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
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 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/
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”
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.
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
Scandinavian Real Heart continues the development work in several areas. In a new study of the company’s unique artificial heart (TAH), a prototype of the heart pump has been evaluated in a pilot study that shows how it can be implanted into the human body. The international journal “Artificial Organ” has published the study with the title “Evaluation of the novel total artificial heart Realheart in a pilot human fitting study”.
The study reports how the implantation technique of Realhart has evolved. A great advantage with Realheart TAH is in the pump’s flexible design since the pump adapts to the available space in the thorax. Moreover, as the pump is built in two separate halves each half can be placed in its side of the thorax.
” We continue to investigate and verify different parts of the project in a scientific way. The intent is partly to strengthen the company’s position internationally and partly to be able to early on optimize the human implant protocol. At the same time we are developing Realheart TAH according to the demands from the FDA”, says Azad Najar, CEO and founder.
The company has completed eight short pre-clinical animal trials on sheep. During the trials Realheart TAH has been adapted to the animal model through an adaptation of the surgical implantation technique, connections to the animal’s vessels and control of de-airing. During the final operation the animal breathed spontaneously and could be transferred to the intensive care unit and stay alive for a few hours.
During the operations on calves that were performed during the spring and fall of 2018 Realheart could note that the amount of blood that flows back from the body and lungs varies heavily. The natural heart controls this variation by changing the pulse and stroke volume. Additionally it can pump different volumes from the right and left side of the heart.
Thanks to this discovery at the calf operations Realheart has performed significant work and developed a new and totally automatic control that controls the pump activity depending on the flow of blood back to the heart and the pressures in the atria. Realheart has during the sheep trials this spring tested this intelligent control which pumps exactly the amount of blood that flows back to the heart pump, and that can also pump different volumes from the right and left half. Another great advantage is that the control can keep the pressures in the atria of the heart pump stable and low, which facilitates the flow of blood from the lungs to the heart pump. This lessens or prevents the risk for pulmonary edema, which is a very common complication with heart pumps.
During the trials Realheart TAH functioned just like the human heart when the automatic control had been started. The control that was used is a first prototype to test the concept. Significant work remain for the completion of a final version.
According to the company, there is no other heart pump on the market or under development that is equipped with atria. Realheart’s patented pump design makes it difficult for other pump manufacturers to develop similar atrium based systems for automatic control.
”Thanks to our latest work Realheart TAH is the only heart pump under development that can automatically control the blood volume by varying the stroke volume and pulse, in in that respect totally mimic the human heart. The automatic control is very important for our future studies and we are now inspired and ready to intiate the upcoming survival trials on animals”, says Azad Najar, the CEO and founder of Realheart.
Realheart works strategically with protecting the company’s technologies on the major current and future markets across the world, and applications are being filed continuously. The latest patent was approved and the registration became official in the end of May, and covers the protection of Realheart TAH in China with its 1.4 billion inhabitants.
Realheart’s strategy is not only to protect the artificial heart’s design and function, but also individual components and supporting technologies. During spring a patent application has been filed to strengthen the protection of an updated version of the connection plates, which helps the surgeon to connect the artificial heart to the vessels and tissue of the body.
In addition to this the company is looking forward and works with the protection of future product version. This has led to two patent applications in process to be submitted to the patent office shortly.
”Patent protection is very important to us, to create value in the company and to secure Realheart’s future commercialization. We thus look at it as a strategic task that we continuously work on in parallel with product development.”, says Azad Najar, CEO and founder.
During the meeting with the American authority FDA in April, sheep was accepted as the animal model for Realheart’s continued work, which is a strategically important milestone.
Using sheep leads to multiple advantages. For example, the sheep’s circulatory system is more similar to humans than the calve’s is. Additionally, this alternative leads to a cost saving of about 75% at this development stage, since the calf trilas would have had to be performed in the U.S. while the sheep operations can be performed in Europe. There are also advantages with regards to quality, the lab that can now be used has an excellent intensive care unit, which increases the chances for successful long time trials. Additionally, the lab has experience of performing GLP studies for data acquisition preceding clinical trials according to FDA’s requirements.
During May, Realheart has performed fitting trials on sheep, and we ave thus benn abled to evaluate and refine the surgical technique. The latest of these trials was performed successfully a couple of days ago.
Realheart TAH has a flexible design which means that it could be adapted to fit the smaller chest volume in sheep. The artificial heart could thereby fit in the body after a couple of attempts and the wound could be closed.
When the pump had been implanted and the heart-lung machine had been disconnected, normal values with regards to blood pressure, oxygen saturation and atrial pressures could be measured. The sheep was breathing by itself and had a normal urine production during the limited time of the trial. Thus, the animal was in a stable condition.
With the successful trials, Realheart now moves to long time trials with the intention to wake up the animal transporting it to the intensive care unit.
“We are very happy with having been able to implant Realheart TAH into the chesct of a smaller animal, which not least proves our design flexibility. It is also with great satisfaction that we can note that we are following the development plan and that we have passed this milestone faster than expected”, says Azad Najar, CEO and founder.