Development of a novel low dose, high resolution, high contrast X-ray detector for medical applications to improve patient diagnoses and reduce the risk of X-radiation induced cancer

Project Information

MAP-Detector

Grant agreement ID: 672619

DOI

10.3030/672619

Project closed

EC signature date 8 April 2015

Start date 1 May 2015

End date 31 October 2015

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

IBEX INNOVATIONS LTD
United Kingdom

Periodic Reporting for period 1 - MAP-Detector (Development of a novel low dose, high resolution, high contrast X-ray detector for medical applications to improve patient diagnoses and reduce the risk of X-radiation induced cancer)

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

Summary of the context and overall objectives of the project

IBEX Innovations Limited (IBEX) is commercialising a patented X-ray detector technology that recovers high sensitivity spectral information from standard, indirect silicon X-ray imaging detectors. This information is then used to classify both materials and thickness in an X-ray image delivering improved detection of impurities, defects and threats. The IBEX technology can also be used to identify and remove scatter in images, leading to significant improvements in contrast-to-noise ratio (CNR) of 8-10x at significantly reduced X-ray dose of at least 2x.

Since incorporation in 2011, IBEX has secured €4.2m (£3m) of venture capital funding and €1.06m (£750k) of grant funding to develop the core technology and build a team of 13 highly skilled engineers, scientists and business professionals. The business has moved rapidly from the research phase to commercialisation and has secured licence deals for its technology in electronics inspection and security inspection markets, with additional commercial deals expected in the food inspection market in the next calendar year. The technology can therefore clearly be identified as at TRL 7-8 in non-medical applications.

X-ray imaging is a valuable medical diagnostic technique, accounting for 47% of the medical imaging market in 2011 and expected to be worth €15bn globally by 2017. Within this, the medical X-ray detector market was valued at €1.24bn in 2014, dominated by €0.77bn of sales of flat panel detectors (FPDs) using silicon megapixel TFT or CMOS sensors. The market for large area medical FPDs is growing strongly, with a forecast CAGR of 6.3% between 2014 and 2019. There has been a significant growth in the use of medical radiography in recent years, and medical radiation exposure of the US population now accounts for close to 50% of the annual per capita total, having increased by 600% since 1980. Medical radiography is not without risk, and 1 in 1,000 patients who have a full body CT scan will go on to develop a fatal secondary cancer. c. 28,000 of the 1.4m cancers diagnosed every year in the USA are directly attributable to CT scans.

Over the past two years, IBEX has engaged with leading clinicians and medical physicists to investigate applications the medical imaging market, and has demonstrated the potential of the IBEX technology to address clinical needs in a number of application areas. The IBEX technology is now at TRL6-7 for selected medical applications. We have used a H2020 Dedicated SME Instrument (“DSI”) Phase 1 grant to investigate commercial opportunities and the route to market for the IBEX technology in medical imaging applications further.

The objective of the DSI Phase 1 project was to carry out a feasibility study for the use of IBEX technology in medical applications and to develop a detailed business plan for its commercialisation. Our feasibility study objectives were:
1. To determine the regulatory requirements and costs to get approval in the medical sector
2. To analyse target applications (e.g. Mammography, Angiography, Digital Radiography, DEXA, CT) and quantify relative benefits of IBEX technology vs existing/evolving technologies
3. To determine the route (licence, detector sale, JV etc.), time to market and barriers to entry by application
4. To plan messaging and assess burden of proof needed. How do we pitch our capability and what level of experimental proof do we need? How should we present this to OEMs / detector manufacturers / market at large?
5. To understand market dynamics - segmentation, technology trends, key players
6. Make initial contact with market, and identification of appropriate development partners and stakeholders
7. To Draft a detailed business plan with financial projections to be used over a 5-year period

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

IBEX has developed an understanding of the potential opportunities for the IBEX MAP technology within the medical imaging market through a mixture of desk and internet research; published market reports; discussions with medical professionals and medical imaging companies. Where possible, assertions and assumptions have been tested with medical imaging system suppliers, clinicians, radiographers and medical physicists to reach the conclusions described in the report.

IBEX commissioned a programme of targeted market research, on an anonymous basis, with leading medical X-ray imaging equipment suppliers. The first study sought to understand the key technology drivers and technical roadmap for each company, and to test the importance of specific parameters such as patient dose, diagnostic quality, scatter and materials classification. The second study sought to confirm IBEX’s readiness to target near-term markets described in the full report. As well as providing valuable first-hand market insights these studies have established contact with senior engineers and executives at all of the major medical X-ray imaging companies which we can exploit when we are ready to actively promote our technology to the market.

Experts in medical device testing and regulatory procedures were commissioned to prepare a report outlining the requirements and costs for regulatory approvals and associated human clinical investigations.
It is possible to draw initial conclusions from the market data as follows:
1. The medical X-ray imaging system market is dominated by a small number of global manufacturers, typically operating across multiple application sectors. This makes licensing the IBEX technology directly to manufacturers a highly efficient revenue model, with over 80% of the market available through just 6 primary targets.
2. The medical X-ray detector market is dominated by an even smaller number of manufacturers, with the top 4 companies accounting for c.86% of the global FPD market. Again, this makes licensing to detector manufacturers a highly efficient market entry strategy for IBEX.
3. There are a number of key medical applications that IBEX can target in the near term, with other smaller applications representing attractive secondary markets.
IBEX has also assessed the potential value of the technology by application within the medical market and has found that it addresses needs consistent with the manufacturer trends listed below and corroborated by clinicians.

Our market research identified a number of consistent manufacturer trends:
• Diagnostic image quality: Maintaining or improving the quality of the diagnostic output of the imaging system remains the overriding priority of all manufacturers.
• Dose Reduction: There is a consistent focus across all manufacturers on methods to reduce patient and operator dose. Dose reductions are most commonly achieved through adaptive collimation and automatic exposure control (AEC), better image processing, or alternatives to ASGs.
• Patient comfort: Improved patient comfort and well-being were consistently stated as development priorities, particularly for women undertaking mammography examinations. This could be improved through shortened image acquisition times and the ability to collect more diagnostic data in a single procedure.
• Work flow and Informatics: There is an increased focus on methods to improve operator work flow and efficiently handle patient data.
A full commercialisation strategy, including a comprehensive clinical investigation plan has also been produced.

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 project has delivered on its main aim of establishing the feasibility of a commercial IBEX product in the medical sector. We have engaged with both end users and OEMs and have performed detailed market assessments in an effort to quantify the commercial potential of the IBEX MAP technology.

The project has indicated that there is strong market pull for a product offering the potential benefits that the IBEX MAP can provide and we have confirmed our freedom to operate through IP landscaping and patent filing.

Based on our understanding of the market data available and assuming a licensing model to manufacturers, we estimate that the IBEX MAP technology could generate revenues for IBEX from the medical market alone of up to €15m by FY2020 following a successful technology development and commercialisation project.

The technology has the potential to reduce dose rates in X-ray imaging procedures by at least a factor of 2, resulting in fewer secondary cancers in patients and also reducing the risk to clinicians carrying out procedures. Additionally, the increased capability to collect rich diagnostic data from a single imaging procedure could minimise the requirement for additional procedures and improve the sustainability of healthcare systems.

Comparison between standard absorption image and bone composition data collected using IBEX MAP tech