Objetivo Breast cancer (BC) is the most common cancer and the first cause of cancer-related deaths in European women. Laser Optoacoustic Ultrasonic 3D Imaging System Assembly (LOUISA-3D) combines optoacoustic functional information from endogenous biomarkers (hemoglobin content and blood oxygen saturation) with high-resolution anatomical images of ultrasound tomography, without the need for ionizing radiation or exogenous contrast media. The objective of LOUISA-3D is to overcome the main limitations of current imaging methods, by validating and introducing to the EU market a novel multi-modality diagnostic device for BC, based on coregistered full view 3D optoacoustic and ultrasonic technology. LOUISA-3D will be a highly effective, safe and affordable imaging method for BC detection, characterization, and evaluation of the effect of neoadjuvant therapy (NAT).Two clinical trials will validate LOUISA-3D. Trial 1 will measure detection rate, recall rate, sensitivity, and positive predictive value of LOUISA-3D as a screening test in a selected female population at increased risk for BC, as compared to standard digital mammography. Trial 2 will assess the LOUISA-3D endogenous biomarkers capability of measuring the NAT effect in the treatment of locally advanced BCs, as compared to contrast-enhanced magnetic resonance imaging. During this feasibility study, an international scientific committee will deliver both trial protocols, and a management board will release a work and financial plan for the trials and a business plan for the production and commercialization of LOUISA-3D, complete market analysis, cost analysis and financial plan.The applying company, Bios, commercializes medical laser systems worldwide. Once validated and CE medical marked, LOUISA-3D will be manufactured and commercialized in EU, representing an important opportunity for Bios to enter the medical imaging market and enable its significant growth. Ámbito científico natural sciencesphysical sciencesnuclear physicsmedical and health sciencesclinical medicineoncologybreast cancerengineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imagingnatural sciencesphysical sciencesopticslaser physicsnatural sciencesphysical sciencesacousticsultrasound Programa(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.3. - Treating and managing disease Tema(s) PHC-12-2014-1 - Clinical research for the validation of biomarkers and/or diagnostic medical devices Convocatoria de propuestas H2020-SMEInst-2014-2015 Consulte otros proyectos de esta convocatoria Convocatoria de subcontratación H2020-SMEINST-1-2014 Régimen de financiación SME-1 - SME instrument phase 1 Coordinador BIOS S.R.L. Aportación neta de la UEn € 50 000,00 Dirección VIA GUIDO ROSSA, 10/12 20090 VIMODROME Italia Ver en el mapa Pyme Organización definida por ella misma como pequeña y mediana empresa (pyme) en el momento de la firma del acuerdo de subvención. Sí Región Nord-Ovest Lombardia Milano Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Enlaces Contactar con la organización Opens in new window Participación en los programas de I+D de la UE Opens in new window Red de colaboración de HORIZON Opens in new window Coste total € 71 429,00
