''This will bring significant commercial benefits. The data we generate can not only be used in the application for approval to start clinical trials but also presented in scientific contexts to continue building interest in our heart. In addition, the collaboration will allow us to connect with clinicians, hospitals and specialists who may be potential future customers," said Realheart CEO Ina Laura Perkins.

On the Virtonomy platform v-Patients, Realheart's engineers and surgeons can perform the implantations themselves via a standard web browser. Initially, five patients are included in the database, and it will be possible to expand the study to more than 50 patients. All are severe heart failure patients and possible candidates for an artificial heart. They represent a diversity in terms of gender, body size and shape of the heart and chest.

Several clinics in different parts of Europe have contributed patients. One is the Hannover Medical School, one of Germany's largest hospitals and among the world's leading institutions for artificial heart implants. It performs up to 100 artificial heart implantations a year, plus a further 20 heart transplants, under the direction of Professor Jan Schmitto.

''We have a strong interest in advancing this field and are therefore happy to participate in interesting research projects that could lead to better treatment of patients with heart failure. There are several new artificial hearts on the way now and Realheart is one that looks very promising," says Professor Jan Schmitto.

Clinical version of Realheart TAH being tested on virtual patients

Oliver Chu shows Realheart's CEO Ina Laura Perkins, the technology for virtual implantations on Virtonomy's web platform v-Patients.

Virtual patient generated from CT scans of an actual heart failure patient Left image: the patient with an enlarged failing heart. Right image: the patient with Realheart TAH virtually implanted.

Scandinavian Real Heart Pty Ltd will be led and run by Dr Marianne Hellers, without any other employees. She holds a degree in Microbiology from Stockholm University and has extensive experience in the Australian life science community as well as a large network that can be valuable for Realheart in taking advantage of the innovation support and research and development opportunities available in the region. Marianne is an alumnus of the BioSA technology incubator in Thebarton and she also led the establishment of the South Australian Health and Medical Institute in Adelaide.

Australia is one of the top five markets for artificial hearts. Several heart pumps including an artificial heart have been developed in the country and thus there is a large pool of knowledge among academic institutions, consultants, suppliers, and test centres. It was this, among other things, that led Realheart to choose Australia's Hydrix as their partner in developing the control unit for its artificial heart recently.

''Hydrix is highly integrated into the Australian medical device ecosystem, and we can benefit from a lot of local knowledge through them, not least when we have our own presence in the country and can work even more closely together," said Ina Laura Perkins, CEO of Realheart.

It is also financially advantageous to locate parts of the research and development in Australia, as 43.5 percent of the investment is paid out as a cash return from Australian Tax Office.

''Our animal studies are ongoing, and we are moving towards clinical trials. These are some of the most expensive activities of medical device development, and by partially locating our activities in Australia, we can reduce costs. Having our own presence in the country is then a big advantage," said Ina Laura Perkins.

Realheart to establish Australian subsidiary

Sara Diab is a former IVA nurse who now works as a medical device specialist with over 10 years of experience in the development of artificial hearts – everything from ethics applications and trial planning to data collection and reporting.

''Sara Diab has an incredibly important skill set based on many years of developing artificial hearts, but her experience in healthcare is just as important in planning for future clinical trials where our heart will be used by patients," said Ina Laura Perkins, CEO of Realheart.

Nicolas Barabino is an expert in medical device innovations such as active implants and various forms of life support devices. He has a PhD in microelectronics and holds two patents related to blood pumps. He has been involved for the last 10 years in the development of heart pumps and brain implants in Uruguay, France, and Spain, working with global medical devices companies. He currently lives and works in Spain as a consultant.

Nicolas Barabino will be based in Spain, but he will also work from Sweden and Australia where Realheart's partner Hydrix, who is developing the clinical control unit, is located. Sara Diab will work mostly from Australia but will also participate in research studies internationally. Hereby the company is strengthening its international network in Europe and Australia.

Both have already joined the company. Realheart plans to start clinical trials in 2023.

Realheart recruits clinical strategist and electronics expert

Realheart, who is developing the world's first four-chamber artificial heart, has received considerable international attention. There is particularly strong interest in the Middle East. This is partly due to the attention given to the inventor and founder of Realheart, Azad Najar, who himself was born and raised in Iraqi Kurdistan. Another contributing factor is that heart failure affects many in the region – and often at a younger age than in the West – while few transplants are performed.

Dr Azad Najar is regularly invited to speak at various medical conferences and, for example, he recently attended the International Conference of Pharmacy and Medicine (ICPM) in Sharjah, where the organizers are already highlighting his attending next year's conference too, set to take place in January 2023. During his visit, Najar participated in several meetings with various stakeholders, including Dr Alkindi, who is a board member of the Sharjah Research Technology and Innovation Park, where the ICPM is held. He will from now on assist the company in liaising with individuals and organizations interested in the Realheart TAH.

''We're seeing a lot of interest, from doctors and researchers as well as potential investors and future partners in this region, and we need to have someone present there to help us both manage that and see how best to capitalize on it. That's where Dr Alkindi has both the knowledge needed and the network of contacts," said Realheart's CEO Ina Laura Perkins.

Realheart hires investment advisor in the UAE

Dr Azad Najar, Realheart

Professor Libera Fresiello has conducted tests of the previous version Realheart TAH (Total Artificial Heart) in a hybrid simulator – a digital model of the human heart, lungs and blood vessels, to which the artificial heart is connected to study its interaction with the body in a variety of scenarios. This information was used to further improve the design of the clinical version currently in production.

''Developing a total artificial heart is a major challenge from both an engineering and a clinical point of view. It must interact safely and effectively with the human vascular system, providing the right support to organs and tissues. By studying it in a simulated environment, we can predict how it would behave in a real human body. I believe this type of methodology will be used more and more as a complement or alternative to animal testing in the future,'' said Professor Libera Fresiello.

One reason limiting the use of artificial hearts is that the products that have been available often lead to for example blood-related complications. This is why Realheart is focusing on creating an artificial heart that mimics the way the natural heart supplies blood to the body's organs in a pulsating flow.

Prof Fresiello's studies show that the Realheart TAH produces such a pulsatile blood flow, which can be adjusted by stroke volume and pulse rate. The two artificial ventricles work independently and if controlled properly, they can attain a right-left balance.

''This is exactly what we aim to achieve. This research will therefore be of great importance in our work. The fact that it is now also presented in a scientific journal such as Artificial Organs will further contribute to greater awareness, trust, and interest in our artificial heart, which is very positive,'' said Ina Laura Perkins, CEO of Realheart.

Artificial Organs is a peer-reviewed biomedical journal covering organ replacement technology. The journal was founded in 1977 and is published monthly. Dr Fresiello's article ''Hemodynamic characterization of the Realheart total artificial heart with a hybrid cardiovascular simulator'' will be published in the next printed issue and has already been published online.

https://onlinelibrary.wiley.com/doi/abs/10.1111/aor.14223

Artificial Organs publishes Libera Fresiello's research

Fresiello Simulator

Realheart is developing the world's first artificial four-chamber heart, designed to mimic the way the natural heart works. The pump membrane, that separates the blood from the drive system, is a critical component of the design. 

Realheart's simulations and tests have shown the precise properties the membrane needs to have to last and to minimize the risk of failure, something that would have immediate consequences for patient safety. The membranes must be manufactured with high precision and unwavering repeatability. The best way to achieve this is to automate the manufacturing process. Therefore, Realheart is collaborating in this project with Berlin Heart, an expert in the field of development and manufacture of membrane technologies successfully used in their extracorporeal MCS devices. 

''The results of the project – an automated membrane production process – will benefit us both, scientifically as well as commercially, and will be crucial for the success of our future human clinical trials. It will also be of great value to the entire heart pump industry" said Realheart's CEO Ina Laura Perkins.  

Eurostars is a program for innovative SMEs participating in international development projects. They can apply for funding to develop market-oriented processes, products and services or to test new markets. Realheart and Berlin Heart have now been awarded grants of SEK 5 million and EUR 450,000, respectively, for this project. 

Realheart aims to launch its artificial heart in 2025, following clinical trials planned to start 2023. Animal testing of the clinical version of the total artificial heart will begin shortly.

Realheart and Berlin Heart receive joint 10 MSEK grant for membrane production

The new version of the Realheart TAH has a higher pump capacity and a smaller size than the prototype. This provides an improved fit in both animals and humans, as confirmed in the winter studies. In addition, it has a built-in advanced sensor system.

''We have confirmed in previous operations that our system works well. The implantations we have done now have been aimed at implementing the latest design changes and fine-tuning the surgical approach for the next series of operations,'' said Realheart CEO Ina Laura Perkins.

The work is progressing according to plan and the company intends to conduct a small series of animal trials with the human version in the spring. Realheart TAH (Total Artificial Heart) is the world's first four-chamber artificial heart, and the development process has attracted considerable international interest. The implantations are being carried out at a clinic in Belgium, and one of the test implantations was filmed by a television team from Germany. Germany is a major European TAH-market. The programme will be broadcast on German television in April.

Update on Realheart's animal studies

Dr Azad Najar is the founder of Realheart and the inventor behind the company's artificial heart. He is originally from Iraqi Kurdistan and has received a lot of attention for his innovation in this region.

''Worldwide, 64 million patients suffer from heart failure, but few are currently treated with an artificial heart because the available product has such serious side effects resulting in low quality of life. Realheart has the potential to change this and save many, many lives – especially in the Middle East where people are falling ill at a younger age and should have many more years to live," said Azad Najar.

Realheart TAH is the first total artificial heart designed to mimic the structure and function of the human heart. It will replace the sick heart to save the lives of patients with advanced heart failure. Preclinical studies are ongoing and clinical trials are scheduled to begin in 2023.

More information is available on the conference website: https://icpm.ae/

Azad Najar a speaker at the ICPM conference today 2022

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Vinnova's aim with the initiative is to create conditions for international competitiveness and sustainable solutions to global societal challenges. Realheart has received funding from Vinnova in two earlier rounds. This new funding will be used for additional expertise to perform blood tests with pumps in clinical use.

Heart failure is one of the most common causes of death in the world. Artificial hearts can save many lives. However, the alternative available so far has many serious blood-related complications resulting in few treated patients. An important step in the development of the next generation of artificial hearts is therefore to increase knowledge of how the pumps affect the blood, something Realheart is working on both in its own lab, in the blood lab created together with Karolinska University hospital and in collaborations with researchers around the world.

''We are very grateful for this contribution. The support will allow us to further strengthen Realheart's competitiveness and continue this important work that is of great importance to the entire heart pump industry," said Realheart's CEO Ina Laura Perkins.

Realheart receives SEK 200,000 funding from Vinnova

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Realheart's research and development work is conducted in three legs: digitally, in the laboratory, and through anatomical and animal studies, all of which are progressing in parallel.

During this autumn's animal studies, the pump was again confirmed to work well. At the same time, the design team discovered in laboratory tests that the newer version of the pump needed less stroke length compared to the previous one. In addition, the right-hand pump was found to require an even shorter stroke length than the left-hand pump, because it works against a lower afterload (pressure in the lungs versus pressure in the aorta). As a result, the clinical version of the Realheart TAH, now in development, will be about 10 percent smaller on the left side and 20 percent smaller on the right.

''There is a tendency towards focussing a lot on the animal studies, but the other parts of the research and development work are just as important and this is a very good example of that. A smaller heart will be easier for the surgeon to adjust to the patient's anatomy – and make our future market potential bigger," said Ina Laura Perkins, CEO.

In January, the company plans to perform a couple of surgeries with a hybrid version to evaluate the latest design changes and train surgeons, before performing the first implantations with the clinical version of the Realheart TAH in the spring.

Realheart's artificial heart becomes 10-20 percent smaller

This patent replaces the previous patent from 2001 which expires shortly. Since then, the design has been further developed and work is now underway to complete the clinical version, which will be preclinically tested in the spring, followed by clinical trials, scheduled for 2023.

''The patent is strategically important as it protects our pump concept in one of the world's largest markets for heart pumps. What sets Realheart TAH apart from other products is, among other things, the way we mimic the natural blood flow. The aim is to minimise the risk of side effects, which up until now have been a major problem and have hampered the entire artificial heart market," says Realheart CEO Ina Laura Perkins.

The patent also protects the idea of using Realheart's concept as a complement to existing heart-lung machines, improving their function by moving from a continuous flow of blood to a pulsating flow, similar to the body's own. This opens up the possibility of developing a further spin-off product later on.

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''Moving on to the ''human'' version of Realheart TAH in our animal studies is the best use or our resources – and a major step forward. In the surgeries performed this autumn, we have confirmed that the system works well and the new surgical team has been able to implant it successfully. In addition, we have identified further design improvements, so now we are choosing to implement these and focus entirely on our clinical version," said Realheart CEO Ina Laura Perkins.

Already last year, Realheart presented a conceptual version of the artificial heart that will be used in human clinical trials in 2023. It will, among other things, have a smaller size and greater pumping capacity than the prototype currently used in animal studies.

Realheart will now allocate more staff to work on finalising this clinical version. In January, the company plans to conduct a couple of surgeries with a hybrid version to evaluate the latest design changes and train surgeons, before conducting the first implantations with the clinical version of the heart in animals in the spring.

The design improvements will also further simplify the surgeons' work, in line with Realheart's ambition to create the most user-friendly artificial heart on the market. 

‘’It is thanks to the vast expertise that exists in the company today, with experience from five other artificial hearts, that we have been able to get to where we are now. Now we are moving forward with the version of our artificial heart that we plan to use in clinical trials – and by making the product even easier to use, we are likely to increase interest from the medical community as well," said Ina Laura Perkins.

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Realheart TAH

Hydrix is an Australian company that specialises in the development of control systems for heart pumps and artificial hearts and has a wealth of knowledge and experience in this field. Their platform has been used in many such systems and is characterised by a strong focus on the needs of the end user.

''Our current controller can run the heart in the way intended for laboratory studies, but when we want to move on to humans it needs to be transformed into a product that is highly user-friendly, safe to use and compliant with regulatory standards. By building the Realheart clinical controller on the Hydrix platform instead of developing our own, development time can also be significantly reduced,'' said Ina Laura Perkins, CEO of Realheart.

The importance of a robust user interface is also evident in the FDA's recalls of TAH products, the majority of which are due to problems in the interaction between the user and the device. Several deaths have occurred when the user misinterpreted alarms from the controller, disconnected cables and was unable to reconnect them.

''Alarms, switches, buttons, and displays must be easy to understand when the patient is using the product themselves without supervision. After all, we want our patients to have a good life with all that entails in terms of work, travel, exercise and playing with children or grandchildren”, said Ina Laura Perkins, and Magnus Ahlström, Hydrix Director Business Development in Europe, added:

“We’re very excited to be working with Realheart on this important project. We hope that our deep experience in controller design will improve quality of life of future total artificial heart recipients”.

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The EUMS-ISMCS conference runs from the 1st 4th of December and Ina Laura Perkins' presentation on Realheart TAH will take place on December 3rd at 2 PM.

''Germany is one of the most important markets for artificial hearts in Europe and I am grateful to be able to raise awareness of our product and what makes it different from our competitors. Also, the conference brings together engineers, doctors, and biomedical researchers from all over the world. We get to meet future suppliers, partners, employees and customers," says Ina Laura Perkins, CEO of Realheart.

More information and a detailed programme can be found here: https://www.congresseums.com/

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Realheart's blood testing laboratory, which is partly funded by a grant from the Winberg Foundation, can perform tests on human blood instead of animal blood, which has previously been the norm. The research aims to minimise side effects in the next generation of artificial hearts, something that has been a major problem until now.

Next to join the laboratory team is Shaikh Faisal Zaman, who has a Masters degree in biomedical engineering from Linköping University. There, he has been part of a research group at the Unit of Cardiovascular Sciences, implementing, among other things, a visualisation of Realheart's total artificial heart to investigate valve movements and heart rates, as well as programming a blood flow analysis to study max speed, kinetic energy and more using magnetic resonance imaging.

''To minimise impact on blood is absolutely crucial to a heart pump. That has been a problem with older solutions which all cause blood damage over time. When we enter clinical trials, it is our ultimate goal to make our heart pump the best on the market. That's why we've designed it to mimic the functions of the human heart, and why we put so much focus on the important issue of blood management," says Realheart CEO Ina Laura Perkins.

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What is special about Realheart's artificial heart is that it mimics the functions of the natural heart with the aim to reduce the risk of side effects. Similar to the human heart, the Realheart TAH adjusts – amongst other parameters – the heart rate and stroke volume according to the body's needs, and to achieve this flexibility it is necessary to identify the optimal settings for the control unit.

This is the purpose of the computer simulation model being built by Joseph Bornoff. It allows a very wide range of operating conditions to be examined to find the pump settings that provide the best energy efficiency and blood handling, and then use this information to program the software. Examining the same amount of operating conditions in laboratory tests would take an extremely long time and cost a lot of money, thus computer simulation saves both time and money.

‘’This computer simulation is very sophisticated because it involves a valve that not only opens and closes, but also moves, and has to be modelled in relation to another valve. What Joseph is doing is really at the forefront of simulation research and is both important to us and extremely exciting to partake in," says Realheart CEO Ina Laura Perkins.

It was at the European Society of Biomechanics in Milan in July that Joseph Bornoff gave his presentation and it is now available here: https://www.youtube.com/watch?v=pqgrOKVYbi4

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