Bergen, Norway 23 June 2022

Today, Lifecare AS will initiate first-in human clinical studies of the diabetes
sensor Sencell, thereby the second of two major milestones in 1H 2022 is in
progress. Lifecare recently announced that the first milestone for 1H 2022 was
completed, namely successfully in-vitro testing and fabrication of the prototype
having the size of a grain of rice. Previous pre-clinical studies of the
technology have given good results. Lifecare's first participant is set today
23. juni 2022, the total number of participants for his study is 15, and the
study is expected to be completed by end of September 2022. Conducting clinical
trials on humans is a significant step towards Lifecares goal of contributing to
help people with diabetes - which in a global perspective counts for 537 million
people - to live a normal life.  

The purpose of the trials is to optimize signal reading from the company's
groundbreaking sensor technology for continuous glucose monitoring for people
with diabetes. The sensor subject to clinical trials is produced at the
company's development department in Reutlingen, Germany, and the studies are
conducted at the company's department in Mainz, Germany. 

Lifecare's glucose sensor Sencell monitors changes in the body's glucose levels
based on variations in osmotic pressure. Lifecare owns a patented method for
monitoring variations in osmotic pressure based on a unique chemical composition
and licensed production method for nano-pressure sensor technology. 
Lifecare aims to offer continuous glucose monitoring with a sensor that is
significantly smaller and has a function time that is 12 times longer than
existing options for people with diabetes. The sensor Sencell is the size of a
grain of rice and will be the first solution for continuous glucose monitoring
that is fully placed under the skin, without a fixed device on the outside of
the body. Lifecare's solution is expected to be significantly cheaper than
existing glucose monitoring solutions. 

Expected progress
When Lifecare now initiates clinical trials, it is the result of focused and
persistent effort following the restructuring of the business initiated in Q2
2021 and effective from September 2021. The combination of structural
adaptations and groundbreaking technological development has been challenging
for the company's development departments. The production of sensors for use in
clinical trials is still a manual procedure through interdisciplinary
collaboration and is time-consuming. We are working to reduce production time
with the help of increased personnel, as well as preparations for automated
production in the form of pilot production in the lead-up to planned additional
clinical studies. In the context of the pressure on the organization up to the
present milestone achievement and forthcoming holiday for key personnel,
Lifecare considers it very important to prioritize quality in the execution of
the study that is now initiated, so that the best possible data is provided. In
addition, the study is based on three phases, during which adjustments and
adaptations will be made between the active phases for optimizing signals from
the sensor. Based on this, the company will estimate that the clinical trial
initiated today will be completed by the end of September 2022. The next
milestone is clinical trial "002" with 50 patients and is dependent on the
completion of the first study "001", and "002" is still considered achievable in
2H 2022. However, general challenges related to the delivery time of necessary
electronic components and some uncertainty about the processing time on the
application for the next clinical trial "002", may cause the clinical study
"002" to be initiated somewhat later than originally planned.

Background
Initiating clinical trials represents the next phase of Lifecare's product
development to meet its goal of providing precise and accurate readings of
variations in the glucose-levels for people with diabetes. The idea of measuring
variations in glucose-levels based on osmotic pressure arose in the 1980s when
Engineer Olav Ellingsen observed his son's physical reactions as a result of
diabetes. Supported by financial collaborators, the idea was turned into
innovations and continued in several early-phase projects in cooperation with
SINTEF, Rikshospitalet, VTT (Finland), Vestfold University College and CSEM
(Switzerland), among others. Since 2014, Lifecare's research has been developed
in close collaboration with the Diabetes Technology Society, USA, represented by
the organization's founder Professor David Klonoff and Pfützner Science & Health
Institute, Diabeteszentrum & Praxis, represented by Professor Dr. Dr. Med
Andreas Pfützner who is engaged as Lifecare AS Chief Scientific Officer.
Lifecare was listed on Oslo Børs (Euronext Growth) in 2018, and from this point
the company's development has accelerated towards the clinical trials starting
now and is a very important milestone. 

During the past 12 months, Lifecare has aquired two independent entities in
Germany and on this base established internal development resources and
accelerated the scientific development as part of preparations to conduct
extensive clinical trials. Lifecare is also in the early stages of establishing
internal production capacity in accordance with regulatory requirements, with
the goal of launching Sencell on the European market in 2024.  

The diabetes market
Over the past few decades, the number of patients in the world with diabetes has
increased with an alarming rate and the International Diabetes Association
refers to the situation as "a pandemic of unprecedented magnitude spiralling out
of control" (IDF Diabetes Atlas, 10th edition, December 2021). The number of
people with diabetes is estimated to be more than 537 million people and the
number is expected to rise to 783 million in 2045. The disease has major
economic effects for private individuals, households, and public health costs.
The International Diabetes Association calculates that more than 11.5% of global
health costs - more than a billion USD - is related to diabetes and
diabetes-complications. Diabetes also entails significant non-economic
consequences for patients, their close related parties and for the society.
According to the WHO, the disease caused 6.7 million deaths globally in 2021 and
is expected to be the 7th leading cause of death globally by 2030.

Based on the International Diabetes Association's regional overviews, Lifecare
has estimated that the potential market for Late Cell in Europe (EU, EFTA, UK
and Switzerland) covers close to 9 million people, while in the US and Canada
the potential market is estimated at more than 10 million people. 

Additional applications for the technology
Lifecare's main objective is to develop the Sencell glucose sensor to a
market-ready product ready for distribution through industrial partnerships,
however the patented technology is considered to have a far broader potential -
beyond the market for diabetes. 

The glucose measurement sensor is based on a reactive chemical composition
consisting of glucose-binding molecules that - depending on the level of glucose
- affect the osmolarity in a nano-chamber, leading to changes in osmotic
pressure. By adapting the reactive chemical composition with molecules that
enables binding properties with other defined molecules, Lifecare's technology
is suitable for continuously monitoring all molecules that may occur in the
human body. Based on the maturity of technology and sensors, Lifecare will
increasingly seek partnerships to develop solutions for molecules other than
glucose, such as lactate. 

Lifecare AS is a sensor technology company headquartered in Bergen. The company
is developing a sensor that measures variations in glucose levels for people
with diabetes based on changes in osmotic pressure, which are documented to
correlate 100% with changes in the incidence of glucose. Lifecare's technology
and methodology are patented, and the company is believed to be the only player
globally that uses osmotic principles as a basis for accurate and stable
continuous glucose measurement. The technology and method are highly usable and
allow for the measurement of a wide range of molecules in addition to glucose.  
       

Further information
Joacim Holter, CEO, Lifecare AS,  joacim.holter@lifecare.no, +47 40 05 90 40

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to Section 5-12 the Norwegian Securities Trading Act. This stock exchange
announcement was published by Kine Hereid, Investor Relations at Lifecare AS, on
23 June 2022 at 08:00 CET