Lifecare ASA

LIFE Study protocol has been finalized for submission to regulatory authorities

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, [email protected], +47 40 05 90 40

Renete Kaarvik, CFO, [email protected], +47 94 83 82 42

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