Lifecare has shown major progress in our plan to bring the smallest Continuous Glucose Monitor (CGM) system to the market. Testing in live tissue, implementation of Quality Management System and set up of manufacturing capabilities form the three main pillars in our market-oriented development.
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FINANCIAL SUMMARY – GROWTH IN GROUP ORGANIZATION
Enhanced activities and operations have led to advancements in product development, regulatory compliance, and manufacturing preparations.
The German public-funded Covid-19 test scheme, which greatly contributed to revenue growth in 2022, has now concluded. Consequently, Lifecare Laboratory GmbH’s revenue for 2023 has reverted to a level comparable with third-party revenue figures before the pandemic.
The increased development activity, in conjunction with stabilized third-party revenue, has affected the Group’s financial performance in comparison to the preceding year, 2022. The total Group revenue for the initial half of 2023 stands at 3.84 MNOK. This represents a decrease in revenue of -4,84 MNOK when compared to the same period in 2022.
The Group’s ongoing expansion and intensified operational undertakings have naturally 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 LONGEVITY
Our first-in-human Clinical Development Study (LFC-SEN-001) was finalized in 1H 2023. The study was designed to obtain a clear proof-of-concept in humans and to provide 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 our sensor 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-vitro with a longevity reaching an operational lifetime of more than 24 weeks (172 days), with a sensor chemistry shelf life of almost 27 weeks (187 days). - This confirms that our technology has a superior longevity compared to existing needle based CGM sensors, as well as an encouraging stability of the chemistry used in the in the sensor. This experiment validates the potential of Sencell to provide 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’s regulatory preparations and commercial outlook. Lifecare’s CEO believes that manufacturing readiness and manufacturability is the most important process in Lifecare in the near future.
Lifecare has decided to set up our first production facility in the immediate vicinity of our existing location in Mainz, Germany and these premises will be ready for take-over in mid 2025. The company plans to establish an intermediate production-line in our existing facilities in Mainz in 2024. This first production line will include automation of key production processes on the nano and micro scale, ensuring high quality sensor and system reproducibility.
- We expect to be ready to start the first automated production operations by end of Q2 2024. This first line of automated production will imply a significant milestone in the Sencell development for several reasons. Firstly, a confirmation of “Manufacturability” is essential for commercialization. We are confident that we will manage the development and engineering necessary to reach production maturity. Second, advancements in production preparations are necessary to gain competence, experience, and data for technical documentation for the future CE mark. Third, reaching the milestone of automated production will position Lifecare as market ready independent of the progression of CE marking, says Holter.
SYNERGIES AND OPPORTUNITIES IN THE VETERINARY MARKET
Lifecare have identified relevant additional markets for our technology and on this basis launched the spin-off company Lifecare Veterinary. The purpose is clear; to assist pets with diabetes with our existing technology. The market opportunity within the dog and cat market is unquestionable, and the regulatory frameworks are less complex compared to the human market.
On the course of our development towards automated production, and regulatory progress towards the CE mark as a medical device (for humans), we see significant synergies towards the animal market without jeopardizing the progress of our main development.
- Aligned with the preparations for automated production and the fact that the veterinary device market is less regulated compared to the human medical device market, we expect to be ready to enter the veterinary market in 2024 – and uphold our progress plan towards CE marking, necessary to enter the human market, says Holter.
UPCOMING STUDY LFC-SEN-002
The next action of studies is to investigate and document our technology longevity (in-vivo) and biocompatibility in-vivo. This action was planned as a clinical (human) study, but on the basis of both ethical and commercial considerations we have decided to proceed with LFC-SEN-002 as a study in dogs. Following the results of LFC-SEN-001, we see no need for additional proof of concept in human subjects, as study in dogs will provide the necessary data in terms of longevity (in-vivo) and biocompatibility. In fact, longevity and biocompatibility studies are normally conducted in animals.
For further information, please contact:
Joacim Holter, CEO, Lifecare AS, joacim.holter@lifecare.no, +47 40 05 90 40
or
Asle Wingsternes, Head of Communications and Public Affairs at Lifecare, telephone +47 41 61 42 52, asle.wingsternes@lifecare.com
This information 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 23 August 2023 at 08:10 CET.
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