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Clinical validation of Laser Optoacoustic Ultrasonic 3D Imaging System Assembly for breast cancer detection and characterization through endogenous biomarkers.

Objective

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.

Fields of science (EuroSciVoc)

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Programme(s)

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Topic(s)

Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.

Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-1 - SME instrument phase 1

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SMEInst-2014-2015

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Coordinator

BIOS S.R.L.
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 50 000,00
Address
VIA GUIDO ROSSA, 10/12
20090 VIMODROME
Italy

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Nord-Ovest Lombardia Milano
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 71 429,00
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