Technology

The novelty of RESPINOR DXT lies in the usage of a small ultrasound transducer in a highly specialized sensor design that can be attached to the skin surface using a patented, disposable, adhesive solution. RESPINOR DXT is easy to use and allows for continuous monitoring of diaphragm excursion and respiratory rate.

Successful proof of concept study completed and presented at the ERS Congress in Milan 2017.

Title: Measuring respiratory function using a novel device in 30 healthy volunteers

Method: RESPINOR DXT compared to spirometry

Conclusion:

  • Liver movement, as a proxy for diaphragm excursion, can be monitored continuously by use of RESPINOR DXT
  • An excellent correlation between spirometer and RESPINOR DXT waveform was observed in each individual
  • An accurate breathing frequency could be continuously recorded by use of RESPINOR DXT

3 feasibility studies approved and enrollment started with the aim to analyze RESPINOR DXT compared with clinical outcomes:

  • Weaning success
  • Reintubation rate
  • Utility in ICU
  • Future study sample size calculation
  • Future study potential enrollment rate

Medical need

The diaphragm is the main muscle of breathing, contributing to 70-75% of the volume of air brought into the lungs in a single breath in normal, healthy people. As such, respiratory problems and failure can be directly linked with diaphragm dysfunction. However, monitoring of the diaphragm is not routinely performed meaning that diaphragm dysfunction is mostly under-recognized.

Our first target application will be patients in the intensive care unit (ICU) under mechanical ventilation (MV), and more specifically for assessing the patient during the weaning process when the breathing tube is removed.

There is currently a severe lack of accurate and cost-effective solutions to support the weaning process. Recent research has shown that ultrasound measurements of diaphragm motion during MV can provide valuable information in the assessment and follow up of patients. However, this technique requires specialized equipment, a skilled operator, and provides only limited and non-continuous data. RESPINOR aims to fill this gap by demonstrating and commercializing a user-friendly, cost-effective patented ultrasound device that will effectively support the weaning process.

Being a platform technology, clinical evidence of application in additional medical diagnostic groups will be pursued in the future.

Progress

Technical

40%
  • Technical development of RESPINOR DXT prototype completed.
  • Development of first commercial version of RESPINOR DXT in process.

Clinical

50%
  • Verification testing in 30 healthy volunteers, completed and presented at the ERS Congress in Milan 2017.
  • 3 observational studies in critical care patients approved and enrolment ongoing, finalized within 2019.

CE mark

40%
  • RESPINOR has a certified QA system according to ISO 13485:2016.

"I was impressed by your device and your signal. I believe there is a lot to do with your system, to monitor the diaphragm in ICU patients, but also way beyond this application."

Key opinion leader 1