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, joacim.holter@lifecare.no, +47 40 05 90 40
Renete Kaarvik, CFO, renete.kaarvik@lifecare.no, +47 94 83 82 42