Scandinavian Real Heart (HEART) Status update summary

Product innovation and patient-centric design

• Developed a patient-focused artificial heart with lighter, quieter, and more user-friendly external units compared to current market leaders.

• Device mimics natural heart function with dual pumps and integrated sensors, automatically adjusting to patient needs.

• Unique features include a single external cable, longer battery life, and proof of concept for wireless charging.

• Demonstrated significant reduction in blood damage and hemolysis compared to competitors.

• Clinical interface and software allow real-time monitoring and adjustment by physicians.

Market opportunity and competitive landscape

• Addressing a global heart failure market with 64 million patients, focusing on the 1.6 million with severe biventricular failure.

• Estimated annual need for artificial hearts in EU and USA is 25,000, rising to 35,000 by 2030.

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

• Main competitors include Syncardia, CarMat, and BioVacore, but current solutions have drawbacks in weight, noise, and patient quality of life.

Preclinical progress and regulatory pathway

• Achieved FDA Humanitarian Use Device Designation, enabling a faster regulatory route in the US.

• Ongoing preclinical studies include blood tests, endurance tests, and animal trials, with milestones such as seven-day survival in sheep.

• Collaborations with leading academic institutions for objective product testing and validation.

• Focus on meeting regulatory requirements for both US and EU markets, with plans for CE marking.