Biovo Technologies signs a prospective, observational, crossover pilot study for Cuffix™ with a leading US Hospital
Comparison of 24-hour endotracheal tube cuff pressure continuously adjusted with a novel device - Cuffix™ to manually adjusted cuff pressures
ROSH HA'AYIN, Israel, Dec. 20, 2021 /PRNewswire/ -- Biovo Technologies Ltd. ("Biovo"), a medical device company focused on devices for Critical Care and Operating Rooms, announced today it has signed an agreement with a leading US hospital based in New Jersey, for performing a clinical study of the Cuffix device. The hospital is recognized as a top performing hospital for treating pulmonary disease and heart failure with a capacity of around 100 ICU beds. Cuffix is the first and only economical, self-contained, continuous, disposable cuff pressure regulator and monitor in the market for use with tracheal and tracheostomy tubes.
This is the first in a series of clinical studies which are planned to be performed at the hospital. Successful completion of these studies will be an important step in entering the American market.
Over- and under-inflation of the balloon cuff on an endotracheal tube (ETT) in a mechanically ventilated patient can result in significant patient morbidity and mortality.
Under-inflation of the balloon may cause aspiration of gastric contents and secretions from the mouth containing bacteria moving into the lungs and causing Ventilator Acquired Pneumonia. In addition, there is a cost risk since VAP and aspiration may increase the length of stay in the ICU.
Over-inflation of the balloon prevents perfusion of the trachea tissues, which can result in tissue inflammation, necrosis, and granuloma and scar-tissue formation in the subglottic space, resulting in sub-glottic stenosis. Anesthesiologists frequently encounter ICU survivors, in whom it is difficult or dangerous to pass an ordinary sized endotracheal tube for subsequent surgery months to years later.
The present system of monitoring cuff pressure – typically once or twice per shift for every patient – is manual, labor intensive and time consuming for nurses and respiratory therapy personnel. Moreover, this random spot check does not detect and respond to changes in the balloon pressure which can happen many times during a shift.
Cuffix is a new single-use medical device whose purpose is to continuously measure and adjust the pressure inside an endotracheal tube balloon while in use, so that it remains within safe limits. The inflation status of the balloon is displayed visible at a glance from a distance by a color-coded LED.
The study, scheduled to start in January 2022, is expected to demonstrate the advantages of using the Cuffix, compared to the common present practice where the pressures are measured and adjusted manually at intermittent times.
About Biovo Technologies
Biovo develops, manufactures, and markets worldwide devices that address unmet clinical needs in Intensive Care Units, Operating Rooms and Anesthesia markets. It is part of the Airway Medix S.A. group, which its shares are traded on the Warsaw Stock Exchange (WSE: AWM).
For further details, please contact:
Biovo Investor Relations, Mr. Ronen Grossman
Tel: +972 72 2151 115 or email: email@example.com
SOURCE Biovo Technologies Ltd