RESPINOR general news

RESPINOR has started the last phase of the clinical program, DE-RISK-WF study in Europe, with DXT before regulatory submission (EU and USA)

By 18. June 2021 No Comments

A multicenter, multinational clinical evidence study, including COVID-19 patients, to validate RESPINOR DXT’s performance to identify patients at increased risk of weaning failure (ClinicalTrials.gov ID: NCT04696406). RESPINOR has secured NOK 14.2M in soft funding from the Research Council of Norway to perform this study and to support our development to secure that our breakthrough technology, RESPINOR DXT, will be available for critically ill patients on mechanical ventilation worldwide.

The aim is to develop predictive indices to optimize the time patients are on mechanical ventilation (MV) by establishing cut-off values ​​to predict weaning outcome. DXT has the potential to optimize extubation timing, reduce re-intubation rate, improve patient outcomes, and reduce healthcare costs.

COVID-19 is arguably the worst pandemic the world has seen in 100 years and has caused more than 75 million cases and 1.6 million deaths worldwide as of mid-December 2020. It is deeply disrupting our health and socio-economic systems and provoking severe shortages of MV capacity, prompting an urgent need for accelerating the development and spread of technologies that can reduce the strain on these resources.

In 2020, RESPINOR finalized feasibility studies with proof of concept and technical proof of principle confirmed. The results were presented at the American Thoracic Society (ATS) International Conference 2021 (see link for abstract: https://www.atsjournals.org/doi/pdf/10.1164/ajrccm-conference.2021.203.1_MeetingAbstracts.A2766). In the feasibility studies, we identified a threshold value of 1.1 cm for weaning outcome. Now, we will confirm this threshold in the newly started Clinical Evidence Study:

  • Primary endpoint: Difference in the rate of weaning failure between patients with a diaphragm excursion (DE) < 1.1 cm compared to those with a DE > 1.1 cm. Median DE measurements taken during the second minute of the SBT will be used in the analysis to ensure that we identify ventilator-induced diaphragm dysfunction early. The hypothesis is that patients with DE < 1.1 will have a significantly higher rate of weaning failure compared to those with a DE > 1.1. The relative risk (RR) statistic will be used to assess the null hypothesis of equality.

Clinical application: If DE < 1.1 cm at time of weaning, the risk of weaning failure is increased due to the fact that the diaphragm has gotten too weak to enable the patient to breathe on their own. The physicians can now initiate rehabilitation of the diaphragm prior to weaning.

The study is expected to be completed in Q4 2021, following the planned product launch in Q4 2022.

Investigator team at Oslo University Hospital, Rikshospitalet. From the left: Andreas Barratt-Due (assistant head of department), Kine Green Pedersen (ICU nurse), Jon Narum (anesthesiologist), and Ingrid Dannevig Landsverk (anesthesiologist and PI). ICU nurse Siri von Krogh is the patient. Courtesy of OUS by Hedda Holth.

RESPINOR:

RESPINOR is a Norwegian MedTech company developing a novel, non-invasive, ultrasound-based medical device for continuous monitoring of the diaphragm, the main breathing muscle. The technology has a wide range of potential benefits in critical care and respiratory medicine,  and the company’s first product is called RESPINOR DXT (“DXT”). The company’s technology has twice been ranked the winner of Horizon 2020 funding, both in Phase I and II, and won the Nordic Life Science Invest (NLSInvest) Rising Star Awards in the Medtech/Diagnostics category in April 2021. The company has successfully completed clinical feasibility studies in Europe for the first target patient segment on mechanical ventilation (MV) with technical proof of concept, and proof of principle confirmed. RESPINOR has recently started a multicenter, multinational clinical evidence study, including COVID-19 patients.

High medical need:

MV is one of the most common therapies in the intensive care unit (ICU). It is treatment patients only receive in the most life-critical situations. Every extra day a patient is on MV the risk of permanent damage to the breathing abilities increases along with the treatment costs. It is, therefore, vital that patients on MV return to normal breathing as quickly as possible. There is currently a lack of predictive, accurate, and cost-effective solutions to support this process – and the introduction of new technologies is highly warranted. After extubation or liberation from the ventilator, breathing difficulties and respiratory failure can often be directly linked to diaphragm dysfunction.

In today’s clinical practice, diaphragm monitoring is not routinely performed, which means that diaphragm dysfunction often goes unnoticed. The introduction of DXT represents a paradigm shift. Annually, 4.5 million patients are treated with MV in the EU and US, costing the healthcare system €35 billion. The introduction of DXT will provide an objective measure of diaphragm function, to ensure that patients are liberated from the MV at the right time. If 10% of patients can be extubated just 1 day earlier, this represents a cost saving of €727 million per year, while providing significantly improved hospital care.

Problems with current methods: 

There is a significant unmet medical need to improve the weaning or liberation process from MV. And the rapid spread of COVID-19 is provoking severe shortages of MV capacity, prompting an urgent need for solutions that can reduce the strain on these resources. If the patients are too long on MV, the risk of permanent damage to their breathing ability increases. However, if they are extubated too early, they risk reintubation. The risks associated with reintubation are severe, including prolonged length of MV support, increased mortality, and increased costs to both the hospital and society. With today’s standard of care, as many as 30% of patients are re-intubated. The introduction of RESPINOR DXT will provide an objective measure of diaphragm function, to assist the specialists in determining when the patient can be liberated from the MV without complications.

 

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