Bergen, February 15th, 2021 - Lifecare AS (LIFE)
Lifecare has received regulatory approval for the first-in-human SencellClinical Study Protocol from the German Federal Institute for Drugs and MedicalDevices (BfArM). With this final remaining approval, Lifecare has reached itsgoal to have clinical pilot trial permission as planned in Q1 2021.
Lifecare CEO Joacim Holter says, "With this regulatory approval, Lifecare hasachieved a major milestone in the development of the Sencell implantablecontinuous glucose sensor for reliable, and long-lasting glucose measurement forroutine medical care."
"The upcoming clinical pilot study will generate first human data for measuringinterstitial glucose during standardized meal tests in subjects with and withoutdiabetes," says Lifecare CSO Prof. Andreas Pfützner.
With this first performance evaluation, Lifecare aims to increase the base forinterpreting read-out signals in human subjects. This data will be used todevelop and optimize algorithms in future wireless and wired versions of theSencell 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 osmoticpressure sensor technology.
Based on nano-sensor technology, Lifecare has over the last year succeeded inminiaturizing the Sencell sensor to a point smaller than the initially targetedsize. This has made it possible to incorporate the Sencell core sensor into aneedle sensor version of the device, which will be employed in theses firststudies. This also opens new collaboration opportunities with existing needlesensor companies.
The Sencell sensor is an osmotic pressure based wireless sensor to measuretissue glucose with a usage time of more than 6 months. Lifecare envisions thatthe Sencell technology also can make a difference as the core component in aneedle glucose sensor device to increase the usage time for wired solutionsbeyond 10-14 days.
Sencell is the dedicated sensing element in the EU-funded project FORGETDIABETESwhere Lifecare, in partnership with European research institutions, aims todevelop a miniaturized closed-loop artificial pancreas device. It is planned tobe implanted in the abdominal cavity to deliver the correct amount of insulinbased on continuous glucose readings provided by the Sencell technology.
While glucose measurements represent the key focus developing the Sencelltechnology, additional areas of use are considered on an ongoing basis.
For more information, please contact:
Joacim Holter, CEOPhone: +47 40 05 90 40Email: firstname.lastname@example.org
Lifecare (LIFE) is a Bergen-based technology company developing a miniaturizedimplantable long-term sensor for glucose measurement for people with diabetesmellitus. Its patented technology is also used as a central component in acurrent rapid SARS-CoV-2 antigen test development and in other future diagnostictests.