Continuous Diaphragm Monitoring of mechanically ventilated patients

Description du projet

Une technologie innovante pour la ventilation mécanique avec surveillance du diaphragme

La ventilation mécanique (VM) est une procédure qui consiste à administrer de l’air aux poumons et à l’évacuer par l’intermédiaire d’un dispositif externe relié au patient. Il est important, tant d’un point de vue clinique qu’économique, de sevrer les patients de la VM et de les ramener à une respiration normale et spontanée aussi rapidement que possible. Toutefois, aucune solution n’a encore été mise au point pour soutenir le processus de sevrage de la VM. L’entreprise norvégienne RESPINOR développe la technologie d’excursion du diaphragme (DXT), un dispositif médical non invasif à base d’ultrasons de surveillance continue du diaphragme des patients. RESPINOR a produit la première version du DXT et a lancé des études cliniques. Le projet DiaMon, financé par l’UE, entend démontrer, dans le cadre d’essais cliniques de grande envergure, que la nouvelle technologie réduit le nombre d’échecs de sevrage par rapport à la norme de soins.

Objectif

Respinor aims to seize a major market opportunity through the clinical validation, technology maturation and commercialization of a unique ultrasound technology for Diaphragm Monitoring – DiaMon. DiaMon is a non-invasive ultrasound device that is designed to provide precise, continuous and real-time information of diaphragm function. The diaphragm is the main muscle involved in breathing.

Treatment with Mechanical Ventilation (MV) results in high costs for healthcare systems. The incremental cost of MV is estimated to be €1,500 per patient per day. With an estimated 1.35 million MV patients in the EU per year for an average of 4-5 days, this represents an expenditure of at least €8.1 billion annually. Therefore, it is highly important both clinically and economically to bring patients off MV and back to normal, spontaneous breathing as quickly as possible.

There is currently a severe lack of accurate and cost-effective solutions to support the MV process. Respinor aims to fill this gap, by demonstrating and commercializing a cost-effective and user friendly ultrasound device, being the only effective non-invasive alternative to invasive catheter based solutions.

Under Eurostars and Horizon 2020 SME Phase 1 grants, Respinor has developed a first version of DiaMon and initiated clinical studies. Preliminary results are very promising. The overall objective of H2020 Phase 2 is to: 1. Demonstrate in large clinical trials (700 patients) that DiaMon can reduce MV failure compared with standard of care and 2. Further develop DiaMon into a commercial product with high usability and acceptance in the ICU setting.

The accomplishment of the proposed project objectives will bring major benefits to Respinor with a forecast significant cumulated turnover by 2025 in the ICU MV market segment. The demonstration of the benefits of DiaMon in the weaving process will foster the entrance in the large respiratory market.

Champ scientifique

Programme(s)

Thème(s)

SMEInst-05-2016-2017 - Supporting innovative SMEs in the healthcare biotechnology sector

Appel à propositions

H2020-SMEInst-2016-2017

Voir d’autres projets de cet appel

Sous appel

H2020-SMEINST-2-2016-2017

Régime de financement

SME-2 - SME instrument phase 2

Coordinateur

RESPINOR AS

Contribution nette de l'UE

€ 2 988 500,00

Adresse

GAUSTADALLEEN 21
0349 OSLO
Norvège

PME

Oui

Région

Norge Oslo og Viken Oslo

Type d’activité

Private for-profit entities (excluding Higher or Secondary Education Establishments)

Liens

Contacter l’organisation

Participation aux programmes de R&I de l'UE

Réseau de collaboration HORIZON

Coût total