Revolutionising Bone Health: Timely Osteoporosis Detection in Post-Menopausal Women
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In this case study, IBEX Innovations, an alumnus company of the Accelerating FemTech programme, shares how their software solution IBEX Bone Health can be integrated into routine breast cancer screening programmes for the early detection and diagnosis of osteoporosis.
Overview
Osteoporosis remains significantly underdiagnosed, with an estimated 80% of cases going undetected due to screening deficiencies and prolonged waiting times for bone density scans (DXA). The condition affects over 20% of women above 50, who are more likely to experience multiple fragility fractures before receiving a proper diagnosis. The negative impact on their health, quality of life and mortality rate is estimated to cost the global healthcare system over $400 billion annually.
IBEX Bone Health (IBEX BH) is an innovative software solution capable of measuring bone density directly from standard digital radiographs, facilitating earlier diagnosis of osteoporosis. IBEX BH enables healthcare professionals to conduct opportunistic bone density screenings and assess fracture risks during routine X-rays performed for various medical purposes, such as follow-up examinations after fractures. This can help to reduce waiting times for DXA scans and ensure timely access to care services for those who need it most.
By integrating IBEX BH with mammography equipment, clinicians can effectively screen the most at-risk cohort for poor bone health during routine breast cancer screenings. As certain breast cancer treatments (e.g., aromatase inhibitors) can adversely affect bone health, IBEX BH offers a convenient solution to monitor bone health alongside regular treatment follow-up mammograms without the need for DXA scanning.
IBEX BH has been proven to identify bone mineral density loss from a single X-ray image. I wish this method had been available long before I had my first fragility fracture. As a radiographer and a patient, I believe that IBEX BH should be used as a screening tool for those at risk.
Dr Margot McBride
Research Diagnostic Radiographer
Journey
IBEX BH was developed as an opportunistic screening tool for general radiology, aiming to address the challenge posed by the National Institute for Health and Care Excellence (NICE) recommendations for osteoporosis assessment. Although NICE advises actively inviting high-risk patients identified through GP records for clinical assessment, the existing DXA infrastructure struggles to accommodate this need.
While both men and women stand to benefit from early osteoporosis diagnosis, the advantages for women are particularly pronounced due to their higher susceptibility to osteoporosis and debilitating hip fractures, especially post-menopause. Incorporating an additional wrist X-ray during routine breast cancer screenings or monitoring mammograms significantly enhances the chances of early detection, diagnosis, and treatment referral for osteoporosis.
In the 2021-22 period alone, about 2.2 million women underwent breast cancer screening. Through IBEX BH, there exists the potential to identify up to 385,000 cases of osteoporosis that would have otherwise gone unnoticed. This would improve outcomes for women at risk and amplify the effectiveness and value of existing screening programmes.
Support from Accelerating FemTech
Participating in the Accelerating FemTech programme has provided IBEX Innovations invaluable opportunities for peer learning and knowledge exchange among healthcare professionals and fellow companies. These interactions have enhanced their understanding of IBEX BH’s potential benefits to the NHS.
Navigating the complex and intricate landscape of the NHS and UK healthcare infrastructure can be challenging without the guidance of experienced practitioners. While there are ongoing challenges, the connections forged by IBEX Innovations through the programme continue to be a valuable source of support for the team.
Impact/Outcomes
- IBEX BH has been adopted by Agfa Radiology in their DensityScan™ product for opportunistic screening in general radiology, with the first NHS pilots currently underway and scheduled to continue throughout 2024. These aim to ultimately enable NHS Trusts to evaluate the potential impact of opportunistic screening on existing care pathways.
- A clinical trial has shown an excellent correlation between IBEX BH and DXA measurements, demonstrating the clinical utility of IBEX BH as an opportunistic screening tool.
- Research into patient and public views of IBEX BH found that general attitudes to the use of predictive software were positive. Users with osteoporosis recognised the potential to speed up diagnosis and reduce associated pain and decline in quality of life that occurs with osteoporosis.
- At the European Congress of Radiology (ECR) 2024, Metaltronica SpA, an Italian manufacturer of mammography equipment, introduced a new multimodality system incorporating a bone mineral densitometry feature based on IBEX BH (Cybele).
If the trial is aimed at all women attending a mammogram appointment, irrespective of whether they have had cancer, then the benefits and convenience of a wrist scan for bone density seem extremely attractive. This would help them monitor bone density through their lives and help them do something about it if it is found to decline.
Initial Patient Feedback
Next Steps
- The development of IBEX BH for both general radiology and mammography applications will progress simultaneously. General radiography services are ubiquitous and offer broad coverage where DXA provision is limited. Mammography services target post-menopausal women, the most at-risk population, and enable access for women in remote locations through mobile breast screening facilities.
- Alternative routes to market through other Original Equipment Manufacturer (OEM) vendors are in progress.
- An Innovate UK-funded feasibility assessment of IBEX BH in a mammography context is underway at Cambridge University Hospitals NHS Foundation Trust and will run through to early 2025. The study focuses on the needs of patients and radiographers ensuring effective alignment with the existing breast screening processes, maximising patient benefits and minimising potential disruption to existing NHS services..
- The development of a clinical investigation plan for the subsequent phase of the feasibility assessment and is likely to be a large-scale multi-site study to evaluate the intervention’s efficacy and benefits.
- Commercial development, in partnership with Metaltronica, is ongoing. This will encompass clinical studies in Italy as well as global market expansion initiatives.
Discover more about IBEX Innovations and how IBEX BH is reshaping the landscape of bone health screening by visiting their website.
Accelerating FemTech helps early-stage companies, university spinouts and academic entrepreneurs focused on women’s health to gain the commercial and funding momentum they need for long-term success. The 10-week programme supports innovators to prepare for a special closed-call funding opportunity through Innovate UK’s Biomedical Catalyst, delivered alongside a collaborative learning programme and facilitated networking with key NHS and health sector stakeholders.
Accelerating FemTech is delivered by the Health Innovation Network (HIN) South London and its partners. It utilises Innovate UK funding as part of the Biomedical Catalyst, in collaboration with the Medical Research Council. The programme builds upon the experience of running the award-winning DigitalHealth.London Accelerator, Propel and other innovator support programmes from the health innovation networks. The first cohort ran from May 2023, where alumni were awarded more than £1m in funding through the Biomedical Catalyst. The second cohort will run between 2024 and 2025. Register your interest now and learn more about Accelerating FemTech via our website.