Clinical version of Realheart TAH being tested on virtual patients

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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.

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 atriums and two chambers) which provides the opportunity to generate a physiologically adapted blood flow that mimics the body's natural circulation. A unique concept in the medical technology world.