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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Dr Katharine Fraser is a lecturer in the Department of Mechanical Engineering at the University of Bath. She works on different types of mechanical support devices for patients with severe heart failure and uses computer simulations and numerical models to study blood damage caused in such devices.

She also leads a research team including a co-funded PhD student, who has carried out a project to create at strategy for using computational fluid dynamics (CFD) to simulate the dynamics governing blood flow in the Realheart artificial heart. In her article, detailing the background, methodology, and results, she concludes that good agreement between computational and experimental data was achieved using this approach.

''One of the things that sets our artificial heart apart from others is that it mimics the way the natural heart works. The purpose is to reduce the risk of blood-related side effects, which have been common historically. This new method will be of great importance as we continue to optimise the product, as will its publication in a trusted scientific journal such as Artificial Organs. It creates greater awareness, trust and interest in our artificial heart," says Ina Laura Perkins, CEO of Realheart.

Artificial Organs is a peer-reviewed biomedical journal that covers organ replacement technology. The journal was founded in 1977 and is published monthly. Katharine Fraser's article ''Video based valve motion combined with Computational Fluid Dynamics gives stable and accurate simulations of blood flow in the Realheart Total Artificial Heart'' will be published in the next printed issue and has already been published in the journal's online edition.

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ESAO 2021 will take place digitally from London on September 7-11. Participants will have the opportunity to present their latest research findings and engage in discussions with clinicians, scientists and engineers from both the public and private sectors on the development of lasting artificial organs.

Ina Laura Perkins will give two lectures, both on Friday September 10:

The first is during the session Blood Damage II – Recent Progress with Haemolysis at 11:00-12:30, where she will discuss factors affecting the outcome of haemolysis tests. Ina Laura Perkins started her academic career in stem cell research and has devoted her entire career to medical innovations related to the blood. Her vast knowledge in this field is why she was invited to speak on this topic. 

Her presentation during the Latest Developments of TAH and RVAD session at 16:00-17:30 will focus specifically on Realheart. Here she will share lessons learned from the previous Realheart prototype and talk about the next steps in the development of the final product.

The full programme is available here: http://esao2021.org/wp-content/uploads/2021/09/Final-Programme-and-Book-of-Abstracts-Final-06.09.21.pdf.

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Digital studies include virtual implantations in 3D models based on real patients – an altogether new way of working in medical technology and one that Realheart is the first user to try – in collaboration with German Virtonomy.

Laboratory studies among many other things include blood tests with the Karolinska University Hospital, performance studies via a hybrid simulator at KU Leuven, blood flow analysis in 4D in collaboration with Linköping University and sustainability studies carried out at Realheart's own laboratory in Västerås.

Long and short-term studies with sheep take place at the Medanex Clinic in Belgium. In the previous series conducted before summer, a remote technology was implemented that allows Realheart's team to participate in surgeries without being physically on site. A new surgical team was trained and they have now learned to implement the product independently.

''This provides optimal conditions for further studies and our product has worked well throughout," said Ina Laura Perkins, CEO of Realheart.

A new series of surgeries will start in September and continue until the end of the year, when the results and conclusions are to be compiled. A number of surgeries may also be performed during spring as a way to keep the team's skills strong and up to date.

Meanwhile human anatomical studies are being conducted in collaboration with Professor Bart Meyns of KU Leuven as one of many preparations for human clinical trials.

''Animal studies are often given a lot of focus, but the other elements are just as important for us in order to move forward and, eventually, gain market approval,'' said Ina Laura Perkins, CEO.

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Codialist is a software development firm for medical devices with special expertise in heart pump technologies having been spun off from Berlin Heart GmbH, a world-leading German manufacturer of assistive devices for patients with end-stage heart failure.

Codialist will help Realheart to carefully analyse the control software for future integration into the new control unit. Together with the experts from Codialist, Realheart's engineers will perform simulations and modelling of the Realheart automated control algorithm in various simulated clinical scenarios. This will ensure that the software works flawlessly rather than having to detect and fix it at a later stage, saving both time and resources.

''Codialist builds its expertise on years of clinical and industry experience. They have unique software expertise in controlling heart pumps and also know the innovation process from idea to market approval. This allows them to quickly gain an understanding of our application and our needs and to complement our own team at this important stage of our development as we are taking the first steps towards the clinical controller," says Realheart CEO Ina Laura Perkins.

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Artificial hearts is a small field that not many people in the world work in and requires a high degree of specialisation. This makes it difficult for Realheart to find skilled candidates, but the fact that the company has received a lot of international attention recently has made recruitment easier.

''When I joined Realheart in 2017, almost no one knew about the company internationally. Now we are being contacted by people with this kind of expertise who want to join the company. We will soon have experience from AbioCor, OregonHeart, Reinheart, SynCardia and Zurich Heart within the company. This makes us extremely strong in terms of expertise, despite our small size," said CEO Ina Laura Perkins.

The three consultants who are now joining the team are Dr. Carl McMillin, a highly experienced materials expert who will work on the fully biocompatible version of the product, ensuring that all materials work well with the body tissue; Oliver Voigt, who has worked at SynCardia, among other companies, and who will be working on commercialisation as well as advising on product development and testing; and finally Ian McEachern, a product designer and systems developer who, among other projects, was responsible for developing Oregonheart from a sketch on a napkin to the prototype that was implanted in a calf in just one year. He will work on the final design version of the product.

''The human body is constantly changing, and the heart needs to be able to adapt to new situations and needs safely. It must never ever fail. That's why we need people with a high safety-critical product development mindset who understand the pitfalls that exist and can navigate around them. This team has that. Their collective knowledge of different designs and controls will be valuable not only in the development of our total artificial heart, but also when it comes to other innovations in the company's future product portfolio," said Ina Laura Perkins.

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Realheart is developing the world's first total artificial heart (TAH) that mimics a human heart, and has been listed on the Spotlight Stock Market since 2014. Since then, the company has completed the development of the principle design and is now in the process of modifying the latest concept version, which is now being tested and verified before human studies can take place.

The Board believes that a change of trading venue for the company's shares to the Nasdaq First North Growth Market will increase market awareness of Realheart and have a positive impact from both a customer and partner perspective. The listing change is seen as a natural step in the company's development and is expected to create value for the company's shareholders.

''The demand for artificial hearts is high, but the product that has been available so far has major shortcomings and is hardly used. In the tests carried out so far, there is no indication that Realheart TAH would not be significantly better. Our heart therefore has the potential to open up a huge market and as the company moves towards commercialisation we will benefit from having a globally renowned player as our listing venue," said Ina Laura Perkins, CEO of Realheart.

''After all, Nasdaq is a global and well-known brand. A listing on the Nasdaq First North Growth Market provides a mark of quality that enhances our ability to build on the strong interest in the company that already exists, both among institutional owners and within retail and other market participants – not least internationally," said Göran Hellers, Chairman of Realheart's Board of Directors.

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Virtonomy, based in Munich, Germany, aims to help companies shorten time to market for medical products by allowing them to conduct data-driven studies on virtual patients in a constantly growing database that reflects anatomical variation, demographic diversity and pathological conditions. 

A pilot project is now underway giving Realheart access to Virtonomy's web platform, allowing it to perform virtual implantations on humans in parallel with long-term studies on animals, which will resume shortly after a summer break. In the past, this work has been outsourced to Virtonomy as it has depended on specific skills and access to advanced software. With the new platform, Realheart’s engineers can test new designs themselves at any time.

’’It is exciting to be the first to test this new way of working in medical technology. We can experiment in a safe environment, which saves significant resources and reduces risks compared to conventional methods. The team can meet in a virtual room, for example, to jointly validate a design change in high-precision 3D anatomical models on any computer’’ said Ina Laura Perkins, CEO of Realheart.

Virtonomy is the first cloud-based SaaS solution for medical device developers using virtual patients for data-driven clinical trials. Through digital testing methods, the preclinical and clinical phases can be accelerated, a process supported by the FDA and corresponding EU agencies.

’’This will help us find the optimal fit for our device to treat as many patients as possible and identify the right anatomical criteria for patients for clinical trials. Virtonomy has helped us in the past to adapt our device to the anatomy of humans and large animals and we look forward to continuing our collaboration as the first users on their platform’’ said Ina Laura Perkins.

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It was at the American Society of Artificial Internal Organs in Washington DC on June 10-12 that Dr Libera Fresiello presented the results from tests of Realheart TAH in a hybrid simulator – a model of the human blood circulation, where one can to study in detail how the product interacts with the body in a variety of scenarios.

The project includes the tests of the atrial pressure sensors in combination with the automatic algorithm in the control unit. It has in part been funded by the Vinnova Medtech4Health project.

Dr Fresiello's presentation is available here: https://www.youtube.com/watch?v=Rcx6Zk7LW4E

At the same conference, Realheart's PhD student at the University of Bath, Joseph Bornoff, gave a poster presentation with an update on the ongoing computer simulation project, which will be presented in more detail at the annual meeting of the European Society of Biomechanics in Milan July 11-14.

‘’ – Dr Fresiello's detailed study of Realheart TAH shows that the product produces a pulsating blood flow that can be adjusted with the stroke volume and pulse, and that the two halves pump independently based on the atrial pressure to create a right / left balance. It is important for us to have this confirmed and presented by an internationally renowned heart pump researcher as it helps to increase trust and interest in our product and our brand”, says Realheart's CEO Ina Laura Perkins.

For more information please contact:
Ina Laura Perkins, CEO, at +46(0)70 406 49 21 or inalaura.perkins@realheart.se
 

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

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The number of surgeries in this study has been limited to one per month due to pandemic circumstances and travel restrictions. Now, as many companies want to restart their testing activities after long breaks during the pandemic, problems arise.

‘’Up until now, we have had no problems getting the times we want, but now when we try to book surgeries, there is a queue. We will therefore take a break and start the next series of surgeries after summer. On the other hand, this gives both our team and the surgical team some well-deserved time off,’’ said Realhearts CEO Ina Laura Perkins.

In the surgeries due to take place this autumn, the aim is to wake the animals up and test that they have normal functions for a certain period of time, while in the series that is now ending, the aim has been to educate and set processes. No animals have therefore been awakened after surgery.

The operations have provided a number of very valuable lessons. They were carried out with a completely new surgical team while Realheart's team participated remotely for the first time. A few problems with the remote technology occurred during the first operation, but these were resolved for further testing.

The new surgical team has now learned to implant the device and complete the operation on their own with a stable system. Realheart is focused on creating a product that is easier for surgeons to use compared to existing technology. 

‘’During the learning process, we have identified several user factors that can now be documented  and included in future manuals, which is exactly what this type of study aims to do. We are very pleased that the product has performed well and feel very confident about the next test series," said Ina Laura Perkins.
 

For more information please contact:
Ina Laura Perkins, CEO, at +46(0)70 406 49 21 or inalaura.perkins@realheart.se
 

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

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Oliver Chu, who joins the company's Mechanical Design team, has over ten years of international experience in the design of medical devices, including Class III products, as well as fluid handling pumps. He joins the company from Essity in Gothenburg, where he was Mechanical Lead. He is a graduate of the Georgia Institute of Technology in Atlanta, USA, and the inventor on five patent applications for medical device solutions. He is fluent in Mandarin and well-connected in Asia, further strengthening the company's international network.

Daniel Jonasson is recruited from the consulting company Sigma Technology Consulting as Systems Developer and will, among other things, work with the development of the smart control unit. Daniel's professional experience includes military service as a CBRN officer for crisis management in chemical, biological, and radio nuclear disasters, and SAAB surveillance where he worked closely with the Armed Forces with communications links. His expertise is in Artificial Intelligence and robotics, both relevant skills for the development of Realheart’s product portfolio.

Soteris Andreou, who will graduate from Cardiff University in Wales with top grades shortly, will work closely with the company’s other engineers in both in vitro testing and mechanical design, including supporting the team with various types of bench testing of prototypes. Soteris also has medical device experience, having worked on the development of innovative electrosurgical products as an Undergraduate Engineer at Olympus (OSTE).

‘’I am excited to have been able to make these recruitments according to our plan. Before the end of the year, we will have doubled the number of engineers employed, with some bringing in completely new skills and others replacing consultants. Working with consultants has given us a level of flexibility but is costly and now we want to build our organisation with our own loyal and highly motivated employees to drive the business forward with even greater vigour. At the same time, we are constantly reviewing our organisation for opportunities to improve efficiency" said Ina Laura Perkins, CEO.

For more information please contact:
Ina Laura Perkins, CEO, at +46(0)70 406 49 21 or inalaura.perkins@realheart.se

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

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‘’I am often asked this and, ironically, the fact that so few implants with artificial hearts are performed is also part of the answer why. It is a complicated operation that requires a great expertise and surgeons who are given little opportunity to learn the technology may refrain from choosing this treatment. My hope is that the new generation of artificial hearts that are now being developed will change that by eliminating some of the problems with existing technology’’ said Robert D Dowling.

He is Professor of surgery and Director of Cardiac Surgery research at Penn State Milton S. Hershey Medical Center in the United States – one of the largest TAH centers in the world with extensive experience in end-stage heart failure surgical options – and an established name among surgeons who work with total artificial hearts.

There are currently 64 million people with heart failure in the world and each year over 100,000 people need a heart in the United States and Europe. At the same time, there is a great shortage of organs for transplantation, and far from everyone who has the disease qualifies for the transplant waiting list. For example, you need to be otherwise healthy and relatively young, and heart failure is a disease that increases with age. In Sweden, only about 60 transplants take place per year. At the same time, 3,500 die of heart failure.

For many of these patients, an artificial heart would be an option, but the currently available total artificial heart, which has now been around for over 40 years, comes with several disadvantages and is therefore rarely used. It costs around SEK 1 million, the operation is complicated and blood-related side effects often occur which means that the patient will need continued care. The patient’s comfort and freedom of movement is also limited due to loud noise, heavy accessories, and short battery life.

All of these aspects are considered by Realheart, developing the world's first artificial four-chamber heart. Many surgeons are involved, both in the daily business, the board of Directors and the scientific advisory team to optimize the surgical procedure. The product is silent, has a high battery capacity and mimics the structure and function of the human heart to minimize side effects.

‘’If you can simplify the operations and eliminate the risk of side effects, a lot has been gained. Then demand will increase. In this way, we can save many more lives with a greater quality of life for patients and reduced costs for healthcare’’ said Professor Dowling.

For more information please contact:
Ina Laura Perkins, CEO, at +46(0)70 406 49 21 or inalaura.perkins@realheart.se

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

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Heart failure is one of the leading causes of death globally. Heart pumps save lives, but today’s pumps cause many blood-related, often life-threatening, side effects. An important step in the development of artificial hearts is therefore to improve our understanding of how the pumps affect the blood. This is the aim of the project ’’Identifying biomarkers of blood damage caused by heart pumps’’. Its results will later be disseminated at conferences and in industry-relevant media.

’’We will introduce analysis of more parameters to study blood damage in heart pumps in greater detail. Today's heart pumps suffer from severe side effects, such as stroke and bleeding. The more knowledge we gather regarding the impact on blood in pumps in clinical use, the better opportunity we have to create the pumps of the future with gentle blood handling," said Ina Laura Perkins, CEO of Realheart.

In an earlier project funded by the Winberg Foundation, Realheart and the Karolinska Institute established a laboratory for testing heart pumps on human blood instead of animal blood, which has otherwise been the norm. A range of clinical heart pumps are already in place and tests have been performed with good results. This lays the foundation for a research platform to start analyzing more parameters of the impact of heart pumps on human blood. New funding is now being added to the project, covering expenses for equipment, blood and reagents for the lab, among other things. ’’We want to create a world leading lab for human blood testing in Sweden; one that drives development forward in the entire industry and makes it possible for Realheart to get to the market faster’’ said Ina Laura Perkins.

The Winberg Foundation operates globally and was created when Nils and Margit Winberg from Västerås, Sweden, bequeathed their assets to support research into cardiovascular diseases.

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