Mid-infrared Wearable for Non-invasive biomarker monitoring

Project Information

MiWear

Grant agreement ID: 101115476

DOI

10.3030/101115476

EC signature date 13 December 2023

Start date 1 January 2024

End date 30 June 2027

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 991 297,00

EU contribution

€ 3 991 297,00

Coordinated by

QUANTUNE TECHNOLOGIES GMBH
Germany

Periodic Reporting for period 2 - MiWear (Mid-infrared Wearable for Non-invasive biomarker monitoring)

Reporting period: 2025-01-01 to 2025-12-31

Summary of the context and overall objectives of the project

Healthcare today primarily addresses problems reactively, often falling short for chronic conditions like metabolic syndrome (MbS). MbS, a growing health issue in Europe, is closely linked to the rising prevalence of obesity and contributes to severe complications such as arteriosclerosis, heart attacks, and strokes. With individuals affected by MbS facing a 68% higher risk of sudden cardiac deaths, early detection and intervention are crucial.

The MiWear project aims to tackle these challenges by developing a miniature Mid-Infrared (MIR) spectrometer for real-time, pain-free health monitoring. Currently limited to laboratory use due to its size and cost, this technology will be integrated into a wearable device capable of measuring key biomarkers related to MbS and chronic conditions like diabetes, non-invasively through the skin. By simultaneously analyzing multiple biomarkers with lab-level precision, MiWear enables personalized healthcare, improving diagnostic accuracy and facilitating proactive disease management.

The project integrates expertise in optical spectroscopy, laser physics, artificial intelligence, and biomedical research, including the gender dimensions of health. MiWear's pathway to impact includes advancing scientific knowledge, fostering healthcare innovation, and promoting sustainability by reducing waste and healthcare costs. Through collaboration with stakeholders and active dissemination, MiWear aims to make cutting-edge health monitoring accessible to diverse populations across Europe.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In its first two years, the MiWear project has made significant progress in developing a wearable Mid-Infrared (MIR) spectrometer for real-time, non-invasive health monitoring. By combining advanced laser technology, biomarker analysis, and system integration, it addresses the critical needs of metabolic syndrome (MbS) detection.

Key achievements include the completion of essential technical components of the MIR spectrometer, such as Quantum Cascade Laser (QCL) chips, sensor and wavelength-selecting filters, were successfully designed and fabricated, achieving lab-grade sensitivity while meeting the size and power constraints required for the PoC demonstrator.

Reference measurements were conducted on aqueous and synthetic biomarker samples using MIR equipment, establishing a robust database for calibration and validation. Dermal interstitial fluid (dISF) was extracted from human skin samples, providing essential data for biomarker detection. Finally the PoC demonstrator was benchmarked with aqueous solutions. Preparations are now underway to test the spectrometer on ex-vivo human skin, which will benchmark its performance under physiologically relevant conditions.

A modular AI framework was developed to process spectral data and quantify biomarkers, demonstrating strong prediction accuracy and scalability for real-time applications. This framework continues to be refined with expanded datasets to enhance its performance. Additionally, the project integrated sex and gender dimensions into biomedical research, hosting a workshop with partners and embedding these considerations into device development, user acceptance, and scalability. A first draft clinical trial outline was also developed and reviewed with partners, paving the way for real-world device testing.

These efforts have laid the foundation for validating the spectrometer’s capabilities and advancing its application in proactive healthcare solutions.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Results
Designed and fabricated laser componets with lab-grade sensitivity.
Miniaturised Mid-Infrared Laser Source for Wearable Photoacoustic Biomarker Sensing
Built a reference database of biomarker spectra for calibration and validation.
Extracted dermal interstitial fluid (dISF) from human skin, generating crucial data for biomarker analysis.
Developed an AI framework for spectral data processing and biomarker quantification, demonstrating high prediction accuracy and scalability for real-time applications.
Integrated gender-specific considerations into device development, ensuring inclusivity and relevance across diverse populations.
Prepared a clinical trial outline for real-world device validation.

Potential Impacts
The MiWear device has the potential to shift healthcare from a reactive to a proactive model, enabling early detection and management of MbS and other chronic conditions. By providing real-time insights, it supports personalized healthcare, reducing misdiagnoses and improving treatment outcomes.
The transition of MIR spectrometry from laboratory settings to wearable devices opens new markets in consumer health tech and clinical diagnostics. This technology is particularly relevant for addressing the growing demand for portable, non-invasive health monitoring solutions.
Advances in photonics and AI-driven biomarker analysis position Europe as a leader in wearable health technology.
The project fosters innovation and provides opportunities for young researchers, contributing to a skilled workforce.
The technology’s scalability supports market expansion, generating economic growth and creating high-quality jobs.

Key Needs for Further Uptake and Success
Validate the device through ex-vivo studies and clinical trials.
Refine AI models for diverse population accuracy.
Secure funding for scaling and commercialization.
Address regulatory and interoperability standards for medical devices.
Protect intellectual property and define final business model.

By addressing these needs, the MiWear project aims to accelerate the translation of its innovations into impactful healthcare solutions, fostering widespread adoption and long-term success.