This announcement follows Lifecare’s regulatory submission on 20 May 2025 for its first-in-human trial of the CGM implant, and the appointment of Professor Simon Nitter Dankel as Principal Investigator at the Research Unit for Health Surveys (RUHS), University of Bergen, as announced on 27 May 2025.

Lifecare’s planned clinical trial marks a key milestone on the path toward clinical validation and commercialization. Pending timely regulatory approval, Lifecare expects to finalize the trial by early Q4 2025, in line with budget and operational plans. The outcome will form the basis for initiating a pivotal CE-mark trial later this year, with finalization expected in 2026. A commercial launch of the CGM implant for human use is planned for 2027.

At PSHI, the trial will be conducted by Dr. Daniela Sachsenheimer and Dr. Julia Jantz, who will serve as site investigators. PSHI is a renowned institution specializing in metabolic research and clinical development. The institute is led by Lifecare’s Chief Scientific Officer, Prof. Dr. Dr. Andreas Pfützner, who also serves as owner and principal of PSHI.

Lifecare and PSHI share a long-standing collaboration. PSHI has previously conducted several key clinical and pre-clinical initiatives on behalf of Lifecare, including clinical trials in 2023.

"Expanding our clinical operations to PSHI in Germany brings valuable experience and continuity through the leadership of Drs. Sachsenheimer and Jantz," said Joacim Holter, CEO of Lifecare ASA. “Our long-standing partnership with PSHI provides a solid foundation for the successful execution of this trial.”

With RUHS in Norway and PSHI in Germany now confirmed as trial sites, Lifecare continues to advance its clinical roadmap for the wireless CGM implant, targeting completion of the initial trial in early Q4 2025 and transition into the pivotal CE-mark trial later this year.