Aire-19, the new ventilation system for COVID-19 patients, developed by researchers from the Polytechnic University of Valencia (UPV), the Institute of Biomechanics (IBV) and Technological Institute AIDIMME, has received the authorization of the Spanish Agency for Medicines and Healthcare Products (AEMPS) for its use in clinical research, which will take place for 12 months in Valencia's Hospital Clínico.
Following the approval of the AEMPS, Aire-19 will be manufactured by Celestica, Ford España and Technología Aplicada a la Maquinaria S.L. (TAM), all of which are companies from the Valencian Community, and commercialised by Mercé V Electromedicina, a leading company in the distribution of healthcare products.
The estimated cost of these devices would be €2,500. The result of this project is a great example of the importance of the collaboration between the scientific and technological fields with the industrial sector, especially in a scenario like the one created by the COVID-19 pandemic, and a clear example of Valencian research capabilities and business fabric.
This will allow the Valencian Community to be better prepared in the event of a second wave of infections.
Aire-19 was developed in the laboratories of the UPV and has become a reality thanks to the joint effort of Valencian researchers and companies of renown national and international prestige. Furthermore, for its development, the contribution of hospitals from our city such as the Clínico or La Fe have also been key."
Javier Saiz, Director, Centre for Research and Innovation in Bioengineering and Project Coordinator, University of Valencia
Saiz also adds that the clinical research approved to take place at the Hospital Clínico of Valencia is open to other hospitals of the Valencian Community or across Spain that wish to adhere to the program.
After overcoming all the tests of the Spanish Agency for Medicines and Healthcare Products (AEMPS), Celestica, Ford España and TAM have already validated the manufacturing process by adapting their manufacturing lines, and could supply up to 200 units a week of the Aire-19 device, if required.
Thus, as well as its importance in the field of medicine and assistance, this project also entails a boost for local employment, as both the manufacturing and distribution of the Aire-19 devices are to be carried out by Valencian companies.
"This project is a clear example of what companies and institutions of the Valencian Community can achieve when we work as a team. Valencian technology and manufacturing which promotes employment.
We hope that Aire-19 will become a reality and reinforce the ICUs that the Valencian government is putting into operation," stresses Mónica Bragado, director of Business Development at Celestica.
Designed and developed in record time
The group headed by the Centre for Research and Innovation in Bioengineering (Ci2B) of the UPV designed and built the first prototype in record time.
To do so, the knowledge and capabilities of the IBV were applied to the development of healthcare products acquired through research projects such as the IVACE 4HEALTH.
Then, AIDIMME, based on their experience of over 30 years developing industrial products and equipment, and with the collaboration of TAM, a company dedicated to designing and manufacturing tailored machinery, developed and manufactured two industrial prototypes, which were used to verify their performance in different preclinical trials.
"Aire-19 was designed for an easy and quick manufacturing, with accessible components on the national market to avoid the international supply issues that are taking place in order to acquire essential elements with which to fight against COVID-19," says Carlos Atienza, director of innovation at the Healthcare Technology department of the IBV.
For its development, the UPV, IBV and AIDIMME team also relied on the collaboration of experts in mechanical ventilation and resuscitation of the CIBER for Respiratory Diseases (CIBERES) - University of Barcelona and the group for Research on Anaesthesia - INCLIVA of the Hospital Clínico of Valencia, as well as the Hospital Universitari i Politècnic La Fe of Valencia and the Catholic University of Valencia.
Preclinical trials with artificial lungs, on an animal model and on electromagnetic safety
Until achieving the authorization of the AEMPS, the device has overcome demanding trials designed for the approval of healthcare products: the first, with an artificial lung, was possible thanks to the collaboration of the Catholic University of Valencia, who provided a simulator that can replicate the physiological conditions of a patient with COVID-19.
"This trial made it possible to confirm that the volumes of air and pressures provided by Aire-19 are suitable for the different types of respiratory issues that patients with COVID-19 suffer from," explains Javier Saiz.
Then, a preclinical trial was conducted on a porcine model, thanks to the collaboration of the Hospital Universitari i Politècnic La Fe of Valencia - Aire-19 kept an animal alive for over six hours with optimum ventilation. And, lastly, a functionality, electrical safety and electromagnetic compatibility test was conducted at the Central Official Laboratory of Electrical Engineering (LCOE).
"The device overcame all the functionality, safety and electromagnetic compatibility tests required by the Agency, and was working uninterruptedly for several days.
Aire-19 has been designed to be reliable in conditions of continued use in hospital environments, with a mechanism comprised by market elements that can be easily supplied, which have been verified for industrial uses, and which allow its manufacturing on an industrial scale to be fast and effective," concludes Luis Portolés, in charge of Strategic Markets and Exploitation of Technological Institute AIDIMME.
To complete the validation of the project and achieve the definitive approval of the AEMPS, the Valencian companies that will be in charge of the mass manufacturing of these devices, Celestica, Ford España and TAM, have manufactured two prototypes that have allowed them to validate its productive process and installation, and to ensure their optimum preparation for a possible manufacturing, if necessary.
The project is also backed by the Valencian government. The Council for Innovation, Universities, Science and Digital Society has funded this initiative through the Autonomic Secretariat for Universities and Research, as part of the call to the Valencian system of innovation and research to fight against the pandemic, conducted by the Council for Innovation in collaboration with the AVI. Furthermore, the Council for Sustainable Economy, Productive Sectors, Commerce and Work, through the IVACE, has backed the IBV and AIDIMME technological centers, which are members of the Valencian Technological Institute Network (REDIT), by providing capabilities and resources to be able to conduct these developments.
Now, with the authorization of the AEMPS, the project is expected to also receive the support of the Council for Universal Health and Public Health, to back the said clinical research in other hospitals of the Valencian Community, and for Aire-19 to be considered a valid option if needed in the future.