Data from Lifecare's Clinical Development Study LFC-SEN-001 confirm that theCompany's Continuous Glucose Monitoring (CGM) system (Sencell) has a solidclinical accuracy: the mean average of absolute error (MARD) between Sencell andmatched relative reference values was 9,6%.
In context, regulatory authorities expect a MARD below 10% to acknowledge CGMfor therapeutic (medical) decisions such as insulin dose adjustments.
In comparison, the MARD of glucose measurements in capillary blood (BloodGlucose Monitoring - BGM), representing the gold standard for patientself-monitoring of glucose, are in the range 5-10%.
The Sencell MARD confirms previous communication from Lifecare that the systemis at least as accurate as commercially available CGM systems, although the nowcalculated MARD of 9,6% significantly exceeds the anticipated outcome from thisfirst-in-human study. At the current development stage, the sensor sensitivityand algorithm development provide accuracy far better than expected.
Lifecare will evaluate the scope of the planned upcoming study LFC-SEN-002. Thepurpose of the study is to investigate longevity and biocompatibility in livetissue. In light of the very encouraging outcomes of study LFS-SEN-001, Lifecarewill consider adjusting the planned study to take advantage of technical andstrategic synergies that can lead to a shorter time to market within the broadfield of glucose monitoring.
"The Sencell MARD is impressively strong. Competing technologies were introducedto the market some 20 years ago with MARD values in the range 12,8-15%. Thefirst CGM with a MARD of less than 10% became a reality in 2010. In this contextit is a huge achievement to already on the pre-product stage confirm a MARD at9,6%. This achievement stands on its own and is a solid signal that Lifecare'stechnology 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 thetechnology's maturity already in the first-in human testing. Considering thatthe sensors from the study also have shown a continued longevity in laboratoryexperiments for more than 12 weeks and still ongoing, the technology potentialis huge. Our fantastic development team will continue to improve both thetechnology and algorithms, and I am confident that the MARD of Sencell willfurther improve and consequently challenge existing CGM technologies, not onlyon size and longevity, but most important on accuracy.", Lifecare CSO ProfessorPfützner states.
For media inquiries or more information, please contact: Asle Wingsternes, Headof Communications and Public Affairs at Lifecare, telephone +47 41 61 42 52,asle.wingsternes@lifecare.attme.dev
This information is considered to be inside information pursuant to the EUMarket Abuse Regulation and is subject to the disclosure requirements pursuantto Section 5-12 the Norwegian Securities Trading Act. This stock exchangeannouncement was published by Joacim Holter, CEO at Lifecare AS, on 20 June 2023at 08:00 CET
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Lifecare AS is a clinical stage medical sensor company developing technology forsensing and monitoring of various body analytes. Lifecare's main focus is tobring the next generation of Continuous Glucose Monitoring ("CGM") systems tomarket. Lifecare enables osmotic pressure as sensing principle, combined withthe ability to manipulate Nano-granular Tunnelling Resistive sensors ("NTR") onthe sensor body for read-out of pressure variations. LifecareŽs sensortechnology is referred to as "Sencell" and is suitable for identifying andmonitoring the occurrence of a wide range of analytes and molecules in the humanbody.