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PODIUM™ - A home device and cloud-based software and algorithm for diabetic foot ulcer monitoring

Periodic Reporting for period 1 - PODIUM (PODIUM™ - A home device and cloud-based software and algorithm for diabetic foot ulcer monitoring)

Berichtszeitraum: 2019-01-01 bis 2019-06-30

Problem being Addressed
There are 60m adults suffering from diabetes in Europe (10.3% of men and 9.6% of women aged 25 years and over). One life-threatening complication of diabetes is the diabetic foot ulcer (DFU). Studies revealed a 12% to 25% lifetime risk of developing DFU for diabetics, meaning at least 7.2m Europeans and 50.6m worldwide (422m diabetics in 2014 according to WHO) might suffer from DFU in their lifetime calculated based on lowest risk of 12%. A serious consequence of DFU is lower limb amputation; 85% of the amputations in diabetes sufferers are reported after unsuccessful DFU treatment amounting to 290,000–450,000 amputations/year in Europe, at a cost of €2–2.5bn/year.

Importance for Society
The PODIUM technology is a novel, highly reliable and highly sensitivity solution for the cost-effective diagnosis and monitoring of DFUs at a patient’s home through rapid temperature imaging and reliable analysis of thermographs. PODIUM will result in increased numbers of prevented DFUs through 10 times higher sensitivity than any competitive solution. A timely response from physicians, facilitated by Podium’s telemedicine feature will reduce DFU-related toe, foot and leg amputations, and a reduction in healthcare costs. If PODIUM technology impacted only 5% of DFU sufferers, this would mean substantial Quality of Life (QoL) improvement for at least 400,000 Europeans and at least 2.5m sufferers worldwide (calculated considering the 12% lower risk of developing DFU), substantially reducing associated healthcare costs. The full costs of DFU care in the EU is €10bn per annum.

Overall Objectives
(1) to optimize the current version, using liquid crystalline cholesteric esters instead of infrared camera as detection method and
(2) to validate the higher efficacy, diagnostic value, convenience and cost-effectiveness of PODIUM over conventional thermal-based approaches for DFU.
Task 1 - Technical feasibility study
a) We have determined the technical features and specifications for the optimization of the hardware and software and created a set of application programs to test various possibilities for improving speed, efficiency and ease of use.
b) A competent advisor in the field of Regulations (EU) 2017/745 and 746 for Medical Devices was found. We are close to completing an ISO13485 compliant QA system that will provide the input data for the Technical File.
c) Medical Device classification for hardware and software was confirmed.
d) A technological study of the specifications required from the hardware was completed and fed into a) above.
e) Assessment of improvement efforts was performed.

Task 2 - Commercial feasibility study
a) Definition of our commercial strategy has been completed.
b) In progress: Identification and selection of a CRO help us in the design of protocols and patient selection in order to carry out a multicentre clinical trial.
c) Definition of a strategy for overcoming market barriers (barriers identified, consulting with various sales channels) was completed.

Task 3 - Financial feasibility study
a) Results of Task 1 and Task 2 above were used to update our Business plan for the next 5 years
b) Initiated and requiring constant monitoring: determination of the necessary steps to get reimbursement coverage in target countries.
c) Evaluation of the total investment required was performed and profit forecast for the next 5 years created (preliminary data were fed into a) above).
Progress beyond state of the art
a) In collaboration with a manufacturer of thermochromic liquid crystal sheets a dedicated multi-layer composite material was created. Testing confirmed that the desired properties were achieved.
b) A potential patentable image acquisition and processing idea was identified.

Results achieved
a) A full technological evaluation of the specifications requested from hardware, software and cloud portal of at least 3 of our potential partners.
b) A commercial strategy
c) Selection of an independent Clinical Research Organization (CRO) to help us in the design of protocols and patients’ selection in order to carry out a multicentre clinical trial across Europe.

Potential impacts
Significant reduction of the incidence of diabetic foot ulceration and subsequent lower limb amputations (450,000 every year in the EU).
Podium Foot Monitor and App Prototype