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Fast optoacoustic mesoscopy, using the skin as a window for therapeutic monitoring of local and systemic disease.

Periodic Reporting for period 2 - WINTHER (Fast optoacoustic mesoscopy, using the skin as a window for therapeutic monitoring of local and systemic disease.)

Reporting period: 2021-01-01 to 2021-12-31

Raster-scan optoacoustic mesoscopy (RSOM), which was developed under the EU Horizon 2020 project INNODERM, enables novel label-free, high-resolution optical imaging of previously invisible pathophysiological features at skin depths of 1-5 mm. The method has already shown great potential in diagnostic dermatology, and through preliminary testing it has become apparent that it can also assess progression and therapy of conditions not only in skin, but also in cardiovascular diseases and diabetes. However, the latter requires improvements in the speed of RSOM, which is where WINTHER begins.

The aim of WINTHER is to design and validate the next generation of RSOM, capable of operating at speeds up to two orders of magnitude faster. Such improvements will allow the new system, fast-RSOM (F-RSOM), to serve as a precision tool for therapy monitoring of inflammatory skin diseases and drive a paradigm shift in therapeutic monitoring of cardio-metabolic diseases.
During the first 24 months (RP1 and RP2) of the project, technical advancements and steps toward obtaining regulatory approvals were the focus of the work. This included four important steps:

1. Design, characterization, and implementation of an optimal illumination scheme for improved illumination efficiency. Partners Sonaxis, TUM and iTHERA have been involved in this effort, by simulating and testing several illumination schemes (Objective 2);
2. Design, manufacture and validation of a new class of single-element transducers. Partner Sonaxis has led the way in this task, developing and testing (with help from TUM and iThera) several new iterations of single-element transducers. Two final transducers are currently being tested, and best-performing will be selected to be integrated into the prototype (Objective 1);
3. Design and testing of the F-RSOM encapsulated handheld prototype, including components such as sensors, lasers, membranes. (Objective 2) Care has been taken that all design and operation protocols adhere to desired specifications and safety standards (e.g. laser MPE limits);
4. Construction and testing of F-RSOM front-end (GUI) and back-end (algorithms) software, including quality control measures. Partners Rayfos, iThera and TUM have investigated information processing systems and computational efficiency computational efforts to bridge the gap between information generation and clinical outputs (Objective 3). The development of the GUI and image processing algorithms (including quality control – SNR and motion correction) will be completed and thoroughly documented as part of the application for regulatory approval.

Following these achievements, the WINTHER consortium will complete and validate (through phantom and in vivo pre-clinical studies – Objective 2) the F-RSOM prototype, with the aim to secure regulatory approval in Europe (CE marking) and the US (501(k)). Following regulatory approval, the focus of the project will steer toward exploitation (gaining clinical acceptance), Objective 5, and research on therapy monitoring of cardio-metabolic diseases through pilot clinical studies by partners TUM and HUNIMED (Objective 4).
The WINTHER F-RSOM prototype will improve the capabilities of the current RSOM device to include fast measurements for assessing and monitoring of skin inflammation and cardio-metabolic diseases. The far-reaching impact of WINTHER, then, is to provide a long-term comprehensive platform for monitoring and diagnosing disease and therapy progress in a portable, non-invasive, inexpensive, label-free, fast and safe way. The ambitions of the project are aligned with the documented unmet clinical need and international physician recommendations.

The major results of this reporting period were technical in nature, with (1) beyond state-of-the-art transducers being developed (Sonaxis, iThera, TUM), (2) the design of a novel new ergonomic, portable scanner for non-invasive imaging (iThera, TUM), and (3) construction of a new clinically-friendly software that will enable high-quality optoacoustic imaging (Rayfos, iThera, TUM).

In addition to going beyond current clinical designs on the market, we imagine the expected results of the F-RSOM technology is to improve on cost, effectiveness and availability of therapeutic monitoring for dermatological and cardiovascular diseases, as well as diabetes. As such, the socio-economic impact of WINTHER could be substantial, as it will provide the first reliable set of parameters that facilitate proper diagnosis, monitoring and optimal treatment early on, which will benefit the healthcare system as a whole. The current state of the project indicates that the promise of F-RSOM bringing “a new dimension to optoacoustic mesoscopy” is plausible and will be soon a reality.
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