Lifecare ASA

LIFECARE RESUBMITS APPLICATION FOR FIRST-IN-HUMAN CLINICAL STUDY

Bergen, Norway, 15 September 2025 -- Lifecare ASA (LIFE), a MedTech company

developing next generation of Continuous Glucose Monitoring (CGM) technology

for diabetes management, today announces that it has resubmitted its

application to the Norwegian Medical Products Agency (NOMA) for authorization

to initiate the company's first-in-human clinical study.

As part of a normal regulatory process, NOMA has provided feedback to ensure

that the study meets regulatory, scientific, and safety requirements. Lifecare

has carefully addressed comments received from NOMA, based on our initial

application. We have updated the documentation in line with the agency's

guidance, ensuring compliance with the latest regulatory requirements, and

resubmitted the application.

The application covers the first-in-human pilot study with Lifecare's

proprietary CGM system consisting of an implantable sensor, software and

read-out device. The study is designed to confirm safety, tolerability, and

glucose measurement performance.

Lifecare expects that the initial approval from the Norwegian Regional

Committee for Medical and Health Research Ethics (REK) will be reissued, as

the committee has already granted approval subject only to minor documentation

updates.

Lifecare's CEO, Joacim Holter, comments:

"We welcome the feedback from NOMA, which has helped us strengthen our

submission. The resubmission is an important forward step in our regulatory

pathway and demonstrates our commitment to meeting the highest standards for

patient safety and product quality. We remain on track with our strategy and

timelines, and this is another milestone on our way to making our innovative

sensor technology available to people with diabetes."

This first-in-human study will pave the way for Lifecare's pivotal CE-marking

study, scheduled for 2026, and the planned European commercial launch in 2027.

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, [email protected], +47 40 05 90 40

Renete Kaarvik, CFO, [email protected], +47 94 83 82 42

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