Lifecare files for human clinical trial, paving the way for CE-mark

20 May 2025 07:00 CEST

Bergen, Norway, 20 May 2025 -- Lifecare ASA (LIFE), a medtech company
developing next-generation Continuous Glucose Monitoring (CGM) solutions for
diabetes management, today announces that it has filed for regulatory approval
to initiate the first human clinical trial of its wireless CGM implant.

The filing for regulatory approval is based on a design freeze deemed
sufficient to support preparations for clinical trials and continued
advancement in manufacturing development.

This filing aligns with previous communication and marks a key milestone in
Lifecare's broader clinical and commercial development strategy. Regulatory
approval is expected in Q3 2025. Subject to timely approval, Lifecare
anticipates completing the trial by early Q4 2025. This progress is in
accordance with both budget and operational plans.

The submission is an essential milestone for the company, laying the
groundwork for initiating a pivotal CE-mark trial later this year. The pivotal
trial is expected to conclude in 2026, with a commercial launch of Lifecare's
glucose monitoring implant for human use planned in 2027.

"Our regulatory filing reflects solid execution of our development roadmap and
continued momentum in line with our strategic goals. This trial is a vital
step toward bringing our glucose monitoring implant to market," says CEO
Joacim Holter.

About us
Lifecare ASA is a medical sensor company developing technology for sensing and
monitoring of various body analytes. Lifecare's focus is to bring the next
generation of Continuous Glucose Monitoring ("CGM") systems to market.
Lifecare enables osmotic pressure as sensing principle. Lifecare's sensor
technology is suitable for identifying and monitoring the occurrence of a wide
range of analytes and molecules in the human body and in pets.

Contacts
For further information, please contact:

Joacim Holter, CEO, joacim.holter@lifecare.no, +47 40 05 90 40

Renete Kaarvik, CFO, renete.kaarvik@lifecare.no, +47 94 83 82 42

More information:
Access the news on Oslo Bors NewsWeb site

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