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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Dr Ina Laura Perkins new CEO of Realheart
After 8 years as CEO of Realheart, founder Azad Najar hands over the leadership to Dr Ina Laura Perkins, who has been Chief Scientific Officer at the company since 2017.
On March 15, Dr Ina Laura Perkins will shoulder the role as CEO of Realheart, thus taking over the leadership of the Västerås company and its development of an artificial heart.
Ina Laura has two master's degrees, in biomedicine, and in innovation and entrepreneurship. In 2010, she won The Prince of Wales Innovation Scholarship for her stem cell work and received her PhD in 2015 from Swansea University Medical School. In 2019, Ina Laura completed an Executive MBA in financial management at The Stockholm School of Economics.
Ina Laura has worked with medical innovations throughout her career. Before joining Realheart in 2017, she was involved in the start-up of The Nobel Prize winner Sir Martin Evans' stem cell company Celixir and worked as Head of Research at Calon Cardio-Technology with the development of a new left-chamber assist device.
“Gaining the board's confidence to lead Realheart into the exciting times ahead is very honourable. Throughout my career, I have made a conscious decision to broaden my skills to be ready to take on a CEO role. Thanks to Azad's innovation and business abilities, it is now a fantastic company I am set to manage. My immediate focus will be to strengthen the organization with more employees so that we can keep a steady pace forward towards clinical trials ", says incoming CEO Ina Laura Perkins.
After the handover, Azad Najar will take on the role of Chief Medical and Innovation Officer and will be responsible for animal studies and the company's innovations.
“Already from being a company with few people, I have constantly worked to develop the competence in Realheart and recruit highly skilled people. Now I can look back and proudly say that we have a good organization with very competent staff. The work with preclinical animal testing is growing and requires great focus in the future. We also need to be at the forefront of innovations in heart failure treatment to achieve our vision “no one should have to die of heart failure". I therefore need to free up more time to work with these two important areas in the company. We have been planning for a long time for Ina Laura to take over the role of CEO. She will be an excellent CEO with her wise leadership, her enormous competence and her large industry network ", comments outgoing CEO Azad Najar.
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 08-03-2021 15:09 CET.
Realheart’s CEO in Al Jazeera interview: “We will solve the problem of the donated organ shortage”
In an interview with the television channel Al Jazeera at the end of last week, Realheart's CEO Azad Najar stated that the 7,000 heart failure patients who receive a donated organ annually represent a fraction of the need in the world.
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.
Realheart’s CEO invited to speak at EUMS
The European Mechanical Circulatory Support Summit is one of the world's largest medical congresses in heart pumps. This year, Realheart's CEO Azad Najar was invited to talk about the company's artificial heart and the research that is being conducted.
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.
Realheart receives new Vinnova financing to increase international competitiveness
This spring, the Swedish innovation agency Vinnova granted financing for Realheart's operations. The company is now launching another project that has received SEK 200,000 in financing, with the motivation that the project aims to create opportunity for international competitiveness and sustainable solutions to global societal challenges.
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.
Advanced sensors make Realheart’s heart smarter
Realheart has signed a supply agreement to procure sensors from a Norwegian company that develops products for extreme and complex environments such as spacecrafts and the human body. The sensors are crucial components for Realheart's self-regulating heart pump, where the system senses the body's need for altered blood flow, for example during physical activity, and automatically regulates it.
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.
Realheart and Linköping University together in the forefront of blood flow analysis
Blood flow analysis is the focus of a new interdisciplinary project. Linköping University and Realheart collaborate to verify and optimize the blood flow in Realheart's artificial heart.
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.
Realheart resumes animal studies
After a period of travel restrictions, Realheart intends to resume its animal studies. They are conducted at the Medanex Clinic in Belgium, the same place where previous trials have been done.
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.
Realheart launches scientific advisory board
Realheart is now launching a scientific advisory board with experts who will help the company to quickly and safely commercialize its artificial heart. The board has three well-established experts: the thoracic surgeon Robert D. Dowling, prof. emeritus Henrik Ahn and prof. Zoltán Szabó.
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.
Realheart strengthens research group with new doctoral student in computer simulation
Realheart has received a joint research grant to hire a doctoral student at the University of Bath in collaboration with Dr Katharine Fraser, expert in computer simulation of heart pumps. A new doctoral student has now been recruited, who will start this fall. The work involves creating models of the latest product version for different types of blood flow simulations.
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.”
Realheart signs an important agreement with largest European heart pump manufacturer
Today Realheart signed a cooperative agreement with Berlin Heart, Europe's largest manufacturer for mid- to long-term ventricular assist devices, and thus reaches an important milestone for 2020. The agreement gives Realheart access to a large and experienced organization with cutting-edge expertise in development, production, and marketing of these complex products.
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.
Realheart establishes new partnerships
Realheart has reached a high level with respect to technical concept development of its artificial heart. In parallel with continued development work, the company is now looking for suitable partners to support Realheart in the continued development work of the version that will eventually be implanted in man.
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.
New high-tech version of Realheart’s artificial heart
Today Realheart presents the design that is intended to be used during clinical studies in humans. It is a self-regulating heart that is smaller than its predecessor and at the same time has higher pumping capacity.
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.
Realheart development plan 2020
Today, Realheart holds a stable position thanks to a number of milestones achieved last year. In 2019, Realheart focused on product development, laboratory tests and chronic animal trials. The company is pleased that great progress has been made in all three areas and ended the year with a successful animal trial where the sheep survived the first most critical 20 hours, which marks the end of the preparation phase within chronic animal trials.
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.
Realheart releases footage from the animal trial surgeries
In 2019, Realheart conducted a series of animal trials on sheep with the aim of verifying the technology for its artificial heart. The goal of these trials has been to be able to wake up the animal and keep it awake for at least ten hours. For the first time, the company is now publishing film material showing the nature of these operations.
Watch the movie here:Realheart behind the scenes
Results from Realheart’s latest trial series: The sheep was awakened and able to eat
Realheart has successfully completed this fall's animal trail series. During the last operation in December, the sheep survived the entire critical post-operation phase with stable vital signs. The animal could be awakened and then eat by itself. The result of the operation means that the company has already reached the trial series goals. Therefore, it has been decided to refrain from the fifth and final operation planned for January.
In the spring of 2019, a series of successful surgeries were performed in which Realheart achieved crucial milestones in terms of improving implant technology. Five operations were planned for the period October to January, where intensive care during the post-operative phase would be improved and standardized. With the aim of switching to increasingly longer trials in order to finally be able to fully awaken the animal.
The result of the fourth operation, which took place in December, shows that with the new intensive care routines established, the animal survived the first most critical hours with good oxygenation, stable blood pressure and blood count. The Sheep opened the eyes and began to take its first meal the night after surgery. Appetite is a clear indication of well-being. In order not to deviate from the test's protocol and ethical rules, the trial was terminated after about 20 hours while the animal's circulation and blood count were still completely stable.
Reaheart TAH's automatic control has been an important factor in achieving success in the animal trials. With its help the circulation of the animal could be regulated automatically and in a physiologically correct way. This prevented the onset of the complications common when implantating total artificial hearts.
“We are now confident that we have a good heart pump with great potential, good properties and a strong ability to integrate into the body's own vascular system, as well as an implantation technique that works. It was emotional to see how Realheart TAH could completely replace the natural heart's activity and give life. However, we still have a lot of work ahead of us. We will continue to develop the project with gradual, steady progress, and mobilize all the power and ability to achieve our vision that no human being needs to die of heart failure, ”says Azad Najar, CEO and founder.
Realheart on display at the Technical Museum
In March 2020, the Technical Museum in Stockholm will launch its new exhibition called Hyper Human where Realheart will participate.
Realheart has been given the opportunity to be part of the Technical Museum's new exhibition Hyper Human to showcase Swedish medical technology innovation power, displayed in the same area as previous Swedish innovations such as the heart and lung machine, the pacemaker and the heart valve.
The company's product Realheart TAH will be displayed as part of the permanent exhibition for a period of five years.
“I'm very happy about this. This is the first time our artificial heart can be viewed at close range by the public. The fact that we are asked by the Technical Museum to participate in Hyper Human testifies both to the fact that Realheart is considered to be medical technical pioneers and that there is a great public interest in the company and what we will achieve, ”comments Azad Najar, CEO and founder of Realheart.
About Hyper Human
Hyper human – part of the Technical Museum's long-term commitment to technology's ever closer relationship with man – is an exploratory experience of living in symbiosis with technology. Among other things, they will address AI, monitoring and strengthening of the human body. The exhibition opens in March 2020 and lasts for five years. Read more about the exhibition here: https://www.tekniskamuseet.se/en/discover/exhibitions/hyper-human/
Realheart reports the fall’s development plan
Realheart continues according to the development plan that was laid out in the beginning the the year and keeps a good pace in its work. After the animal trials during spring and summer and refinement of the implantation technique, the fall and winter will include, among other things, further animal trials and additional development activities to fulfill the requirements of the American authority FDA, which is a prerequisite to be allowed to go through with studies on humans.
The development plan that was communicated in the beginning of the year consists of three parts: product development, laboratory tests and longtime tests on animals. The focus areas of the fall for each part are described below.
Product development
Control
Realheart TAH is the only pump concept in the world that is equipped with atria. Because of this the system can detect the amount of blood flowing back to the atria. This provides information that makes it possible to control the pump through the software of the control system. This development step, that was reached during spring of 2019, has increased the intelligence of Realheart TAH and leads to minimizing complications and increased usability for the patient. The first software prototype for the control system is developed and has shown good results. During fall and spring the control system will be developed and tested further.
Reliability and capacity
Realheart TAH now works well medically. There are, however, still significant work to attain a stable, durable product that ir ready for production and clinical trials in humans. The next step is some adjustments to increase the pump capacity and extensive evaluations in test rigs to ensure the long term reliability according to one of the FDA:s requirements. That work has been initiated and several test rigs have been developed.
Laboratory tests
Blood tests
Realheart has during this year performed blood tests in a laboratory in Germany. The company is now building its own laboratory in cooperation with Karolinska Institutet,and performs necessary tests in the study that shall establish the exact effect that the heart has on the blood.
Ling time tests on animals
Animal tests
A new series of animal tests on sheep is started in the middle of October and continues until the end of January. The plan is to successively improve the surgical technique to finally wake the animals up completely. One important step is to develop an optimal post-operative intensive care, which is now being established.
”It feels very satisfying that our team together with the network of experts has succeeded to achieve the mile stones we have set up in the ambitious development plan. We have also succeeded in developing the first prototype for an automatic control and increase Realheart TAH:s unique characteristics. Now I am loking forward to the work during fall and winter when we continue to prepare the product for the initial trials on humans in 2022”, says Azad Najar, the CEO of Realheart”
Realheart TAH is gentler to the blood according to comparative study
During the meeting with the American authority FDA during the spring, Realheart’s blood tests were discussed. These are a requirement to be allowed to perform clinical studies, since the tests investigate potential presence of blood damage. The company has now performed the first of several tests. The results show that Realheart TAH is gentler to the blood than a pump that is already commercialized.
One occurring side effect of heart pump implants is that red blood cells are damaged, which can lead to clotting. Therefore blood tests are a crucial factor when the authorities asses whether a company shall be allowed to perform clinical trials on humans.
During the year Realheart has developed custom built test rigs together with researchers, recruited personnel and cooperated with an European test lab to see how Realheart TAH affects blood. The first tests are performed and were done as a comparative study which compared Realheart TAH with a heart pump which is already on the market.
The result has now been analyzed and shows that the tested version of Realheart TAH causes less blood damage than the comparison pump. The study now continues with more comparative tests to extablish the exact effect that the TAH has on the blood.
”These results are in line with what researchers earlier have been able to conclude theoretically after performing computerized flow analyses. It is extremely pleasing that our unique design has performed well in these tests which show how gentle it is to the blood”, says Azad Najar, CEO and founder.
Real Heart optains grant of 500 000 SEK
The foundation ”Stiftelsen familjen Nils Winbergs fond” has decided to award Scanidinavian Real Heart AB a grant of 500 000 SEK. The grant will be used to establish a Swedish blood test lab together with Karolinska institutet.
There is currently no established laboratory for evaluation of heart pumps with human blood, which means that tests of heart pumps are performed with animal blood. The results that are obtained are insufficient to verify different ways to lessen side effect due to blood damage, as human blood differs from animal blood. For human blood there are more tests available to evaluate different ways to reduce or avoid blood damage, so using human blood would lead to greater knowledge. It would also lead to a reduction in the need for animal blood. This will all in all lead to the development of safer heart pumps.
The coperation between Karolinska Institutet and Real Heart is promising in many ways, partly considering that Karolinska Institutet is locate next to Stockholm’s largest blood center and partly because Real Heart is far ahead with the development of a novel, unique concept for an artificial heart. Real Heart has invested in a number of clinically used reference pumps that can be used for development- and validation work.
”We are incredibly thankful for the grant that we have received from “Stiftelsen familjen Nils Winbergs fond”. A Swedish blood test lab can come to be world leading with regards to human blood tests, drive development for the entire heart pump industry, as well as supporting Real Heart to reach the market quicker with a safe product”, comments Azad Najar, the CEO of Real Heart