SMARTSHAPE · Development of a smart shape-memory sensor for biological pressure monitoring applications

Hypertension is the leading global contributor to premature death, accounting for over 9M deaths worldwide each year. Elevated blood pressure (BP) is a chronic lifetime risk factor. If left undiagnosed or poorly controlled, high BP can lead to serious cardiovascular and cerebrovascular events. Whereas long-term BP monitoring is required in many high-risk patients, there is no clinically accepted method of continuous BP monitoring that can be used outside of hospital settings. Thus, there is an unmet clinical need and a huge market opportunity for a medical-grade, user-friendly, and minimally invasive solution for long-term, continuous BP monitoring. The SMARTSHAPE consortium has developed and IP-protected a technologically disruptive sensor for continuous pressure measurement. However, several challenges related to biocompatibility, longevity, and delivery to the target tissue need to be overcome to deliver the sensor to the market. This project will address these challenges by formulation of an innovative biomaterial: a novel temperature-dependent shape memory polymer (SMP). The use of SMPs will enable the development of a microsensor that can be curled up, introduced into the body through a minimally invasive procedure, and ‘opened up’ when placed at body temperature to take a pre-defined shape. After integration of the biomaterial in the sensor, validation data will be generated for proof-of-performance, longevity, biocompatibility, safety, and sensor delivery through bench testing and in vivo preclinical studies. Quality and manufacturing aspects will be addressed and a regulatory strategy and lifecycle assessment delivered. BP monitoring will represent the first application, but the potential of the sensor goes far beyond that. Use cases for other healthcare applications such as intraocular or intracranial pressure will be explored, which will significantly broaden the potential and market-creating value of the project results.