Realheart Successfully Completes Second Animal Implant of its Total Artificial Heart

Press Release, 8 July 2022

On July 6th, Scandinavian Realheart’s Total Artificial Heart (TAH) was successfully implanted in a sheep for the second time. This follows the first successful implantation of the Company’s TAH reported on June 1st. Both implantations were part of an ongoing animal study designed to assess the performance of the clinical version of Realheart® TAH before entering human clinical trials, expected to start in 2024.

The procedure was performed in Belgium by Drs. Dilek Gürsoy, Joeri van Puyvelde, and Professor Bart Meyns, three experienced cardiac surgeons. Overall, the surgery was rapid and went well. A key milestone of survival over 24 hours has been reached. On the second day following the implant, the animal moved a lot, dislocating some of the life support equipment and the decision was taken to end the study. Measures have been taken to avoid recurrence.

This time the implantation was performed on a slightly smaller sheep than the previous one. Thanks to the smaller pump in Realheart’s clinical TAH version, the device could still be implanted successfully. "The pump is really good, I really believe in it," commented heart surgeon Dr. Dilek Gürsoy after the implantation.

The Company plans to achieve longer survival times in future sheep studies. The next surgery is planned for early September 2022.

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.