Corporate Information
Lifecare sensor longevity experiment concluded: 6 months operational lifetime
Posted: 18. July 2023
Lifecare's Sencell Continuous Glucose Monitoring (CGM) sensor has reached an
operational lifetime of more than 24 weeks (172 days), with a sensor chemistry
shelf life of almost 27 weeks (187 days).
This achievement confirms the Sencell CGM technology potential and validates
Lifecares expectation of a minimum 6-month sensor longevity.
The longevity results were achieved by the use of a sensor that was first
implanted and tested clinically in human (in vivo), and then explanted and
transferred to continued testing in vitro. This innovative approach allows
Lifecare to demonstrate the longevity of the Sencell sensor in a more realistic
and relevant environment, as well as to document a solid sensor robustness. The
experiment also confirms the stability of the chemistry used in the sensor and
demonstrates that the technology has a superior longevity compared to existing
needle based CGM sensors.
In May 2023, Lifecare finalized the first Clinical Development Study confirming
proof of concept in humans and an encouraging sensitivity compared to
commercially available glucose sensors.
Based on study data analysis, Lifecare disclosed the study results in June 2023
at the American Diabetes Conference in San Diego, including a mean absolute
relative difference (MARD) of 9,6%. The MARD value positions the Sencell
technology with an accuracy that is acceptable for therapeutic (medical)
decisions, such as insulin dose adjustments. Furthermore, the study results
include a consensus error grid analysis that confirms that all the 261 data
points collected in the study were within zones A (90.3%) and B (9.7%), meaning
that the study results meet regulatory requirements for Continuous Glucose
Monitoring systems.
-With our prototype sensors, we have shown a clinical accuracy to base medical
decisions and we have concluded data readings within regulatory acceptable
ranges. As we now also can confirm a sensor longevity of 6 months in vitro, we
are even closer to disrupt the market with our superior technology. We have
initiated important preparations for production and the whole Lifecare
organization focuses on quality measures to provide our long-term and accurate
Continuous Glucose Monitoring system for people with diabetes, says Joacim
Holter, CEO of Lifecare.
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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.
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For further information, please contact:
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 Joacim Holter, CEO at Lifecare AS, on 18 July 2023
at 08:00 CET.