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A medical device for airflow simulation of the human upper airways

Periodic Reporting for period 1 - NASALFLOW (A medical device for airflow simulation of the human upper airways)

Période du rapport: 2019-06-01 au 2019-09-30

Nasal airway obstruction (NAO) can be defined as nasal ventilatory difficulty of a patient that is unable to achieve enough air volume in the upper airways to keep a quiet breathing without perception of obstruction or resistance. From 30% to 40% of population suffer from NAO, 259 million people in Europe alone.
Some of the patients suffering nasal diseases need to undergo surgery, a procedure that is potentially hazardous for the patient, but also very expensive for patients and governments.
Nowadays, the most used tests by the clinicians are Peak Nasal Inspiratory Flow, Acoustic Rhinometry and Rhinomanometry. These tools are used inefficiently in clinical practise due to its limitations. Hence, there is an upcoming need for new objective and accurate technologies that provide more detailed information about the airflow patterns inside nasal cavity.
The revolutionary NASAL~ FLOW® from N.A.S.A.L company (Spain) is an automatised medical device based on the Computer Fluids Dynamics (CFD) analysis of human nasal cavities. A standardised procedure is set to study systematically the flow patterns of each patient and provides a huge amount of medical information that traditional methods are not able to obtain.
In addition, it embedded a Virtual Surgery tool (VS), where several surgery methodologies can be assessed computationally without invasive procedures for the patient, saving time and money for health system.
Therefore, this approach will help doctors and surgeons to better diagnose and carry out surgical planning for nasal diseases.
The main objective of this project is based on the paradigm shift in the diagnosis and treatment of the main diseases that affect the upper respiratory system and the enablement of NASAL~ FLOW® as a standard objective in rhinology, achieving its introduction in the daily clinical practice.
During the Feasibility Study, we have analysed main key points to verify the viability of the Project from a technical, commercial and financial point of view.
Regarding Technical aspects, we defined the work plan to be implemented to better achieve the development and upgrade of NASALFLOW features necessary to reach the market launch status. In this sense, in addition to global improvements (especially the virtual surgery tool), the feasibility of forced breathing and particle dynamics models has been validated. Furthermore, the necessary framework has been defined to carry out the clinical tests that allow to verify the validity of NASALFLOW as a diagnostic and treatment tool.
Regarding the commercial section, we have carried out an extensive prospective analysis of the market for medical devices in the ENT area, anticipating trends and needs to be able to define a new market niche in which to place NASALFLOW, since we cannot fit it into a specific submarket.
In addition, given the novelty of our service, we have evaluated the different options to protect it from competitors, as well as the detailed study of the existing IPR barriers that enable us to operate in our target markets.
Finally, we have defined our commercial and dissemination policy for the project in order to involve the greatest number of stakeholders.
In relation with financial section, we have prepared 5-year financial projections in which the main conclusions derived from the technical and commercial sections have been taken into account, as well as we have estimated the required funding to undertake the project under these conditions. All this output data has allowed us to update the business plan of the project and offer mitigation solutions in case of unforeseen events.
Simulation is a very powerful tool that is increasingly being applied more and more to the world of medicine. It is currently used in the field of hemodynamics and structural analysis of bones and muscles. Probably, in a few years, all the processes that occur within our body can be reproduced by computational simulation and, therefore, it will be a game-changer of the healthcare in the future.
In our case, we are ready to lead the simulation sector of the upper respiratory system thanks to NASALFLOW. So far, we have assessed some companies with similar activity but they are at an early stage or they are still ongoing projects, far from our level of development.
For example, thanks to our Virtual Surgery tool, we can greatly improve the success rate of operations related to nasal obstruction and even prevent patients from undergoing inefficient operations, saving a significant volume of medical resources as well as emotional connotations for a patient to go through the operating room.
NASALFLOW In.house rack installation
Virtual surgery tool
3D viewer of NASALFLOW
Example of Wall stress shear data from NASALFLOW
Airflow inside the nose
NASALFLOW In-home device
Example of output data from NASALFLOW