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Continuous Diaphragm Monitoring of mechanically ventilated patients

Project description

Innovative technology for mechanical ventilation with diaphragm monitoring

Mechanical ventilation (MV) is the procedure of delivering air to and from the lungs via an external device connected to the patient. It is important, both from a clinical and an economic perspective, to wean patients off MV and return them back to normal, spontaneous breathing as quickly as possible. However, solutions to support the MV weaning process have not yet been developed. RESPINOR in Norway is developing diaphragm excursion technology (DXT) as a non-invasive, ultrasound-based medical device for continuous monitoring of the patients’ diaphragm. RESPINOR has produced the first version of the DXT and initiated clinical studies. The EU-funded DiaMon project aims to demonstrate in large clinical trials that the new technology reduces MV weaning failures compared to the standard of care.

Objective

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.

Call for proposal

H2020-SMEInst-2016-2017

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Sub call

H2020-SMEINST-2-2016-2017

Coordinator

RESPINOR AS
Net EU contribution
€ 2 988 500,00
Address
GAUSTADALLEEN 21
0349 OSLO
Norway

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Norge Oslo og Viken Oslo
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost
€ 2 988 500,00