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ICone: a novel device to scale up robotic rehabilitation and unlock the potential of motor recovery for stroke survivors.

Periodic Reporting for period 1 - ICone (ICone: a novel device to scale up robotic rehabilitation and unlock the potential of motor recovery for stroke survivors.)

Reporting period: 2019-11-01 to 2020-02-29

Heaxel srl is was founded in 2018, with the goal of enabling widespread and affordable access to advanced rehabilitation services for patients with neurological diseases, with an initial focus on stroke.
Heaxel developed the ICone, the first portable medical robotic device cleared for use also outside the hospital, even at the patients’ home premises (CE medical device, lass IIA).
ICone robots are connected into the IConeCloud architecture, with a centralized data management system. The IConeCloud is the first network of rehabilitation robots, distributed over rehabilitation hospitals, ambulatories, and physiotherapy gyms. Thanks to its wide accessibility and an affordable pay-per-use business model, ICone is the ideal tool to enable the continuum of care paradigm for stroke patients’ and represents an effective answer to chronic patients, who might have no further access to rehabilitation treatments. Heaxel is now working towards a pilot study for clinical validation of the IConeCloud and its large-scale deployment. Key objectives of the development are 1) hardware and software optimization for large scale deployment, 2) validation of the IConeCloud ecosystem in operational conditions through a pilot clinical trial; 3) set-up of a large-scale production line; 4) update CE mark certification for IConeCloud ecosystem.
Throughout the duration of the feasibility assessment, Heaxel defined the customer & users’ requirements for the ICone platform, consolidated the business model, reviewed the product development plan, defined the scale-up activities, and scouted for key stakeholders to support in the in-field validation. The market segments and opportunities have also been evaluated, and a commercialisation strategy has been defined. The Phase 1 feasibility assessment showed a compelling opportunity for the project, confirming the technical and commercial viability of the ICone. The EIC Accelerator Phase 2 funding could provide the needed support for the successful implementation of planned activities.
In 2035 there will be 4.6 million stroke survivors only in the EU. Unfortunately, due to non-optimal rehabilitation opportunities, only 12% of them will recover motor arm functionality. Stroke is in fact the second cause of disability in the world: while stroke mortality is declining, and this represents a clinical medicine success story, the number of strokes is expected to increase, due to the ageing population (1.4 Billion people will be over 60 in 2030). The economic burden of stroke in EU is huge, being €27 Billion in 2010. The largest part of it is linked to disability-related costs.
By creating a capillary network of rehabilitation robots, enabling affordable stroke rehabilitation, ICone will address the call of the World Health Organisation (WHO) for an improved rehabilitation offer. Intensive rehabilitation is key to stimulate “cortical plasticity” of stroke patients and ensure proper motor recovery, even in chronic patients, i.e. long-term patients that are currently not anymore treated, also due to shortage of financial resources. ICone is poised for reducing disability, enabling independent living, and thus reducing direct and indirect costs of reduced mobility. Moreover, it will increase the quality of life of people with stroke and their families and caregivers.