"First ""All-in-one"" and Adjustable Supraglottic Airway Device for a Safely Clinical Airway Management"

Informations projet

Safe SAD

N° de convention de subvention: 826840

DOI

10.3030/826840

Projet clôturé

Date de signature de la CE 20 Juillet 2018

Date de début 1 Août 2018

Date de fin 30 Novembre 2018

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

SINGULARITY AG
Switzerland

Periodic Reporting for period 1 - Safe SAD (First ""All-in-one"" and Adjustable Supraglottic Airway Device for a Safely Clinical Airway Management)

Période du rapport: 2018-08-01 au 2018-11-30

Résumé du contexte et des objectifs généraux du projet

The main objective of SAFE SAD, is to scale up an assembly plant to automate the manufacturing process to meet quality requirements and adapt the tools to produce SAFE SAD units in adult and children sizes. Once the CE marking is granted, a definitive clinical unit, will be used to conduct initial clinical trials (on 120 patients) in order to validate it in compliance with directive 93/42/EEC on medical device type class 2a. Further testing of all sizes and extended CE certification will be also be done.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Based on the results of the comprehensive market research that we conducted, we determined the customer needs, and also identified the most promising markets that we should target for initial entry. This also revealed the existence of a lucrative at €1.42 billion global niche market for airway management devices with a CAGR of 5.6% between 2018 and 2023.
The market study results were then used together with our marketing capacity and taking into consideration the activities of competitors to make 5 year financial projections of the SAFE SAD project post commercialisation. . SAFE SAD is expected to contribute €109.5M to Singularity’s annual revenue by the 5th year after commercialisation. Profits are also forecasted to grow to €41.6M in the 5th year.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

SAFE SAD is the first “all in one” functional SAD whose improved technical features will lead to an increase in safety and efficacy under operating conditions when compared with current technologies on the market. Furthermore, SAFE SADS have been deliberately designed to be manufactured using a fully automated production line, reducing the current production time for each device, from 40-45 minutes to 4 seconds; thus, reducing the average price by 30-50%. SAFE SAD will benefit all patients undergoing operations involving anaesthesia, as well as those suffering from respiratory diseases and complications (e.g. elderly people with COPD). The main benefits is that the new device offers better injury prevention during both insertion and the intervention; thereby, lowering associated risks and diminishing post-operative issues. . The improved performance of the device will not only shorten turnaround time but benefit society by reducing the costs associated with the complications derived from the use of SAD in operating rooms and post-operation issues and for the healthcare system as a whole

All-in-One Supraglottic Airway Device