A next generation diagnostic device that effectively screens for breast cancer in all tissue types, without the use of ionising radiation

Project Information

OE Scan

Grant agreement ID: 807804

DOI

10.3030/807804

Project closed

EC signature date 23 February 2018

Start date 1 January 2018

End date 30 April 2018

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

TIRO MEDICAL LTD
United Kingdom

Periodic Reporting for period 1 - OE Scan (A next generation diagnostic device that effectively screens for breast cancer in all tissue types, without the use of ionising radiation)

Reporting period: 2018-01-01 to 2018-04-30

Summary of the context and overall objectives of the project

Our Breast screening technology is intended to increase breast cancer detection in the female population. Our imaging device will greatly improve the accuracy of breast cancer screening. The current gold standard technique, mammography, fails to detect around half of cancers in women with dense breast tissue. These cancers will eventually be diagnosed, but will likely have progressed to a stage requiring more expensive treatments. Our product is a simple and highly effective screening device which is aimed to be the leading personalised screening tool for woman underserved by mammography. Our technology will increase the accurate detection of breast cancer, enabling clinicians to carry out earlier interventions and make better informed decisions. In addition it will improve screening programme compliance due to lack of radiation and pain.

We now need to update the device with engineering upgrades, gain medical device certification, and perform and pivotal clinical trial.

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

During the study we redefined the product specification based on the user requirements. From this updated specification we built up a development plan to achieve the defined specification and the cost to achieve this. We assessed the development plan and took into consideration what activities could be undertaken in house and where we would need to include external support. We identified the need for a Contract Manufacturing Organisation for the device manufacturing, a Clinical Research Organisation for managing the pivotal trial, and Breast Centres for providing study participants. We then initiated contact with these organisation.
We also undertook a deeper market analysis in which we identified 5 market segments and we defined each of their market size. We also undertook a deeper analysis of market risks and a barriers. Financial projections were also updated based on the updated market data and costs of development.

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)

X-ray mammography is currently the preferred technology of choice with over 18 million women undergoing mammography each year. The main competitors in this space are GE Healthcare, Siemens. Toshiba Medical Systems Corp. and Hologic Inc. Our device will act as an additional personalised test for women that are underserved by current screening systems in order to improve clinical decision-making.

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