PRESSRELEASE, 23 June 2022
Today, Lifecare AS will initiate first-in human clinical studies of the diabetes sensor Sencell, thereby the second of two major milestones in 1H 2022 is in progress. Lifecare recently announced that the first milestone for 1H 2022 was completed, namely successfully in-vitro testing and fabrication of the prototype having the size of a grain of rice. Previous pre-clinical studies of the technology have given good results. Lifecare’s first participant is set today 23. juni 2022, the total number of participants for his study is 15, and the study is expected to be completed by end of September 2022. Conducting clinical trials on humans is a significant step towards Lifecares goal of contributing to help people with diabetes – which in a global perspective counts for 537 million people – to live a normal life.
The purpose of the trials is to optimize signal reading from the company’s groundbreaking sensor technology for continuous glucose monitoring for people with diabetes. The sensor subject to clinical trials is produced at the company’s development department in Reutlingen, Germany, and the studies are conducted at the company’s department in Mainz, Germany.
Lifecare’s glucose sensor Sencell monitors changes in the body’s glucose levels based on variations in osmotic pressure. Lifecare owns a patented method for monitoring variations in osmotic pressure based on a unique chemical composition and licensed production method for nano-pressure sensor technology.
Lifecare aims to offer continuous glucose monitoring with a sensor that is significantly smaller and has a function time that is 12 times longer than existing options for people with diabetes. The sensor Sencell is the size of a grain of rice and will be the first solution for continuous glucose monitoring that is fully placed under the skin, without a fixed device on the outside of the body. Lifecare’s solution is expected to be significantly cheaper than existing glucose monitoring solutions.
Expected progress
When Lifecare now initiates clinical trials, it is the result of focused and persistent effort following the restructuring of the business initiated in Q2 2021 and effective from September 2021. The combination of structural adaptations and groundbreaking technological development has been challenging for the company’s development departments. The production of sensors for use in clinical trials is still a manual procedure through interdisciplinary collaboration and is time-consuming. We are working to reduce production time with the help of increased personnel, as well as preparations for automated production in the form of pilot production in the lead-up to planned additional clinical studies. In the context of the pressure on the organization up to the present milestone achievement and forthcoming holiday for key personnel, Lifecare considers it very important to prioritize quality in the execution of the study that is now initiated, so that the best possible data is provided. In addition, the study is based on three phases, during which adjustments and adaptations will be made between the active phases for optimizing signals from the sensor. Based on this, the company will estimate that the clinical trial initiated today will be completed by the end of September 2022. The next milestone is clinical trial “002” with 50 patients and is dependent on the completion of the first study “001”, and “002” is still considered achievable in 2H 2022. However, general challenges related to the delivery time of necessary electronic components and some uncertainty about the processing time on the application for the next clinical trial “002”, may cause the clinical study “002” to be initiated somewhat later than originally planned.
Background
Initiating clinical trials represents the next phase of Lifecare’s product development to meet its goal of providing precise and accurate readings of variations in the glucose-levels for people with diabetes. The idea of measuring variations in glucose-levels based on osmotic pressure arose in the 1980s when Engineer Olav Ellingsen observed his son’s physical reactions as a result of diabetes. Supported by financial collaborators, the idea was turned into innovations and continued in several early-phase projects in cooperation with SINTEF, Rikshospitalet, VTT (Finland), Vestfold University College and CSEM (Switzerland), among others. Since 2014, Lifecare’s research has been developed in close collaboration with the Diabetes Technology Society, USA, represented by the organization’s founder Professor David Klonoff and Pfützner Science & Health Institute, Diabeteszentrum & Praxis, represented by Professor Dr. Dr. Med Andreas Pfützner who is engaged as Lifecare AS Chief Scientific Officer. Lifecare was listed on Oslo Børs (Euronext Growth) in 2018, and from this point the company’s development has accelerated towards the clinical trials starting now and is a very important milestone.
During the past 12 months, Lifecare has aquired two independent entities in Germany and on this base established internal development resources and accelerated the scientific development as part of preparations to conduct extensive clinical trials. Lifecare is also in the early stages of establishing internal production capacity in accordance with regulatory requirements, with the goal of launching Sencell on the European market in 2024.
The diabetes market
Over the past few decades, the number of patients in the world with diabetes has increased with an alarming rate and the International Diabetes Association refers to the situation as “a pandemic of unprecedented magnitude spiralling out of control” (IDF Diabetes Atlas, 10th edition, December 2021). The number of people with diabetes is estimated to be more than 537 million people and the number is expected to rise to 783 million in 2045. The disease has major economic effects for private individuals, households, and public health costs. The International Diabetes Association calculates that more than 11.5% of global health costs — more than 966 billion USD — is related to diabetes and diabetes-complications. Diabetes also entails significant non-economic consequences for patients, their close related parties and for the society. According to the WHO, the disease caused 6.7 million deaths globally in 2021 and is expected to be the 7th leading cause of death globally by 2030.
Based on the International Diabetes Association’s regional overviews, Lifecare has estimated that the potential market for Late Cell in Europe (EU, EFTA, UK and Switzerland) covers close to 9 million people, while in the US and Canada the potential market is estimated at more than 10 million people.
Additional applications for the technology
Lifecare’s main objective is to develop the Sencell glucose sensor to a market-ready product ready for distribution through industrial partnerships, however the patented technology is considered to have a far broader potential – beyond the market for diabetes.
The glucose measurement sensor is based on a reactive chemical composition consisting of glucose-binding molecules that – depending on the level of glucose – affect the osmolarity in a nano-chamber, leading to changes in osmotic pressure. By adapting the reactive chemical composition with molecules that enables binding properties with other defined molecules, Lifecare’s technology is suitable for continuously monitoring all molecules that may occur in the human body. Based on the maturity of technology and sensors, Lifecare will increasingly seek partnerships to develop solutions for molecules other than glucose, such as lactate.
Lifecare AS is a sensor technology company headquartered in Bergen. The company is developing a sensor that measures variations in glucose levels for people with diabetes based on changes in osmotic pressure, which are documented to correlate 100% with changes in the incidence of glucose. Lifecare’s technology and methodology are patented, and the company is believed to be the only player globally that uses osmotic principles as a basis for accurate and stable continuous glucose measurement. The technology and method are highly usable and allow for the measurement of a wide range of molecules in addition to glucose.
Contact:
Joacim Holter, CEO, tel. +47 40059050, epost: joacim.holter@lifecare.no