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

Periodic Reporting for period 1 - LOUISA-3D (Clinical validation of Laser Optoacoustic Ultrasonic 3D Imaging System Assembly for breast cancer detection and characterization through endogenous biomarkers.)

Reporting period: 2015-05-01 to 2015-10-31

Breast cancer is the first cause of cancer-related death in European women. Current breast imaging technologies present some important limitations: ionizing radiation, unsafe contras media, standardization, diagnostic accuracy, high costs.
Laser Optoacoustic Ultrasonic 3D Imaging System Assembly (LOUISA-3D) is a non-ionizing modality combining 3D optoacoustic functional imaging from blood endogenous biomarkers with anatomical 3D ultrasound. BIOS S.r.l. aims at producing in EU and commercializing worldwide LOUISA-3D, to expand its medical laser market and to overcome current breast imaging limitations.
LOUISA-3D is at technology readiness level 6-7, and needs a sound clinical validation to get regulatory approval.

The objectives of the LOUISA-3D H2020 SME Instrument Phase 1 Feasibility Study were:
• To design the protocol of the clinical validation trial.
• To develop the work plan for the clinical validation trial, including cost estimates and the necessary partners and subcontractors.
• To elaborate the business plan for the LOUISA-3D production and commercialization, after its validation.
The Feasibility Study allowed to design the trial protocol and the trial work plan, and to elaborate a business plan for LOUISA-3D production, marketing, and commercialization.

The protocol of a multicenter international prospective diagnostic study was designed. The trial will involve 4 main cancer centers: P.S.Donato Milan University (IT), Vienna Medical University (AU), H. de la Ribera, Valencia (ES), and County H. Falun (SE), and will be leaded by Prof. Sardanelli. 600 subjects will be enrolled and LOUISA-3D will be investigated in terms of sensitivity, specificity, neoadjuvant therapy monitoring, patient compliance, and reading time. Statistical analysis, informed consent, good clinical practice, personal data protection, and adverse event management were considered.

A 3 years trial plan was developed, with 8 workpackages, each with measurable objectives and clear deliverables. Trial management, start-up, monitoring and data management, technical and research support, and dissemination were defined. A GANTT chart with 21 milestones, and a detailed costs table were issued. Key subcontractors (technology suppliers, research partners, and management consultants) were identified, pursuing best value for money, and involved in the plan design.

Business Plan. A detailed analysis of the breast imaging technology market, acquired by a specialized company, showed significant business opportunities for the introduction of new and safe modalities. SWAT, regulatory, intellectual property and risk analysis were performed. The business strategy was defined, including: production modality, suppliers and costs, product lifetime and maintenance, price policy, placement policy, and marketing plan. A financial plan was developed for the 3 years of trial and 5 following production years, including: P&L, balance sheet, and cash flow.
At the end of the H2020 SME Instrument Phase 1, we achieved a complete and detailed Feasibility Study for the LOUISA-3D project, including clinical trial protocol, trial work plan and business plan. We are now ready to prepare the H2020 SME Instrument Phase 2 proposal for the next available call deadline, to pursue the EU funding of the clinical validation trial of the LOUISA-3D new diagnostic device.
If the proposal will be financed, BIOS will endeavour LOUISA-3D clinical validation during the next 3 years, according to the plan designed in the Feasibility Study. Then BIOS will apply for the CE regulatory clearance, start the marketing campaign, and introduce LOUISA-3D to the European market. As a consequence, BIOS will expand its medical device products portfolio and will enter into the breast imaging technology market, significantly increasing its turnover and hiring new employees.
The market availability of LOUISA-3D will empower radiologists with a new safe tool allowing better breast cancer detection and characterization, and this will ultimately turn into an increased quality of life for European women.
LOUISA-3D prototype