The decision to shift from quarterly to biannual reporting follows the company’s internal overview and is an initiative to increase product development efficiency and decrease company costs. The transition is made in accordance with marketplace rules (First North Growth Market Rulebook, chapter 4.4). The company will continue to update the market via its official channels, including press releases and social media, on notable events connected to the company’s activities. As previously communicated, all future communications from Realheart will be in English.

The published results demonstrate that Realheart® TAH automatic control algorithm maintains proper left-right balance, balancing blood pressure between the systemic and pulmonary circulation in the cardiovascular system. Further, data show that Realheart® TAH automatically increased cardiac output by up to 2.1 times during exercise from rest and decreased cardiac output by 25% during sleep whilst maintaining stable pressure in the atria. This was shown in simulations evaluating a healthy state, as well as in varying levels of pulmonary hypertension. Collectively, these results demonstrate the device’s ability to adapt to rapid transitions between physiological states.

“Our data show that Realheart® TAH stands out in its ability to enable different levels of physical activity for patients who want to remain active. The combination of pressure-sensor based feedback control and the power of the pump mechanism to provide exercise flow makes it unique. We look forward to pursuing further studies and evaluating it against currently approved devices,” says Dr. Seraina Dual, Assistant Professor in Biomedical Signal Processing at the Department of Biomedical Engineering and Health Systems, Royal School of Technology, Sweden.

The study builds upon a joint project between Realheart and KTH, which has built a state-of-the-art cardiovascular “hybrid simulator”, including a digital model of the heart, lungs, and vessels that can be physically coupled to Realheart® TAH. The setup allows simulations of patient-specific scenarios and refinement of the pump’s control algorithms. The project is enabled by two back-to-back grants, totalling SEK 8 million, funded by Vinnova’s Smart Electronics program, a joint effort with Formas and the Swedish Energy Agency (Energimyndigheten).

“Objective studies of our device’s physiological control, performed by research field experts, are of pivotal importance to increase our innovation's overall credibility and confidence, demonstrate its performance and potential, and teach us about areas where we can continue to improve. By using the hybrid system, we can conduct rapid iterative development cycles to adjust the software and rapidly test a large number of different physiological scenarios,” says Ina Laura Perkins, CEO, Realheart.

The article, "Physiological Control of Realheart® Total Artificial Heart”, is featured in Artificial Organs vol. June 17, 2025. https://onlinelibrary.wiley.com/doi/10.1111/aor.15036

The newly approved patent (US patent no. 12318603 B2) covers the key technology of Realheart® TAH, the only artificial four-chamber heart that mimics the physiology of the natural 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. The structural design may provide important benefits, e.g., a reduced risk of stroke, bleeding, and anemia – common side effects seen with treatments using currently approved artificial heart devices.

The patent approval confers market protection for the device in the US until 2037.

Millions globally suffer from heart failure – but worldwide only 8,000 patients annually receive a heart transplant due to organ shortage. To address and describe the current technological shift in treating heart failure, the French-German public service network ARTE TV has produced a documentary illustrating the potential role of total artificial hearts in the future of heart failure treatment. The documentary features a visit to Realheart and showcases one of the company’s preclinical implantation procedures. Additionally, Realheart^® TAH is demonstrated in the lab, highlighting its unique adaptive pressure system and the patient-friendly controller that is under development.

Further, the documentary includes an interview with the first female patient implanted with the only approved system in the EU. This interview highlights the possibilities of improving the sound level and external powering of currently approved artificial heart devices. Among the professionals who demonstrate and comment on the Realheart system are Dr. Thomas Finocchiaro, CTO of Realheart, and Dr. Dilek Gürsoy, M.D. and board-certified heart surgeon at the private cardiac surgery clinics Mönchengladbach and Clinic Bel Etage, who has first-hand experience of implanting Realheart^® TAH.

“Realheart^® TAH is the only total artificial heart device in the world that mimics the structure and physiology of the natural human heart. Its mechanical construction makes it silent, and as a result of collaborations with patients and healthcare personnel, we have developed a patient-friendly monitoring unit that provides an easy overview for its users. We are very happy to have been given the opportunity to showcase our unique system to viewers around Europe,” says Ina Laura Perkins, CEO, Realheart.

The documentary is available for public viewing: https://www.arte.tv/de/videos/117722-000-A/ein-herz-auf-bestellung/

Realheart develops Realheart® TAH, the world’s first total artificial heart mimicking the shape, function, and blood flow pattern of the human heart. The patent (JP7656624B2) covers a pressure sensor with a biocompatible housing with integrated pressure-sensitive components used in the device. The sensor is designed to ensure accurate and safe pressure measurements in medical environments. By enabling real-time monitoring, the sensor supports automated control of artificial hearts and circulatory support systems, such as Realheart® TAH, contributes to optimized blood flow and has a potential positive effect on treatment outcomes. The design is engineered for integration into advanced medical systems, particularly within the field of artificial hearts and circulatory support.

The granted patent confers protection for the device in Japan until 2041.