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Regulatory press release

Realheart Presents Successful Results From a Preclinical Implantation Using Its Total Artificial Heart

Scandinavian Real Heart
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Västerås, Sweden, January 30, 2025 – Scandinavian Real Heart AB (publ) announces today that the company has successfully completed a 7-day animal study with its total artificial heart Realheart® TAH. The results show that the device provided adequate cardiac function, automatically adapted to rest and movement and maintained good blood biochemistry.

“We are very pleased to share this positive update. Results from the implantation test show that Realheart® TAH achieved the targeted cardiac output, resulting in adequate perfusion of the body with low mechanical stress and damage to red blood cells” says Ina Laura Perkins, CEO of Realheart.

Throughout the study the device functioned as intended. At one week the study was terminated as there had been some signs of bleeding which is a common complication of large cardiac surgery.

“A 7-day chronic implantation is a meaningful milestone for our development as this duration affords the assessment of the device performance in an animal that is awake and ambulatory and under various cardiac loads and allows for the elimination of many post-surgical effects”, says CEO Ina Laura Perkins.

The company is currently conducting a preclinical program to evaluate the safety and function of Realheart® TAH prior to conducting clinical studies in heart failure patients. The results from this test will guide further preclinical testing of Realheart® TAH and serve as an integral part of the data set used in dialogue with regulatory agencies.

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, www.skmg.se

About Us
Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function, and blood flow pattern of the human heart. These unique product features provide completely new opportunities to save lives and give patients a good quality of life while waiting for a heart transplant. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with severe heart failure. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive preclinical trials ahead of a first clinical study in patients. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se

This information is information that Scandinavian Real Heart is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-01-30 13:40 CET.

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Realheart Presents Successful Results From a Preclinical Implantation Using Its Total Artificial Heart

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