Periodic Reporting for period 2 - SMARTSHAPE (Development of a smart shape-memory sensor for biological pressure monitoring applications)
Période du rapport: 2024-06-01 au 2025-11-30
Arterial 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, a number of challenges related to biocompatibility, longevity, and application to the target tissue need to be overcome to deliver the sensor to the market. This project addresses 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.
The SMARTSHAPE consortium has developed and IP-protected a technologically disruptive sensor for continuous pressure measurement. However, a number of challenges related to biocompatibility, longevity, and application to the target tissue need to be overcome to deliver the sensor to the market. This project addresses 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.
SMARTSHAPE is developing a minimally invasive implantable microsensor system for continuous arterial pulse pressure monitoring. The solution combines a small subcutaneous sensor placed near an artery with a wrist-worn reader to enable continuous measurements without active patient interaction. Work in this period focused on improving delivery feasibility, product lifetime, and biocompatibility.
Work performed and main achievements
• Biomaterials: Evaluated sterilisation approaches for key materials and assembled sensors to preserve performance; conducted longevity testing to confirm sensor sensitivity and material stability over time; completed biocompatibility screening tests; advanced development and characterisation of next-generation shape-memory polymer/hydrogel candidates.
• Microsensor development and validation: Advanced an ultrathin polymer-based pressure sensor platform and demonstrated feasibility through bench testing and controlled preclinical evaluations; improved long-duration performance through dedicated stability studies; developed signal processing methods to improve signal quality and enable physiologically meaningful pressure waveform reconstruction.
• Preclinical and delivery feasibility: Established and refined procedures to support minimally invasive implantation and reliable pressure measurements in an animal model; progressed required documentation and approvals for subsequent in vivo phases; continued safety and proof-of-performance studies.
• Market and stakeholder insights: Conducted structured engagement with clinicians and patient representatives to validate unmet needs, refine intended use and workflow requirements, and confirm priority focus on continuous blood pressure monitoring in high-risk populations; completed comparative landscape analysis to inform positioning and evidence generation priorities.
• Sustainability and impact: Advanced environmental and circularity assessments by defining assessment scope, collecting inventory data, modelling environmental impacts for the evolving design, and evaluating alternative materials and processes; refined frameworks for economic and social impact assessment.
• Regulatory and manufacturing readiness: Progressed regulatory planning activities (classification strategy, evaluation planning, software and design control planning) and advanced risk management; mapped manufacturing steps and began preparation for prototype-scale build procedures and supplier planning.
• Dissemination and exploitation: Continued coordinated dissemination and exploitation planning informed by stakeholder input, strengthening the pathway toward future clinical translation and scale-up.
Work performed and main achievements
• Biomaterials: Evaluated sterilisation approaches for key materials and assembled sensors to preserve performance; conducted longevity testing to confirm sensor sensitivity and material stability over time; completed biocompatibility screening tests; advanced development and characterisation of next-generation shape-memory polymer/hydrogel candidates.
• Microsensor development and validation: Advanced an ultrathin polymer-based pressure sensor platform and demonstrated feasibility through bench testing and controlled preclinical evaluations; improved long-duration performance through dedicated stability studies; developed signal processing methods to improve signal quality and enable physiologically meaningful pressure waveform reconstruction.
• Preclinical and delivery feasibility: Established and refined procedures to support minimally invasive implantation and reliable pressure measurements in an animal model; progressed required documentation and approvals for subsequent in vivo phases; continued safety and proof-of-performance studies.
• Market and stakeholder insights: Conducted structured engagement with clinicians and patient representatives to validate unmet needs, refine intended use and workflow requirements, and confirm priority focus on continuous blood pressure monitoring in high-risk populations; completed comparative landscape analysis to inform positioning and evidence generation priorities.
• Sustainability and impact: Advanced environmental and circularity assessments by defining assessment scope, collecting inventory data, modelling environmental impacts for the evolving design, and evaluating alternative materials and processes; refined frameworks for economic and social impact assessment.
• Regulatory and manufacturing readiness: Progressed regulatory planning activities (classification strategy, evaluation planning, software and design control planning) and advanced risk management; mapped manufacturing steps and began preparation for prototype-scale build procedures and supplier planning.
• Dissemination and exploitation: Continued coordinated dissemination and exploitation planning informed by stakeholder input, strengthening the pathway toward future clinical translation and scale-up.
In RP2, the project advanced beyond the state of the art for out-of-hospital BP monitoring by demonstrating an implantable, minimally invasive, battery-free wireless pressure microsensor system capable of continuous direct pressure sensing with supporting preclinical evidence. Key advances include:
• System-level validation of an ultrathin polymer-based implant plus external reader, verified through bench and ex vivo testing to capture continuous pressure waveforms and support real-time visualisation/calibration in software.
• Chronic large-animal implantation evidence supporting device functionality and initial safety/biocompatibility over multi-week to multi-month follow-up, including successful pressure readings in awake conditions.
• Longevity and stability studies indicating sustained sensor performance over extended operation, directly addressing product lifetime limitations.
• Signal processing methods that improve signal quality and enable physiologically meaningful reconstruction of BP waveforms, strengthening clinical interpretability versus existing wearable approaches.
• Biomaterial readiness progress including sterilisation compatibility, longevity testing, and biocompatibility screening, alongside advancement of next-generation shape-memory candidates to support long-term implant use.
• System-level validation of an ultrathin polymer-based implant plus external reader, verified through bench and ex vivo testing to capture continuous pressure waveforms and support real-time visualisation/calibration in software.
• Chronic large-animal implantation evidence supporting device functionality and initial safety/biocompatibility over multi-week to multi-month follow-up, including successful pressure readings in awake conditions.
• Longevity and stability studies indicating sustained sensor performance over extended operation, directly addressing product lifetime limitations.
• Signal processing methods that improve signal quality and enable physiologically meaningful reconstruction of BP waveforms, strengthening clinical interpretability versus existing wearable approaches.
• Biomaterial readiness progress including sterilisation compatibility, longevity testing, and biocompatibility screening, alongside advancement of next-generation shape-memory candidates to support long-term implant use.