Feasibility Assessment of a Foot INflammation Detection Device

Hemics is a medical device company focusing on monitoring solutions for inflammatory joint diseases. This report describes how Hemics (SME) will deliver a feasibility study on the development, validation and commercialization of an imaging device (FootScan) to monitor joint inflammation in the feet of patients with Rheumatoid Arthritis (RA).
Current treatment of RA focuses on the reduction of disease activity to remission by use of drug therapy. Treatment of RA is guided by monitoring the disease activity. The latest scientific evidence shows that tight control strategies (frequent monitoring) are recommended in the early stages of RA as the best way of preventing escalation of the disease. The DAS28 score is the most used monitoring method, although it is too subjective, time consuming and painful for the patient.
Given the time constraints tight control is hardly possible through the DAS28 method. Other, more objective and sensitive, methods (eg. Ultrasound, X-Ray, MRI) are time-consuming and too costly to use as a regular basis for monitoring. This proves the clinical need for an objective, sensitive and time saving method to monitor RA, enabling tight control and treatment of, now often undiagnosed, subclinical inflammation.
Early 2015 Hemics received CE mark for its HandScan, fulfilling this need for monitoring inflammation in hands and wrists. In 2015 Hemics plans to start the product engineering phase for a commercial FootScan. To reach that milestone, this Phase 1 feasibility assessment covers a technical feasibility study as well as a business feasibility study. The objective of the feasibility assessment is to optimize the optical technology for the FootScan and to develop a business and implementation plan for successful commercialization.

In the technical feasibility study Hemics focused on the light penetrating the tissue of the feet and measuring the hemodynamic response (related to inflammation).
In this project, a prototype has been realized which was used for volunteer and patient testing. The measurement results have been used to demonstrate the potential of the FootScan and to obtain a set of specifications for a commercial device.

Two obstacles are tackled in this assessment:
1. the thickness of the body part (feet are thicker than hands which influences light absorption). To be able to measure the level of inflammation in the feet (as opposed to the hands) one needs stronger light sources than the lasers that are currently used in the HandScan. Several feet have been measured by positioning them over the highest intensity part of the HandScan illumination module. From these measurements, FootScan specifications have been created for the required illumination intensity.
2. the anatomical structure of the foot. Because of the anatomical differences between hand and feet the feet will react differently to the cuff inflation that is performed during the scan. This requires a different data analysis model to translate the measured response into an image representing the level of inflammation. A group of rheumatoid arthritis patients have been measured using a FootScan prototype. A modified handscanner algorithm has been applied to evaluate the potential of inflammation assessment.
Results of this technical feasibility study have been elaborated this report which will be used for further development of the FootScan.

An economic and business feasibility study was performed for the FootScan, including value proposition, competitive analysis, target market, entry and growth strategy, cost and pricing, market size, market share and sales forecasts, and a high level plan for reimbursement in the first target markets (Netherlands, Germany) was created.

Approximately 3 out of 4 rheumatologists we interviewed see a need for a FootScan (together with a HandScan) in their own practice, to enable a full exam in a sensitive, objective and time saving manner. The combination of Hand- and FootScan allows rheumatologists to
- increase the efficiency of their rheumatology practice. The scans can be performed by an assistant, and the rheumatologist can focus more on patients who have disease activity and less on patients who are in remission.
- more frequently monitor patients with early and/or active RA. Frequent monitoring in those groups is recommended by rheumatologist societies due to striking evidence of better outcome.
- detect and treat inflammation in “sub clinical” cases, in which the inflammation cannot be detected by clinical exam but does cause irreversible damage in the joints if left untreated. Detecting and treating these cases results in better outcome.
- make their treatment decisions based on objective data, rather than subjective measurements, increasing the transparency of the (expensive) pharmaceutical treatment.
- base treatment on a full exam, including the feet. Currently, rheumatologists often have too little time during a consultation to examine the feet of RA patients, and clinical exam of the feet is very difficult and thus not very reliable. However, under-treatment of the feet has the risk of unnecessary damage to the joints and over time, disability.

Better outcome for RA patients in the long run reducing joint damage, functional loss and discomfort for RA patients is of course an important societal impact by itself. Better outcome has also been shown to significantly reduce health care costs, as costs are linked heavily to disease activity, and societal costs due to disability, sickness leave and disability.

For Hemics, the FootScan is source of revenue, but also an enabler of increased HandScan revenue.
Increased revenue leads to more employment at Hemics and its manufacturing partner.

Periodic Reporting for period 1 - FIND (Feasibility Assessment of a Foot INflammation Detection Device)

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