Functional Electrical Stimulation for at Home Rehabilitation

Project Information

WalkHome

Grant agreement ID: 816385

DOI 10.3030/816385

Closed project

EC signature date 4 May 2018

Start date 1 June 2018

End date 30 September 2018

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost € 71 429,00

EU contribution € 50 000,00

Coordinated by

FESIA TECHNOLOGY SL
Spain

Periodic Reporting for period 1 - WalkHome (Functional Electrical Stimulation for at Home Rehabilitation)

Reporting period: 2018-06-01 to 2018-09-30

Summary of the context and overall objectives of the project

Neurological diseases affect the capacity of motor control in people suffering them, in severe cases, the complete absence of muscular function. Eating, dressing, walking or self-care can become difficult tasks due to the loss of that function. Looking only to stroke incidence in EU27, this is happening to over 1 254 000 people per year. However, due to brain neurosplasticity principle, it has been shown that patients can recover part or the whole lost function with rehabilitation. In most cases people are treated in acute and subacute periods through manual therapy with some orthotics support. However, in the last years emerging technologies have made huge progress to develop solutions/medical devices to enhance rehabilitation of different pathologies through neuroimaging, neurostimulation, robotics or muscle oriented technologies. Some of them are still in research and demonstrating its effectiveness in different studies since others (like Functional ElectroStimulatio, FES) have already shown its efficacy vs. manual therapy and orthotics, and are now being introduced to the market. In the FES field the conventional technology is using one anode and one cathode to make the stimulation, facing some challenges in effectiveness and in the expertise level required for a clinician to use it due to positioning/calibration of the electrode and selectiveness/precision of the stimulation. Fesia Technology was born to solve this issues with the final mission to improve quality of life of people that have lost motor function through selling medical devices. Based on a new FES technology, matrix electrode, our product can stimulate each area more precise and selectively and allows an automatic parametrization of the stimulation pattern which brings many improvements: fatigue reduction allowing more intense rehabilitation, reach more natural movements, do not require FES expertise, reduces set up times and is dynamically adjustable. This helps clinics and rehabilitation centres to treat better the patients and achieves certain level of independence of the patient in the first phases of the pathology but not in the final and longest step, chronic stage. What if we could bring this technology to patient’s home for the chronic stage? Imagine a person that has suffered a drop foot pathology and has the possibility to wear continuously a neuroprosthesis that can help him going securely (without the possibility to fall) and naturally (without compensatory movements) to the supermarket to buy groceries, sitting down to have a coffee in a coffee-shop and walking through a park with his/her children once anbulatory period has end. Additionally, during all this time his brain would be training and re-learning the function of walking due to neuroplasticity ability so with the time the assistance of the neuroprosthesis will be less and less necessary. This would imply a radical change in the life of this people and also in the way health systems cand treat these pathologies. Achieving that new standard through a solution based in Fesia technology is our goal.

Therefore, overall objective of the Fesia Walkhome project is to develop a neuroprostheses that will help patients in a better, more independent and more customized rehabilitation of drop foot pathology. For that purpose, we needed to understand many things that were analysed in the SME Phase project: differences that the home product should have vs. the clinical product (in terms of technology, market needs, business model, regulatory), key markets for this product (based on incidence, market reimbursement strategies, etc.), current competitive landscape, potential business model, market willingness to pay, and go-to-market strategy. This has help us developing a solid development and business plan to pursue the opportunity.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work performed

First part of the action has been drawing up many things about the FES home market that the company was not knowledgeable of. We started with a deep analysis in incidence and prevalence data as well as review of market reports for FES. With this, we have estimated coherent market figures crosschecking top-down and bottom-up analyses. We also have looked at competitors in FES market and also analysed other “similar” categories that are more advanced in development of home market such as robotics trying to understand product characteristics, business models, prices, etc. We also have reviewed the reimbursement strategy of different countries which is a key purchasing driver for patients.

For all this we have used a twofold strategy:
• Leverage solid secondary sources and market reports
• Primary research (interviews with different stakeholders). In this case we have tried to bring perspective of clinicians (neurologists and physiotherapists), medical equipment manufacturing companies, research centers with capabilities in FES and end user associations or individual patients). A list of interviews performed can be found in the Annex of this document

Considering all this work, we have built a development plan and business projections for the project.

Results achieved so far

FES have shown is effectiveness vs. manual therapy or orthotic solutions for neurological disease rehabilitation but there is a clear need to improve current FES solution technology to achieve all its potential in clinic environment and Fesia can bring this step forward with its current innovative technology and products. Bringing FES rehabilitation home will be even a larger step towards improving patients’ quality of life. Other technologies such as robotics or connected health (i.e. fall detection devices) have started with the development of this market but in case of FES is still an unexplored territory. To be successful on it Fesia still needs to improve and adapt its products and go-to-market strategy.

If we crack the FES Home Market we will be solving many problems to patients (possibility to rehabilitate earlier and better and therefore achieve better quality of life through a customized rehabilitation) and to health system (reducing costs through making telerehabilitation possible and reducing collateral pathologies due to better rehabilitation). This FES home market is not only good for main stakeholders, but is also attractive for a company that would like to explore and develop it. We have estimated for EU28 a market between 1.600-2.400M€.

There are certain countries more attractive than others within EU to start with the market entry strategy. These countries have either reimbursement code or easiness to apply for it with FES technology, have a large potential of users and are more used to introduce FES and, in general, technology in hospitals.

Many changes need to be applied to a clinical FES rehabilitation product to transform it in a FES neuroprostheses that would help the patients after leaving the ambulatory treatment, in chronic period. The main changes are in automatization of the stimulation pattern (introduce machine learning to enhance adaptation of the pattern to patient evolution and day-to-day status), miniaturization of the product (making possible to wear it without visible) and cost reduction (patients in general will not be willing to pay more than 2.000€ for such a device).

Changes will be also necessary in go-to-market strategy. The final client is different (clinics vs. patients / insurance companies) and the channels that are necessary to exploit to reach it have also very different drivers (in one case you need to reach decision makers in hospitals normally through the presence in a catalogue of an important distributor of medical devices, in the other orthopaedics and even B2C strategies such as Internet sales are going to be key).

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

We are developing a product that is non-existent for a market that exists and requires it (we are solving some clearly stated problems to the different stakeholders of neuromuscular disease rehabilitation field). The product will generate Industrial Property for Fesia and will contribute in many positive aspects for the company:
• Adding 9,6M revenues by 2025, WalkHome will be the main product of Fesia
• Sustaining the recruitment of 5 qualified team members by 2021, 9 by 2025
• Contribution in healthy cash flow generation from 2022, reaching 4,6M€ in 2025

Additionally, we will add up some intangible metrics:
• Pioneering global positioning in ready to crack at-home market
• Development of knowledge in end user go-to-market
• Positioning as technology based innovative company in an sector where innovation perception is key
• Improvements in technology that could be in part also applied to other Fesia products
• Develop needed portfolio to penetrate North American market

But not only this. The product will also help the health systems increasing effectiveness and efficiency in neurological disorder rehabilitation treatment. And even more important, it will be a huge impact for the patient in its daily life because it will allow a quicker/stronger way to regain daily functions and thus improve significantly the quality of life.

Fesia Walk Rehab product

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