Today we can announce that we have finalized the Sencell Clinical Development Study (LFC-SEN-001) and it reveals accurate sensor performance in human subjects. – This is a very important step in the right direction to develop the next generation Continuous Glucose Monitor (CGM) for people with diabetes, says CEO Joacim Holter.
In this first clinical development study, the osmotic pressure based continuous glucose sensor was clearly shown to track subcutaneous glucose concentrations at least as good as the commercially available needle sensors.
CEO Joacim Holter and CSO Prof. Andreas Pfützner at Lifecare.
– The study output is as good as we had hoped for, and the production and product development has been even better than expected throughout the study. Both in an academic and strategic setup it is important for us to ensure that our groundbreaking results are communicated clearly to the diabetes technology community, and we have therefor decided to disclose our scientific results, says Holter. The detailed results of this first-in human clinical study with Sencell will be presented during the scientific program of the upcoming American Diabetes Conference in San Diego on June 24th.
– Beside successful results we are incredibly satisfied with how the organization has overcome very challenging issues. Holter reminds that the sensor company operates with complex and pioneering sensor technology, while always having a focus on ensuring high quality at all stages of the process. – The Lifecare team should be very proud of what they have achieved so far, says CSO Prof. Andreas Pfützner.
The clinical performance characteristics of these wired prototypes provide us with strengthened and valuable knowledge for the next steps of product development. – We strongly believe that this forms a solid knowledge base when we develop the sensor with integrated wireless data transmission, says Holter.
In April Lifecare announced that a sensor first used in our Clinical Development Study had confirmed an operational longevity of 12 weeks in a continued laboratory (in vitro) set up. – All this together is absolutely a breakthrough, considering today’s CGM technology. Hopefully this is a significant step towards Lifecare’s goal of contributing to helping people with diabetes to live a normal life.
Lifecare’s Q1 Report 2023
Today Lifecare publish Q1 2023 interim report.
The consolidated group financials show a revenue in Q1 of 2.61 MNOK, compared to 1,98 MNOK in Q1 2022, while the Operating result in Q1 2023 ended at -6.38 MNOK, up from -4,88 MNOK in Q1 2022 due to increase in company’s activities after reaching the clinical stage.
On the operational side the company can today disclose:
– Lifecare’s first Clinical Study has been successfully finalized
– Lifecare Laboratory achieved ISO 9001 certification with effect from April 17th, 2023
– Lifecare’s sensor continue to prove its robustness in combined in-vivo/in-vitro experiments
Lifecare subsidiary Lifecare Laboratory GmbH in Mainz, Germany, has been successfully audited.
– Yesterday we received the official confirmation that the company are ISO 9001 certification with effect from April 17th, 2023. It is reassuring that our operational organization has passed this audit without any major findings. This is a good fundament for our continued work on regulatory processes, says Senior QMS Manager Barbora Tencer.
Senior QMS Manager Barbora Tencer and CEO Joacim Holter
Lifecare’s main focus is to achieve regulatory approval to bring the smallest glucose sensor in the world to the market. Starting 2021, the Lifecare Group has been significantly staffed up, and it has been a priority to ensure a high degree of quality, throughout the growing corporate organization.
– Our ultimate goal, the CE-mark for our osmotic-pressure based sensor technology, depends on additional ISO certification of the Lifecare organization. Lifecare has prioritized implementing the general ISO 9001 in the first step as the core building block in our regulatory system. This ISO forms the basis for the Medical Device-specific ISO 13485, which in turn is the fundament for the regulatory sensor approval, says CEO Joacim Holter.
Presentation at ADA 2023 in San Diego
Lifecare’s CSO, Prof. Dr. Dr. Andreas Pfützner, is invited as a speaker to present the Sencell results at American Diabetes Association’s 83rd Scientific Sessions, June 23-26, 2023 in San Diego, California. – We are naturally flattered by the offer to present our pioneering work at such a recognized arena, says the CSO at Lifecare.
CSO Prof. Dr. Dr. Andreas Pfützner at Lifecare. (Photo: Cecilie Bannow)
The American Diabetes Association 83rd Scientific Sessions is often mentioned as the world´s premier meeting on diabetes. This meeting offers the opportunity to engage with world-renowned professionals in the diabetes research and treatment communities dedicated to improving the lives of all those affected by diabetes. American Diabetes Association anticipats approximately 7,800 in-person professionals and approximately 5,000 online professional attendees. This is an opportunity to meet with global leaders in diabetes research and diabetes-related diseases, as well as the physicians and clinicians whose patients depend on the medical advancements presented at the Scientific Sessions.
– It is of course a great honor to have the opportunity to present our work in this important arena. Cutting edge technology and science are presented and discussed here and you meet the most significant experts within the sector, says Pfützner
At Prof. Dr. Dr. Pfützner is invited to present his abstract: Proof-of-Concept Study Results with a New Osmotic-Pressure–Based Continuous Glucose Sensor as a poster presentation at the scientific session. Lifecare´s poster is a “late-breaking” poster which means that the presentation is rated even higher. This happens if an author is submitting such an abstract after the official submission deadline, it is only accepted if the organizers believe that the results are so outstanding that they should not be missed in the conference. – This is the case with our poster as we have just finished the study, I submitted the abstract in April and the official submission deadline was already in January, says Pfützner.
The Scientific Sessions at ADA 2023 offers researchers and health care professionals an amazing opportunity to share ideas and learn about the significant advances in diabetes research, treatment, and care. Over the course of four days, attendees will receive exclusive access to more than 190 sessions and over 2,000 original research presentations, take part in provocative and engaging exchanges with leading diabetes experts, and expand professional networks with colleagues from around the world.
Lifecare signes lease agreement for 1000 sqm production and laboratory premises in Mainz
During the last two weeks, Lifecare has both signed a lease and had the honor of attending the solemnly ceremonial for the first “Spatenstick” for our new production facility and a laboratory in Mainz.
– The lease of production premises ensures modern and effective facilities needed for Lifecares planned scale up of production, with necessary clean room facilities and infrastructure for volume production. At the same time, this contract will give us the desired co-location of our two German subsidiaries, which are now located in Mainz and Reutlingen, says CEO Joacim Holter.
Lifecare’s future German department will thus be located at the very entrance to the city of Mainz, in the immediate vicinity of Johannes Gutenberg University and Mainz Technical College. “LAB 1” is being built here, covering around 3,000 square metres. Lifecare AS will rent around 1,000 square meters on the first floor. The company with headquarters in Bergen is now scheduled to move into LAB 1 in the summer of 2025. The duration of the lease is 10 years.
– It has been important for us to ensure continuity in an attractive and central area in Germany with strong traditions in medtech. It has a close location to the academic environment, and this is the first construction stage of a new innovation park that will reinforce the innovative environment that already characterizes the city and the region, says Holter.
Photos from the “Spantenstick” in Mainz (1 and 2), gifts from Lifecare to Minister-President of Rhineland-Paltinate, Malu Dreyer (3) and the Lifecare team in talks with the Mayor of Mainz, Nino Haase (4).
CSO in Lifecare, Prof. Andreas Pfützner points out that the building construction and the facilities at the new innovation park also meet the physical requirements necessary for Lifecare.
– We are developing sensor technology at the nano level. For this we need a building optimized to avoid vibration or electrical interference, so that our sensitive production procedures are not affected or disturbed by external conditions. The co-location of the German units will also strengthen cooperation, make future operations more efficient and provide even better utilization of our skilled employees”, says Pfützner.
Lifecare is the first player to have signed an agreement in the new innovation park. On Wednesday 3 May, there will be a ceremonial laying of the foundation stone with the mayor and several ministers present.