Lifecare ASA

Regulatory Filings • Dec 11, 2025

Lifecare receives preliminary assessment from NoMA in first-in-human study application

Lifecare receives preliminary assessment from NoMA in first-in-human study application

Bergen, Norway, 11 December 2025 - Lifecare ASA (LIFE), a MedTech company

developing next generation Continuous Glucose Monitoring (CGM) technology for

diabetes management, announces that it has received a preliminary assessment

from the Norwegian Medical Products Agency (NoMA) regarding the company's

application to initiate its first-in-human clinical study.

NoMA's preliminary assessment is a normal and expected step in the standard

review process for medical device investigations under Regulation (EU)

2017/745 (MDR). As part of routine procedure, NoMA has requested additional

information - a clarification step that can occur at any point in the review.

When this happens, the review timeline is paused until updated documentation

is provided.

NoMA has emphasized that its request relates to procedural and technical

clarifications, which are typical for first-in-human implantable devices.

Importantly, NoMA has not questioned the scientific rationale, intended use,

or overall risk-benefit basis for conducting the study.

NoMA has informed Lifecare that it has used 39 of the standard 45 review days,

and that the review clock is now paused. Once Lifecare submits the requested

updates, NoMA will have 26 days remaining to complete its assessment and issue

a decision, reflecting the MDR-permitted flexibility to extend review time by

20 days when expert input is required.

Lifecare is preparing its response and updated documentation in close

collaboration with its partners and expects to submit the updates within the

coming weeks.

As previously communicated, Lifecare's application covers the pilot study for

the accuracy and clinical performance evaluation of the company's proprietary

CGM system, consisting of an implantable sensor, software, and read-out

device. The study is planned to take place at the University of Bergen, under

the supervision of Professor Simon Dankel as Principal Investigator.

Outlook

NoMA's request for additional information is fully in line with normal

regulatory procedure and reflects the agency's detailed evaluation of complex

medical devices. Based on the current communication, final decision is now

expected in Q1 2026.

As a matter of financial responsibility and good governance, Lifecare will not

initiate the production of implants intended for the first-in-human study

before NoMA has granted authorization. This means that the study timeline will

naturally align with the regulatory process and the subsequent availability of

manufactured devices.

The pilot study will generate critical data for Lifecare's pivotal CE-marking

trial planned for 2026 and supports the company's roadmap towards European

market 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 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