Cutting edge microwave imaging device for safe and accurate breast cancer screening

Project Information

MammoWave

Grant agreement ID: 830265

DOI

10.3030/830265

Project closed

EC signature date 10 October 2018

Start date 1 October 2018

End date 31 August 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 990 163,50

EU contribution

€ 1 393 114,45

Coordinated by

UMBRIA BIOENGINEERING TECNOLOGIES SOCIETA A RESPONSABILITA LIMITATA
Italy

Periodic Reporting for period 3 - MammoWave (Cutting edge microwave imaging device for safe and accurate breast cancer screening)

Reporting period: 2021-04-01 to 2021-08-31

Summary of the context and overall objectives of the project

The MammoWave project addresses the shortcomings and risks associated with mammography. Mammography has been the medical industry’s “gold standard” breast cancer screening tool for nearly four decades. However, a number of adverse effects, including those caused by exposure to x-rays, are now limiting the use of mammography as a mass screening.

Finding a reliable and safer alternative to mammography is key to reduce the burden of breast cancer to society. Breast cancer is the most prevalent form of cancer in women. One in nine women will acquire breast cancer at some point in their life and one in thirty will die from the disease.

The overall objectives of the MammoWave H2020 project are:

1) Development of a interoperable application for MammoWave imaging management
2) Prove MammoWave large scale manufacturability and assembly repeatability
3) Validate MammoWave’s performances in international clinical study
4) Develop international commercial channels

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Throughout the entire, UBT has been working on all the five work packages, with significant results secured:

1) Development and delivery of the suite of software managing the operations of the MammoWave device (WP1)
2) Conversion of the MammoWave’s output into DICOM format for the complete interoperability of the device in every hospital environment (Milestone of this project, WP1)
3) Assembly and successful testing of the first batch of 8 MammoWave units (MammoWave IV generation) (WP2)
4) Ethics committee authorisation from hospitals San Martino (Genova, Italy), Humanitas (Milan, Italy), Hospital Virgen de la Salud (Toledo, Spain) (WP3)
5) Clinical validation performed on 354 patients in 3 clinics, showing positive results of Mammowave (WP3)
6) Publications on prestigious journals such as Scientific Reports (a natureresearch journal) and Biomedical Signal Processing and Control (Elsevier)(WP4)
7) Identification of strong potential commercial partners and significant progress with selected investors (WP4)

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The international clinical study confirmed MammoWave's overall accuracy above 80%. The clinical study was conducted on 354 patients, way above the 250 limit needed to collect statistical significant data for obtaining fast market approval. These results are expected to fast track MammoWave's entry into the EU market. Therefore, the MammoWave H2020 project can have a big impact on the company boosting UBT's growth and commercial success. And, most importantly, on the millions of patients looking for a safer and reliable breast cancer screening alternative.

The team standing behind the newly assembled MammoWave