Realheart Sets February 2028 Target to Be Ready for First-in-Human Implantation and Provides Development Update
Realheart Sets February 2028 Target to Be Ready for First-in-Human Implantation and Provides Development Update
Västerås - Scandinavian Real Heart AB (publ) today announced that the Company's Board of Directors has adopted a new strategic goal: that the Company shall be ready for the first-in-human implantation of the Realheart® Total Artificial Heart in February 2028.
The goal for February 2028 is that the Company shall be ready for a first in human implantation.
"We have made substantial progress across several critical development areas, and the Board's decision establishes a clear framework for the activities required to achieve first-in-human readiness. We believe February 2028 represents an ambitious but achievable target for the Company,” says Ina Laura Perkins, CEO of Realheart.
Update on 2026 Development Goals
The Company's communicated 2026 objectives remain important milestones on the path toward first-in-human implantation readiness.
The Company remains on track with two of its three key objectives for the year:
- Increased production rate of the Realheart® Total Artificial Heart system and related components, enabled by the recent move to new facilities, a larger team, process improvements, and an ERP system for finance and production planning.
- Progress towards a 10-day in vivo implantation study, with ongoing development activities supporting this objective and the recent ethics approval for chronic studies by our collaborators at Sahlgrenska University Hospital.
- Full system reliability testing: the Company has made progress during the year but now assesses that demonstration of six-month full-system reliability will be ready in Q1 2027
The reliability program has generated valuable long-term performance data and enabled continued improvements to the system. However, validating long-term reliability for a complete artificial heart system has proven more time-consuming than initially anticipated.
"While demonstration of six-month full-system reliability is expected to be ready in Q1 2027, the program continues to generate important long-term performance data and support ongoing system improvements," says Ina Laura Perkins, CEO. "Our overall development trajectory remains aligned with our path toward first-in-human readiness."
The Company will continue to provide updates on its development milestones and the progress toward its newly established February 2028 readiness target.