Mid-infrared Wearable for Non-invasive biomarker monitoring

Informazioni relative al progetto

MiWear

ID dell’accordo di sovvenzione: 101115476

DOI

10.3030/101115476

Data della firma CE 13 Dicembre 2023

Data di avvio 1 Gennaio 2024

Data di completamento 30 Giugno 2027

Finanziato da

• The European Innovation Council (EIC)

Costo totale

€ 3 991 297,00

Contributo UE

€ 3 991 297,00

Coordinato da

QUANTUNE TECHNOLOGIES GMBH
Germany

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

Periodo di rendicontazione: 2025-01-01 al 2025-12-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.