Regulatory approval for first-in-human Clinical Pilot Evaluation

Lifecare has received regulatory approval for thefirst-in-human Sencell Clinical Study Protocol from the German FederalInstitute for Drugs and Medical Devices (BfArM). With this final remaining approval, Lifecare has reached its goal to have clinical pilot trial permission as planned in Q1 2021.  

“With this regulatory approval, Lifecare has achieved amajor milestone in the development of the Sencell implantable continuousglucose sensor for reliable, and long-lasting glucose measurement for routinemedical care”, says Lifecare CEO Joacim Holter.

 

“The upcoming clinical pilot study will generate first human data for measuring interstitial glucose during standardized meal tests in subjects with and without diabetes,” says Lifecare CSO Prof. Andreas Pfützner.

  With this first performance evaluation, Lifecare aims to increase the base for interpreting read-out signals in human subjects. This data will be used to develop and optimize algorithms in future wireless and wired versions of the Sencell osmotic pressure sensors.   Lifecare plans for additional pre-clinical and clinical trials in 2H 2021, preparing to later initiate the CE mark approval process for the Sencell osmotic pressure sensor technology.   Based on nano-sensor technology, Lifecare has over the last year succeeded in miniaturizing the Sencell sensor to a point smaller than the initially targeted size. This has made it possible to incorporate the Sencell core sensor into a needle sensor version of the device, which will be employed in theses first studies. This also opens new collaboration opportunities with existing needle sensor companies.   The Sencell sensor is an osmotic pressure based wireless sensor to measure tissue glucose with a usage time of more than 6 months. Lifecare envisions that the Sencell technology also can make a difference as the core component in a needle glucose sensor device to increase the usage time for wired solutions beyond 10-14 days.   Sencell is the dedicated sensing element in the EU-funded project FORGETDIABETES where Lifecare, in partnership with European research institutions, aims to develop a miniaturized closed-loop artificial pancreas device. It is planned to be implanted in the abdominal cavity to deliver the correct amount of insulin based on continuous glucose readings provided by the Sencell technology.   While glucose measurements represent the key focus developing the Sencell technology, additional areas of use are considered on an ongoing basis.   For more information, please contact:   Joacim Holter, CEO Phone: +4740 05 90 40 Email: joacim.holter@lifecare.attme.dev     Lifecare(LIFE-ME) is a Bergen-based technology company developing a miniaturized implantable long-term sensor for glucose measurement for people with diabetes mellitus. Its patented technology is also used as a central component in a current rapid SARS-CoV-2 antigen test development and in other future diagnostic tests.