Scandinavian Real Heart AB has decided to continue to communicate only in English from the publication of the Q1 report on May 11, 2023. This means that all regulatory, including Market Abuse Regulation press releases, will be published only in English.
The exception is annual reports, which according to current regulations must always be available in Swedish for Swedish-registered companies. An English version will also be available.
Scandinavian Real Heart (the “Company”) today announced the publication of the world’s first combined computational fluid dynamics (CFD) and fluid-structure interaction (FSI) methodology for simulating positive displacement bileaflet valves in series. The article “Overset meshing in combination with novel blended weak-strong fluid-structure interactions for simulations of a translating valve in series with a second valve” is the result of an international collaboration of scientists at Scandinavian Real Heart and researchers at the University of Bath (UK) and was published in the scientific journal “Computer Methods in Biomechanics and Biomedical Engineering”.
The researcher group, led by K. Fraser, at the Department of Mechanical Engineering of the University of Bath, have created an efficient and accurate method for simulating two mechanical heart valves in series, a fundamental requirement for simulations of the Realheart® TAH (Total Artificial Heart). The team has achieved this by using sophisticated CFD tools (overset meshing together with a blend of weak and strong coupling) to generate accurate calculations of the fluid shear stress in critical regions during the opening and closing of mechanical heart valves. By doing so, the scientists were able to balance the computational efficiency needed to simulate the whole Realheart® TAH with the accuracy required to resolve the dynamics of blood flow.
“Heart valves are notoriously difficult to model. The Realheart® TAH contains a two valves in series design so that the up and down movement of the first valve creates the pressures that moves the second valve. This makes computational modelling more complex,” commented Ina Laura Perkins, CEO of Realheart and one of the co-authors of the study. “The model published here is the foundation for the Realheart® TAH computational modelling methodology developed by the Company that was recently published in Nature Scientific Reports (https://www.nature.com/articles/s41598-023-32141-2). Developing and using such breakthrough computational modelling tools enables us to learn more from simulations, thus saving significant development and testing time and resources,” Ina Laura Perkins, added.
Computer Methods in Biomechanics and Biomedical Engineering Publishes research on computational biomechanics and biomedical engineering, including cell mechanics, biofluids, hemodynamics, modeling, design and assessment. It is affiliated with the European Society of Biomechanics and published by Taylor & Francis. The article can be accessed here: https://www.tandfonline.com/doi/full/10.1080/10255842.2023.2199903
Scandinavian Real Heart (the “Company”) has published results demonstrating that the Company’s Realheart Total Artificial Heart (TAH) prototype V11C has lower rates of hemolysis compared to published data from studies of the Reinheart's large and small TAH. The peer-reviewed study titled ”In Vitro Hemolytic Performance of the Realheart V11C TAH Prototype with Porcine Blood” was published on-line, ahead of print, in the Journal of Artificial Organs.
The paper summarizes work performed by an international team of researchers led by Drs. Ina Laura Perkins and Azad Najar of Scandinavian Real Heart in collaboration with scientists at the Swansea University Medical School in the United Kingdom.
High rates of hemolysis requiring repeat and frequent blood transfusions are a key factor limiting the utility of currently available TAHs. Furthermore, hemolysis testing is a regulatory requirement for all new devices intended for the treatment of patients with heart failure. In this study, the so called “Aachen Rig” is used as a step towards creating a gold standard for testing pulsatile flow blood pumps.
In order to compare the outcomes of hemolysis testing with data published in the literature, the researchers utilized the Aachen Rig to test the Realheart V11C TAH prototype. By utilizing the continuous flow pump BPX-80 from Medtronic Inc. as a control, the authors demonstrated that the Realheart V11C TAH has a lower absolute and relative rate of hemolysis when compared to published results obtained with both the large and small ReinHeart TAH (ReinHeart TAH GmbH) devices.
"Developing a TAH is a technical and clinical challenge and ensuring that hemolysis is as low as possible is a key factor impacting the design of artificial hearts. It is against this background that we are developing the Realheart TAH with pulsatile blood flow. Thanks to the design of our artificial heart, with two atria, two chambers and an AV plane, we can generate natural blood flow which we expect will contribute to a reduced risk of hemolysis. The research published in this article is the foundation for the methodology we are using in our ongoing comparison with the market-leading pump SynCardia,” said Ina Laura Perkins, CEO of Realheart.
Artificial Organs is a peer-reviewed biomedical journal that publishes research in the field of artificial organs and medical technology. The journal was founded in 1977 and is published monthly. The publication can be accessed via: https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.14533
(Access fee may be required).
Realheart's planned Annual General Meeting (AGM) will be moved from May 26 to June 16, 2023. The reason for this is that the company intends to arrange a physical meeting in Västerås and the previously communicated date conflicts with other planned activities. In connection with this, the publication of the annual report for 2022 is also moved forward to May 26, i.e. three weeks before the date of the meeting, in accordance with current regulations.
Notice of the AGM will be sent out as usual four weeks before the meeting, i.e. on May 19.
Realheart has several international collaborations with researchers and PhD students to develop the world's first four-chamber heart. One of these is Joseph Bornoff, a PhD student at the University of Bath in the UK. Bornoff has developed an advanced Computational Fluid Dynamics (CFD) model of the Realheart® TAH (Total Artificial Heart) to study blood flow in the pump and optimize its function. The work, co-authored with colleagues at Realheart, has now been published in the Springer Nature journal Scientific Reports.
The Realheart model can be simulated across a wide range of operating conditions where variations in heart rate and stroke volume were investigated. The model was validated using Assistant Professor Libera Fresiello's hybrid simulator, a work published in the scientific journal Artificial Organs in 2022, and showed excellent agreement between simulation and experimental results. The computational model builds upon previous work by Joseph where he developed a fluid-structure interaction method to simulate complex valve motion.
Based on detailed descriptions of the background, methodology and results, Joseph concluded that the risk of blood damage was low, thanks to the low levels of shear stress in the pump. In addition, the excellent drainage of blood through the pump during operation was comparable to other similar devices examined, suggesting that the thrombogenic potential was low.
Bornoff holds a first class MEng (Hons) in Mechanical Engineering from the University of Bath, and is currently undertaking a PhD at the University of Bath, where he is researching a multiscale analysis of a novel total artificial heart, in collaboration with Scandinavian Real Heart since 2020. Bornoff is active in several research areas, such as fluid-structure interaction, artificial hearts, and numerical models and computational fluid dynamics.
“The use of computational modelling enables us to increase productivity in development of the Realheart TAH and future products by enabling reduced testing with simultaneous increased understanding of links between form and function. This puts us in the forefront of sophisticated preclinical testing methodology that saves resources and reduces the need for animal testing” said Ina Laura Perkins, CEO of Realheart.
Scientific Reports is a globally renowned peer-reviewed journal that covers all areas of the natural sciences, psychology, medicine, and engineering, and was the 5th most-cited journal in the world in 2021. Joseph Bornoff’s article: “Fluid-structure interaction modelling of a positive-displacement Total Artificial Heart” has been published in the Artificial Organs collection which covers new methods applicable to improving artificial organs, or studies assessing their function, and is online here: https://rdcu.be/c9T04
Industry players and Realheart estimate that the market potential for total artificial hearts (TAHs) is over 200,000 units per year in Europe and the US. Realheart believes it is well positioned to take significant market share with its four-chamber artificial heart.
"Sales will likely only be limited by the number of artificial hearts we have the capacity to produce," said the company's CEO Ina Laura Perkins. "We have great advantages with our TAH because we have started to automate parts of the production process at an early stage of development. Having said that, we have no long-term limitations for volume production," Ina Laura continues.
An important factor in the production is the awarded Eurostars 3 grant of 10 MSEK that Realheart has received together with Berlin Heart to automate the process of membrane production. The membranes are a critical component of the company's artificial heart and must be manufactured with high precision and unwavering repeatability. The best way to achieve this is to automate the manufacturing process. This is why Realheart collaborates with Berlin Heart, who are experts in the field of developing and manufacturing membrane technologies that are successfully used in their external heart pumps.
According to WHO and several other actors, cardiovascular diseases are today the most common cause of death globally in high-income countries, and the number of people affected is only increasing, as well as the number of years the patient can live with their disease. All of this means a significant increase in the burden and cost of healthcare. According to research[1], the global bill will increase from USD 346 billion in 2012 to USD 400 billion in 2030. Heart failure is a type of cardiovascular disease where the heart is no longer able to pump the amount of blood the body needs. Around 300,000 Swedes[2] have heart failure and around 64 million[3] people are affected globally.
New treatment options are needed, and an artificial heart may be a near-term option for patients with severe heart failure. A sufficiently good TAH can help reduce the suffering of those affected and at the same time has the potential to reduce the cost of care for heart failure.
Realheart expects to initiate clinical trials in 2024 and a market launch in 2025/2026.
[1] Lippi, Giuseppe; Sanchis-Gomar, Fabian. 2020. Global epidemiology and future trends of heart failure. AME Medical Journal.
[2]https://janusinfo.se/lakemedelskommitte/lok/artiklar/lakemedelsbehandlingvidkroniskhjartsvikt.5.6b0cec9617a2d3d28f8699b5.html
[3] (1): Savarese G, Lund LH. Global Public Health Burden of Heart Failure a comprehensive and updated review of epidemiology, https://pubmed.ncbi.nlm.nih.gov/28785469/
Artificial hearts open the door to a paradigm shift in the care of patients with severe heart failure. Here, saving lives and reducing healthcare costs go hand in hand. There is an increased interest in the possibilities of total artificial hearts (TAH) and the interest in Realheart is much higher this year compared to last year's conference. Ina Laura Perkins will present the company at 12.00 on March 30, followed by several personal meetings with European medtech investors.
For the second year in a row, Realheart is participating in Business Sweden's healthcare conference Swiss Nordic Bio (https://www.swissnordicbio.com/) in Zurich. The conference is aimed at companies and investors in life science and the market interest in total artificial hearts (TAH) is great. Currently, there are very limited viable options for the millions of patients in need of a new heart. Realheart is at the forefront of developing a TAH solution expected to offer significant benefits over artificial hearts available today. Some of these expected benefits include a TAH design closely resembling the human heart; having natural, pulsating blood flow (expected to reduce the risks of blood-related side effects); and featuring sensor-based self-regulation. In addition, the TAH is composed of two separate pumps providing a better fit in the chest and has a long battery life. A good enough alternative can save lives and maintain a good quality of life, while reducing healthcare costs.
"It is fantastic that the knowledge of the possibilities offered by a new generation of TAHs is spreading. We see it not only in the range of exhibitions and conferences, but also in the growth of our network of surgeons and other specialists, which results in us being able to recruit highly qualified people with extensive experience in heart pumps and thoracic surgery," said CEO Ina Laura Perkins.
The number of potential patients for Realheart is unfortunately unlimited and the supply of heart transplants is nowhere near matching the need for a new heart. Today, 9 million people die annually from cardiovascular disease and stroke, which together are the most common cause of death globally. The company's French competitor has forecast sales of over SEK 100 million already this year, i.e. the first year they are fully commercialized in the TAH market. Realheart estimates that the market for Realheart® TAH will only be limited by the number of units that can be manufactured. One advantage of the company's heart is that it does not consist of any biological tissues, but only pure mechanics and a modular construction method. This means that there are no limitations when it comes to mass production.
"We are developing our total artificial heart to be the absolute best for the patients and give them a continued good quality of life, but also to enable a fast surgery, which we have also shown in our animal studies. We have a huge challenge ahead of us, but with the knowledge that each TAH could give the patient 5-10 years more to live – and is also replaceable, the challenge feels very relevant and the target for market launch remains 2026," said Ina Laura Perkins.
The conference is a very good opportunity for the company to showcase Realheart® TAH to medtech investors and spread the message of a coming paradigm shift in the care of end-stage heart failure patients. 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. With the company's TAH on the market, heart failure patients' lives will be saved, while contributing to reduced healthcare costs for society.
Cardiac surgeon Ulf Kjellman, who recently joined Realheart's medical advisory board, has now agreed to become the company's Chief Medical Officer (CMO). Kjellman, who has many years of experience in advanced cardiac surgery, will be clinically responsible for the company's preclinical and clinical studies.
"I feel incredibly confident that Ulf Kjellman takes over as medical director and thus assumes clinical responsibility. I will continue as head of innovation with room to focus even more on the continued development of Realheart's entire planned product line, mainly a smaller version of Realheart suitable for women and smaller patients," said company founder Azad Najar.
Ulf Kjellman has over 35 years of experience in cardiac and thoracic surgery. His experience includes a deep involvement in initiating and developing programs for heart transplantation and heart pump treatments at several hospitals, both in Sweden and in other countries, most recently at the National Guard Hospital Riyadh in Saudi Arabia.
“It was an easy decision for me to take on the role as Chief Medical Officer at Realheart. Realheart's TAH is an extremely interesting concept and a paradigm shift in artificial hearts. As a product, it fills a gap in the care of heart failure patients with the potential to save tens of thousands of lives within a decade," said Ulf Kjellman.
Kjellman was one of the first to implant both HeartMate 2 and HeartMate 3, after CE marking. (left ventricular assist devices developed by Abbott). He was also the cardiac surgeon who performed the first implantation of the SynCardia artificial heart in Sweden and Scandinavia in 2008. Kjellman has published several scientific articles on cardiovascular diseases in general and on heart pumps specifically. Thanks to his professional experience, Ulf Kjellman has a large network of contacts among potential customers, suppliers, and partners in Sweden, Europe, and the Middle East.
“We are extremely happy and proud that Ulf Kjellman chooses to step into the role of Chief Medical Officer. Although his expertise has been available to us for some time, it is now even clearer what an important role he will play in our continued development. Dr Kjellman will be a very valuable addition to the management team, where he brings extensive experience in cardiac surgery and transplantation. This in turn will be of great importance for our future clinical trials when patients will receive Realheart® TAH," said Ina Laura Perkins, CEO of Realheart.
Scandinavian Real Heart AB ("Realheart" or ''the Company'') today announces the outcome of the exercise of warrants of series TO1. A total of 7 183 148 warrants of series TO1 were exercised, corresponding to approximately 70 percent of the total number of warrants, which brings the Company approximately SEK 4.2 million before issuing related costs.
The subscription period ran from 1 – 28 February 2023 and the warrants were issued in connection with the Company's issuance of units in the third quarter of 2021. Four (4) warrants entitled the holder to subscribe for one (1) new share.
A total of 1,795,787 shares were subscribed for at the fixed subscription price of SEK 2.36. The exercise of the warrants increases the number of shares from 33 183 461 to 34 979 248. For existing shareholders, the dilution from the exercise of the warrants amounts to approximately 5.1 percent.
As soon as the issue has been registered with the Swedish Companies Registration Office and Euroclear, which is expected to take place in mid-March 2023, interim shares (IS) will be converted into ordinary shares and admitted to trading on the Nasdaq First North Growth Market.
Financial Advisor and Issuing Agent
Skills Corporate Finance Nordic AB is the financial advisor and Nordic Issuing AB is the issuing agent to Realheart in connection with the exercise of warrants of series TO1.
Realheart's founder and innovator Azad Najar was the keynote speaker at the "Future of Innovation" conference held in Dubai at the end of February 2023. The conference, organised by the Dubai Innovation Association, brought together innovators, hospital management, scientists and representatives from the government of Dubai as well as other states in the UAE.
Dr Najar had the honour to talk about the innovation journey of Realheart® TAH, i.e. the path from an idea to a soon-to-be finished product. The journey takes many years of research, development, funding solutions and the need for excellence. But Azad also stressed the importance of patience and courage to succeed.
"We are delighted that the unique benefits of Realheart® TAH, have been so widely adopted around the world. This specific conference has great significance as it is organised by local innovators in the UAE, opening the door to meetings with new interest groups, in addition to the medical researchers, surgeons and physicians we have previously presented to. Our strategy is to reach out to several major markets in the world at the same time" said Azad Najar, Chief Innovation and Medical Officer of Realheart.
Realheart® TAH is the world's first artificial heart designed to mimic the structure and function of the human heart. It will be able to completely replace diseased hearts, saving the lives of patients with life-threatening heart failure. Pre-clinical studies are currently underway, with the goal of initiating clinical trials in 2024.
64 million patients worldwide suffer from heart failure, but few are currently treated with an artificial heart because the options available so far are not good enough. Realheart develops a total artificial heart that produces a physiological blood flow with the aim to reduce common side effects, to enable a better quality of life for patients. In the Middle East, about 3.8 million people suffer from heart failure, and patients are affected on average ten years younger than in the West.
* Equity ratio: equity divided by total capital.
** Earnings per share: profit for the period divided by 33 183 461.
The Board of Directors propose that the company's earnings be carried forward in the amount of 5 873 671.
No dividends will be paid to shareholders.
Scandinavian Real Heart is working with research and development and currently has no sales of any products. The income reported for the period consists mainly of foreign currenty exhance gains. Research and development costs of Realheart® TAH were capitalized during the year with 21.2 MSEK. During the period, write-downs of capitalized costs for research and development were made by 0 MSEK.
The item other external costs of 24.5 MSEK consists of costs for purchased services of 10.2 MSEK and various other costs of 14.3 MSEK. Of these costs, 21.2 MSEK has been capitalized.
With a cash balance of 11.3 MSEK, the companty has funding that will last into second quarter of 2023. In order to solve the Company's longer-term financing needs, Realheart works continuously to evaluate alternatives for further capitalization of the Company.
• In early October, Realheart's CEO Ina Laura Perkins will appear at the Transplantation Forum organised by Focus Patient in collaboration with The Gift of Life and the European Society of Organ Transplanta- tion, ESOT, at the City Conference Center in Stock- holm. Among the speakers will be Dr Bartley Griffith, an American surgeon who recently performed a high-profile pig heart transplant for a human.
• At the end of October, it is announced that Realheart's artificial heart is featured in a German TV documentary on heart disease and new scientific developments, broadcast on ZDF on 25 October. Both Realheart's founder 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 last thing to happen in October is that the third implantation on animals is completed and trials continue. Once again, the implantation went quickly and progress was made, among other things, in the optimal placement of the pump.
• A step into January, the company reaches a new milestone with Realheart TAH. Since the series of animal trials with the clinical version of the company's artificial heart began in 2022, Realheart has been able to progressively increase survival time from the previous milestone of one day to four days. After implantation, the animal has been able to stand up and eat. In addition, several key performance criteria were confirmed.
• In the second half of January, a press release announces that Realheart and KTH are optimising heart function in Sweden's first patient simulator. The collaboration between Realheart and KTH to develop the simulator (scientific term: "hybrid simulator") started in 2022 after a grant of SEK 4 million from Vinnova Smart Elektronik.
• At the end of January, it is announced that Dr. Ulf Kjellman strengthens Realheart's medical council. Ulf Kjellman has over 35 years of experience in cardiac and thoracic surgery and was involved in the introduction of HeartMate II, HeartMate 3, Centrimag, Maquet pumps, Berlin Excor and SynCardia TAH, among others.
• The last event of January is that the company is offering subscription right holders the right to subscribe to HEART TO1. The subscription period will run from 1-28 February 2023.
In the last three months of the year, we made progress in three areas: international marketing, soft funding and our animal studies. In October, our Realheart® TAH was featured in prime time on the German TV channel ZDF in a documentary on heart disease.
A German TV crew visited one of our surgeries to interview the company's founder Azad Najar and the heart surgeon Dilek Gürsoy who performs the operations. Interviewer was a German celebrity chef who has a heart condition himself, and the show followed a young woman with heart failure on her road to a successful heart transplant. The documentary highlights Realheart as a promising alternative solution to the organ shortage.
Germany is one of the largest markets in Europe for artificial hearts. To learn more, I visited the clinic that performs the most heart pump surgeries in the country: the Medical University of Hannover. There I interviewed heart surgeon Professor Jan Schmitto, who said that in Germany alone, 40,000-60,000 artificial hearts are needed each year. This means that we have underestimated the need.
Proof of the strong need is the sales forecast for 2023 from our European competitor. They started selling in November and expect to sell over 100 hearts in the first year at revenues of €10-13 million and scale up production to 1000 hearts by 2027. This is great news for heart failure patients in Europe, but it is only enough for a fraction of patients. Doctors are reminding us that even more artificial hearts are urgently needed.
The situation is similar in the rest of the world. In December, I spoke at the Critical Heart Disease Congress in China. The digital conference has so far been viewed by 24,000 viewers, including doctors and healthcare professionals from Australia, the UK, Austria, Italy, the US and China. I also gave an introduction to the International Society for Mechanical Circulatory Support (ISMCS), for which I have been on the Board since May. Through these networks, we can find the right partners and future customers faster, and raise awareness of artificial hearts as a cure for heart failure. The marketing has already had an impact as I have received enquiries from doctors in Brazil and elsewhere.
To start clinical trials, we need good results from animal studies in addition to blood and durability tests. During the year, we have worked on the surgical process and animal care, for example on the settings of the heart-lung machine. We have realized that this is not readily available knowledge but that we are building up valuable unique know-how within the team. Therefore, we decided not to communicate as frequently and in as much detail about our animal studies as we had done in the past. I understand that this may frustrate shareholders, but I can assure you that we have quietly made great progress: 4 days of survival without blood damage.
Developing an artificial heart requires excellence throughout the entire chain – from idea to marketing and sales. This chain is complete with us, we have all the pieces needed to get to market. Here, our international expertise from several artificial heart projects contributes greatly, as it is a challenge to find equivalent in Sweden. I am convinced that our diversity contributes strongly to our success. It is awesome that we have over 100 years of combined expertise.
In addition to a strong team and good results, continued funding is needed to reach the market. Therefore, we are working on the due diligence process for the European Innovation Council fund which has nominated us for €15 million investment, as well as on finding soft funding. We are very grateful that ALMI chose to continue supporting our work with an innovation loan of 7.6 million SEK. In the first quarter of 2023, our shareholders can further strengthen our cash position via the share option. The funding will be used for animal studies and to start the blood tests on the clinical version of Realheart TAH – we are proceeding nicely according to our plan in other words.
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 best treatment 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 good quality 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 permanent 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.
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.
The interim report has not been reviewed by the Company's auditor.
Submission of Interim Report
Västerås, Februari 24, 2023
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-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/
February 24 is the last day for trading in warrants of series TO1 in Scandinavian Real Heart AB ("Realheart" or the "Company"). The subscription period for the warrants runs until 28 February 2023. Please note that some trustees will close their registration earlier than 28 February 2023. The last day for trading is Friday 24 February.
For holders who have their warrants registered in a trustee's account, for example in a custody account at a bank, it is important to notify in good time that you wish to exercise your warrants. Realheart recommends that holders who have not received notification from their custodian make contact themselves immediately to avoid the risk of the warrants expiring worthless. Holders should either actively subscribe for shares by 28 February 2023 (note that trustees may have an earlier deadline for response) or sell them via First North by 24 February 2023.
Exercise of warrants, directly registered holders
Directly registered holders of HEART TO1 must notify the exercise of warrants by completing and submitting a special notification form to the issuing institution, Nordic Issuing AB. The notification form must be received by Nordic Issuing AB no later than 28 February 2023. Please note that payment for the new shares must also be received by Nordic Issuing AB no later than 28 February, in accordance with the instructions on the notification form. The subscription form for direct registered holders can be downloaded from Nordic Issuing's website, https://nordic-issuing.se/
Exercise of warrants, nominee-registered holders
Trustee-registered holders of warrants (i.e., for example, if the holding is held in a custody account with a bank or stockbroker) must notify the exercise of warrants by contacting their trustee and following the trustee's instructions regarding notification of subscription and payment. Please note that trustees may have a deadline for replying which falls before the closing date for registration.
Delivery of new shares
The new shares will be delivered to subscribers' accounts as interim shares (HEART IA). They will then be admitted to trading on First North as soon as the issue has been registered with the Swedish Companies Registration Office and Euroclear, which is expected to be in mid-March 2023.
Outcome and delivery of new shares
The outcome of the exercise of the TO1 warrants will be announced via press release as soon as possible and is expected to take place a few days after the end of the subscription period. As soon as the issue has been registered with the Swedish Companies Registration Office and Euroclear, interim shares (IA) will be converted into ordinary shares and admitted to trading on the Nasdaq First North Growth Market.
TO1, terms in brief:
The subscription price was set on 27 January at SEK 2.36 per share in accordance with the option terms, i.e. 70 per cent of the volume-weighted average price during the period.
Full terms and conditions for HEART TO1
The full terms and conditions of HEART TO 1 can be downloaded from www.realheart.se. Warrant exercise instructions and application form are available at www.realheart.se.
Financial advisor and underwriter
Skills Corporate Finance Nordic AB is the financial advisor and Nordic Issuing AB is the issuing agent to Realheart in connection with the exercise of warrants of series TO1.
The warrants, with ISIN code SE0016589246, are traded on Nasdaq First North Growth Market. For more information about the warrants of series TO1, please contact Nordic Issuing.
The Swedish company Realheart, which is developing the world's first four-chamber artificial heart, is further strengthening its expertise when Belgian surgeon Bart Meyns joins the company's medical advisory board. Dr Meyns is a Professor at the University of Leuven in Belgium and is also leading Realheart's surgical team in the ongoing animal study.
Bart Meyns has been President of both the European Society of Artificial Organs, ESAO, and the International Society of Mechanical Circulatory Support, ISMCS, of which Realheart's CEO, Dr Ina Laura Perkins, is a board member. He has also published more than 350 peer-reviewed articles in scientific journals.
He is currently head of the Department of Cardiac Surgery at the University Hospital UZ Leuven and a professor at the Faculty of Medicine at KU Leuven. Professor Bart Meyns is part of the surgical team performing the implantations in Realheart's ongoing animal study, paving the way for clinical trials scheduled to begin in 2024.
''Bart Meyns is one of the most skilled and experienced cardiac surgeons available for heart pump implantations. He has been invaluable at the operating table during our animal trials, and I am delighted to be able to bring him even closer to us. His knowledge will be a very valuable addition to our competent medical board'' says Ina Laura Perkins, CEO of Realheart.
The medical advisory board also includes Professors Henrik Casimir Ahn, Robert D. Dowling and Zoltán Szabó and Dr Ulf Kjellman.
Realheart's founder, innovator and now medical director, Azad Najar, had the honor of presenting the company's artificial heart as keynote speaker at a congress in Cairo early this year. The congress had Artificial Intelligence (AI) as its main theme and was organized by the Ministry of Youth and Sports.
“We are delighted that knowledge of our artificial heart has reached so many parts of the world, especially the Middle East, where very few heart transplants are performed, so almost all heart failure patients, regardless of age, die from the disease. The average age of heart failure patients is also about 10 years younger than in the Western world. There are about 100 million people living in the Middle East, including about 10 million in Cairo. Realheart has the potential to save lives and improve the quality of life for those affected, especially important where people are falling ill earlier and should have many years to live”, says Dr Azad Najar.
The interest in Realheart and Azad Najar's innovation has long been noticed in the Middle East and now Azad had the chance to, once again, spread the word about the company's artificial heart to an interested audience.
The congress gathered 125 participants from 25 countries and was mainly aimed at young researchers in applied artificial intelligence, including in the healthcare sector. Azad Najar presented his thoughts on how AI could be used in artificial organs in the future. Specifically, he discussed how AI can help improve patient safety in heart pump patients.
“Realheart® TAH is automatically controlled by sensors that detect the amount of blood flowing back to the heart, allowing it to control that the right amount of blood is pumped out of Realheart® TAH's chamber. The controller generates a large amount of data and we have been investigating how AI could be used to make sense of it for more than a year”, says Azad Najar.
In all studies conducted by the company, the system has demonstrated high efficiency and accuracy in automatic blood flow regulation. Realheart® TAH is one of the most advanced control systems available for artificial hearts. The control system's advanced control algorithm allows the artificial heart to meet the body's blood needs by adjusting the same factors as the human heart does, including heart rate and stroke volume, but also how to balance blood flow to the lungs and to the body.
Scandinavian Realheart AB ("Realheart" or the "Company"), issued during the third quarter of 2021 warrants of series 2021/2023 TO1 ("TO1"). The subscription period runs from February 1-28, 2023. Four (4) warrants of series TO1 entitle the holder to subscribe for one (1) newly issued share in Realheart. The subscription price has been set at SEK 2.36 per share in accordance with the terms of the warrants.
The previous press release stated the subscription price to be SEK 3.37, which is the volume weighted average price for the period 9-27 January 2023. According to the terms, the correct price shall be 70 percent of the volume weighted average price during the period, which amounts to SEK 2.36.
A total of 10 250 002 warrants of series TO1 are issued. Upon full exercise of the warrants, the number of shares in the company will increase from 33,183,461 by 2,562,500 shares to 35,745,961 shares, corresponding to a dilutive effect of approximately 7.2 percent of the capital and votes of Realheart.
Subscription instructions
Holders whose warrants are registered with a trustee (i.e. the warrants are held in a share deposit account, ISK account or endowment insurance) subscribe and make payment in accordance with the instructions of their bank or other trustee. If you have any questions, please contact your bank/trustee well in advance of Tuesday 28 February 2023, as different trustees have different processing times.
Directly registered holders (holding on VP account) of warrants of series TO1 must notify the redemption of warrants by completing and submitting the notification form for redemption of TO1, so that it is received by the issuing institution Nordic Issuing no later than 3.00 p.m. on 28 February 2023. The notification form for directly registered holders can be downloaded from Nordic Issuing's website, https://nordic-issuing.se/.
Issue and delivery of new shares
The outcome of the exercise of warrants of series TO1 will be announced via press release as soon as possible and is expected to take place a few days after the end of the subscription period.
As soon as the issue has been registered with the Swedish Companies Registration Office and Euroclear, interim shares (IA) will be converted into ordinary shares and admitted to trading on the Nasdaq First North Growth Market.
Subscription price calculated and fixed
The subscription price for TO1 was fixed on 27 January 2023 at SEK 2.36 per share in accordance with the terms of the option.
Financial advisor and issuing agent
Skills Corporate Finance Nordic AB is the financial advisor and Nordic Issuing AB is the issuing agent to Realheart in connection with the exercise of warrants of series TO1.
The warrants, with ISIN code SE0016589246, are traded on Nasdaq First North Growth Market. For more information on the warrants of series TO1, please contact Nordic Issuing.
Link to document for full terms and conditions (in Swedish): https://realheart.se/wp-content/uploads/2023/01/fullstandliga-villkor-teckningsoptioner-realheart-to1.pdf
Scandinavian Realheart AB ("Realheart" or the "Company"), issued during the third quarter of 2021 warrants of series 2021/2023 TO1 ("TO1"). The subscription period will start soon and run from February 1-28, 2023, during which four (4) warrants of series TO1 will entitle to subscribe for one (1) share in Realheart. The subscription price for one new share has been set at 3.37 in accordance with the terms of the option.
A total of 10,250,002 warrants of series TO1 are issued. Upon full exercise of the warrants, the number of shares in the company will increase by 2,562,500 shares to 35 745 961 shares, corresponding to a dilution effect of approximately 7.2 percent of the capital and votes of Realheart.
Subscription instructions
Holders whose warrants are registered with a trustee (i.e. the warrants are held in a share deposit account, ISK account or endowment insurance) subscribe and make payment in accordance with the instructions of their bank or other trustee. If you have any questions, please contact your bank/trustee well in advance of Tuesday 28 February 2022, as different trustees have different processing times.
Directly registered holders (holding on VP account) of warrants of series TO1 must notify the redemption of warrants by completing and submitting the notification form for redemption of TO1, so that it is received by the issuing institution Nordic Issuing no later than 3:00 p.m. on 28 February 2022. The notification form for directly registered holders can be downloaded from Nordic Issuing's website, https://nordic-issuing.se/
Issue and delivery of new shares
The outcome of the redemption of the TO1 warrants will be announced via press release as soon as possible and is expected to take place a few days after the end of the subscription period.
As soon as the issue has been registered with the Swedish Companies Registration Office and Euroclear, interim shares (IA) will be converted into ordinary shares and admitted to trading on the Nasdaq First North Growth Market.
Subscription price calculated and fixed
The subscription price for TO1 was fixed on 27 January 2023 at 3.37 SEK.
Financial advisor and underwriter
Skills Corporate Finance Nordic AB is the financial advisor and Nordic Issuing Fondkommission AB is the issuing agent to Realheart in connection with the exercise of warrants of series TO1.
The warrants, with ISIN code SE0016589246, are traded on Nasdaq First North Growth Market. For more information on the warrants of series TO1, please contact Nordic Issuing.
Link to document for full terms and conditions (in Swedish):
Realheart further strengthens its expertise with the appointment of Dr. Ulf Kjellman to the company's Medical Advisory Board. Dr. Kjellman has many years of experience in advanced surgical treatment of heart failure and was the surgeon who performed the first implant of an artificial heart in Scandinavia in 2008.
Ulf Kjellman has over 35 years of experience in cardiothoracic surgery. Among other things, he was deeply involved in initiating and developing the heart transplantation and mechanical circulatory support (MCS) programme at Sahlgrenska University Hospital in Gothenburg, Uppsala University Hospital, Karolinska University Hospital in Stockholm, King Faisal Specialist Hospital Riyadh Saudi Arabia, and National Guard Hospital Riyadh Saudi Arabia. In addition, he introduced HeartMate II, HeartMate 3, Centrimag, Maquet pumps, Berlin Excor, and SynCardia TAH.
In addition to extensive clinical professional experience, Kjellman has authored numerous scientific articles with a focus on cardiovascular diseases. Furthermore, his experience extends to the field of MCS, both LVAD/RVADs with single ventricle support and TAH.
“We are incredibly pleased and proud that Ulf Kjellman has chosen to assist us with his valuable expertise. His experience in cardiac surgery and transplantation at several major hospitals is of great importance for our future implantations where patients will receive Realheart® TAH. Kjellman also has an enormous network of contacts among potential customers, suppliers and partners, both in Sweden, Europe and the Middle East. I am so grateful to be able to connect him even more closely to our development work," says Ina Laura Perkins, CEO of Realheart.
Together with KTH, Realheart has developed a patient simulator to test the algorithm that controls the company's artificial heart enabling it to adapt to the body's needs.
The simulator is a digital model of the human heart, lungs and blood vessels connected to a mechanical test rig that can be used to model and measure the performance of the Realheart® TAH. The collaboration between Realheart and KTH to develop the simulator (scientific term: "hybrid simulator") began in 2022 after a contribution of SEK 4 million from Vinnova Smart Elektronik.
"Vinnova's mission is to strengthen Swedish competitiveness and we are excited to be part of this mission. A patient simulator in Sweden gives us and other Swedish companies the possibility to use local simulators for testing innovative devices. This gives us a substantial cost advantage since we no longer need to travel abroad to access simulators elsewhere in Europe and the US'', says Dr Ina Laura Perkins, CEO of Realheart.
The simulator developed by Realheart and KTH is similar to the one at ETH Zürich, which also supported this project. A key advantage of the Swedish simulator is that it uses technology potentially allowing testing in an MRI scanner.
"This is of particular interest to us, as we have developed an MR-compatible version of our artificial heart in collaboration with Linköping University. The patient simulator brings together two areas of research that contribute to increased patient safety in clinical trials and reduce the need for animal studies," says Dr Perkins.
By connecting the Realheart® TAH to the patient simulator, the interaction of the pump with the body can be studied in different scenarios and performance refined accordingly. This significantly streamlines product development and reduces costs. This will enable MiniHeart – the company's next artificial heart to be developed for women and patients with smaller bodies – to reach the market faster. Implantable cardiac support for patients with small body size is currently unavailable and urgently needed. Current devices are not designed for their needs.
Dr. Perkins has led the project together with Dr. Seraina Dual, Assistant Professor at the Department of Biomedical Engineering at KTH and an expert in testing heart pumps, sensor systems, MRI systems and control algorithms. Dr Dual has shown that smaller patients, such as women, suffer more side effects if heart pumps are not designed for them.
''A lot is happening in medical sensors and cardiovascular devices in Sweden right now and this will increase the innovative potential in the research area. I am proud to have built such a complex system during my first year in Sweden as an assistant professor at KTH, and to be able to contribute to fewer animal experiments'', said Dr Seraina Dual.
Scandinavian Real Heart AB, the company developing the world's first four-chamber total artificial heart (TAH), successfully extended the survival of animals implanted with Realheart’s TAH.
Since the series of animal trials with the clinical version of the company's TAH began in 2022, Realheart has been able to increase survival time from one to four days.
After implantation, the animal was able to stand up and eat. In addition, Scandinavian Real Heart was able to confirm key TAH performance criteria, including:
''I am incredibly pleased with how much we have been able to achieve after just a few implantations of our TAH. The fact that we see no signs of haemolysis or blood clots, combined with the fact that we can achieve good left-right balance, a pulsatile blood flow, and natural blood pressure, is extremely satisfying. We are now moving forward with the aim of continuing to further prolong survival time by optimising the surgical methodology,'' said Ina Laura Perkins, CEO of Realheart. The company plans to initiate human clinical trials in 2024.
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.
In November 2022, the company discovered a misstatement of grants in the Q3 report, as the government grants received are reported as other operating income. The terms of the government grants require the grants to fund the company's development projects and are recorded as advance government grants on the balance sheet. The net amount does not affect the cash flow of the enterprise but is a transfer from the income statement to the balance sheet.
The impact on the Parent Company and the Group for Q3, 2022 will be as follows:
