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COVID-19 ICU-CARE – A ground-breaking ICU bed-side COVID-19 trachea flushing system that can cut healthcare costs and reduce COVID-19 spread between ICU patients and staff

Periodic Reporting for period 1 - COVID-19 ICU-CARE (COVID-19 ICU-CARE – A ground-breaking ICU bed-side COVID-19 trachea flushing system that can cut healthcare costs and reduce COVID-19 spread between ICU patients and staff)

Reporting period: 2020-08-01 to 2021-07-31

Problem:
When the severely ill COVID-19 patients are admitted to the Intensive Care Unit (ICU) for respiratory support (breathing with the support of a mechanical ventilator), it is crucial that the upper airways of these patients are being suctioned many times daily to remove secretion and mucus, in order to prevent lung infections. If not removed efficiently, there is >50% likelihood of mortality. Unfortunately, the suctioning techniques today have 2 major limitations 1) it can’t remove secretions efficiently and hence upper airway lung infections are introduced in min. 25% of all patients and 2) it induces a very high risk of COVID-19 spread amongst ICU patients and staff, as secretion and mucus are suctioned outside the patient’s body.

Solution:
AWT has developed TrachFlush, the world’s first device that can remove secretion efficiently and also preventing COVID-19 spread. With TrachFlush secretion can be removed with the push og a button, and without the need for tracheal sucitoning

Benefits for Hospitals and society by implementing TrachFlush:
Hospitals:
1) Low risk of lung infections in the upper airways for the COVID-19 patients: TrachFlush flushs’ ALL fluid and secretion out of the upper airways
2) A daily workload of 1 minute per COVID-19 patient: Absolutely NO workload for ICU nurses, as each TrachFlush procedure is only 10 seconds. This is >90% Workload reduction and dramatically lower cost of care of patients
3) NO spread of COVID-19 between patient and ICU staff: NO COVID-19 contamination risks for ICU nurses and other patients, as the fluid and secretion remains inside the patient’s body.
Economic impact:
The economic impact of TRACHFLUSH on public hospitals is tremendous. With a more efficient secretion removal, less nurse workload and complete elimination of COVID-19 contamination, our device will enable positive economic impact for public hospitals across Europe and Globally.
In our simulation case then when TrachFlush removes secretion 90% more efficiently and the suctioning cost by 90%, the typical hospital will save €998K per year, compared to current suctioning devices. This is a true game-changer for ICUs

Objectives:
Our overall objective in the COVID-19 COVID-19 ICU-CARE project is to clinically validate the TrachFlush Device value proposition through a COVID-19 patients large-scale clinical study and thereby thoroughly documenting its efficacy as a bedside tool that:
1. Removes secretion 90% more efficiently compared to current technologies
2. Reduces ICU nurse suctioning workload by 90% compared to current technologies
3. Completely eliminates COVID-19 contamination risks compared to current technologies
Work performed:
The COVID-19 ICU-CARE project activities, was to run a multi centre clinical trial (MCCT) across 5 sites in Europe, and our activities in the entire project period were:
1. Draft a study protocol
2. Obtain Ethical Approval for all sites
3. Manufacture and install TrachFlush at all sites and perform training for all staff members including verification of usability (to make sure they know how to use TrachFlush)
4. Initiate study and monitor enrollment, consenting, eCRF fill out etc, and then enroll first patient
5. Conduct study at Clinical sites, including supervising on patient enrolment, data collection and archiving, eCRF fill out, from patient inclusion to patient completion
6. Collect and Analyse data from sites
7. Prepare Dissemination / business plan
8. Full analysis and article preparation

All the above activities, except the article preparation (#8 in part), have been executed on time and cost.
Completing the proposed COVID-19 ICU-CARE project allows AW Technologies to accelerate the market launch of the TrachFlush Device, addressing a one-time sales global market size of €1.8Bn and an annual recurrent sales market size of €1Bn, with limited competition and addressable market barriers which we believe will be mitigated upon completion of the COVID-19 ICU-CARE project.

Our go-to-market plan is based on distribution partners in multiple geographical areas. We estimate to grow our revenues from €2.8M in 2021 to €100M in 2025

Our growth is based on the unique value proposition we create during the COVID-19 COVID-19 ICU-CARE project.

The economic benefits of TrachFlush are tremendous.
A simulation case shows that when TrachFlush improves secretion removal by 90% (and preventing lung infections) and cuts overall suctioning workload and cost by 90%, the average hospital will save €1M per year, compared to current suctioning procedures.

On a macroeconomic level, we have calculated that our innovation can lower healthcare costs by €7,3Bn per year in Europe alone during normal conditions, generating a tremendous ROI for hospitals, by reducing the Lung infections, and thereby reducing the length of stay for ICU ventilated patients, increasing efficiency in the industry.
With the current COVID-19 pandemic the cost reduction is expected to exceed all previous expectations

TrachFlush does not change work-procedures in the ICU. The ICU nurses today, that performs the suctioning procedure, will perform the TrachFlush procedure, although, the TrachFlush procedure takes 1min to perform, where the current suctioning procedure takes 10min to perform.
Patient comfort is much higher with TrachFlush. With current suctioning procedures, the patient is getting a “vacuum cleaner inserted into their airways”, obstructing breathing, making it extremely uncomfortable for the patient. The patient preparation before the suctioning, and the patient stabilization after the suctioning, is mentally a tiresome process for both patient and nurse. With TrachFlush, the patient continues breathing, there is no obstruction of airways, no preparation etc., it is simply a “normal cough” which is performed.

The impact for AW Technologies are huge, and we consider the COVID-19 ICU-CARE project to have a major impact for AW Technologies accelerated market launch.
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