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Disruptive technologies for effectively rehabilitating chronic ambulatory disability

Periodic Reporting for period 3 - MARSI (Disruptive technologies for effectively rehabilitating chronic ambulatory disability)

Reporting period: 2020-09-01 to 2021-02-28

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 2030, the first paediatric exoskeleton worldwide for NMDs and Cerebral Palsy to be used during the children rehabilitation sessions.
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 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 clinical trial demonstrating the usability and absence of side effects of ATLAS 2030.
Explanation of the work carried out during the project:

WP1. Product industrialisation, components and system ready for industrial production. During the project ATLAS was reengineered, covering all aspects of electro-mechanical systems, manufacturability, quality and safety. We have prepared 2 zero batch units and 4 clinical series units devoted to completed the clinical trials.

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. We have obtaing the PEMS manufacturer licence and the ATLAS CE marking.

WP3. Demonstrate the positive impact of ATLAS in the rehabilitation of the patients and quality of life. To demostrate the safety and usability of ATLAS 2030, we designed a clinical trial including SMA and CP children. Based on the results of the systematic review and the clinical data collected on the safety and usability of the ATLAS 2030 exoskeleton , we have concluded that this device is satisfactory and allows mobility with minimal risk for patient safety. During the clinical report it has been demonstrated that the ATLAS 2030 device complies with the required criteria of security, benefit / risk ratio, performance and acceptance of side effects, thus achieving a favourable clinical evaluation for its use therapeutic.

WP4. Implementing exploitation strategy
A very intensive work has been conducted towards understanding the Frech 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 dissemination and communication activities has been performed focused on establish strong networks at national and international level with patient associations, hospitals, rehabilitations centres, 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 project results:
-ATLAS 2030 reingeneering towards industrialization
-PEMS licence manufacturing licence
-ATLAS 2030 CE marking
-Exhaustive understanding of the German, French and UK Healthcare system. Marketing plan defined.
-Business model update: route to market srategy, Product portfolio evolution plan and continuous R&I, Customer acquisition strategy, Redefined financials, strategies and plans, pricing models.
-Extension of Patents to US and European Countries
-Contacts and Dissemination actions towards stakeholders: policy makers, Stakeholders of public and private healthcare sector, Distributors, Families and patient associations, etc.
-Agreements with distributors for international commertialization.
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.

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.
Physical therapy with ATLAS 2030