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Scandinavian Real Heart
Scandinavian Real Heart (HEART) investor relations material
Scandinavian Real Heart Status update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Status update summary14 Jan, 2026
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.
What preclinical data is critical for human trials?
How does auto-adjustment improve patient outcomes?
Detail surgeon training and certification process
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Next Scandinavian Real Heart earnings date
Q4 202519 Feb, 2026
Scandinavian Real Heart
Next Scandinavian Real Heart earnings date
Q4 202519 Feb, 2026
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Frequently asked questions
Scandinavian Real Heart AB is a medical technology company based in Sweden that specializes in the development of artificial heart devices. The company's primary product is a heart pump designed to mimic the body's natural circulatory system, serving as a temporary solution for patients awaiting heart transplants. The artificial heart, known as the Realheart TAH, aims to replicate the human heart's function by providing a pulsatile blood flow, which is crucial for maintaining organ health during the transplant waiting period. The company is headquartered in Västerås, Sweden, and its shares are listed on the Nasdaq Stockholm.
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