2025-03-25 09:16:41
Bergen, Norway, 25 March - Lifecare ASA (LIFE), a medical sensor company
advancing product development for the next-generation Continuous Glucose
Monitoring (CGM), announces a first positive indication that the recently
communicated enhanced sensor chemistry is demonstrating increased sensitivity
also in real-life settings.
The improved chemistry, previously reported to achieve up to a fivefold
improvement in sensitivity in laboratory experiments, has now been tested in
Lifecare's ongoing longevity study in dogs. This study is an essential part of
Lifecare's product development process.
The initial in-vivo results show a promising and encouraging trend, aligning
with the earlier in-vitro test results. While previous in-vitro testing refers
to laboratory-based experiments, the ongoing in-vivo testing refers to testing
in live tissue that provides insight into real-world biological responses and
long-term performance.
Importantly, the testing of the improved chemistry is being conducted as an
additional feature within the broader framework of the ongoing product
development. As such, this additional testing does not impact or delay the
progress of product development in any way.
Significance of sensor sensitivity
Sensor sensitivity is a key performance parameter for CGM technology,
influencing the ability to detect small glucose fluctuations. Previous data from
Lifecare (LFC-SEN-001) confirmed that the initial CGM system achieved a Mean
Absolute Relative Difference (MARD) of 9.6%, meeting the standard for clinically
acceptable accuracy (MARD <10%). The improved chemistry has the potential to
enhance accuracy further. While the testing so far provides a firm expectation
that the sensitivity and the MARD will be positively impacted, final conclusions
in this respect remains subject to further data collection.
"Observing a continued positive trend in the testing and now in live tissue
represents an exciting step forward. These real-life results reinforce our
confidence in the potential of our enhanced chemistry. Our team remains
dedicated to refining our CGM technology to ensure the highest precision and
reliability for patients," says Joacim Holter, CEO of Lifecare.
Further validation is required
The ongoing longevity study in dogs is designed to investigate biocompatibility,
foreign body responses and in general provide product development related
information. The study is not designed to provide collection of data to conclude
on the measurement sensitivity as is, and consequently the current results are
highly encouraging but not conclusive. Further data collection will be required
to fully validate the impact of the improved chemistry under real-life
conditions.
Lifecare continues to push the boundaries of CGM innovation and is committed to
conducting further studies to confirm the performance benefits of its improved
sensor chemistry.
Ongoing product development
The progress of product development remains very much in line with the
forward-looking statements outlined in Lifecare's Q3 and Q4 2024 reports,
further underlining the company's consistent and focused development trajectory.
Moreover, this progress strengthens Lifecare's preparations for upcoming
regulatory testing, which is required to document the features and claims of the
CGM system in support of CE marking and market approval.
About us
Lifecare ASA is a 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. 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