Development of an innovative biosensor with specific surface technology for continuous glucose monitoring with long operational life

Implantable biosensors can be used to treat multiple medical conditions at home and in clinical environments. However, any foreign or non-human material introduced into human tissue triggers a rejection response, which can lead to excessive immune reactions impacting the device’s biocompatibility and the host’s health. Implantable biosensors can be used for continuous glucose monitoring (CGM) on diabetic patients. Nonetheless, current care practices - focusing on repeated surgical interventions for the insertion of long-term implantable biosensors in diabetic patients - are prone to recurrent infectious wound-healing complications. ZP is developing a specific biosensor to be used with a GP5 patented innovative coating. The combined solution offers great potential to reduce current re-operation rates and patient sequelae, while simultaneously preserving device integrity and function. Our first target market are diabetic patients (existing or potential users of CGM). We estimate that, worldwide, around 90 million users of devices for insulin measurement could benefit from lifelong sensor accuracy and fully biocompatible implantable medical devices (IMDs). DEISUF will run for 36 months and dovetail ZP´s (project leader) expertise with a specialized Danish surface coating company (Safe Implant Technology, SIT) and a renowned university in health technology (Aalborg university). This Eurostars will enable ZP to finalize R&D activities and perform the necessary preclinical validation studies. Project activities include: (1) production of a functional prototype of a biosensor with innovative GP5 surface coating; (2) efficacy demonstration in animal models; (3) patent-protection of the product and its sub components. DEISUF will provide the necessary preclinical data for preparation of subsequent Phase I clinical trials, preparation of regulatory documentation and market entry, whilst building traction with KOLs and future customers.