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LandNorge
ListaEuronext Growth Oslo
SektorHälsovård
IndustriMedicinteknik
Lifecare är ett norskt bolag verksamma inom medicinteknik. Idag är bolaget specialiserade inom forskning och utveckling av diabetes. Produkterna är patenterade och används som glukosgivare. Mikrosensorerna injiceras under huden på patientens handled, och fungerar vidare som en realtidsuppdatering av glukosnivån i patienten. Utöver bidrar tekniken med larmsensor samt tillgång till historisk data över patientens glukosnivå. Bolaget etablerades under 2006 och har sitt huvudkontor i Bergen, Norge.
2023-10-17 08:00:00
Bergen, Norway, October 17th, 2023: Today, Lifecare AS (LIFE), a clinical stage
medical sensor company developing the next generation Continuous Glucose Monitor
(CGM), can reveal an important announcement about regulatory confirmation from
Norwegian Medicines Agency (Statens Legemiddelverk).

In the process of Lifecare's initial planning and preparations to bring Sencell
CGM to the veterinary market, Lifecare Veterinary has asked for regulatory
clarifications from the Norwegian Medicines Agency. As a governmental
decision-making body, the Norwegian Medicines Agency are responsible to evolve
and safeguard public and animal health by ensuring efficacy, quality, and safety
of medicines and medical devices, administering and enforcing the Norwegian
Medical Devices Regulations.

The Norwegian Medicines Agency has now assessed Lifecare's microchip nanosensor
(Sencell CGM) and considers the product itself as non-medicinal product. This
governmental statement confirms, as expected, that Sencell CGM is to be
considered as a medical device in the veterinary market. They further confirm
that, as of today, no specific regulations exist for medical devices for animals
in Norway. Consequently, the Sencell CGM will not be subject to any specific
regulatory requirements for veterinary use, and hence launch in the veterinary
market in Norway. Assuming that Lifecare Veterinary's product is to be injected
into animals, the product is intended to be used by veterinarians, the Norwegian
Medicines Agency also confirms.

- This important confirmation from the Norwegian authority is relevant to the
timeline and previously communicated milestone to launch the first product in
the veterinary market mid 2024. While the statement from the Norwegian body is
in line with our expectations, this also increase our confidence that EU states
in general will conclude accordingly, says Managing Director Jo Oeding Amundstad
at Lifecare Veterinary.

- The veterinary business case for Sencell CGM is a spin-off towards a
tremendously huge market. The experience gained from the veterinary market will
also be very valuable as it will provide a unique source of a large amount of
data and knowledge about product properties of the Sencell CGM. We expect this
to be extra useful in the development towards Lifecare's ultimate goal