Bergen, Norway, 28 October 2025 -- Lifecare ASA (LIFE), a MedTech company
developing next generation Continuous Glucose Monitoring (CGM) technology for
diabetes management, announces that it has received an update from the
Norwegian Medical Products Agency (NOMA) regarding the handling time for the
company's application to initiate its first-in-human clinical study.
In line with the company's announcement of 15 September 2025, in which
Lifecare reported the resubmission of its application as part of a normal
regulatory process, NOMA has now confirmed validation of the application and
that the documentation is considered complete in accordance with Regulation
(EU) 2017/745 (MDR), Article 70.
Following validation, NOMA has informed that the scientific assessment phase
has commenced and will follow a standard handling time of 45 days from the
validation date of 23 October 2025. This period may be extended by up to 20
days if external expert consultation is required or temporarily paused should
NOMA request additional documentation.
The application covers Lifecare's pilot study for the accuracy and clinical
performance evaluation of its proprietary continuous glucose monitoring
system, consisting of an implantable sensor, software, and read-out device.
The study will be conducted at the Research Unit for Health Surveys,
University of Bergen, under the supervision of Professor Simon Dankel as
Principal Investigator.
Based on NOMA's communicated handling time, final regulatory approval can at
the earliest be expected mid-December 2025. Lifecare expects the study
initiation to take place in Q1 2026.
The pilot study will form an important foundation for Lifecare's pivotal
CE-marking trial planned for 2026, leading to the company's 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 ("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