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Jonas Caspari Bark New CFO at Realheart

Press release 27 June, 2022

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

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

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

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

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

Second Animal Implantation To Take Place July 6

Press Release, 23 July 2022

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

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

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

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

Realheart to Host International Conference in Västerås 15 June

Press release, 15 June 2022

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

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

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

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

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

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

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

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

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

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

First Animal Trial with Clinical Version Completed

Press release, 2 June 2022

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

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

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

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

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

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

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

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

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

Realhearts CEO Elected to the ISMCS Board of Trustees

Press release 20 May, 2022

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

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

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

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

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

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

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

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

Press release 27 May, 2022

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

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

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

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

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

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

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

Realheart and KTH Receive SEK 4 Million Grant from Vinnova

Press release 26 May, 2022

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

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

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

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

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

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

Implantation with clinical version rescheduled for change of animal

Press release, 19 May 2022

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

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

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

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

Realheart Releases the Annual Report for 2021 in English

Press release, 13 May 2022

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

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

Realheart is recruiting Lead Systems Engineer

Press release, 9 May 2022

Realheart has recruited a Lead Systems Engineer from Texas. Bruce Wedding most recently came from a role as a senior software engineer at LivaNova, PLC. Bruce will start working for Realheart on May 9, at the same time as he plans to move himself and his family to the head office in Västerås.

Now Realheart strengthens the product development team with Bruce Wedding, who has over 30 years of diverse software engineering and project management experience. In his current role, he is the team leader in the development of a Class III implantable medical device. Bruce also has experience from active implants, including cardiovascular applications, and has been trained on regulatory requirements for software development, verification and validation of medical devices and other mission-critical applications.

“We want to be able to continue to maintain good momentum towards clinical trials and then Bruce will be a very good support to the team and the continued work of developing the clinical control unit. His many years of experience from having developed Class III medical equipment, of which four of them have received FDA approval, will be very valuable to the Company, says Realheart's CEO Ina Laura Perkins.”

Bruce will, in collaboration with Hydrix, mainly support and monitor the development of controls and peripherals for the clinical control unit.

"When I learned about the great work Realheart is doing, developing the 

world's first four-chamber heart, I had to be a part of it. I've helped develop many medical devices which make people's lives better but none more important than Realheart’s artificial heart. I am excited to contribute to the team with my experience architecting and designing safe, robust, Class III medical device software and firmware.", says Bruce Wedding.

Realheart has been granted two more US patents

Press release 2 May, 2022

Realheart is developing the world's first artificial four-chamber heart. The company has now been granted a new US patent that protects the entire principle behind it through 2037. In addition, the company has obtained similar protection for its sternal prosthesis, a separate product designed to facilitate chest surgery.

''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 releases the annual report for 2021

Press release 1 May, 2022

Today, Realheart publishes the mandatory annual financial report for 2021. A layout version (in English) with reports, collaborations and milestones during the year will be released in connection with the invitation to the Annual General Meeting that is scheduled for May 11, 2022.

The entire annual report and the auditor's report are available on the company's website, www.realheart.se and as an appendix to this press release (in Swedish).

Improved controller for clinical trials results in six-month delay

Press release 28 April, 2022

Realheart has decided to equip patients in the first clinical trial with the full version of the controller – a kind of remote control – instead of a simpler version as previously envisaged. This will benefit patients and shorten the overall development time of the controller but will delay the human trial by six months, now set to begin in the first half of 2024 instead of the second half of 2023.

''Our goal is an artificial heart that allows the user to lead a good life with great freedom of movement. This also applies to the patients participating in our clinical trials. We want even the very first patient to be able to leave the hospital, and for this to work in practice, the external controller needs to be both safe and really easy to use'' said Ina Laura Perkins, CEO of Realheart.

The controller that Realheart has used so far to test and refine the design in bench and animal trials was developed in-house, but to move to humans, a more advanced one is needed as it will be used by the patient themselves without supervision from healthcare professionals or experts. During fall 2021, Realheart started a collaboration with the Australian company Hydrix, which specialises in the development of control systems for heart pumps. Their platform is characterised precisely by a strong focus on the needs of the end user.

''The controller is technically very advanced, but for those who will live with our artificial heart in the future, it must be extremely easy to use. We already have an updated electronic architecture in place and by not producing a special test version but going straight to the final version we can save time overall, while somewhat delaying the first implantation in a human,'' said Ina Laura Perkins, CEO of Realheart.

This disclosure contains information that Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 28-04-2022 12:00 CET.

Realheart to recruit new CFO

Press release 26 April, 2022

Realheart has initiated the process of recruiting a new Chief Financial Officer to take over when current CFO Andreas Hultdin leaves on 31 July.

Realheart is a Swedish company headquartered in Västerås, which is developing the world's first artificial four-chamber heart. The company has recently taken several important steps forward, not least in leaving the prototype behind and instead test the clinical version of the Realheart TAH in the animal studies that are about to be initiated.

''As we step by step move closer the clinical trial phase, we see interest in the company growing among physicians, patients, the media and investors alike, and we need to have a dedicated, full-time CFO. Unfortunately, our current CFO Andreas Hultdin has commitments outside of Realheart and cannot extend his involvement, so we are looking for his successor instead'' said Ina Laura Perkins, CEO.

Andreas Hultdin will resign on July 31, but will stay on to support the company until a new CFO is in place.

Realheart set to begin animal studies with clinical version

Press release 13 April, 2022

Production of the clinical version of Realheart's artificial heart – the one that will eventually be used by human patients – is almost completed and will now be tested in a series of animal trials. Six surgeries are scheduled, with the first taking place mid-May.

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 initiates collaboration with researchers at KTH

Press release 7 April, 2022

Realheart has initiated collaborations with Lisa Prahl Wittberg and Seraina Dual, both researchers with expertise in heart pumps at the Royal Institute of Technology, KTH, in Stockholm. These collaborations bring additional expertise to the company in the areas of blood testing and evaluation of the control unit for the clinical version of the Realheart TAH, as well as in the company's research on new products.

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.

Clinical version of Realheart TAH being tested on virtual patients

Press release 31 March, 2022

Realheart has been pilot testing the German Virtonomy web platform v-Patients containing 3D anatomical models of heart failure patients for some time. Now the company is moving forward with a full license and more patients to test the clinical version of its artificial heart virtually and collect data in preparation for human clinical trials and the subsequent market launch.

''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.

Realheart to establish Australian subsidiary

Press release 23 March, 2022

Realheart, who is developing the world's first artificial four-chamber heart, is setting up a subsidiary in Australia to take advantage of the knowledge and financial benefits offered by the Australian market related to product development and clinical trials.

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 recruits clinical strategist and electronics expert

Press release 17 March 2022

Realheart has brought on board Australian consultant Sara Diab, who will support the company's regulatory and clinical strategy, and electronics expert Nicolas Barabino, based in Spain, who will support the development of the clinical control unit for the Realheart TAH.

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.