Periodic Reporting for period 1 - DiaMon (Continuous Diaphragm Monitoring for mechanically ventilated patients)
Reporting period: 2016-03-01 to 2016-08-31
The diaphragm is the most important respiratory muscle and yet, it is rarely measured during weaning, due to the complicated and personnel-intensive method of standard ultrasound imaging and low diagnostic accuracy of palpation. Further, continuous monitoring is not possible with either of these alternative techniques. DiaMon is the first ever ultrasound sensor that can stick to the skin during weaning to provide continuous, objective data in a non-invasive way to support decision making during extubation from MV.
The objectives set out in our SME phase 1 application have been achieved as described in this report. We have confirmed a clinical need, identified a clinical indication (weaning), established a business plan based on market research, commenced clinical testing and established collaborations for future validation trials. Our clinical plan has been constructed in such a way that it minimises risk of failure in the validation phase.
After successfully completing the feasibility study, we strongly believe that Respinor AS is ready to undertake the SME Instrument phase 2 project to realise our development, clinical validation and commercialisation objectives.
In line with the objectives of the SME instrument phase 1 project, the focus of this project has been on delivering the following tasks:
1. Define value proposition of DiaMon with key stakeholders.
2. Develop a market study and financial risk analysis and compile it into a business plan.
3. Prepare clinical trials for Phase 2.
The outcomes from this project have led us to develop and test a feasible business model on engaging stakeholders. We’ve further initiated a clinical feasibility study and both of these outcomes have reduced the overall risks of the SME instrument phase 2 project to be submitted for consideration in January 2017.
It is critical to provide optimally adjusted MV to secure a safe, efficient, and as short as possible treatment. Overextending the lungs during initial set-up can lead to lung injury. Poorly adjusted ventilation and untimely discontinuation (too soon/too late) is associated with a prolonged need for treatment and involves substantial strain on the patient and healthcare resources. The continuous monitoring of the diaphragm movement through DiaMon will significantly enhance the MV process from initiation to discontinuation.