Lifecare ASA receives regulatory feedback on first-in-human application, and has engaged Link Medical as advisor for a re-submission

09 Mar 2026 22:34 CET

Bergen, Norway 9 March 2026 - Lifecare ASA, a MedTech company developing
next-generation implantable Continuous Glucose Monitoring (CGM) technology,
announces that the Norwegian Medical Products Agency (NOMA) has completed its
review of the company's application to conduct a clinical investigation of its
CGM implant.

Following its assessment, NOMA concluded that the submitted documentation is
not yet sufficient to support authorization of the clinical investigation, and
that additional documentation and clarifications are required before approval
can be granted. The company will address these items in the re-submission.
While the application was formally rejected at this stage, Lifecare emphasizes
that such outcomes are not uncommon in the regulatory process for
first-in-human studies involving innovative medical technologies. Regulatory
reviews frequently involve iterative feedback to ensure that all safety and
documentation requirements are fully addressed before clinical trials begin.

The company considers the feedback constructive and valuable and views the
review as an important step in the ongoing regulatory process. The review has
helped further clarify regulatory expectations and provides clear guidance on
the areas where additional technical documentation and validation should be
strengthened.

Lifecare has engaged LINK Medical for assistance in the final phase toward
regulatory approval for the first-in-human study.

"We appreciate the detailed review and the constructive input from NOMA," said
Joacim Holter, CEO of Lifecare ASA. "Regulatory dialogue is an important part
of developing breakthrough medical technologies. Importantly, the feedback
primarily relates to technical documentation and supporting validation,
including areas such as biocompatibility, sterilization procedures and
manufacturing controls, rather than the underlying scientific rationale or
intended use of the technology. The feedback we have received provides clear
direction for the remaining documentation updates following the significant
progress already achieved during the review process."

The Lifecare sensor is an implantable continuous glucose monitoring technology
designed to measure glucose levels using osmotic pressure sensing. The
upcoming clinical investigation is intended to evaluate the device's accuracy
and performance in humans as part of the development pathway toward a future
commercial product.

The company remains committed to advancing the technology and progressing
toward clinical validation and future regulatory approval.

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

This information has been submitted pursuant to the Securities Trading Act §
5-12 and MAR Article 17. The information was submitted for publication,
through the agency of the contact persons set out above, at 2026-03-09 22:34
CET.

More information:
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