Bergen, Norway, 5 August 2025 -- Lifecare ASA (LIFE), a MedTech company
developing next-generation Continuous Glucose Monitoring (CGM) technology for
diabetes management, is pleased to announce that it has received approval from
the Regional Committee for Medical and Health Research Ethics (REK) in Norway
for its planned first-in-human trial of the implantable GCM sensor.
This marks a significant milestone, bringing Lifecare one step closer to
initiating regulatory testing of its wireless glucose sensor for human use.
The approved trial is designed to assess the safety, tolerability, and
glucose-sensing accuracy of the implant in individuals with type 1 diabetes.
"We are grateful for REK's endorsement of our study protocol. This approval
reflects the scientific and ethical integrity of our work. It is a key step
toward bringing a discreet, reliable and user-friendly CGM solution to people
living with diabetes," says Joacim Holter, CEO of Lifecare ASA.
The REK approval is conditional upon minor documentation updates and does not
represent the final regulatory clearance to initiate the trial. Lifecare is
currently awaiting final approval from the Norwegian Medicines Agency
(Direktoratet for medisinske produkter), the national authority responsible
for clinical trial authorization, before the trial can begin.
The first-in-human trial will be conducted in Norway and Germany, in
collaboration with leading academic and clinical partners. Professor Simon
Dankel, a recognized expert in metabolic research and head of the Research
Unit for Health Surveys (RUHS) at the University of Bergen, will serve as
Principal Investigator. The RUHS in Bergen will host the Norwegian clinical
trial site.
This milestone follows previously announced technical verifications confirming
achievements demonstrating that Lifecare's GCM system meets core radio
frequency (RF) and electromagnetic compatibility (EMC) requirements. These
successful tests demonstrated the device's ability to wirelessly transmit
glucose date safely and reliably, a prerequisite for real-world use.
Together, the technical verifications and ethics approval highlight Lifecare's
consistent progress toward regulatory readiness and clinical evaluation of its
implantable CGM technology.
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