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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - MARSI (Disruptive technologies for effectively rehabilitating chronic ambulatory disability)

Teaser

PROJECT CONTEXT Worldwide, about 60 million people have some kind of difficulty in walking. Approximately 40% of affected population correspond to physically disabled by cerebral palsy (14 million), neuromuscular diseases (NMD, 4 million), spinal cord injury (3 million) and...

Summary

PROJECT CONTEXT
Worldwide, about 60 million people have some kind of difficulty in walking. Approximately 40% of affected population correspond to physically disabled by cerebral palsy (14 million), neuromuscular diseases (NMD, 4 million), spinal cord injury (3 million) and spina bifida (3 million). For all these neurological disorders, when the absence of mobility becomes chronic due to a progressive muscle weakness and wasting, the person suffers from a series of physical and psychological complications that together with the patient\'s own disease, accelerates notably the loss of health.
Rehabilitation is crucial for keeping the quality of life of walking disabled. On one hand, it can keep to a minimum the level of disability and, therefore, its impact in the overall condition of the patient. On the other hand, it reduces the psychological impact, helping patients keeping active and more social. Within this context, in the last twenty years, most advanced orthoses have been developed thinking on people that have lost their capability to walk, leading to robotic exoskeletons, but the focus was put just on orthoses designed for the rehabilitation of adults suffering from spinal cord injury (paraplegia, only affecting legs), not considering patients suffering from cerebral palsy or degenerative disorders such as NMDs which cause long-term ambulatory disability from chilhood or adolescence.
In this context, MARSI has developed ATLAS 2020, the first paediatric exoskeleton worldwide for NMDs to be used during activities of the daily life extending rehabilitation from short periodic sessions to 24*7 model paradigm. With this project we want to accelerate industrialization and market uptake.

OVERALL PROJECT OBJECTIVES
To achieve full business potential of ATLAS at international level, we propose the following objectives:
1. Accelerate the industrialisation of ATLAS and its conversion into a full market product, and become ready for industrial production.
2. Get CE and FDA labelling for this product, carrying out all required tests and complying with required normative and standards.
3. Reinforce and extent strategic alliances with medical institutions, private insurances and foundations in our initial target countries.
4. Perform a full multicentre international clinical trials demonstrating the usability and absence of side effects of ATLAS.

Work performed

Explanation of the work carried out per Work Package during Period 1:

WP1. Product industrialisation, components and system ready for industrial production. During the period 1 we have prepared the first two units of ATLAS industrial demonstrators.

WP2. Completing ATLAS industrialisation & product certification.
In order to prepare our company to get the certification of our medical devices, we have implemented a quality management system based on the ISO 13485:2016 standard. Also a number of test benches have been introduced.

WP3. Demonstrate the positive impact of ATLAS in the rehabilitation of the patients and quality of life.
The documentation on pre-clinical data has been already finished. The development of the protocol for the trials has started in period 1 by the scientific coordinator Hospital Raymond Poncaré (Garches, Paris) and will be finished along period 2.

WP4. Implementing exploitation strategy
A very intensive work has been conducted towards understanding the German healthcare system, given its main role in the European market and its complexity. One dedicated business developer has been fully dedicated to this endeavour, moving to Munich for this period. He has been approaching clinicians, patient associations, and distributors presenting our technology to all of them.

WP5. Dissemination & Communication
An intensive first year of dissemination and communication activities has been performed focused on establish strong networks at national and international level with patient associations, hospitals, rehabilitations centres, e-health companies, health insurance companies and healthcare professionals in order to promote ARES technology to look for business opportunities and in the long term to sign stable commercial agreements throughout its lifetime.

Main results achieved in so far:
-Development of two zero-batch units
-Certification protocol of ATLAS product
-Preparation of Test benches
-Preclinical documentation, technical file of medical device and risk and safety assessment documentation.
-Selection of scientific coordinator and the 2 hospitals for the trial.
-Business model update
-Extension of Patents to US and European Countries
-Exhaustive understanding of the German Healthcare system and reimbursement. Marketing plan defined.
-Contacts and Dissemination actions towards stakeholders.
-Participation in the most relevant national and international congresses, events and fairs related to medical industry.

Final results

PROGRESS BEYOND THE STATE OF THE ART

Novelty in terms of market addressed and dynamics to generate.
MARSI’s ambition around Marsi Bionics is to open a new market based on a full range of high-tech robotic orthoses especially adapted for 24*7 use by chronic patients in order to maximise the benefits of rehabilitation, even along degenerative processes with changes into patients’ condition and needs.

Business model novelties.
MARSI’s products will be commercialized including renting models. This will allow patients directly acquiring them for daily use, which creates a great market opportunity.

Technological novelties. Marsi Bionics provides:
-The first clinical evidence on the usability and reliability of a robotic orthosis for ambulatory rehabilitation of NMD children.
-The first versatile and adaptable orthoses. Thanks to ARES technology (patented), our products are 100% modular, so exoskeletons are used adding or removing ARES elements (hip, knee, ankle as well as the balance module).
-The first wearable paediatric gait exoskeleton.
-The first in-house rehabilitation device. Marsi Bionics products adapt the footstep automatically to any terrain, enabling the mobility in all kind of surfaces and all directions.

EXPECTED RESULTS UNTIL THE END OF THE PROJECT
The following results are expected until the end of the project:
-ATLAS industrialization.
-Full cost analysis related to production, logistics and distribution channels.
-Implementation of a Quality Management System compliant with the ISO 13485 norm.
-Multicentre international clinical trial to demonstrate the usability and absence of side effects of ATLAS.
-CE Marking of ATLAS.
-To Implement and establish strategic alliances and agreements with international customer segments including corporate foundations, health institutions and health insurance companies.
-Scaling business model to international markets with special focus in Germany and France

POTENTIAL IMPACT
MARSI will have a major social impact on a particularly disfavoured group of patients; children suffering NMDs, also on their families and affective circles as well as caregivers and medical community. MARSI will improve the physical state of the patient by prolonging ambulation. This is not only important for improving their quality of life, but even for preserving their physical state. Furthermore, MARSI will also have a positive impact on health expenditure by preventing / delaying important health complications from non-ambulation.

Website & more info

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