Lifecare has shown major progress in our plan to bring the smallest ContinuousGlucose Monitor (CGM) system to the market. Testing in live tissue,implementation of Quality Management System and set up of manufacturingcapabilities form the three main pillars in our market-oriented development.
- The results from studies concluded in 1H 2023 and the status of the initialproduct development phase strengthen our belief that we will be market ready in2024, says CEO Joacim Holter.
FINANCIAL SUMMARY - GROWTH IN GROUP ORGANIZATION Enhanced activities and operations have led to advancements in productdevelopment, regulatory compliance, and manufacturing preparations.
The German public-funded Covid-19 test scheme, which greatly contributed torevenue growth in 2022, has now concluded. Consequently, Lifecare LaboratoryGmbH's revenue for 2023 has reverted to a level comparable with third-partyrevenue figures before the pandemic.
The increased development activity, in conjunction with stabilized third-partyrevenue, has affected the Group's financial performance in comparison to thepreceding year, 2022. The total Group revenue for the initial half of 2023stands at 3.84 MNOK. This represents a decrease in revenue of -4,84 MNOK whencompared to the same period in 2022.
The Group's ongoing expansion and intensified operational undertakings havenaturally led to increased costs mainly related to R&D and product development.Notably, the operating result for the first half of the year is -14,26 MNOK,compared to -6.36 MNOK in the first half of 2022.
LFC-SEN-001 STUDY RESULTS: ACCURACY AND LONGEVITYOur first-in-human Clinical Development Study (LFC-SEN-001) was finalized in 1H2023. The study was designed to obtain a clear proof-of-concept in humans and toprovide data for signal read-out and accuracy.
Data from LFC-SEN-001 confirms a solid clinical accuracy of our technology(Sencell). The mean average of absolute error (MARD) was 9,6%, meaning that oursensor technology is in line with the gold standard for glucose monitoring(range 5%-10%).
Two weeks into Q3 2023 Lifecare concluded the continued experiments in-vitrowith a longevity reaching an operational lifetime of more than 24 weeks (172days), with a sensor chemistry shelf life of almost 27 weeks (187 days). - Thisconfirms that our technology has a superior longevity compared to existingneedle based CGM sensors, as well as an encouraging stability of the chemistryused in the in the sensor. This experiment validates the potential of Sencell toprovide long-term and accurate glucose monitoring for people with diabetes,while reducing the need for frequent sensor replacements, says Holter. MANUFACTURING PREPARATIONS - AUTOMATION Q2 2024 Preparations for manufacturing are essential in the context of Lifecare'sregulatory preparations and commercial outlook. Lifecare's CEO believes thatmanufacturing readiness and manufacturability is the most important process inLifecare in the near future.
Lifecare has decided to set up our first production facility in the immediatevicinity of our existing location in Mainz, Germany and these premises will beready for take-over in mid 2025. The company plans to establish an intermediateproduction-line in our existing facilities in Mainz in 2024. This firstproduction line will include automation of key production processes on the nanoand micro scale, ensuring high quality sensor and system reproducibility.
- We expect to be ready to start the first automated production operations byend of Q2 2024. This first line of automated production will imply a significantmilestone in the Sencell development for several reasons. Firstly, aconfirmation of "Manufacturability" is essential for commercialization. We areconfident that we will manage the development and engineering necessary to reachproduction maturity. Second, advancements in production preparations arenecessary to gain competence, experience, and data for technical documentationfor the future CE mark. Third, reaching the milestone of automated productionwill position Lifecare as market ready independent of the progression of CEmarking, says Holter.
SYNERGIES AND OPPORTUNITIES IN THE VETERINARY MARKET Lifecare have identified relevant additional markets for our technology and onthis basis launched the spin-off company Lifecare Veterinary. The purpose isclear