Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ABLE (Home use, affordable and lightweight exoskeleton for people with lower-limb paralysis)

Teaser

Spinal cord injury (SCI) is a catastrophic event that thrusts 5 million people worldwide into a life challenged by disability. This generates dependency in Activities of Daily Living; health complications associated with lack of mobility (osteoporosis, chronic pain, pressure...

Summary

Spinal cord injury (SCI) is a catastrophic event that thrusts 5 million people worldwide into a life challenged by disability. This generates dependency in Activities of Daily Living; health complications associated with lack of mobility (osteoporosis, chronic pain, pressure sores, and cardiovascular, digestive and urinary problems); high economic costs (350 k€ 1st year, 40 k€ next); and severe social and psychological consequences.
People with a SCI could walk again if they had a robotic exoskeleton to restore the leg movements affected by the injury. However, the devices on the market are expensive, heavy and require professional supervision. Therefore, they are only found in large hospitals and are out of reach for the patient.
The World Health Organization estimates that there are 250 to 500 thousand new SCI cases every year. In industrialized countries, 60% of the injuries are incomplete (some sensory or motor function below injury level). Half of these patients (99.000 in EU and 117.000 in US) maintain certain control over the hip, but not the knee and ankle joints, and do not have technology adapted to its specific motor needs.
ABLE is the first lightweight, easy-to-use and affordable exoskeleton that allows SCI people to walk again. It is based on an electric actuator that flexes and extends the knee during walking, mimicking human natural movement, and an inertial sensor that detects the user’s intention to take the step forward. A unique and patented control method leverages the user experience with the exoskeleton by seamlessly detecting their intention, without performing unnatural postural cues. Furthermore, algorithms’ parameters are constantly updated using machine learning techniques to meet specific user requirements during gait.
The objective of the feasibility study was to validate the business plan for the ABLE project for SCI, including market segmentation assessment, commercialization strategy validation and close agreements with key partners and stakeholders. However, during this Phase 1 implementation, we have been able to obtain additional public funding to bring the product for SCI individuals to the market. Therefore, we have taken this opportunity to identify other medical applications where the ABLE technology can fit.
Now we can conclude that the most promising application is STROKE, due to its large and rising market and the need for customized solutions. We can also confirm, after a deep analysis, that adapting the ABLE technology to post-stroke individuals is technically, financially and commercially feasible. This is why we have decided to apply to EIC Accelerator with a proposal named Lazarus, to proceed with the implementation phase and bring the product for stroke to market. We have built a complete roadmap, sizing the team and analyzing the budget required to bring this innovative technology to the market to improve the quality of life of many people.
Developing a product for this new market will have a great economic impact on our company. In addition, having a product portfolio for several applications will allow us to offer a complete solution to a wider spectrum of users in a continuum care basis.

Work performed

During the SME Instrument Phase 1 we have studied in detail the market for medical exoskeletons to see if ABLE technology can benefit additional groups of individuals. We have conducted interviews with industry experts and relevant stakeholders such as medical doctors, physiotherapists and individuals with hemiplegia due to stroke, while researching on competitors and market trends and sizes.
The overall conclusion has been that the ABLE technology has great potential and interest beyond SCI. In fact, the feasibility study has helped us to identify a medical application with a larger market than SCI, in which our technology has generated a high level of interest among clinical professionals and patients: POST-STROKE individuals. This is the medical market with the highest growth potential and added value where our technology could fit, given its flexibility to be adapted. We have also observed recent movements of the main competitors in the market in this direction.
Every year, 15 million people worldwide suffer a stroke. Stroke is a leading cause of movement disability in the US and Europe. By 2030, it has been estimated that there could be as many as 70 million stroke survivors around the world. Developing a product for this new potential rising market will have a great economic impact on our company. In addition, having a product portfolio for several applications will minimize product launch risks and allow us to offer a complete solution to a wider spectrum of users.
Our engineering team has extensively analyzed the technical feasibility of adapting technology to stroke. The main changes that need to be are implemented are the integration of a powered ankle, non-paretic limb sensors and force sensors to detect human-robot interaction. Software also needs to be adapted by means of new adaptive control algorithms and personalized motor-sensory rehabilitation exercises. Although it is an important challenge, our engineering team has confirmed it is technically feasible to adapt the ABLE technology for stroke survivors in a 2-years’ time frame.
For all this, we have decided to develop this new product for post-stroke individuals, a project we aim to submit to SME Instrument EIC Accelerator, under the name Lazarus. The implementation phase will begin in early 2020. Lazarus is an innovative and high-impact project which shows potential to be developed to the level of investment readiness/market maturity, and only requires additional funding.

Final results

Below there is the value proposition (expected impact) with this new product for clinics and patients:
Clinics
• Demonstrate clinical benefits:
o Improve early mobility
o Quantifiable improvement of motor function
o Promote independence
o Faster recovery
• Quantify cost-effectiveness:
o Less medical visits
o Reduce risk of readmission
o Less PT resources, less physical strain
o Reduce rehabilitation time

End-users
• Provide continuum care
• Social integration with family and friends
o Autonomous ambulation: to perform Activities of Daily Living
• Get constant customer feedback and provide agile and great support
• Accessible price point:
o Technology adapted to end-user needs
o Seek reimbursement
o Renting models (monthly fee)
o Adding diagnostic features

Developing a product for this new market will have a great economic impact on our company. In addition, having a product portfolio for several applications will allow us to offer a complete solution to a wider spectrum of users in a continuum care basis. Lazarus will deliver gait training not only in the clinical setting but also in a daily basis at home to improve their independence and quality of life.
The implementation of EIC Accelerator will boost the company’s growth, resulting in significant turnover, profit and the creation of many quality jobs. Also, during the project implementation several pre-sales agreements with clinical institutions around the globe will be made.

Website & more info

More info: http://www.ablehumanmotion.com.