Realheart is part of the first batch of deep tech companies invited to submit the full application to the second stage of evaluation. Now, Realheart has 1 year to apply in step 2, starting from the upcoming deadline of June 16, 2021. A decision on whether to receive funding from Horizon Europe will be made within approximately 4 months after the application has been submitted.

About the EIC Accelerator

The EIC Accelerator is the Horizon Europe’s flagship funding scheme for innovative start-ups and SMEs. The highly competitive funding programme awards deep tech companies with a combination of grants and optional equity investments up to  17.5 million Euro.

About the First Evaluation Stage

In the first stage of evaluation, four experts from the European Commission assess the excellence and impact of the innovation. Realheart has passed this first evaluation stage with four GOs out of the four experts. A “Seal of Quality” that recognises several years’ of dedicated work within Realheart with the ambition of gaining access to various types of soft funding in addition to share capital.

About the Application

“We have taken the feedback from previous applications into account, and with each new application we have received a higher score. Other companies we have spoken to have applied up to 6 times before they have received financing, so we have understood that it can be a process that takes time, but which probably pays off if you make the necessary improvements”, says Realheart's CEO Dr Ina Laura Perkins.

Realheart's vision is that no one should die of heart failure. Realheart develops an artificial heart (TAH) of ground-breaking technology that is based on 20 years of research and development and is at the forefront of science. The company works intensively with preparations to make the heart available to patients as soon as possible and thereby save lives and healthcare costs. Heart failure causes an enormous amount of suffering and is one of our major global public health problems and one of the most common causes of death. Realheart's total capital requirement is estimated at approximately SEK 450 million until the commercial phase is reached. The goal is for at least 50 percent of the capital requirement to be able to be financed with various types of soft funds, R&D tax subsidies etc. Realheart estimates that the total market potential for current product execution is at least 129,000 TAH in Europe and the USA, which corresponds to approximately SEK 130 billion annually.

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‘’This research is incredibly important for understanding how Realheart TAH performs and identifying any areas that need improvement. These are collaborations at the absolute forefront of research together with experts who possess unique cutting-edge expertise. We are proud to present the results at these conferences, and believe that it will increase trust and interest both in our product and in our brand’’ said Realheart's CEO Ina Laura Perkins.

The first presentation will take place at the annual meeting of the American Society of Artificial Internal Organs in Washington, DC, June 10-12, where Dr. Libera Fresiello from Katholieke Universiteit Leuven will show results from tests of Realheart TAH in a hybrid simulator – a model of human blood circulation where one can study how the product interacts with the body.

The project includes the tests of the atrial pressure sensors in combination with the automatic algorithm in the control unit. It is partly funded by the Vinnova Medtech4Health initiative.

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

The purpose of this research is to build a new and more detailed model of the new version of the Realheart TAH under development and then use the model to simulate, among other things, how the blood flows inside the pump and identify the best settings for improved blood handling.

‘’Blood flow is a key in the development of our artificial heart. If we can reduce the risk of side effects, which is a problem with existing technology, we will be able to save many more lives with a greater quality of life for patients while at the same time reducing health care costs’’ said Ina Laura Perkins.

Both conferences are mainly conducted digitally.

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The Realheart total artificial heart includes four valves that mimic the function of the natural heart’s four valves. These are critical components of the Realheart system and having secured a supply agreement for the mechanical valves reduces risks and brings the pump a step closer towards its final design based on inclusion of these components.

Realheart CEO, Ina Laura Perkins, says that “the valve type that we are incorporating into the pump has existing regulatory approvals and is ideal for our artificial heart, having been used in our bench testing, blood testing and animal trials to date.”

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Dr Azad Najar is the inventor of the Realheart total artificial heart (TAH), and founder of the Swedish company Scandinavian Real Heart AB. Originally from Iraqi Kurdistan, he has been following the research on heart failure in the Arab countries of the Middle East with a growing concern.

‘’Worldwide, 64 million patients suffer from heart failure, a disease that kills half of all patients within 5 years after the diagnosis. The situation is particularly difficult in the Middle East where patients fall ill at a younger age, at least 10 years earlier than in, for example, Europe. So of course the expectations on our heart are great here’’ said Dr 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 patient’s own heart to save the lives of people with advanced heart failure. At the conference, Azad Najar will talk about innovations and how the Realheart TAH was developed.

‘’Globally, the need is huge, and not least among these patients who are often only in their late fifties or sixties and still have many years to live. We want to establish a presence in this region and can see many opportunities to create fruitful alliances. We are currently open to suggestions for future collaborations’’ said Ina Laura Perkins, CEO of Realheart.

For further information please contact:
Azad Najar: +46(0)736-673 463 or azad.najar@realheart.se

Or visit the conference webpage: https://icpm.ae/

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Animal study data is required to obtain approval to initiate clinical trials, and studies are conducted to identify any product design problems that cannot be detected by other test methods. Animal studies require ethical approval, which is usually given in two steps. Firstly, an approval to perform acute studies for up to 24 hours, followed by approval to perform chronic trials, the length of which is determined by the authorities. Realheart is in the second stage.

Due to the pandemic's travel restrictions and the severe shut down in Belgium – where the animal lab carrying out Realheart's operations is located – it was not possible to follow the company's original plan to carry out these trials in 2020. Now, a solution in collaboration with Belgian partner Medanex Clinic is in place, in which Realheart's staff and other clinical experts will be able to follow and participate in the operations digitally in real time.

Realheart has for a few months trained a veterinarian who will act as a TAH operator during the operations. Furthermore, software and technology have been developed so that Realheart's staff can control the heart from a distance if the need arises. To strengthen local expertise, another experienced cardiac surgeon has been recruited: Dr Dilek Gürsoy. She runs a heart pump clinic in Germany and has extensive experience from artificial hearts, both in the treatment of heart failure patients and in animal studies.

To prepare the studies on live animals, a number of training operations on deceased animals have already been carried out successfully.

Today, the first series of several chronic trials begins. Results will be analysed continuously. When the results are positive, the planned survival time will gradually be extended.

“I am very hopeful now when we start our first chronic trials, and it is exciting to use completely new digital technology. We are very grateful for the support from our partner Medanex in this transition. The plan has always been that local staff will sooner or later be able to perform operations without our presence. The pandemic only made us take this step earlier. If this turns out well, it will release a lot of resources, which means that we can move forward at a faster pace,” says Ina Laura Perkins, CEO of Realheart.

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In 2020, Realheart's development work focused on the areas of product development, supplier and collaboration agreements, as well as working towards FDA requirements. In light of the Corona pandemic, the company has succeeded in achieving most of the set goals. The new partner Berlin Heart – Europe's largest heart pump manufacturer, Realheart's newly established blood test laboratory, and new pressure sensors are three important milestones. However, chronic animal trials needed to be postponed due to the pandemic.

Development plan 2021

The efforts towards future clinical trials continues. The three areas Realheart will focus its operations on in 2021 are: product development, animal studies, and work towards meeting FDA requirements.

Product development

Objective: Implement 2020's advances in design and create a fully functional prototype

– Carry out reliability tests

– Mount fully integrated sensors

– Fine-tune the algorithm in the automatic control

– Optimise the mechanical properties of the pump

Animal studies

Objective: Carry out chronic animal trials

– Initiate remote animal studies and evaluate the method

– Carry out the first series of chronic animal trials in which the animal is meant to survive more than 24 hours. Evaluate results and adjust the intensive care phase and the aftercare

– When reaching positive results from the first series, work towards increasing the survival time

FDA requirements specification

Objective: Blood test and animal study methods that have passed FDA's review

– Carry out chronic animal trials (as above) and blood tests

– Submit a report to FDA for review of updated blood test and animal study methods

– When passing FDA´s review, use the methods to test the final version of the pump and collect data prior to approval to begin clinical trials

“My ambition with this year is for Realheart to take giant steps forward on our journey towards launching the world's first four-chamber artificial heart. Initiating chronic animal trials in sheep will be such a step, and a long-awaited one. To take the company quickly and safely to clinical trials, which is the major milestone we are heading towards, requires a strong and enforced organisation. Last year we made several new recruitments, and my plan for the near future is that we will continue to expand the team", comments Ina Laura Perkins, Realheart's new CEO.

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Scandinavian Real heart has sent a translation of a press release with MAR-legend sent this morning. Later in the afternoon, a translation of the same press release was sent in English. The translated press release was sent by mistake with a MAR-legend. This means that the press release with the heading "Dr Ina Laura Perkins new CEO of Realheart" sent at 15:09 should not be sent with the MAR-legend.

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Realheart's CEO Azad Najar was asked about the global need for the company's artificial heart during a live interview in Al Jazeera last Thursday. He explained how less than two percent of all heart failure patients in the world receive an organ transplant, which today is the only possible treatment for patients with severe heart failure, and that there is an enormous need for a well-functioning artificial heart.

"This is the reason for developing Realheart's product. A mass-produced artificial heart lacks the limitations which results in only 7,000 organs can be transplanted annually. There is no limit to how many millions of people we can save”, Azad Najar concluded.

The Al Jazeera interview ended a couple of weeks where both BBC, MBC and Sky News have discovered the news about Realheart and its founder Azad Najar, who was born and raised in Iraqi Kurdistan, featuring it in their global Arabic channels.

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The European Mechanical Circulatory Support Summit brings together the world elite in heart pump surgery, both industry representatives and researchers. This fifteenth congress took place digitally during five days from 30 November to 4 December.

Azad Najar, CEO of Realheart, was contacted by the Congress' Scientific Committee with an invitation to be one of the speakers. Among other things, Azad talked about the intelligence in Realheart TAH's automatic regulation, which is a prerequisite for increasing patient friendliness and reducing the risk of complications.

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Earlier this week it was announced that Realheart has been granted SEK 200,000 by Vinnova within the strategic innovation program Medtech4Health. It is the same program that this spring supported another one of Realheart's projects. This time it is co-financing the competence enhancement in a project to further develop and refine the automatic control in Realheart's artificial heart. Vinnova's rationale for the financing is that "the project aims to create opportunity for international competitiveness and sustainable solutions to global societal challenges".

The automatic control adapts the heart's pumping to match the body's needs, with the aim that the patient should be able to live a normal life even after the implantation of an artificial heart. It is deemed a crucial factor in creating an internationally competitive product.

During the project, the automatic control will be tested in a human body simulator by Dr Libera Fresiello who is an advisor to the expert panel in medical devices and in vitro diagnostics at the European Commission Directorate – General for Health and Food Safety.

“We are very grateful for the strategic innovation program Medtech4Health and its support in this project. It´s very much in line with the activities and goals we want to achieve. The support means that we can further strengthen Realheart's competitiveness with unique cutting-edge expertise that few people in the world possess. Furthermore, this is something that can be done despite the Corona pandemic's influence in the world. We will start the project immediately and our employees will work with full force going forward ", comments Realheart's CEO and founder Azad Najar.

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Unlike existing heart pumps on the market, Realheart TAH has the ability to automatically adjust its pumping activity and deliver different amounts of blood based on the body's needs. For example, Realheart TAH will detect when a user starts exerting themselves and regulate blood flow accordingly. Sensors inside the heart pump are the crucial components that pick up that signal.

Real Heart has for a long time been looking for sensors that can meet the company's high component requirements. Now, an agreement has been signed with a Norwegian company that manufactures some of the world's most reliable pressure sensors which are used for instance in NASA spacecrafts and other extreme environments.  The alternative for Realheart would have been to develop its own sensor, which would take about two years at an estimated cost of 20 million SEK.

“Through this agreement and collaboration, Realheart will have access to ready-made, well-proven sensors. We thereby avoid taking a long and costly path with our own development. By using these sensors, we shorten the development path to the market significantly", says Azad Najar, Realheart's CEO and founder.

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Realheart mimics the way the natural heart pumps blood. This is a big advantage over competing solutions because it leads to a more favourable treatment of the blood and thus fewer complications. Superior blood treatment is expected to lead to a strong position in the market when launching the product and at the same time facilitate approval of the product by FDA, the US certification authority for medical devices. Before FDA can approve Realheart, the methods need to be verified.

Realheart invests in blood flow analysis focused on implantation in humans

With the aim to measure, optimize and minimize the impact Realheart TAH has on blood, Realheart invests in blood research. One example is computational flow analysis in collaboration with Bath University. And earlier this year, a blood lab was established together with Karolinska Institutet in Stockholm.

Now, the Västerås company together with Linköping University is starting a collaboration that will lead to further optimization with the aim of achieving the best results when Realheart TAH is implanted in humans. This is done through a specially made prototype of the heart that will be used in some of the world's most advanced X-ray machines to create an exact digital twin of Realheart TAH.

The research takes place at the Centre for Medical Imaging and Visualization (CMIV) at Linköping University. They conduct frontline research in the development of future methods and tools for image analysis and visualization in relation to health care and medical research. The project is part-financed by the MeDigiT platform (Medical Digital Gemini), whose goal is to facilitate the use of individual-specific digital models in healthcare. The research team is led by Professor Tino Ebbers, a leading researcher in blood flow analysis. The team will work together with Realheart's CEO Azad Najar, who has also been offered a research position to later be able to do a PhD in the subject.

“It is an honour to do research together with some of the world's most talented in this field. We have been innovative in the development of a unique heart pump and now we are once again innovative in finding new methods to visualize and verify blood flow. I look forward to working with the team and putting another piece of the puzzle in place to create an artificial heart in a class of its own,”says Azad Najar, CEO and founder of Realheart.

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This spring, Realheart had to cancel the animal studies due to the corona crisis travel restrictions. Since then, Realheart has worked intensively with adjusting the heart pump based on FDA requirements and conducting research focusing on blood tests among other things. Before the turn of the year, trials on animals are planned to be resumed with the aim of moving over to long-term trials during the first half of 2021. The surgeries, where Realheart's artificial heart is transplanted into sheep, take place at Medanex Clinic in Belgium, one of few clinics in Europe approved by FDA.

Belgium's borders are currently open, but covid-19 is a difficult-to-predict pandemic and new restrictions may be imposed. The company is in close dialogue with the clinic and if it is not possible to start before Christmas, there is readiness to temporarily perform the trials at another clinic or find new dates further on.

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Realheart's scientific advisory board is a panel of experts with relevant specialist competence that will advise the company in research work and product development, for example on preclinical and clinical studies. But with its strong links to the market, the board also provides access to knowledge about the prerequisites for breaking through the barriers. This leads to a faster and safer journey towards the goal of commercializing Realheart TAH.

The council consists of Henrik Casimir Ahn, professor emeritus in thoracic surgery with extensive clinical experience in heart pumps, Zoltán Szabó, professor of anaesthesiology with expertise in circulatory physiology and experimental surgery and thoracic surgeon Robert D. Dowling who is an well-established name in implants of artificial hearts.

“In order to move forward towards clinical studies and achieve our goals, it´s important to have access to expertise that is active in the field. Thanks to the unique product and continuously good results, we have succeeded in attracting some of the world's most meritorious experts to us in the new scientific advisory board, and more will be recruited as we go along. It feels great and is very important for the future ", says Azad Najar, CEO and founder of Realheart.

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A total artificial heart is a blood pump and must therefore be very good at managing the blood to minimize the risk of blood damage-related side effects. Therefore, the company places great emphasis on analysing the blood flow in the pump by various methods. One such method is computer simulation (computational fluid dynamics) of how the blood moves in the pump.

An earlier prototype version that was analysed showed a low risk of blood damage, which is good news. The next step is to analyse the latest prototype version to investigate how the pump design can be further developed to minimize blood damage. Through this collaboration we gain access to a resource of expertis for 3.5 years.

CEO, Azad Najar comments “We are very pleased to be able to continue the successful research collaboration we have initiated with Dr Fraser at the University of Bath with enhanced resources. Realheart® TAH's flexible design where we can fine-tune how the AV plane moves and incorporate it into the automatic control algorithm means that we have very good conditions for identifying the ideal pumping rhythm to minimize the risk of blood damage.”

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In accordance with the 2020 development plan, Realheart has actively searched for partners and suppliers who can assist with essential competence as the company now faces the most important development phase of its artificial heart. In the global search, the German-based company Berlin Heart stood out as an ideal partner.

Berlin Heart has succeeded in establishing world leadership in development, production, and commercialization of ventricular assist devices. The company has many years’ experience in polyurethane processing to secure the path towards finished products and has more than 30 years of experience in clinical use of their own products approved for marketing in the EU, North America and Asia, for heart disease patients of all body sizes, from infants to adults for left, right or biventricular circulatory support. Berlin Heart was also one of the first companies in the world with a quality management system that was reviewed and approved under the new Medical Device Regulation (MDR). The latter can facilitate the future certification work for Realheart.

The collaboration agreement means that the companies will work side by side in a joint research and development project which will ensure that Realheart TAH's most critical parts – the parts through which blood flows and therefore needs to be durable – are developed in collaboration with a company with many years of relevant expertise.

“We are very satisfied with the collaboration, which also releases resources for us and make it possible to focus on other component parts and preparation for the upcoming preclinical and clinical trials,” says Azad Najar, CEO and founder of Realheart.

“We look forward to sharing our knowledge and experience in this exciting research project, so closely aligned to our own mission to sustainably improve patients' lives,” comments Sven-René Friedel, Managing Director of Berlin Heart.

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After this winter's successful animal testing, Realheart's focus has been on reviewing the manufacturing strategy for the upcoming clinical trials. The company has identified two alternative routes. Either to build your own organization with the necessary resources, or to find certified suppliers and partners with expertise in the development of medical technology products.

Realheart estimates that large investments would be required over a couple of years to build up our own plant and organization. Therefore, in order to save time and money, the company has chosen to seek partners who have the necessary expertise in materials, development and manufacture of implantable medical products. Recently, Realheart has therefore worked actively to identify possible partners both in Sweden and internationally.

Realheart establishes new partnerships

During a press conference at the Technical Museum, Realheart today presented a high-tech version of its artificial heart. After several months of product development, Realheart has come to version 12, which is intended to be used in the clinical trials on humans that are scheduled to start in 2022.

As a result of components being downsized, the new version is smaller than its predecessor, and also scalable which allows making it in other sizes for people with smaller bodies. Pump capacity has been increased by more than 20% through new motors with higher speeds. At the same time the motors have more power thanks to a smaller and more advanced control system. This allows the user to engage in more demanding physical activities. The new heart is self-regulating and automatically adjusts the pumping capacity to the user´s behaviour thanks to built-in sensors and advanced software.

Tests and modifications of the new version are now taking place as part of the product preparation for the human studies.

“We are moving forward at high speed and our product development is becoming more and more advanced. I strongly feel that with version 12 we will revolutionize the heart pump technology. Holding the prototype of the new heart in my hand fills me with great respect for the know-how of our technicians and experts, and not least confidence for the future, ”says Azad Najar, CEO and founder.

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Development Plan 2020

The three areas Realheart intends to work with during 2020 are: productization, supplier and partner collaborations for manufacturing, and FDA requirements specification.

productization

– Optimizing the mechanical properties of the pump

– Completing the design work to meet production requirements

– Initiating certification of the company according to ISO 13485 for medical technology companies

Supplier and partner collaborations for manufacturing

– Identifying suppliers and partners with experience in manufacturing high quality medical technology products

– Ensuring access to the most suitable suppliers for all critical components

FDA requirements specification

– Continued animal studies focusing on chronic animal trials and developing the surgery procedure

– Perform blood tests and flow studies using computerized programs and magnetic cameras

– Continuing the durability tests

“I am very proud of the work done by the team in 2019. It has prepared Realheart well for 2020 and onwards. Although it´s a few years left until Realheart TAH reaches the market, our work is becoming more and more concrete. I feel that not least now when we are actively searching for production partners”, says CEO and founder Azad Najar.

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