Public Funding for Ibex Innovations Ltd

Osteoporosis is a serious health problem for older women. Fracture rates for weak bones exceed rates for heart attacks, stroke and breast cancer combined\[12\]. Complications resulting from hip fractures can be fatal, with a quarter of women aged 50 or over dying within a year\[4\]. Long-term care following a fracture costs the NHS and Social Services more than £1billion every year\[3\]. Some breast cancer treatments\[13\] can reduce bone strength causing 1in5 women to sustain a fracture after a typical 5-year course of treatment\[5\]. Effective treatments for osteoporosis are available\[14\] but take time to work so early diagnosis is vital. NICE recommends offering a baseline risk assessment and regular monitoring of at-risk women during aromatase inhibitor cancer treatment\[7\]. This means additional hospital visits for women and long waiting lists for standard bone health DXA scans\[15\]. IBEX Innovations and Cambridge Breast Unit (CBU) are working together to develop a more convenient method which uses the IBEX BH software, a combination of machine learning and advanced physics models, to assess a patient's bone health from a wrist X-ray taken on the same mammography machine during the same visit as her mammography follow-up appointment. A small feasibility study has been designed with input from patient representatives to validate the technology for use in a hospital setting which will: * Test the method by asking 24 volunteers to have a wrist X-ray and compare the IBEX BH results with their standard tests * Review timings of the assessment and impact on patient flow * Assess patient experience through a questionnaire and interviews * Assess clinical impact to understand how IBEX BH software can be used to improve patients' lives and what benefits it can bring to the NHS. Participants will also be provided information on lifestyle changes that promote improved bone health and we hope to raise awareness more widely through dissemination activities at imaging conferences and with public facing organisations such as the Royal Osteoporosis Society. Nearly 3 million women in the UK are living with osteoporosis\[9\], and half of women over 50 will break a bone because of it\[16\]. However nearly four in five women are not diagnosed or offered the appropriate treatment\[17\]. Women over 50 are offered a mammogram every three years with around 2.2m women attending each year. Assessing bone health during the same visit would be a convenient and cost-effective way to identify osteoporosis risk and start treatment early, ideally before their first fracture.

This project will demonstrate a unique method of screening for osteoporosis using widely available mammography services and screening programs. Osteoporosis is a condition that affects over 20% of women over the age of 50\. Fragility fractures resulting from the condition have a devastating impact on health, mortality and quality of life and cost the global healthcare system over $400bn per year. Following a fragility fracture: * 40% of patients are unable to walk independently * 60% encounter difficulties with at least one essential daily activity such as bathing * 80% are restricted in other activities such as driving or shopping * 27% enter a nursing home for the first time Despite effective drug treatments being available to reduce risk of fractures following an osteoporosis diagnosis, there is no routine osteoporosis screening program. The condition is currently 80% underdiagnosed and women will typically suffer multiple fractures prior to a diagnosis. The IBEX Bone Health (IBEX BH) software product has been developed to opportunistically identify bone health from routine X-rays that have been taken for other investigations, for example following a fracture. This project will demonstrate the feasibility that the BH product can be extended to deliver a bone health measure from a simple wrist X-ray collected using existing mammography equipment and services alongside mammograms collected for breast cancer screening and treatment. Mammography provides a unique opportunity to identify poor bone health, since women at risk of osteoporosis are in the most at-risk demographic for developing osteoporosis. Aligning with their routine breast screening appointments offers a perfect opportunity to identify osteoporosis in this at-risk group by taking an additional wrist X-ray during their hospital appointment. The long-term vision is that all women have their bone density measured alongside their routine mammogram and are given the treatment to avoid debilitating fractures and live healthy, active lives.

Trueview is an advanced software product that enables bone health diagnoses to be made using standard X-ray scans, rather than the specialised DXA scans currently required. The technology has been shown to provide accurate diagnosis of osteoporosis on forearm X-rays and this project will further develop the technology to allow it to be used on a wider range of body parts that can be assessed to provide a bone health diagnosis including ankle, pelvis, femur and humerus. The project will assess the performance of these developments in a human clinical study at the University of Exeter, with the final outputs supporting regulatory certification and ongoing commercialisation and adoption activities. A successful project will facilitate roll-out and adoption of a product that will have a significant impact on osteoporosis treatment waiting times and will reduce the numbers of fragility fractures incurred, along with their associated health and social care costs.

Osteoporosis is a debilitating disease that leads to deterioration of bone structure and density, resulting in a significantly increased risk of fragility fractures. An estimated 17% of men and 34% of women are affected by osteoporosis worldwide and in 2017, fragility fractures cost the UK €5.5bn with an associated one-year mortality rate of 33%. This project will assess the feasibility of further developing the Trueview bone health product such that it can be used for chest X-rays, which account for 28% of all X-rays taken in the UK annually. This will improve the detection of poor bone health, enabling wider and earlier identification and treatment of osteoporosis.

The Covid-19 pandemic has seen a huge increase in the number of hospital admissions for patients requiring care in intensive therapy/care units (ITU). These patients are often critically ill, immobile and in need of rapid interventions to assist with breathing, feeding and deployment of other health support systems. This influx has also highlighted how inadequate current mobile imaging systems are for the provision of care for these patients, with imaging for placement of tubes, lines and other devices often requiring repeats due to poor image quality. This increases the strain on an already stretched NHS resource pool and results in other services being reduced in a time of crisis. IBEX Trueview is a novel physics-based X-ray imaging technology that has been demonstrated to enhance image quality in mobile chest X-rays (CXR) through accurate removal of the deleterious effects of scatter. This project will additionally demonstrate the potential for IBEX Trueview to improve the quality of tube and line imaging through application of unique "composition-guided post processing" (CGPP) methods. This project will build upon the core CGPP algorithm to develop novel methods to enhance the visibility of lines and tubes whilst retaining high quality diagnostic images. The value of this for improved treatment in the ITU setting will be tested through an evaluation on consented patient images, and a health economics study which will determine its impact for the future sustainability of NHS ITU services during healthcare emergencies.

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This project will develop the proof of concept of an innovative multi-channel AI method to improve the prevention and diagnosis of fragility fractures. Digital radiology (DR) remains the standard imaging protocol for fracture detection after trauma and whilst the majority of pathologies are correctly identified, a significant proportion are missed, leading to a delay in diagnosis, increased pain and suffering and additional costs from repeated diagnostic tests and treatment. Radiologists assess many features of a standard DR image to predict the presence of pathologies or the risk of future fractures that requires a more detailed inspection of bone structure in the affected region. However, trauma radiologists have limited time to manipulate image contrast and determine patient risk based on pre-determined factors, and certain pathologies will be missed if they are not immediately obvious in the radiograph. The project will build upon the unique IBEX Trueview(r) technology which has been developed with the support of previous InnovateUK funded projects. Using standard DR images, Trueview generates improved image quality and unique composition-based outputs to suppress soft tissue contrast and boost bone fine detail, thereby improving the visibility of subtle fractures and other pathologies. It is also able to provide an accurate measure of bone health based on bone density. Trueview includes a proprietary AI-based bone segmentation algorithm to accurately segment bone from soft tissue with limited training data. The project will have three primary aims: 1) To further enhance the proprietary "IBEX XNET" AI-based bone segmentation method to generate an additional quantitative bone morphology output; 2) To develop new composition-guided post processing methods to create independent bone-enhanced and tissue-enhanced diagnostic images; and 3) To automate the process of detecting or determining risk or future fragility fractures.

"The project will develop and commercialise novel technologies to radically improve the safety, effectiveness and patient comfort of X-ray breast imaging. Firstly, the project will adapt the IBEX Trueview(r) gridless scatter correction method for use in mammography and Digital Breast Tomosynthesis (DBT) systems and demonstrate its effectiveness to reduce patient dose and improve image quality in mammograms and DBT reconstructions. The in-vivo and ex-vivo data generated during this initial phase will be used to market the capability to leading medical X-ray system integrators and secure commercial licence deals within the first year of the project. Secondly, the project will develop and demonstrate the effectiveness of a prototype 3D X-ray imaging system capable of creating full, high-contrast 3D reconstructions of uncompressed breasts at less patient dose than a standard 2D mammogram and without injected contrast agents. This radical new product has the potential to transform breast screening and cancer diagnosis, especially for women with dense breasts. The ex-vivo data collected during this second phase will be used to inform a commercialisation strategy and a future human clinical study."

"The project aims to demonstrate a production-compatible X-ray food inspection system capable of reliably detecting both plastic contaminants during the manufacture of chocolate confectionary products, and bone fragments in the meat processing industry. The project will combine a novel multi-spectral X-ray imaging technology from IBEX Innovations Limited (IBEX), with innovations in detector and production inspection technologies from Mettler-Toledo Safeline Limited (MTSL). Successful adoption of the resulting product is expected to lead to increased detection of impurities in the food processing industry, leading to increased consumer safety and a reduction in expensive product recalls."

IBEX Innovations has recognised an opportunity to adapt its patented X-ray detector technology to Cone Beam Computed Tomography (CBCT). CBCT is a medical X-ray imaging technique that enables 3D reconstructions of body parts to be collected using a much simpler, cheaper and more flexible set-up compared to conventional Computed Tomography (CT) systems. However increased levels of scattered X-rays reach the detector, resulting in reduced image quality compared to standard CT. This has restricted the adoption of CBCT in medical imaging to niche markets such as extremity imaging. The IBEX technology has been proven to reduce the effect of scatter in standard digital radiography systems used in fracture clinics and also provides accurate materials information, such as Bone Mineral Density data, that can be used to diagnose Osteoporosis. This project will adapt the IBEX technology to CBCT imaging with the result of improving image quality to a level similar to regular CT and providing additional materials information to aid in diagnosis of a variety of conditions. Project success will enable widespread adoption of CBCT for medical imaging and offer significant benefits to patients and the NHS in terms of dose and cost savings, improved patient comfort and equipment availability.

Mammography is a widely-adopted X-ray screening method used to detect and diagnose breast cancer earlier. Abnormalities in the breast are identified through contrast changes in the X-ray image. X-ray mammography is the only mass screening programme where patients are exposed to ionising radiation in a radio-sensitive organ, increasing the risk of radiation-induced cancer in healthy women. Mammograms are currently assessed subjectively which can lead to false positive/negatives in diagnosis, resulting in considerable distress and delay in treatment. IBEX have developed a core technology that can more accurately discriminate between tissue types and can improve image clarity to make it easier for clinicians to make accurate diagnoses. Additionally, the technology could be used to image patients at a lower dose than is currently used, further reducing the risk to women showing no symptoms during screening. This project aims to show that the materials information obtained is sufficiently sensitive to be able to discriminate between body fat and glandular tissue in the breast at lower patient doses

IBEX Innovations has successfully demonstrated, in a previous Development of Prototype project, the materials classification capability of its Multi-Absorption Plate (MAP) X-ray detector technology. The ability to identify materials in a medical image using the MAP technology integrated to a standard medical flat panel detector (FPD) offers significant benefits, including the ability to measure bone mineral density (BMD) on standard Digital Radiography (DR) equipment. Angiography systems use X-ray absorption contrast of a radio-opaque contrast agent, usually an iodine solution, to visualise blood vessels and organs in the body and are used to assist in diagnosis and treatment of heart conditions (Coronary Angiography) or brain conditions (Neuro-vascular Angiography). Iodine-based contrast agents are known to impair renal function through Contrast Induced Nephropathy (CIN) in around 2% of angiography procedures, increasing to 20-30% in high risk patients. This project seeks to demonstrate that the IBEX materials classification methods can identify contrast agents by their material type rather than their X-ray blocking characteristics. This offers the potential to image much lower concentrations of iodine with no loss in contrast, or to use new types of non-harmful contrast media that can be distinguished by virtue of their material differences from the structures of the body. The project will also demonstrate that the IBEX materials classification technology can generate images of moving contrast agent in in real time. Finally, the project will seek to demonstrate suppression of bone and tissue in the dynamic image as an alternative approach to digital subtraction angiography (DSA) methods.

IBEX Innovations (IBEX) has successfully demonstrated, in an InnovateUK PoC project, the potential for its virtual anti-scatter grid (VASG) concept to improve diagnostic quality and significantly reduce patient dose in medical radiological examinations Physical anti-scatter grids (ASGs) are extensively used in medical X-ray imaging to reduce the levels of unwanted X-ray scatter reaching the detector and are essential to achieve diagnostic quality images, especially on thicker body parts such as the torso, head and breast. However, as well as blocking unwanted scatter, physical ASGs also absorb a significant proportion of useful direct X-rays and result in patient doses being increased by between a factor of 2x and 8x to achieve acceptable images. By contrast, the proposed IBEX Virtual Anti-Scatter Grid (VASG), takes materials data generated by the IBEX Multi Absorption Plate (MAP) and advanced IBEX software algorithms and uses it to deconvolve the scattered X-ray component, utilising the scattered Xray data to improve image contrast without the need for a physical ASG. By usefully employing more of the available X-ray photons to create an image instead of just blocking unwanted scatter with a physical ASG, the VASG is expected to generate improved contrast at significantly lower patient doses, whilst further improving the sensitivity of the IBEX materials classification, leading to further improvements in the diagnostic value of radiographic examinations. The VASG concept relies fundamentally upon the IBEX materials classification technology successfully developed under a previous InnovateUK DoP project, and has been shown to work in a PoC project which completed in July 2015.

IBEX Innovations, a developer of advanced X-ray detectors for low-dose, high contrast imaging, are looking to identify techniques to manufacture a complex repeating 3D micro-scale structure at a thickness beyond what can be achieved using traditional electroforming methods.

IBEX Innovations has developed an advanced X-ray imaging technique that adds materials information to conventional silicon based indirect detectors. The technology has been developed for use in industrial quality inspection within the electronics industry and clear benefits to image quality and dose reduction have been identified within medical applications. IBEX has identified a number of other markets in which the technology could provide competitive advantages to customers including industrial non-destructive testing (NDT) in industries typically dominated by technologies such as ultrasound or where NDT has not previously been possible. This technology potentially presents a step change in NDT capability and this project seeks to identify the market opportunity for a variation of the IBEX advanced X-ray detector technology within industrial NDT applications. The proposed Advanced X-ray NDT System would have the potential to identify changes in materials thickness and composition of a product without any assumptions and would also be able to identify inclusions and defects.

IBEX Innovations (IBEX) has identified a technological innovation that has the potential to improve contrast and significantly reduce patient doses in medical radiological examinations. Physical anti-scatter grids (ASGs) are currently extensively used in medical imaging to block unwanted X-ray scatter from reaching the X-ray detector, and are essential to achieve acceptable diagnostic images, especially on thicker body parts such as the head and breast. However, physical ASGs also block a significant proportion of useful direct X-rays and result in patient doses being increased. The proposed IBEX “Virtual Anti-Scatter Grid” technology replaces the physical ASG with a structured X-ray absorber based on the IBEX multiabsorption plate (MAP) originally developed for industrial inspection applications in an existing TSB DoP project, and novel complex mathematical algorithms. Instead of blocking unwanted scatter, this technology has the potential to instead identify scattered X-rays by determining their energy shift, allowing either their digital removal from the image, or using them to add information about the material from which they have been scattered, or a combination of both. The net result of the proposed technology is the possibility to create better diagnostic images at significantly lower patient doses.

IBEX have recognised the opportunity to develop an innovative new X-ray detector that can deliver images with superior contrast at substantially lower X-ray doses than currently available alternatives. The IBEX technology adds high resolution energy discrimination to the megapixel flat-panel TFT and CMOS detectors most commonly used in X-ray inspection systems, providing a materials identification capability that is currently only available from small, slow and expensive Direct X-ray Detectors. A major advantage of the technology is that it can be used to upgrade existing detectors and is retrofittable. This reduces the barrier to entry to many markets. This technology can be applied to a range of different industries such as industrial NDT, security and medical imaging. The effectiveness of PCB inspection equipment for identifying faults and defects could be substantially improved by adding materials identification. In medical imaging it has the potential to improve detection rates of small tumours through improved discrimination of tissue compositions, plus the ability to collect images at substantially reduced patient dose will reduce the number of deaths from cancers induced by X-ray imaging procedures. In food inspection it will improve identification of impurities, particularly organic matter with a similar density to the food being inspected. The core technology has been demonstrated in a recent Proof of Concept Award where it has been used to discriminate between different materials used in the manufacture of printed circuit Boards.

Eshtech have recognised an opportunity to develop an innovative new x-ray detector which will be more accurate and affordable than existing equipment. Currently available indirect xray detectors have superior imaging capability but cannot distinguish different materials to a high enough degree of accuracy. Direct x-ray detectors can pick up spectroscopic information to characterise different materials but they have performance issues, are very expensive and currently can only be obtained in low resolution arrays. These limitations mean that they cannot be used in applications where resolution is key, such as mammography, PET scanning and industrial inspection. In an ideal world companies in the medical and industrial image sectors would like to combine the high resolution images available in indirect detectors with the spectroscopic abilities of direct detectors. This would enable the earlier detection of cancers in medical imaging and the identification of process faults in industrial imaging. This technology can be applied to a range of different industries, the first being electronics inspection to examine the type of material and thickness in different layers of a PCB. Faults can be diagnosed and solder joints can be checked. We will also look at defence where there is a requirement to screen for radio isotopes, and at industrial metrology. A much larger market where this innovation could have a profound influence on is in medical imaging and particularly mammography. The ability to detect the early changes in tissue composition could allow for the much earlier detection of cancer.