CEO of Realheart. 

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart Team Attends ESAO Conference in Austria

Realheart’s Faisal Zaman to Present at Blood Injury Conference

Press Release 29 August, 2022

Realhearts biomedical engineer Faisal Zaman is attending a conference on blood damage in heart pumps, organised by the University of Rostock in Germany, on 1-2 September. Faisal Zaman will present the company's work on developing methods to measure blood damage in pulsating pumps.

Faisal Zaman holds a master's degree in biomedical engineering from Linköping University. He was recruited to Realheart 2021, where he among other things is responsible for the work related to blood testing in the company's blood lab at Karolinska University Hospital.

Blood testing is a central part of developing an artificial heart, as the aim is to achieve as little blood damage as possible. Among other things, they measure haemolysis, i.e. the leakage of haemoglobin from red blood cells, and here they want to achieve the lowest possible value. Faisal Zaman will present the results of these tests, the most important of which is that the Realheart® TAH haemolysis value is less than half that of the leading product on the market today.

Historically, this type of test has been designed for rotary pumps that generate a continuous flow, but Realheart® TAH, the world's first four-chamber artificial heart, is based on a completely different principle with a pulsatile blood flow. A different test methodology is then needed to ensure that the haemolysis measurement is accurate. Faisal Zaman will demonstrate how he and the rest of the team work to optimise the test rig and analyse the outcome with clinical experts.

''In developing the Realheart® TAH, we are creating a tremendous amount of new knowledge that is in high demand internationally. That's why we often get invitations like this one. We are keen to share this knowledge – and at the same time, as a company, we can update ourselves on ongoing research and complement our own knowledge in the field of blood injury," said Ina Laura Perkins, CEO of Realheart.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart's Faisal Zaman to Present at Blood Injury Conference

Interim Report 220101-220630

Press Release 19 August, 2022

Summery of Interim Report

First to Second Quarter 2022
(2022-01-01 – 2022-06-30)

• Operating income amounted to 903 789 (528 702) SEK.

• Earnings after financial items amounted to – 5 911 082 (-4 008 690) SEK.

• Earnings per share * amounted to SEK -0.18 (-0.18).

• Equity / assets ratio was 93% (83%).

Second Quarter 2022
(2022-04-01 – 2022-06-30)

• Operating income amounted to 685 380 (527 625) SEK.

• Earnings after financial items amounted to – 3 209 011 (-2 229 708) SEK.

• Earnings per share * amounted to SEK – 0.10 (-0.10).

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

** Equity ratio: Equity divided by total capital.

Amounts in parentheses refer to the corresponding period last year.

Significant Events During the Second Quarter of the Year

• At the beginning of April, Realheart starts collaborations with researchers with expert knowledge about heart pumps, at KTH in Stockholm. The collaborations add to the company additional expertise in the areas of blood testing and evaluation of the control unit to the clinical version of Realheart® TAH, as well as in the company's research on new products.

• In mid-April, the clinical version will be announced of Realheart's artificial heart – the one to be used by human patients – is almost finished and will now be tested in a serie of animal experiments. Six surgeries are booked, with the first operation already in mid-May.

• At the end of April, Realheart begins the recruitment of a new Chief Financial Officer to take over when the current CFO Andreas Hultdin ends July 31.

• Improved control unit for clinical studies provides six months delay, the company announced at the end of April.

The delay is due to the decision of giving the patients in the first clinical study the chance to be equipped with the final version of the control unit – a kind of remote control – instead of a simpler version as previously thought.

• On May 1, a layout version of the annual report for 2021, is released, including reportage with Dr Dilek Gürsoy.

• May also begins with Realheart being granted additional funding for two US patents until 2037, including one that protects the principle behind the four-chamber heart in its entirety.

• During the second week of May, the recruitment of a Lead

Systems Engineer is completed. Bruce Wedding from Texas,comes recently from a role as a senior software engineer at LivaNova, PLC.

• In mid-May, the company announces that the first try of clinical implantation is postponed due to the change of animals.

• One of the last events in May is that Realheart and KTH receives a grant of SEK 4 million from Vinnova to jointly develop a Swedish hybrid simulator that should enable advanced testing of the control algorithm which governs Realheart's artificial heart.

• May also ends with Realheart's CEO Ina Laura Perkins presenting Realheart® TAH blood results at the Internatio- nal EUMS-ISMCS Conference in Hanover.

• In connection with the ISMCS conference it is announced that Ina Laura Perkins has been elected to the Board of International Society for Mechanical Circulatory Support (ISMCS).

• The first event in June is that the first implan- tation with the clinical version is performed on animals. Surgically, the experiment is very successful and the pump performs optimally. The surgical team implants the pump in only 2 hours and 10 minutes – a key factor in the animal's survival.

Significant Events After the End of the Period

• July begins with the second successful implantation of the clinical version in animals. The animal survives for 24 hours, which is an important milestone for the company.

Revenue and Result

Scandinavian Real Heart is currently working with research and development and currently has no sales of any products. The turnover reported for the period consists of grants received. Research and development costs of Realheart® TAH were capitalized during Q2 with 8.2 million. During the period, write-downs of capitalized costs for research and development were made by 0 million.

The item other external costs of 9.6 million consists of costs for purchased services of 6.3 million and various other costs of SEK 3.3 million. Of these costs, 6.6 million has been capitalized.

Financial Position

Following the rights issue completed in 2021, the Company is now in a strong liquidity position with approx. SEK 24 million in liquid funds. Together with the grant of SEK 25.7 million that we have been granted from the EIC and which we will receive in 2022/2023, we have funding that will last into quarter 2, 2023.

In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company. One possibility is to be able to finance the Company in the future via equity from financially strong additional owners as well as from other sources such as EU support and non-profit foundations.

CEO Ina Laura Perkins has the word

In June, we started our animal studies with the clinical version of Realheart® TAH! For this series, we have a strengthened surgical team as well as new expertise in aftercare and an enhanced aftercare protocol. A heart replacement is among the largest surgical procedures that can be performed, and while a human patient is kept sedated for the first critical day, a sheep must be awakened shortly afterwards, making aftercare particularly complex. There are many things we want to confirm during each operation – from ease of use from the surgeons' perspective to a stable and controlled transition from the heart-lung machine. The smooth implantation of the Realheart® TAH resulted in a relatively short total time on the heart-lung machine – something that is of great importance for survival and really impressed everyone involved. The performance of the pump also impressed. Now we continue with high expectations for future operations.

We have also started our virtual study this spring. Using three-dimensional digital replicas of real heart patients, we can test how our product fits in different bodies, among other things. We have already performed implantations on ten virtual patients and our artificial heart fit all eight male patients, but not the two female ones. The study will continue with at least twenty more patients and can be further expanded, if we need more data. Through these studies, we are collecting anatomical measurements to define the patient population for the application to start clinical trials, but also for our other product MiniHeart, which is being developed for women and other patients with smaller body sizes.

At the same time, we are continuing to work on our blood tests, a key part of the development process, as we want to move away from the blood-related side effects that have so far limited the use of artificial hearts. In addition, to enter clinical trials, it is a requirement to show that haemolysis – the leakage of haemoglobin from red blood cells – is at least as low as in a product in clinical use. We are comparing with SynCardia, the most widely used artificial heart on the market, and in tests with the previous version of Realheart we got very good results that were far below SynCardia's. Soon we will start tests with our clinical version, where we hope to get even lower.

Many people follow our work with interest and anticipation, and it was against this background that the European Mechanical Circulatory Support Summit (EUMS) and the International Society for Mechanical Circulatory Support (ISMCS) asked me to present our blood results at their joint conference in Hannover. While there, I received a lot of feedback from physicians who are frustrated by the lack of a good TAH. International physicians are increasing amongst our social media followers, and since that conference we have received an offer of help in future clinical trials from physicians in the US.

We recently hosted an international conference ourselves to disseminate the research results generated within the company and among our partners. The dream would be to welcome the ISMCS conference to Sweden sometime in the future, now that I have been elected to the board, and described as ''a bridge between research and industry''!

What we do is ground-breaking, and our collective expertise continues to grow. Oliver Voigt, who started working with us as a consultant last year, has now taken a seat on our board. He was previously General Manager of SynCardia in Europe and led their expansion from two to 26 countries. Greater knowledge of marketing and selling artificial hearts is not to be found anywhere in the world. The Board has also gained two additional new members with valuable experience: Patrick Schnegelsberg, who among other things, has been CEO of medtech and biotech start-ups and has led ten heart-related products to market approval; and Solveig Bergström, who has led companies from start-up to establishment of international subsidiaries, acquisitions and sales for 30 years.

In addition, we are supported by seven cardiac surgeons, who help us in various ways to drive the project forward: Henrik Ahn, Robert Dowling, and Ulf Kjellman, who contribute to the planning and preparations towards clinical trials; Jan Schmitto, who has given us access to patients for the virtual study: and Dilek Gürsoy, Bart Meyns and Joeri van Puyvelde, who are at the operating table in our animal studies. Having access to their expertise is invaluable, and the fact that they believe so strongly in our product gives us extra confidence.

Ina Laura Perkins
CEO, Scandinavian Real Heart AB

Scandinavian Real Heart AB

Swedish innovation power has given the world medical technology inventions such as the heart and lung machine, the pacemaker and the dialysis machine. The next big innovation is Realheart's artificial heart. A Swedish patented innovation that will save the lives of heart failure patients. Every year, 3,500 people die of heart failure in Sweden alone. Today, the only rescue is a heart transplant, but the number of donated hearts is only enough for 2% of those in need.

The start-up of the company was initiated by the doctor Azad Najar in 1999 when he started sketching an artificial heart that completely mimics the biological. In 2007, Azad co-founded Scandinavian Real Heart with two partners. The original idea behind Realheart® TAH is based on flow analyzes made at KTH 2002-2005 and is based on constructing an artificial heart that mimics the biological. By imitating its basic principle, a pressure and flow is created that reduces the risk of blood clots and provides an energy-efficient blood flow. These factors are important to give the patient a good quality of life. The development of the product has progressed strongly over the years. Blood circulation, pump function, pressure, and pulse generation have been verified in ethically approved animal experiments. Today, research and development takes place in close collaboration with world-leading heart surgeons, researchers and engineers.

Patent Protection

Realheart has granted patents in Sweden, Germany, the United Kingdom, the United States, China and India that protect the original pump principle in TAH. This patent also provides protection for future products: RealVAD® and PulsePump®.

Patent protection is also available on the latest version of Realheart® TAH in Sweden, USA, UK, Australia and Japan. The patent application for it has also been filed for Germany and Canada. The patents provide protection in the markets that are largest and most important for artificial hearts right now, with the exception of China and India which are considered important emerging markets. In addition to the patent protection described above, Realheart has also approved patents in Sweden, the USA and the United Kingdom for the future Sternal prosthesis product. The application is also submitted in Germany and France. In 2018, a new connection was designed for a simple and secure connection between Realheart® TAH and the body's circulatory system. The patent application for this has also been filed.

Finally, the patent application has been filed in two parts for the use of pressure sensors for the automatic control. Given the existing patents together with the new patent applications, the Board believes that the company has a strong patent situation and strong intellectual property protection.

Mission and Goal

Realheart's mission is to use medical technology solutions to save as many heart failure patients as possible and to create the best conditions for a life-affirming continuation of life. The company's overall goal is for the artificial heart to be commercialized and become a full-fledged treatment alternative for patients with heart failure. The heart should have a better function than the solutions that are on the market today. It should be possible to use both as a bridge to transplantation and as final therapy.

The Stock

Scandinavian Real Heart AB was listed on the Nasdaq First North Growth Market in December 2021. Nasdaq First North GM is a registered SME marketplace for growth companies that enables Nordic and international entrepreneurs to gain access to growth capital to develop and expand their operations. As of December 31, 2021, the number of shares in Scandinavian Real Heart was 33,183,461.

Largest Shareholder in the Company per 2022-06-30

Shareholders                                                    Numbers of Shares               Votes (%)              Capital (%)

Najar Medical & Invention AB                                    3 262 635                            9,83                        9,83

Eskilstunahem Fastighets AB                                   1 650 006                             4,97                        4,97

Försäkrings AB Avanza                                             1 471 845                            4,44                         4,44

Ålandsbanken ABP (finland) Swedish branch            852 181                              2,57                         2,57

Najar Bilend                                                               516 263                               1,56                        1,56

Forslund Lars                                                             489 474                              1,48                         1,48

Nordnet Pensionsförsäkring AB                                 464 334                              1,40                         1,40

Smartgroup Holding AB                                             417 316                              1,26                          1,26

Staffan Ewerth                                                           350 000                              1,05                           1,05

Gilbert Raux                                                              306 500                               0,92                           0,92

Others                                                                     23 402 907                           70,52                         70,52

Total                                                                       33 183 461                          100,00                        100,00

Principles for the Preparation of the Interim Report

The interim report has been prepared in accordance with the Annual Accounts Act and with the application of general advice, recommendations and statements from the Swedish Accounting Standards Board.

Audit Review

The interim report has not been reviewed by the Company's auditor.

Upcoming Financial Reports

Interim Report Q3, 2022 2022-11-18

Year-end Report, 2022 2023-02-24

Submission of Interim Report

Västerås, August 19, 2022

The Board

Scandinavian Real Heart AB

For Further Information, Please Contact

Ina Laura Perkins

CEO Scandinavian Real Heart AB

Phone: +46 70 406 49 21
E-mail: inalaura.perkins@realheart.se

Jonas Caspari Bark

CFO Scandinavian Real Heart AB

Mobile +46 70 643 88 61
E-post: jonas.bark@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

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

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

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Interim Report 220101-220630 (Copy of Press Release)
Interim Report 220101-220630

Realheart Successfully Completes Second Animal Implant of its Total Artificial Heart

Press Release, 8 July 2022

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

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

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

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

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

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart Successfully Completes Second Animal Implant of its Total Artificial Heart

Jonas Caspari Bark New CFO at Realheart

Press release 27 June, 2022

Realheart has recruited Jonas Caspari Bark as its new Chief Financial Officer. He joins Realheart from a similar position with Ecokraft Sverige AB and has previously, among other things, worked in various roles within the ABB group. Jonas Caspari Bark starts on August 5.

Realheart is a Swedish company, headquartered in Västerås, that is developing the world's first artificial four-chamber heart. The company has recently taken several important steps forward, not least in leaving the prototype behind and now testing the clinical version of the heart in animal studies, with clinical trials expected to begin in 2024. As a result of this, interest in the company is increasing, and with it the need to further strengthen the finance function.

''I am so pleased to have been able to add Jonas Caspari Bark to our team when our current CFO Andreas Hultdin cannot be available to the extent we need going forward. He has been extremely important to Realheart and it is thanks to his skill and commitment that Jonas can now take over a finance function with well-structured and secure procedures and develop it further'' said Ina Laura Perkins, CEO.

Andreas Hultdin will leave his role on 5 August when Jonas Caspari Bark takes over, but Andreas will remain as a consultant to support the company as needed.

''Realheart's artificial heart is a super exciting product that will help save a lot of lives in the future. I am really looking forward to being involved in the work towards commercialisation. I have previous experience of getting onboard at this phase of the development process and hope to be able to contribute to our success, says Jonas Caspari Bark.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Jonas Caspari Bark New CFO at Realheart
Jonas Caspari Bark

Second Animal Implantation To Take Place July 6

Press Release, 23 July 2022

Earlier this month, the first in a series of animal implantations to test the newly developed clinical version of Realheart's artificial heart was performed. The next surgery has now been scheduled for 6 July.

The implantations are performed in an animal laboratory in Belgium by Dr. Dilek Gürsoy, Dr Joeri van Puyvelde and Professor Bart Meyns, all experienced cardiac surgeons. The scheduling of the surgery depends on the availability of all three surgeons and the laboratory. The next surgery has now been scheduled for July 6 and preparations are underway.

This will be the second implantation of the clinical version of the Realheart® TAH – the version that will eventually be used in humans. Clinical trials are to begin in 2024 according to plan.

''We feel very satisfied after the previous operation. The surgical team managed to implant the pump in just over 2 hours, which is an extremely important factor affecting the patient's chances of survival. The pump's performance was optimal and our expectations for the next surgery are very high'' said Ina Laura Perkins, CEO of Realheart.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Second Animal Implantation To Take Place July 6

Realheart to Host International Conference in Västerås 15 June

Press release, 15 June 2022

On June 15, Realheart will host an international conference on artificial hearts to share the research results generated within the company and its network of scientists during the development of the Realheart TAH. The conference will take place in Västerås, where the company has its headquarters and development labs.

This is the first time that an international conference on artificial hearts has been held in Sweden, and the company hopes to invite even more international participants next time.

''It would be great to showcase Västerås and promote Sweden to researchers from countries that are strong in this field of research – and important markets for heart pumps – such as Belgium, Germany, Turkey, the UK, and the US," said Ina Laura Perkins, CEO of Realheart.

The conference is multidisciplinary, and participants range from engineers specializing in electronics, computer systems and mechanics to medical professionals such as biomedical analysts, nurses, perfusionists and surgeons. In addition, there are investors within the life science industry who can bring a financial perspective to the discussions. Students, graduate students, professors, and senior industry executives also participate. With 40% of female speakers, the conference also contributes to the company's work towards the UN's sustainability goals by striving to increase women's influence in technology in general and the heart pump industry specifically.

As part of the program, Professor Michael Uhlin from Karolinska Institutet and Professor Henrik Ahn from Linköping University will moderate a discussion on hemocompatibility for pulsating artificial hearts. Katharine Fraser from the University of Bath will lead a session on data modelling – which will also feature Realheart founder Azad Najar – and Professor Libera Fresiello, University of Twente, will give a session on circulatory mock loop testing.

''We hope this will help build stronger expertise in Sweden in this area. It would create a breeding ground for faster development, not only for our own future product portfolio, but also for other medical technology start-ups in Sweden'' said Ina Laura Perkins.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart to Host International Conference in Västerås 15 June

Realheart’s CEO in Filmed Company Presentation: “the biggest news for 2022 is that the clinical version of Realheart® TAH is fully developed and under production”

In a filmed presentation on the occasion of Realheart's Annual General Meeting, CEO Ina Laura Perkins describes what the company has done during the past year and what is in the pipeline for 2022.

Among other things, Ina Laura explains what the four key factors for success are and why the Company has started a subsidiary in Australia.

Link to the Filmed Presentation: https://youtu.be/DQAErlgdRBE

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart's CEO in Filmed Company Presentation: "the biggest news for 2022 is that the clinical version of Realheart® TAH is fully developed and under production"

First Animal Trial with Clinical Version Completed

Press release, 2 June 2022

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

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

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

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

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

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

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

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

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

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

First Animal Trial with Clinical Version Completed

Realhearts CEO Elected to the ISMCS Board of Trustees

Press release 20 May, 2022

Realheart's CEO Ina Laura Perkins has been elected to the Board of Trustees of the International Society for Mechanical Circulatory Support, ISMCS. The announcement was made at the society's annual conference in Hannover, Germany, May 24 to 27.

The ISMCS is an international forum for discussion of the research, development, clinical use and social acceptance of rotary blood pumps and related forms of mechanical circulatory support. The aim is to improve the quality of life for patients and provide cost-effective availability of emerging therapies.

At least once a year, ISMCS holds an international meeting, alternating amongst Europe, the US and Japan. In collaboration with the International Federation of Artificial Organs, ISMCS also publishes the journal Artificial Organs, which is a platform for discussing the current state of research.

Realheart's partner professor Libera Fresiello from Belgium is also a member of the board of ISMCS.

''It is a great honour to be among these extremely knowledgeable people and to represent Swedish research in this context. I look forward to sharing their vast collective knowledge and to sharing my own lessons learned in developing Realheart® TAH'' said Ina Laura Perkins.

Ina Laura Perkins has worked with medical innovation throughout her professional career. Prior to joining Realheart in 2017, she worked as a research manager at Calon Cardio-Technology. She started her academic career in stem cell research and completed her PhD at Swansea University Medical School and holds an Executive MBA from Stockholm School of Economics.

''It is our pleasure to welcome Ina Laura Perkins to the Board. We look forward to her being a bridge between the industry and research field with her outstanding experience and knowledge in developing a total artificial heart and joining us in promoting the mechanical circulatory support field throughout the world,'' said Professor Toru Masuzawa, President of the ISMCS.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realhearts CEO Elected to the ISMCS Board of Trustees
Ina Laura Perkins, Elected to the ISMCS Board of Trustees.

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

Press release 27 May, 2022

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

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

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

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

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

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

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

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart’s CEO Presents Blood Results at the ISMCS Conference in Hannover
Ina Laura Perkins in the blood lab, Karolinska University Hospital

Realheart and KTH Receive SEK 4 Million Grant from Vinnova

Press release 26 May, 2022

Realheart and KTH have received a grant of SEK 4 million from Vinnova to jointly develop a Swedish hybrid simulator that will enable advanced testing of algorithms that control Realheart's artificial heart, but also will contribute to increasing Sweden's overall competitiveness in cardiovascular device innovation.

A hybrid simulator consists of digital model of the human heart, lungs, and blood vessels, to which an artificial heart, for example, can be physically connected to study how the device interacts with the body. Similar methodology was used in the development of the clinical version of the Realheart® TAH and will in the next step be used to refine its physiological control algorithm.

Currently, hybrid simulators are available in Australia, Belgium, Germany, Switzerland, and the USA. This gives local companies an advantage in the ability to test their innovations at a low cost and iterative way. Importantly, testing in a hybrid simulator reduces the need for animal testing.

''This is a methodology that is being used more and more and we want Sweden to be at the forefront of this development. We also want a strong breeding ground for new products in our future product portfolio, such as our smaller artificial heart, MiniHeart, which is still in development. Having access to a hybrid simulator here in Stockholm will then be crucial'' said Ina Laura Perkins, CEO of Realheart.

The work will be led by Dr Ina Laura Perkins and Dr Seraina Dual, Assistant Professor at the Department of Biomedical Engineering and Health Systems at KTH, who has many years of experience in testing heart pumps, sensor systems, and control algorithms.

“I am excited to co-lead this initiative to build a hub for cardiovascular device innovations here in Stockholm, Sweden. The hybrid simulator will help us get a step closer to patient-specific testing of novel innovative device concepts – such as the Realheart,” said Dr Seraina Dual.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart and KTH receive SEK 4 million grant from Vinnova

Implantation with clinical version rescheduled for change of animal

Press release, 19 May 2022

Realheart is conducting a series of implantations in sheep this spring to test the newly developed clinical version of its artificial heart. However, in preparation for the first surgery, it was discovered that the sheep made available at the lab did was not suitable for the surgery. The first surgery was therefore postponed until early June to prepare a new animal.

The clinical version of the Realheart® TAH – the version that will eventually be used in humans – is now at the animal lab in Belgium where it is undergoing sterilisation pending surgery.

It was during a preliminary test operation in a virtual environment that the team discovered that the intended animal was not suitable to undergo the surgery. Virtual implantation techniques are widely used prior to artificial heart treatment in humans, precisely because we all look different inside. This also applies to animals. Virtual technology is also used as part of Realheart's testing and in the collection of data for future animal and human clinical trials.

''This is very frustrating for all of us in the team who have been eagerly awaiting this implantation, but we are also grateful that we were able to identify this now, rather than during surgery. Through these careful preparations, we want to optimize the chances of successful results, and now we look forward to getting started in a couple of weeks,'' said Ina Laura Perkins, CEO of Realheart.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Implantation with clinical version rescheduled for change of animal

Realheart Releases the Annual Report for 2021 in English

Press release, 13 May 2022

Today, Realheart publishes the annual report for 2021 including a report on the Company's surgeon Dilek Gürsoy and points of reference for the development plan until launch. Ina Laura Perkins writes in the CEO's statement "we took a big step forward when we left the prototype behind us to completely focus on the clinical version of our total artificial heart".

The entire annual report is available on the company's website www.realheart.se and as an appendix to this press release.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

Scandinavian Real Heart AB develops a total artificial heart (TAH) for implantation in patients with life-threatening heart failure. Realheart® TAH has a unique, patented design that resembles that of the natural human heart. The artificial heart consists of a four-chamber system (two atria and two ventricles) designed to generate a physiological blood flow pattern that mimics the body's natural circulation. A unique concept in the medical technology world.

Realheart Releases the Annual Report for 2021 in English
Realheart Annual Report 2021 English