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Innovative Dermatology Healthcare based on Label-Free Spectral Optoacoustic Mesoscopy

Periodic Reporting for period 3 - INNODERM (Innovative Dermatology Healthcare based on Label-Free Spectral Optoacoustic Mesoscopy )

Reporting period: 2019-03-01 to 2021-08-31

Diseases and conditions of the skin are currently exclusively diagnosed and monitored using subjective visual methods, which do not give information about the depth of morphological, physiological, or changes at the cellular level. These details are very important factors for diagnosis, monitoring, and treatment evaluation. In many instances, it would be ideal to be able to determine the depth of the lesion or to determine anatomical, cellular, vascular and biochemical changes as an indication of disease. Although there is clearly a need to assess the entire skin thickness (up to 4 mm), this is not attainable by current imaging methods.

The primary aim of the INNODERM project was to address this unmet clinical need by developing a novel, handheld, portable Raster-Scan Optoacoustic Mesoscopy (RSOM) device. RSOM was developed to image features in the skin at the meso- and micro- scopic levels. Compared with competing optical methods, RSOM images larger fields of view, images deeper and resolves new contrast, thereby improving the availability of non-invasive diagnostic methods for skin cancer and other dermatological conditions.

In order to fully develop and bring RSOM to the clinical environment, several objectives were defined:

1. Design a scalable clinical RSOM prototype;
2. Validate ability to clinically resolve diagnostic and theranostic morphological and spectral features;
3. Quantitatively measure improvements in disease detection and monitoring;
4. Develop and update an exploitation plan for RSOM market introduction.

INNODERM brought together the expertise of iThera Medical GmbH, Rayfos Ltd, Sonaxis SA, the Technical University of Munich (TUM), and Humanitas University Milan (HUNIMED). The consortium represents an effort to contribute to cooperative efforts for improving European excellence in the photonics technology sector and improve patient experience by creating more individualized healthcare.
During INNODERM, many technological and scientific advances were made while developing the RSOM and validating its applications for healthcare. Some of the highlights include the:

1. Design, manufacture, and commercialization of the RSOM imaging device, which is now installed in 20 locations around Europe, Asia and the US. Three patents related to the RSOM have been filed, two of which have been granted in Europe, and it is expected that the RSOM C50 will achieve registered medical device status (i.e. CE marking) in 2022. These achievements correspond to the tasks in WP2 (Optoacoustic Transducer Development), WP3 (Portable RSOM Clinical Protoype), and WP6 (Exploitation).

2. Successful validation and application of the RSOM to pathophysiologic diagnosis and treatment research including being able to image melanoma at the single-cell resolution and quantitatively assess inflammation burden due to dermatological conditions like psoriasis, eczema, and allergies. Pre-clinical and clinical studies are ongoing in several locations where RSOM devices are installed, and we expect to outperform the current gold standards for preoperative melanoma depth estimation (ultrasound) and clinical severity assessment of dermatological conditions (PASI Index). These achievements correspond to the tasks in WP5 (Portfolio of Imaging Features).

3. Extension of the consortium with a follow-up EU Horizon 2020 project, WINTHER (Grant No. 871763), which will improve the RSOM further and enable assessment of cardio-metabolic diseases, like type-2 diabetes. This achievement is related to work performed in all WPs.

4. 2021 European Commission ECS Innovation Award, which was presented at the 2021 EFECS Meeting. Additional awards resulting from work performed during the project went to the Coordinator (Gottfried Wilhelm Leibniz-Prize; Karl Heinz Beckurts Prize), lead scientist (DDG Psoriasis Prize), and students (e.g. poster awards at EMIM 2021).

INNODERM includes advancements that go beyond RSOM, including improved high-frequency probe and preamplifier technologies developed in WP2. Sonaxis is now one of the few high-frequency transducer probe manufacturers in Europe and USA, placing them in a strategic position for the fast-growing semiconductor market. We have also promoted growth of our SME partners, iThera, Rayfos and Sonaxis, securing contracts, licensing agreements and EU projects, to continue development, diversify product portfolios, and become market leaders in optoacoustic devices, software and components. Dissemination, Communication and Exploitation (WP6) have also come in the form of 20+ high calibre peer-reviewed publications, and the involvement of students (M.S. Ph.D. medical students, Dermatology Residents), effectively setting the stage for cultivating the next generation of scientists to lead the field of optoacoustic imaging.

Overall, the technological, scientific, and exploitation, dissemination and communication efforts of project INNODERM have been highly successful and ultimately, INNODERM has and will continue to contribute to cooperative efforts to improve European excellence in the photonics technology sector, lessen the burden caused by unnecessary or ineffective treatments in the healthcare industry caused by inadequate means to diagnose and monitor diseases, and improve healthcare for patients by creating more individualized healthcare.
Current diagnosis and assessment methods (e.g. PASI Index, OCT, ultrasound) for dermatological conditions and diseases that manifest in the skin are often subjective, cannot image the entire depth of the skin (crucial for determining the depth of lesions), or do not have sufficient biochemical and physiological contrast. INNODERM sought to answer this unmet clinical need and push beyond state of the art by developing a portable RSOM device.

During INNODERM, the RSOM produced precise images of biomarkers associated with a range of dermatological and metabolic conditions at the resolution of microvasculature throughout the whole skin depth. This enabled RSOM to visualize disease severity and response to treatment in patients at depth, precision and sensitivity not imaginable before. In addition, we could determine the penetration depth of melanoma with single cell resolution, which sets the RSOM to outperform the current gold standard (ultrasound) for preoperative melanoma depth estimation, providing clinicians with a long-awaited, reliable tool for better assessment. These are major successes, being that melanoma is one of the most deadly cancers and psoriasis is a highly prevalent chronic disease causing high socioeconomic burden. Furthermore, RSOM has demonstrated the potential to be a valuable imaging technology to provide quantification of vascular changes associated with diseases such as diabetes and systemic sclerosis.

With highly prevalent chronic diseases with immense socioeconomic burden, we expect to have a strong positive impact on the healthcare system. Using the RSOM device, we are able to provide a fresh view on different major skin diseases outperforming the standard methods for severity assessment. As such, the socio-economic impact of INNODERM will be substantial since it can provide the first reliable set of parameters that facilitate proper diagnosis and consequently optimal treatment early on, which in turn will benefit the healthcare system as a whole.
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