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

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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.

For more information please contact:

Ina Laura Perkins, CEO

Phone: +46(0)70 406 49 21 

E-mail: inalaura.perkins@realheart.se

Certified Adviser: Svensk Kapitalmarknadsgranskning AB, Phone: +46 11 32 30 732, email: ca@skmg.se

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