LIFE: First positive indication of increased sensor sensitivity in ongoing longevity study
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.