Gianluigi Tiberi is the co-founder of UBT, an Umbrian start-up. We came in contact with him thanks to the Marie Curie International Program for the mobility of researchers (ROVER project for the development of intelligent wireless networks for ICT applications and medical devices): with his intervention he shows the strengths and weaknesses of the patented technology developed by his company for diagnostic imaging.

Mammowave is a device for the detection of breast tumors that replaces ionizing radiations with simple microwave; it uses a frequency similar to the one used for cellphones with very low potency, therefore harmless. Mammowave is now completing the validation process for mammograms and can also be used for the detection of stroke in pre-hospitalization or in industrial applications to indicate the presence of an inclusion in objects.

In Mammowave the software for data acquisition and data processing is already available in stand-alone mode, with output images in PDF and MATLAB. Subsequently, Mammowave will be integrated into the hospital system through the international standard DICOM.

The first goal of Mammowave is to promote early detection in the prevention of breast injuries, especially in the younger population. It is known that mammographic screening (based on ionizing radiation) currently excludes age groups of less than 45 years. However, according to data from Global Cancer Research, 20% of breast cancers is found in women under the age of 45.So it would be important to be able to extend the screening thanks to this non-invasive methodology to younger women as well.

Another strong point is the possibility to carry out closer examinations over time, while the X-ray examination may present contraindications such as using it at high frequency and consequently cannot intercept the so-called interval tumors.

Clinical Trial e Regulatory Procedure

This aspect – together with AI and software solutions – is one of our main point of interest: through our Regulatory Affairs & Materiovigilance Service in outsourcing, JSB experts support medical device manufacturers in compliance and risk management activities, while as CRO we support instructions in clinical studies and in the protection and promotion of patient health.

Regarding Mammowave, Gianluigi Tiberi explains that a clinical study on 150 patients started in Umbrian hospitals in 2017 has just been completed, the final report is expected in the coming weeks. The primary objective was to determine the diagnostic capacity of the machinery. A new international trial is currently underway on 500 patients to quantify performance in sensitive and specific areas. Mammowave is a II a Class medical device that will soon be awarded with the CE mark. For an EC-labelled IIa Class medical device, the regulatory procedures for obtaining the green light for testing by ministries, health authorities and ethics committees in EU countries are generally fairly long (about 6-9 months).

We ended the Tech Talk hoping that Mammowave could become #thenewordinary breast screening and prevention.

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