Scandinavian Real Heart (HEART) Status update summary

Product innovation and patient-centric design

• Realheart TAH uses dual pumps and integrated sensors to mimic natural heart function and automatically adjust to patient needs.

• Patient-focused design features lighter, quieter external units, a single cable, longer battery life and proof of concept for wireless charging.

• Demonstrated reduced blood damage and hemolysis compared with competitors.

• Clinical interface and software support real-time physician monitoring and adjustment.

Market opportunity and competitive landscape

• Global heart failure population is 64 million, including 1.6 million with severe biventricular failure targeted by the product.

• Estimated annual artificial heart need in the EU and US is 25,000, rising to 35,000 by 2030.

• Market potential estimated at $34 billion, with device cost around $220,000.

• Competitors include Syncardia, CarMat and BioVacore; existing solutions face limitations in weight, noise and patient quality of life.

Preclinical progress and regulatory pathway

• FDA Humanitarian Use Device Designation provides a faster regulatory route in the US.

• Realheart TAH is undergoing extensive preclinical evaluation ahead of a first clinical study in patients.

• Preclinical work includes blood and endurance tests and animal trials; a seven-day survival milestone has been reached in sheep.

• Collaborations with academic institutions support objective product testing and validation.

• Regulatory planning covers US and EU requirements, including plans for CE marking and ongoing dialogue with regulators.