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SMARTSHAPE

About SMARTSHAPE

Using cutting-edge technology and novel materials, SMARTSHAPE is working on a sensor designed to be ultra-thin, clinically accurate and non-intrusive in monitoring. This way, SMARTSHAPE hopes to offer a practical, long-term and safe monitoring solution for patients living with chronic hypertension.

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Smart sensor

How will the SMARTSHAPE device work?

The SMARTSHAPE device will consist of two components: a tiny, flexible sensor, and a wearable wrist strap to read your blood pressure. Via an app, you will be able to access these readings 24/7.

A wearable wrist strap

A tiny, flexible sensor

In two steps, the SMARTSHAPE device aims to provide accurate and continuous blood pressure readings.

The microsensor is implanted just under the skin via a needle.

The sensor material is thin and very flexible, allowing it to be positioned near an artery to provide reliable, accurate readings.

The IP-protected SMARTSHAPE sensor will use a novel temperature-dependent “shape memory polymer”. This special type of material will allow for the flexible characteristics of the sensor. After reaching body temperature, it returns to its original shape and starts measuring the blood pressure. This information will be sent continuously and wirelessly to the wearable wrist strap.

The wearable wrist strap will read the data from the sensor and send it to the SMARTSHAPE app.

By downloading the SMARTSHAPE app, you will be able to see your blood pressure readings 24 hours a day, track trends and share the results with your care team.

blood pressure monitoring 24/7

Time-on-Target

Time-on-Target (ToT) is a way of measuring how long a medication exerts its effect in the body. For example, in patients with type I diabetes, ToT measurements show how long insulin keeps their blood glucose levels within the normal range, and when new insulin intake would be required.

Similar ToT measurements are valuable for patients taking lifelong medication to control hypertension. In such cases, ToT for both systolic and diastolic blood pressure offers a powerful tool to identify those at a higher risk of serious vascular events (such as a stroke) due to uncontrolled blood pressure levels. However, it is difficult and time consuming to obtain these ToT estimates with currently available ambulatory blood pressure measurement systems.

To tackle this, the SMARTSHAPE solution aims to offer fast and accurate ToT estimates for patients who require careful and precise hypertension control, avoiding the need for intrusive methods like ambulatory cuff-based blood pressure monitoring.

Smart sensor

Work packages

The project is structured in eight work packages (WP), each focussing on different aspects of the SMARTSHAPE project.

WP 1

Development of an implantable smart polymer

Lead

University of Birmingham

Partners Involved

University of Galway, Scinnovation, TSQ/TSQE

The starting point of this project is the development of a temperature-dependent shape-memory polymer by University of Birmingham, which will allow to create a material that takes a “curled-up” shape at room temperature, and opens up when placed in the body and reaching body temperature. A range of materials will be tested and appropriate biomaterials identified in this WP will be passed to WP2 for integration into the sensor system. The influence of different sterilization processes on the material will be assessed. In vitro tests will be performed to test the biocompatibility of the biomaterial.

WP 2

Sensor technology development

Lead

University of Galway

Partners Involved

University of Birmingham, TSQ/TSQE, Scinnovation, Merakoi

Building on the outcomes of WP1, the University of Galway will redesign their wireless sensor by integrating the newly developed biomaterial. A reader device will be developed to collect the blood pressure data wirelessly from the implanted sensor. This WP will also focus on ways how to implant the sensor under the skin, via an injection.

WP 3

End-user insights and use case assessment

Lead

Merakoi

Partners Involved

University of Galway, Scinnovation, TSQ/TSQE

Merakoi will conduct a feasibility study for potential use cases of the pressure sensing technology and validate the findings on the initial indication of blood pressure monitoring. Merakoi will also build a patient advisory board to gather direct patient input on the SMARTSHAPE concept and development program, assess market demand and competitive solutions for additional potential applications. Working together with the patient advisory board will reduce the risk that SMARTSHAPE technologies are not sufficiently adapted to end-user/patient needs. Merakoi will map patient experiences, gather insights into patient unmet needs, and identify opportunities for SMARTSHAPE solutions from the patient perspective. This will help defining the exploitation strategy for the SMARTSHAPE technology.

WP 4

In vivo preclinical studies

Lead

Explora Biotech Srl

Partners Involved

University of Galway, University of Birmingham, TSQ/TSQE

Explora Biotech and University of Galway will investigate what the best sites are to implant the sensor, and what is the most effective way to deliver the sensor to that site. The different sites and delivery methods will be compared in a sheep model. Two studies will be performed on safety and efficacy. One study will focus on how well the microsensor can be implanted without evoking an immune response against the sensor. The other study will focus on the efficacy of the microsensor in measuring blood pressure.

WP 5

Sustainability, Circularity, and Economic Assessment

Lead

Scinnovation

Partners Involved

University of Birmingham, University of Galway, Merakoi, TSQ/TSQE

Scinnovation will perform a comprehensive sustainability and circularity assessment for SMARTSHAPE. The environmental life cycle impacts of the technology will be computed and assessed extensively. Moreover, the economic and social impacts will be analyzed, covering all phases of the product from technological development through manufacturing and market delivery. All environmental, economic, and social impacts will be integrated in a socio-eco-efficiency analysis for SMARTSHAPE.

WP 6

Regulatory and early manufacturing

Lead

TSQ Engineering and Quality

Partners Involved

University of Galway, University of Birmingham, Scinnovation

The goal of this WP is to define the strategy for the regulations and main documentation which is required for medical device development. To ensure that the developed solution is in line with the requirements for manufacturing, TSQ/TSQE will prepare a design for manufacturing and the University of Galway will perform a pilot production. In this pilot production, potential risks for future large-scale production will be identified. This process will be informed by the results from WP5 and will require contact with WP1 and WP2 on the biomaterial and microsensor development.

WP 7

Dissemination, Communication & Exploitation

Lead Dissemination and Communication

Catalyze

Partners Involved

All

Lead exploitation

University of Galway

The consortium will obtain input from key stakeholders (e.g., through end-user advisory boards established in WP3) and promote knowledge exchange and collaborations at an EU-wide level. The consortium is committed to involving patient representatives in all phases of research and development through the activities of Merakoi and communicating results in accordance with open science principles. University of Galway will take the lead in preparing for future commercialisation of the novel blood pressure sensor. Catalyze will be mainly responsible for dissemination and communication, with support from all partners.

WP 8

Project management

Lead

Catalyze

Partners Involved

All

The final work package focuses on day-to-day management of the SMARTSHAPE consortium and implementation of the activities. It entails management of the project timelines, budgets, and administrative issues. Catalyze will interact with EU authorities to deliver the required documentation such as progress reports, financial reports, and other deliverables.

About SMARTSHAPE

How will the SMARTSHAPE device work?

Time-on-Target

Work packages

Development of an implantable smart polymer

Sensor technology development

End-user insights and use case assessment

In vivo preclinical studies

Sustainability, Circularity, and Economic Assessment

Regulatory and early manufacturing

Dissemination, Communication & Exploitation

Project management

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