2024-08-22
Realheart Expands Preclinical Operations to Swedish Veterinary Center for Further Development of Realheart® TAH
Västerås, Sweden, August 22, 2024 – Scandinavian Real Heart AB (publ) today announces that the company has entered into a collaboration with a leading veterinary large animal unit at the University of Gothenburg in Sweden for the continued pre-clinical safety evaluation of the artificial heart Realheart® TAH. The purpose is to conduct high quality large animal experiments required to eventually conduct a clinical study. This will also facilitate the preparation of the clinical trial planned to be conducted in Sweden.
For the first clinical study of Realheart® TAH, the authorities require a comprehensive pre-clinical data package based on safety studies, blood tests and reliability studies.
The company has so far conducted all implant trials with Realheart® TAH at a veterinary center in Belgium that has long and extensive experience of both pre-clinical surgical procedures and interactions with regulatory authorities in the United States and Europe. The collaboration with this institution will continue during the further pre-clinical development. The expansion of the safety evaluation to a Swedish institution means increased proximity to and strengthened collaboration with the surgical team that will participate in future clinical studies. This has significant benefits for the further development of Realheart® TAH. The next step in the collaboration is to submit an application for ethical approval to conduct the planned implantation trials.
"We are very pleased to have partnered with the University of Gothenburg. The expansion of the pre-clinical implantation trials to Sweden will allow the team from the Thorax Clinic at Sahlgrenska, who will participate in the first patient study, to better understand the technology and contribute to the further development of our treatment protocols," said Ina Laura Perkins, CEO of Realheart.
About Realheart
Scandinavian Real Heart AB (publ) is developing the first artificial heart that mimics the shape, function and blood flow patterns of the human heart. These unique product features provide new opportunities to save lives and provide patients with a good quality of life while waiting for a heart transplant. Realheart® TAH (Total Artificial Heart) is now being evaluated in extensive pre-clinical studies in preparation for a first clinical study in patients expected to start in 2025. Realheart® TAH addresses a significant and urgent medical need – today, 8,300 people around the world are waiting for a heart transplant and many patients unfortunately die during their time on the waiting list. In the future, artificial hearts may also become an alternative to transplantation for broader groups of patients with very severe heart failure. The company's shares are traded on Nasdaq Stockholm First North Growth Market. For more information, visit www.realheart.se