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AI Enabled Managemement of Patients at Risk of Diabetic Foot Ulcer

Periodic Reporting for period 3 - DELTA (AI Enabled Managemement of Patients at Risk of Diabetic Foot Ulcer)

Reporting period: 2022-03-01 to 2022-11-30

Diabetic foot ulcers (DFU) lead to approximately 150,000 amputations and €23 billion in costs in Europe each year. Of the 60 million people with diabetes in Europe, 1.5 million currently have a diabetic foot ulcer and 15 million will develop on at some point in their life. Each ulcer takes 3-6 months to heal and costs upwards of €14,000 to treat, however, if hospitalisation or amputation is required these costs can be as high as €100,000. Diabetic foot ulcers pose a significant burden on healthcare systems around the world. The NHS in England spends almost 1% of its entire annual budget (£1.13 billion) on the diabetic foot. Almost all of these ulcers and amputations are preventable through early identification and proper care. Bluedrop Medical are developing a remote monitoring system that uses computer vision and machine learning to predict and prevent diabetic foot ulcers (DFUs). The home-based device, taking the form of a bathroom scales, performs a daily scan of the patient’s feet. In 10 seconds, thermal and photographic data is collected and sent to the cloud. Advanced algorithms monitor daily foot scans to detect DFUs before they develop, providing actionable alerts to both patient and healthcare provider. The technique of temperature monitoring has been proven to prevent 70% of DFUs and Bluedrop Medical are building this technique into an easy and quick to use device enabled by advanced sensor technology, computer vision algorithms and machine learning. By preventing ulcers, the technology can prevent hundreds of thousands of amputations, improving lives and saving healthcare systems millions of euro each year. Bluedrop Medical is targeting the highest risk patients who currently have a 30-40% annual incidence of ulceration by preventing ulcers in this group a potential average saving of €3,000 per patient can be achieved.

The objectives of this project were to complete product development of both the hardware and software components of the system, achieve regulatory approvals to market the product, and to commence pilot activities to generate real-world data regarding the product. All of this has been complete. Alongside these milestones the commercial strategy has been developed.

At completion of this project Bluedrop Medical is in a position to aggressively target the huge market for diabetic foot ulcer prevention and provide real impact to both patients and healthcare systems around the world.
Over the course of this project considerable progress has been made. The key area of focus has been on product development of both the hardware and software aspects of our product. We have completed all product development activities, with the final hardware design, packaging design, labelling design and sentinel software design all complete. Final validation testing is complete and production of devices us underway. Results of this testing, as well as design documentation has been submitted to necessary regulatory bodies with approvals required for US launch in place.
We have grown our medical advisory board to include influential clinicians and experts in clinical research. This Medical Advisory Board has assisted with the drafting of Instructions For Use documents, pilot study protocols and monitoring protocols.
In addition to product development, regulatory and clinical activities. We have conducted commercial activities involving the expansion of our IP portfolio to new regions and conducting a health economic benefit analysis. We have engaged with further potential distribution partners as well as continuing to work with existing partners.
At the end of this SME Instrument Phase 2 project we have a completed device with regulatory approval in place that is ready to be adopted. Our technology could help with the management of patients at high risk of developing diabetic foot ulcers – preventing amputations and saving money for healthcare systems around the world.