Respiratory support for preterm infants in the Neonatal Intensive Care is a life-saving treatment due to their poorly developed lungs and respiratory muscles. Despite an increasing trend in using CPAP respiratory support for preterm infants (avoiding the complications related to endotracheal intubation), correct application of the CPAP interface is challenging. A poorly applied CPAP interface can result in ineffective respiratory support (too loose), or skin pressure injury (too tight), either of which can result in prolonged hospital stay and adverse developmental consequences. Nurses are currently recommended to remove the CPAP interface and check for signs of pressure injuries hourly, a labour-intensive process which risks de-stabilising the critically ill infant. CPAP has been named as the most common cause of facial skin damage, yet no tools exist to assist nurses in its correct application.
CPAP Buddy provides continuous monitoring and feedback regarding the quality of the CPAP interface application in preterm infants. Uniquely, CPAP Buddy measures both the interface-skin contact pressure and the level of delivered respiratory support. Measurements are displayed in real-time on the CPAP Buddy’s LCD display, with the ability for users to set the desired level and mode of respiratory support, as well as configure the desired audio-visual alarms. Additionally, the quality of the CPAP interface application is indicated visually with a coloured light on the interface itself, providing immediate feedback to users when applying or adjusting the CPAP interface and throughout the use of CPAP.
CPAP Buddy in its initial development will be specifically targeted at neonatal intensive care worldwide. There are over 15 million infants worldwide born preterm per annum, all of whom require respiratory support in their first few weeks of life. In Australia alone, 150 preterm infants are on CPAP support per day, and over 1.6 million hours of CPAP support are delivered per year. The global neonatal intensive care market is projected to reach USD 9 billion by 2025, with the majority of the market being in respiratory support.
CPAP Buddy in its later development will be adapted for in-hospital, and home CPAP support systems for all ages (including adults with sleep apnoea), with the aim to provide feedback to users regarding quality of CPAP application, thereby minimising discomfort and increasing overall compliance of CPAP use.
Currently, there are no other competitors in the market that provide users/caregivers with continuous feedback of the CPAP interface-skin contact pressure, and no commercially available independent devices providing continuous feedback of delivered CPAP support which can be coupled to any CPAP system.
Some CPAP systems have integrated measurement of delivered CPAP support, as part of a closed looped controlled feedback for the CPAP system to adjust CPAP delivery, but these can only be used as a complete CPAP system therefore potentially requiring costly replacement of existing systems which are not compatible. Furthermore, these expensive systems do not measure interface-skin contact pressure.
Over the past 2 years, we have collected over 4,000 hours of real-time data regarding delivered CPAP support in preterm infants and studied the immediate physiological effects of ineffective CPAP support at the Royal Hobart Hospital. Encouraging feedback has been reported from nursing staff interviews. The clinical need for a better solution is clear.
We will next develop a trial-ready prototype and undertake a clinical and user market trial to introduce and further refine CPAP Buddy at the Royal Hobart Hospital. The findings from our clinical trial will raise global awareness and fast-track the market uptake of CPAP Buddy globally.
The main revenue stream is through leasing of equipment, and sales of consumable parts. This would be attractive to hospitals in avoiding high unit cost per device, while ensuring a sustainable longer-term profit for our company. Additionally, we plan to work with existing developers of CPAP systems to integrate CPAP Buddy to their current CPAP interfaces, providing a revenue through licensing deals.
We intend to submit a provisional patent application for the CPAP Buddy device and system, and trademark CPAP Buddy to protect our product name, and logo.
The next technical step involves completion and refinement of our preliminary prototype through joint development partnership, and prototype (alpha) testing. We will then need to obtain seed funding for unit production for clinical and market trials in neonatal intensive care units within Australia.
The CPAP Buddy team is a group of doctors and engineers with a passion for improving preterm infant care. The dynamics of our team forms a perfect balance in each component of developing CPAP Buddy and translating CPAP Buddy from research to clinical use. We have a history of world-class research in neonatal respiratory support, and a successful track record in commercialising innovations on a global scale (e.g. SLE 6000 Oxygenie, OxySim).