NovioSense Progress Status
The following outlines the current technology readiness level of NovioSense Glucose Sensor. Â We are currently finalising TRL 6, in-vivo testing has demonstrated a representative device functioning in a relevant animal model. Â The next phase of development focusing on TRL 7 through TRL 9 will demonstrate clinical validation and efficacy and safety in a clinical setting.
2016 – 2018 Clinical Validation
In 2016 we began the preparation and execution of the clinical validation of the NovioSense platform for tear glucose completion of this will represent the achievement of TRL 7. In 2018 we published the first results of our clinical trial showing that glucose can be measured in the tears of diabetic patients.
2014 – 2015 The road to clinical validation
With the proof of principle in handÂ and successful animal trials, we completed our first clinical testing phase in 2015. In this phase, we completed TRL 6.
2013 – Proof of Principle
Following on from our proof of concept work we spent the 2013 period developing the device from the ground up as a medical device for the measurement of glucose in tears. Â We have worked together with Fraunhofer IMS to develop two application specific integrated circuits that push the boundaries of power consumption and sensitivity for wearable sensors. In December 2013 we demonstrated the first complete devices capable of measuring tear glucose levels as well as the first tolerance studies of our newly designed devices in animals. During this period we progressed from technology readiness level 3 to 5
2012 – Proof of Concept
In 2012 we began work on developing the NovioSense Sensor technology, we have developed laboratory prototypes for the sensor element and demonstrated the ability to develop highly sensitive devices capable of measuring glucose levels found in tears. In addition, we undertook an exercise to painstakingly analyse the composition of human tears to recreate our proprietary tear fluid model possessing all the components found in human tears as well as to delineate the most attractive biomarkers for our platform device. During this period we progressed from technology readiness level 1 to level 3.