LIFE Study protocol has been finalized for submission to regulatory authorities

10 Oct 2024 07:00 CEST

Bergen, Norway, 10 October 2024: Today, Lifecare ASA (LIFE), a clinical stage
medical sensor company developing the next generation Continuous Glucose
Monitor (CGM), can announce that we have internally concluded on the next
human study protocol to progress with our clinical sensor development towards
regulatory approval.

Reference is made to the Q2 report 27 August 2024 when the company presented
the progress plan for studies and regulatory compliance in 2024, including
preparations and regulatory approval for CE study for clinical use
(LFC-SEN-003).

A working group consisting of Lifecare's CSO Prof. Prof. Dr. Andreas
Pfützner, member of Board Prof. Dr. Lutz Heinemann and Chairman of the
Scientific Advisory Board Prof. David C. Klonoff has prepared and concluded on
a draft protocol for a long-term human clinical study that will be presented
to relevant regulatory authorities. As set forth in the progress plan for
studies and regulatory compliance, it is planned to submit the protocol by end
of 2024. However, the working group emphasizes that the submission of the
study protocol is pending Sencell (for human) product design freeze.

In preparations for submitting the protocol to the regulatory authorities, we
will engage a Contract Researcher Organization (CRO) to assist us in the
processes and conclude on study sites for the clinical trials. One of these
sites will be at Pfützner Science and Health GmbH in Mainz, Germany, which
also conducted the first-in-human clinical Sencell study.

- This is a clear indication that we have come a step further in the
preparations for the next study phase, the CE study for clinical use. The
draft protocol will be submitted as soon as we are ready to engage a CRO and
can conclude the design freeze of Sencell. Our aim is to meet these targets by
end of year and submit for approval, says CEO Joacim Holter at Lifecare ASA.

About us
Lifecare ASA is a clinical stage medical sensor company developing technology
for sensing and monitoring of various body analytes. Lifecare's main focus is
to bring the next generation of Continuous Glucose Monitoring ("CGM") systems
to market. Lifecare enables osmotic pressure as sensing principle, combined
with the ability to manipulate Nano-granular Tunnelling Resistive sensors
("NTR") on the sensor body for read-out of pressure variations. Lifecare's
sensor technology is referred to as "Sencell" and 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

More information:
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629308_LIFE Study protocol has been finalized for submission to regulatory authorities.pdf