Bergen, Norway 23 June 2022
Today, Lifecare AS will initiate first-in human clinical studies of the diabetessensor Sencell, thereby the second of two major milestones in 1H 2022 is inprogress. Lifecare recently announced that the first milestone for 1H 2022 wascompleted, namely successfully in-vitro testing and fabrication of the prototypehaving the size of a grain of rice. Previous pre-clinical studies of thetechnology have given good results. Lifecare's first participant is set today23. juni 2022, the total number of participants for his study is 15, and thestudy is expected to be completed by end of September 2022. Conducting clinicaltrials on humans is a significant step towards Lifecares goal of contributing tohelp people with diabetes - which in a global perspective counts for 537 millionpeople - to live a normal life.
The purpose of the trials is to optimize signal reading from the company'sgroundbreaking sensor technology for continuous glucose monitoring for peoplewith diabetes. The sensor subject to clinical trials is produced at thecompany's development department in Reutlingen, Germany, and the studies areconducted at the company's department in Mainz, Germany.
Lifecare's glucose sensor Sencell monitors changes in the body's glucose levelsbased on variations in osmotic pressure. Lifecare owns a patented method formonitoring variations in osmotic pressure based on a unique chemical compositionand licensed production method for nano-pressure sensor technology. Lifecare aims to offer continuous glucose monitoring with a sensor that issignificantly smaller and has a function time that is 12 times longer thanexisting options for people with diabetes. The sensor Sencell is the size of agrain of rice and will be the first solution for continuous glucose monitoringthat is fully placed under the skin, without a fixed device on the outside ofthe body. Lifecare's solution is expected to be significantly cheaper thanexisting glucose monitoring solutions.
Expected progressWhen Lifecare now initiates clinical trials, it is the result of focused andpersistent effort following the restructuring of the business initiated in Q22021 and effective from September 2021. The combination of structuraladaptations and groundbreaking technological development has been challengingfor the company's development departments. The production of sensors for use inclinical trials is still a manual procedure through interdisciplinarycollaboration and is time-consuming. We are working to reduce production timewith the help of increased personnel, as well as preparations for automatedproduction in the form of pilot production in the lead-up to planned additionalclinical studies. In the context of the pressure on the organization up to thepresent milestone achievement and forthcoming holiday for key personnel,Lifecare considers it very important to prioritize quality in the execution ofthe study that is now initiated, so that the best possible data is provided. Inaddition, the study is based on three phases, during which adjustments andadaptations will be made between the active phases for optimizing signals fromthe sensor. Based on this, the company will estimate that the clinical trialinitiated today will be completed by the end of September 2022. The nextmilestone is clinical trial "002" with 50 patients and is dependent on thecompletion of the first study "001", and "002" is still considered achievable in2H 2022. However, general challenges related to the delivery time of necessaryelectronic components and some uncertainty about the processing time on theapplication for the next clinical trial "002", may cause the clinical study"002" to be initiated somewhat later than originally planned.
BackgroundInitiating clinical trials represents the next phase of Lifecare's productdevelopment to meet its goal of providing precise and accurate readings ofvariations in the glucose-levels for people with diabetes. The idea of measuringvariations in glucose-levels based on osmotic pressure arose in the 1980s whenEngineer Olav Ellingsen observed his son's physical reactions as a result ofdiabetes. Supported by financial collaborators, the idea was turned intoinnovations and continued in several early-phase projects in cooperation withSINTEF, Rikshospitalet, VTT (Finland), Vestfold University College and CSEM(Switzerland), among others. Since 2014, Lifecare's research has been developedin close collaboration with the Diabetes Technology Society, USA, represented bythe organization's founder Professor David Klonoff and Pfützner Science & HealthInstitute, Diabeteszentrum & Praxis, represented by Professor Dr. Dr. MedAndreas Pfützner who is engaged as Lifecare AS Chief Scientific Officer.Lifecare was listed on Oslo Børs (Euronext Growth) in 2018, and from this pointthe company's development has accelerated towards the clinical trials startingnow and is a very important milestone.
During the past 12 months, Lifecare has aquired two independent entities inGermany and on this base established internal development resources andaccelerated the scientific development as part of preparations to conductextensive clinical trials. Lifecare is also in the early stages of establishinginternal production capacity in accordance with regulatory requirements, withthe goal of launching Sencell on the European market in 2024.
The diabetes marketOver the past few decades, the number of patients in the world with diabetes hasincreased with an alarming rate and the International Diabetes Associationrefers to the situation as "a pandemic of unprecedented magnitude spiralling outof control" (IDF Diabetes Atlas, 10th edition, December 2021). The number ofpeople with diabetes is estimated to be more than 537 million people and thenumber is expected to rise to 783 million in 2045. The disease has majoreconomic effects for private individuals, households, and public health costs.The International Diabetes Association calculates that more than 11.5% of globalhealth costs - more than a billion USD - is related to diabetes anddiabetes-complications. Diabetes also entails significant non-economicconsequences for patients, their close related parties and for the society.According to the WHO, the disease caused 6.7 million deaths globally in 2021 andis expected to be the 7th leading cause of death globally by 2030.
Based on the International Diabetes Association's regional overviews, Lifecarehas estimated that the potential market for Late Cell in Europe (EU, EFTA, UKand Switzerland) covers close to 9 million people, while in the US and Canadathe potential market is estimated at more than 10 million people.
Additional applications for the technologyLifecare's main objective is to develop the Sencell glucose sensor to amarket-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 compositionconsisting of glucose-binding molecules that - depending on the level of glucose- affect the osmolarity in a nano-chamber, leading to changes in osmoticpressure. By adapting the reactive chemical composition with molecules thatenables binding properties with other defined molecules, Lifecare's technologyis suitable for continuously monitoring all molecules that may occur in thehuman body. Based on the maturity of technology and sensors, Lifecare willincreasingly seek partnerships to develop solutions for molecules other thanglucose, such as lactate.
Lifecare AS is a sensor technology company headquartered in Bergen. The companyis developing a sensor that measures variations in glucose levels for peoplewith diabetes based on changes in osmotic pressure, which are documented tocorrelate 100% with changes in the incidence of glucose. Lifecare's technologyand methodology are patented, and the company is believed to be the only playerglobally that uses osmotic principles as a basis for accurate and stablecontinuous glucose measurement. The technology and method are highly usable andallow for the measurement of a wide range of molecules in addition to glucose.
Further informationJoacim Holter, CEO, Lifecare AS, firstname.lastname@example.org, +47 40 05 90 40
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 Kine Hereid, Investor Relations at Lifecare AS, on23 June 2022 at 08:00 CET