Lifecare submits updated documentation to NoMA: regulatory review resumes in first-in-human study application

05 Feb 2026 07:56 CET

Bergen, Norway 5 February 2026 - Lifecare ASA (LIFE), a MedTech company
developing next-generation Continuous Glucose Monitoring (CGM) technology for
diabetes management, announces that it has submitted updated documentation to
the Norwegian Medical Products Agency (NoMA) in connection with the Company's
application to initiate its first-in-human clinical study.

The updated submission addresses the procedural and technical clarification
points raised by NoMA in its preliminary assessment communicated on 11
December 2025. These clarifications relate to standard documentation
expectations for first-in-human investigations of implantable medical devices
under Regulation (EU) 2017/745 (MDR).

As previously communicated, NoMA's preliminary assessment did not raise any
concerns regarding the scientific rationale, intended use, or overall
risk-benefit profile of the planned study. The requested clarifications
covered, among other things, documentation related to biocompatibility,
sterilization processes, manufacturing controls, and the presentation of
existing preclinical data, in line with applicable MDR guidance and standards.

Lifecare has prepared the updated documentation in accordance with NoMA
guidance, relevant MDCG documents, and applicable ISO standards, and confirms
that the response was submitted on 4 February 2026.

Following submission of the updated documentation, the regulatory review
process resumes. As previously stated by NoMA, the agency has 26 review days
remaining to complete its assessment and issue a decision, in accordance with
standard regulatory procedures. Should NoMA request additional clarifications,
the review timeline may be paused in line with normal regulatory practice.

Outlook
Based on current communication with NoMA and the remaining review timeline,
Lifecare continues to expect a final regulatory decision within Q1 2026.

The application concerns a pilot first-in-human study designed to evaluate the
accuracy and clinical performance of Lifecare's proprietary CGM system. The
study is planned to be conducted at the University of Bergen, under the
supervision of Professor Simon Dankel as Principal Investigator.

The first-in-human study represents an important step in Lifecare's clinical
and regulatory roadmap and will generate data supporting the Company's planned
pivotal CE-marking study.

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

More information:
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664891_Lifecare submits updated documentation to NoMA- regulatory review resumes in first-in-human study application.pdf