UBT has been awarded a SME Instrument Phase 2 grant of €1.4 million under grant agreement No. 830265. Within such SME Instrument project, UBT further developed and tested MammoWave, the innovative x-rays free microwave mammogram. MammoWave has be used in an international clinical study involving prestigious hospitals in Italy, Spain and Germany. What is the SME Instrument? The SME Instrument is a programme under the Horizon 2020 framework run by the EASME, the European Executive Agency for Small and Medium-sized Enterprises. UBT already secured a Phase 1 SME Instrument grant in 2017. The Phase 2 project continued the work started in Phase 1 and
allowed UBT to achieve key milestones such as:
• Development of an interoperable application for MammoWave imaging;
• Proving MammoWave large scale manufacturability and assembly repeatability;
• achieving CE marking;
• ISO 13485;
• validating MammoWave’s performances in international clinical study.
The international clinical study has been successfully performed at:
• Hospital Virgen de la Salud, Toledo, Spain;
• Ospedale Policlinico San Martino, Genova, Italy;
• Humanitas Research Hospital, Milano, Italy.
Clinical trial is based on the protocol “A multicentric, single arm, prospective, stratified clinical investigation to evaluate the ability of MammoWave in breast lesions detection”, which has been finalized in collaboration with the C.R.O: MTA – Medical Trials Analysis. Clinical trial has been registered at ClinicalTrials.gov: Enrollment has been successfully completed in August 2021.