Highlights:

• Achieved design freeze for first-in-human trials and veterinary launch
• Appointed Principal Investigator and trial sites for upcoming trial
• Filed for first-in-human trials, paving the way for CE mark
• Started preparations towards CE marking
• Supported funding through warrant exercise

Diabetes is a pandemic spiralling out of control, affecting more than 600 million people worldwide. Lifecare plans to take part in driving the next wave of innovation in the field of diabetes technology. Lifecare aims to bring the next generation of Continuous Glucose Monitoring (GCM) systems to market, improving diabetes management for humans and pets.

- Operations, development and costs in Q2 were executed as planned. We have accelerated our development by additionally streamlining sequential processes into parallel workstreams. This enables us to continue on track with our ambitious timelines, says Lifecare’s CEO Joacim Holter.

Lifecare has received approval for first-in-human trials from the Norwegian Regional Committee for Medical and Health Research Ethics, based on conditions of minor documentation updates. Pending final approval from the Norwegian Medicines Agency, Lifecare continue preparations for the trial to start as planned in the second half of 2025. This first-in human trial will pave the way for the company’s pivotal study planned to start in 2026.

Lifecare started the preparations to achieve CE marking of our CGM system as a fully regulated medical device, in line with our plan to reach market readiness by the end of 2026. This comprehensive effort entails complete quality documentation covering all aspects of the technology and manufacturing processes.

- To realize the full potential of Lifecare’s innovative CGM technology and accelerate market entry, securing sufficient capital is critical. In June, we successfully raised funds through the exercise of warrants, and I would like to thank our investors for their trust and support. While this funding allows the company to maintain progress, Lifecare will require additional capital to finance the next stages of development. Continued support from both existing and new shareholders will be essential to sustain our momentum and bring our CGM technology to market, says CEO Joacim Holter.

Q2 2025 results presentation and strategic update:
CEO Joacim Holter and CFO Renete Kaarvik will present live at Vestland på Børs, Scandic Flesland Airport Hotel, Bergen today at 10:45 a.m. CEST.

To access the webcast Join the meeting here.

A recording of the webcast will be available on our website after the event.