Hopp til innhold

Corporate Information

LIFE: LIFECARE STUDY CONFIRM CLINICAL ACCURACY IN LINE WITH GOLD STANDARD

Posted: 20/06/2023
LIFE: LIFECARE STUDY CONFIRM CLINICAL ACCURACY IN LINE WITH GOLD STANDARD
Data from Lifecare's Clinical Development Study LFC-SEN-001 confirm that the
Company's Continuous Glucose Monitoring (CGM) system (Sencell) has a solid
clinical accuracy: the mean average of absolute error (MARD) between Sencell and
matched relative reference values was 9,6%.

In context, regulatory authorities expect a MARD below 10% to acknowledge CGM
for therapeutic (medical) decisions such as insulin dose adjustments.

In comparison, the MARD of glucose measurements in capillary blood (Blood
Glucose Monitoring - BGM), representing the gold standard for patient
self-monitoring of glucose, are in the range 5-10%.

The Sencell MARD confirms previous communication from Lifecare that the system
is at least as accurate as commercially available CGM systems, although the now
calculated MARD of 9,6% significantly exceeds the anticipated outcome from this
first-in-human study. At the current development stage, the sensor sensitivity
and algorithm development provide accuracy far better than expected.

Lifecare will evaluate the scope of the planned upcoming study LFC-SEN-002. The
purpose of the study is to investigate longevity and biocompatibility in live
tissue. In light of the very encouraging outcomes of study LFS-SEN-001, Lifecare
will consider adjusting the planned study to take advantage of technical and
strategic synergies that can lead to a shorter time to market within the broad
field of glucose monitoring.

"The Sencell MARD is impressively strong. Competing technologies were introduced
to the market some 20 years ago with MARD values in the range 12,8-15%. The
first CGM with a MARD of less than 10% became a reality in 2010. In this context
it is a huge achievement to already on the pre-product stage confirm a MARD at
9,6%. This achievement stands on its own and is a solid signal that Lifecare's
technology has the potential to disrupt the market for CGM's.", Lifecare CEO,
Joacim Holter states.

"Study LFS-SEN-001 has provided very encouraging data, confirming the
technology's maturity already in the first-in human testing. Considering that
the sensors from the study also have shown a continued longevity in laboratory
experiments for more than 12 weeks and still ongoing, the technology potential
is huge. Our fantastic development team will continue to improve both the
technology and algorithms, and I am confident that the MARD of Sencell will
further improve and consequently challenge existing CGM technologies, not only
on size and longevity, but most important on accuracy.", Lifecare CSO Professor
Pfützner states.

For media inquiries or more information, please contact: Asle Wingsternes, Head
of Communications and Public Affairs at Lifecare, telephone +47 41 61 42 52,
asle.wingsternes@lifecare.no

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 Joacim Holter, CEO at Lifecare AS, on 20 June 2023
at 08:00 CET

_____________________

Lifecare AS 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. LifecareŽs 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.