Periodic Reporting for period 1 - MammoWave (The first ultra-high sensitive breast imaging device based on non-ionizing safe microwave) Reporting period: 2017-08-01 to 2017-11-30 Summary of the context and overall objectives of the project UBT aim is to become the first medical device company providing a completely safe breast cancer screening device. The device MammoWave uses safe radiofrequency signal in the microwave band, rather than dangerous ionizing radiation (X-rays). This means, that around 40% of all women in EU (age 25-49 years old), which present 20% of breast cancer cases in Europe, will able to make breast cancer screening upon the need without safety concerns. The key objectives are to finalise the design of the complete system and to confirm the accuracy through a large scale multi-country clinical trial. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Throughout the duration of the project, we defined the MammoWave specifications, reviewed its development plan and supply chain, expanded our knowledge of the market and regulations, and established a commercialisation strategy. The clinical validation was defined with the key objective of confirming the safety, accuracy and usability of the imaging device to deliver and deploy the conventional screening. During the project, a detailed analysis of the potential business models applicable for MammoWave imaging device has been performed. The Phase 1 feasibility assessment has established that a development plan for the MammoWave imaging device is technically and commercially viable, and that implementation of an industrialisation and commercialisation plan should be pursued. SME Instrument Phase 2 funding could provide the correct amount of funding and support to allow the stated activities to be implemented successfully. 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) The MammoWave imaging device will contribute to increasing the access to better and safer healthcare, by introducing a novel effective diagnostic method that complement existing technologies, and reduce the need of performing invasive biopsy procedures. MammoWave also promotes a more sustainable public health system by reducing capital and operational costs of cancer diagnosis and treatment. Breast cancer is the most common cancer in women worldwide and the second most common cancer overall, with nearly 1.7 million new cases diagnosed annually. The incidence in Europe is 0.5 million, affecting approximately 1 in 8 women in the lifetime. MammoWave model
