''This is extremely valuable as it provides a strong two-layer protection for our artificial heart in one of the world's most important markets and further strengthens our overall patent portfolio'' said Realheart CEO Ina Laura Perkins.

In December, Realheart was granted a US patent protecting the unique pumping principle used in Realheart's artificial heart, which can also be used in other products. Now, in addition to that, it has received a new patent, number US11202902B2, which protects the Realheart TAH as a whole. This patent has already been granted in Europe, Japan and Australia.

The second patent, number US11191578B2, protects Realheart's sternal prosthesis, a zipper-like innovation that allows the chest to be reopened and closed if necessary after surgery. It is also intended to relieve pain. This patent too has already been approved in Europe.

Both new patents are valid until 2037.

Realheart has been granted two more US patents

Ina Laura Perkins

The aim is the same as in previous trials, i.e. chronic animal studies with the aim of prolonging survival time, but with the difference that it is the clinical version being tested. It has an improved external design, smaller size, integrated pressure sensors and control algorithm compared to the prototype that has previously been used.

This is a major step forward in the development process and the company has therefore strengthened the operating team. There are now three highly experienced cardiac surgeons working together: Professor Bart Meyns, Dr Dilek Gürsoy and Dr Joeri van Puyvelde. The veterinary protocol has also been updated and an expanded animal care team, with ten years of experience in the care of animals with artificial hearts, is now present, responsible for the selection, preparation and aftercare, including medication.

''In all previous surgeries, we have confirmed that the pump is working properly. Issues that we have needed to address have rather been related to the adaptation to the animal's body. Its anatomy differs from that of a human and requires a completely different type of care approach. In 2021 and 2022, we have recruited more expertise in this field and updated our protocol to best care for the animal,'' said Ina Laura Perkins, CEO of Realheart.

She describes the animal studies as a team effort with many people involved where everything needs to flow smoothly between surgeons, the person operating the heart-lung machine, engineers, veterinarians, and animal caretakers all the way from preparation to aftercare.

''During the surgery, the pump is implanted and after that we monitor the animal closely. Should we encounter any problems, these will be addressed before future surgeries. The first day after surgery is always the most critical and we start by getting past that, to gradually build up from there. We will only keep the animal alive for as long as we can do so without causing suffering,'' said Ina Laura Perkins.

Realheart set to begin animal studies with clinical version

Realheart collaborates with a number of international scientists at various institutes and universities developing the world's first four-chamber artificial heart. Through these new collaborations, the company aims to strengthen its Swedish network to benefit from it both in the development of Realheart TAH and other future products.

''At present we recruit mostly internationally to find the skills we need for our growth, but it would be beneficial to be able to find them at home in the future. We want to strengthen Sweden's international competitiveness in research and development of heart pumps. It is therefore an advantage if students learn about artificial hearts and the specialist skills required in this field early on in their education," said Realheart CEO Ina Laura Perkins.

The core of Professor Lisa Prahl Wittberg's research is flow analysis with a focus on complex fluids in the human body, such as blood. In particular, she focuses on blood flow and the risk of blood clots occurring in the body or in pumps, cannulas and other components used in the treatment of critically ill patients The research is conducted in close collaboration with clinical partners.

Seraina Dual is Assistant Professor in the Department of Biomedical Engineering. Her research focuses on the use of sensor systems to predict, prevent, and cure cardiovascular diseases. Her work has shown how heart pumps should be used in patients with smaller bodies, such as women, and how a combination of different sensors could help.

Realheart has collaborated with KTH before. When founder Azad Najar began sketching what would become Realheart in 1999, the basic idea was to develop an artificial heart that mimics the human heart. This idea was based on flow analyses conducted by Professor Said Zahrai at KTH.

''We've come a long way since then and it is great to now return to KTH for continued collaboration as we move towards clinical trials. Seraina's vast expertise will be invaluable in further improving the equipment we use for the blood tests, and with Seraina's help we will be able to subject the controller to even more advanced stress tests to ensure it is safe even under the most stressful conditions in the human body,'' said Ina Laura Perkins.

Assistant Professor Seraina Dual

Professor Lisa Prahl Wittberg

''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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