The overall aim for Lifecare in 2022 is to initiate clinical activities in line with our development milestones. The planned activities will bring our unique Sencell osmotic sensing technology a significant step closer to regulatory approval as a medical device for diabetes care. Preparations to ensure a regulatory approved platform have been initiated and we are strengthening the team in Germany at Lifecare NanoBioSensors with supplementary expertise in nano-microfabrication techniques and project control.
Technology White Paper
Lifecare’s vision is to change lives through medical technology. Based on years of research and international networking, we have established a basis consisting of three comprehensive technology elements. The core feature is Lifecares proprietary Sencell osmotic sensing technology for glucose detection. Based on our cooperation with the University of Bath (UK) we are continuously working to develop and improve the chemistry used in the Sencell sensors to detect further body analytes. Last – and physically least – we have secured access to the Nanoss3Dprint technology acquiring our German subsidiary Lifecare NanoBioSensors, so that we are able to print strain sensors in the nanoscale to ensure production of Sencell sensors at the size of a grain of rice.
Throughout 2022 Lifecare will launch a series of White Papers with the purpose to explain our technologies, individually and in the overall Sencell context, to a broad public audience.
The first White Paper in this series is named “Continous Glucose Measurement by Means of Sencell Osmotic Pressure Sensor” and can be downloaded here: https://lifecare.no/publications/white-paper/
Development in focus
Lifecare NanoBioSensors is responsible to produce miniaturized Sencell prototypes for our planned first-in-human pilot study. As informed in December 2021, the laboratory has succeeded to manufacture nanogranular tunneling strains (NTR) on the prototype Sencell electrodes. Following this important achievement, Lifecare NanoBioSensors has concluded that the functionality of the NTR’s is promising as both electrical tests and additional pressure tests show results and read-out results as expected.
Currently the development is on track with our guided timeline and the development evaluation and further sensor characterization is ongoing with full focus. The tasks ahead of us are of interdisciplinary nature, and hence both complex and depending on external suppliers and service providers.
Attracting new employees
We are pleased to announce that the team at Lifecare NanoBioSensors will be strengthened with the recruitment of Dr. Preeti Sharma who will join the company in February. Dr. Sharma is a PhD physicist with expertise in nano-microfabrication techniques to realize nano-microfluidic devices, sensors and patterned interfaces. She has 10 years of experience as post-doc and doctoral researcher and engineer at Laboratoire Interdiciplinaire de Physique in Grenoble, France and Wageningen University & Research, Holland.
Quality and regulatory compliance
The planned outcome of the upcoming clinical activities is to obtain regulatory approval and CE-mark for Sencell as a medical device. Lifecare has started the new year with important preparations for the regulatory pathway implementing a certified electronic Quality Management System from the Swedish company MedQdoc.
By help of this user-friendly system, Lifecare’s Quality Assurance staff will be able to effectively implement an ISO 13485-compliant Quality Management System in the mother organization, including our German subsidiaries. The implementation of this certified Quality Management System will enable Lifecare to comply with the existing comprehensive EU regulations for design and manufacturing of medical devices as our clinical activities evolve.