Bergen, February 15th, 2021 – Lifecare AS (LIFE)
Lifecare has received regulatory approval for the first-in-human Sencell
Clinical Study Protocol from the German Federal Institute 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.
Lifecare CEO Joacim Holter says, “With this regulatory approval, Lifecare has
achieved a major milestone in the development of the Sencell implantable
continuous glucose sensor for reliable, and long-lasting glucose measurement for
routine medical care.”
“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
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: +47 40 05 90 40
Lifecare (LIFE) 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