Periodic Reporting for period 1 - INNOGAIT (Innovative Reflex-based Gait Rehabilitation)
Período documentado: 2020-01-01 hasta 2020-05-31
Stroke is a main cause of morbidity and mortality in adults and the leading cause of disability in all industrialized countries, affecting 15 million people worldwide every year. Gait (walking) problems are present in two thirds of stroke victims and half of those will still have persistent gait problems when they have completed their normal rehabilitation.
These impairments have significant impact in patient's life and considerable costs for health and social services: stroke rehabilitation is estimated in approx. €4.4bn in Europe and €3.3bn in the USA. The indirect cost to society (e.g. loss of productivity) is also severe, surpassing €11.5bn in the USA alone.
We have developed and patented the world’s first reflex-based gait training device, Incedo™ that gives a 20% improvement in gait speed and better gait symmetry as compared to conventional rehabilitation, while perfectly adapting to the current clinical practice.
Our objectives are to improve the product and prepare for the for-market expansion by updated market research, identification of distributors, define strategy for a clinical testing program, define reimbursement strategy and inclusion into clinical guidelines, expansion of the products indications, and validation of improved technical requirements.
These impairments have significant impact in patient's life and considerable costs for health and social services: stroke rehabilitation is estimated in approx. €4.4bn in Europe and €3.3bn in the USA. The indirect cost to society (e.g. loss of productivity) is also severe, surpassing €11.5bn in the USA alone.
We have developed and patented the world’s first reflex-based gait training device, Incedo™ that gives a 20% improvement in gait speed and better gait symmetry as compared to conventional rehabilitation, while perfectly adapting to the current clinical practice.
Our objectives are to improve the product and prepare for the for-market expansion by updated market research, identification of distributors, define strategy for a clinical testing program, define reimbursement strategy and inclusion into clinical guidelines, expansion of the products indications, and validation of improved technical requirements.
In the period we have evaluated the technical feasibility of optimizing the system to improve usability by the physiotherapist and the patient. This has been documented in a separate technical report.
We have surveyed 5 hospitals as a part of a feasibility report that documents our work and our analysis of the market expansion including geographical markets, route-to-market, competitor analysis, reimbursement strategies. This report clearly identifies the need for clinical trials in the different geographical markets to obtain validation and endorsement of the technology.
A Business Plan has been developed outlining the to the go-to-market strategy including possible stakeholders where we have initiated dialogue.
We have set up all the needed regulatory documents to plan the clinical evaluation Incedo™ system as a Class IIa medical device in the required regions and we have acceptance from the relevant institutions that they will conduct the clinical trials.
We have surveyed 5 hospitals as a part of a feasibility report that documents our work and our analysis of the market expansion including geographical markets, route-to-market, competitor analysis, reimbursement strategies. This report clearly identifies the need for clinical trials in the different geographical markets to obtain validation and endorsement of the technology.
A Business Plan has been developed outlining the to the go-to-market strategy including possible stakeholders where we have initiated dialogue.
We have set up all the needed regulatory documents to plan the clinical evaluation Incedo™ system as a Class IIa medical device in the required regions and we have acceptance from the relevant institutions that they will conduct the clinical trials.
Our work in this period have confirmed our belief that the use of Incedo™ device for training of stroke patients will: improve training outcome and shortens the stays at the rehab centres; b) it will allow a faster return of the patient to his/her active live also improving his/her dignity; c) eventually, the patient’s self-confidence will be improved with a faster recovery of his/her independence for daily life activities that ultimately may be translated into the return to a professionally active life, and; d) diminishing the socio-economic burden for informal caregivers/family. All together, these represent clear personal and socio-economic benefits.