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Beskrivning

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.
2023-08-23 08:10:15
Lifecare has shown major progress in our plan to bring the smallest Continuous
Glucose Monitor (CGM) system to the market. Testing in live tissue,
implementation of Quality Management System and set up of manufacturing
capabilities form the three main pillars in our market-oriented development.

- The results from studies concluded in 1H 2023 and the status of the initial
product development phase strengthen our belief that we will be market ready in
2024, says CEO Joacim Holter.

FINANCIAL SUMMARY - GROWTH IN GROUP ORGANIZATION
Enhanced activities and operations have led to advancements in product
development, regulatory compliance, and manufacturing preparations.

The German public-funded Covid-19 test scheme, which greatly contributed to
revenue growth in 2022, has now concluded. Consequently, Lifecare Laboratory
GmbH's revenue for 2023 has reverted to a level comparable with third-party
revenue figures before the pandemic.

The increased development activity, in conjunction with stabilized third-party
revenue, has affected the Group's financial performance in comparison to the
preceding year, 2022. The total Group revenue for the initial half of 2023
stands at 3.84 MNOK. This represents a decrease in revenue of -4,84 MNOK when
compared to the same period in 2022.

The Group's ongoing expansion and intensified operational undertakings have
naturally led to increased costs mainly related to R&D and product development.
Notably, the operating result for the first half of the year is -14,26 MNOK,
compared to -6.36 MNOK in the first half of 2022.


LFC-SEN-001 STUDY RESULTS: ACCURACY AND LONGEVITY
Our first-in-human Clinical Development Study (LFC-SEN-001) was finalized in 1H
2023. The study was designed to obtain a clear proof-of-concept in humans and to
provide data for signal read-out and accuracy.

Data from LFC-SEN-001 confirms a solid clinical accuracy of our technology
(Sencell). The mean average of absolute error (MARD) was 9,6%, meaning that our
sensor technology is in line with the gold standard for glucose monitoring
(range 5%-10%).

Two weeks into Q3 2023 Lifecare concluded the continued experiments in-vitro
with a longevity reaching an operational lifetime of more than 24 weeks (172
days), with a sensor chemistry shelf life of almost 27 weeks (187 days). - This
confirms that our technology has a superior longevity compared to existing
needle based CGM sensors, as well as an encouraging stability of the chemistry
used in the in the sensor. This experiment validates the potential of Sencell to
provide long-term and accurate glucose monitoring for people with diabetes,
while reducing the need for frequent sensor replacements, says Holter.

MANUFACTURING PREPARATIONS - AUTOMATION Q2 2024
Preparations for manufacturing are essential in the context of Lifecare's
regulatory preparations and commercial outlook. Lifecare's CEO believes that
manufacturing readiness and manufacturability is the most important process in
Lifecare in the near future.

Lifecare has decided to set up our first production facility in the immediate
vicinity of our existing location in Mainz, Germany and these premises will be
ready for take-over in mid 2025. The company plans to establish an intermediate
production-line in our existing facilities in Mainz in 2024. This first
production line will include automation of key production processes on the nano
and micro scale, ensuring high quality sensor and system reproducibility.

- We expect to be ready to start the first automated production operations by
end of Q2 2024. This first line of automated production will imply a significant
milestone in the Sencell development for several reasons. Firstly, a
confirmation of "Manufacturability" is essential for commercialization. We are
confident that we will manage the development and engineering necessary to reach
production maturity. Second, advancements in production preparations are
necessary to gain competence, experience, and data for technical documentation
for the future CE mark. Third, reaching the milestone of automated production
will position Lifecare as market ready independent of the progression of CE
marking, says Holter.


SYNERGIES AND OPPORTUNITIES IN THE VETERINARY MARKET
Lifecare have identified relevant additional markets for our technology and on
this basis launched the spin-off company Lifecare Veterinary. The purpose is
clear