At the recent annual jENS conference prominent neonatologists from all over Europe gathered to learn about the latest developments in the field. One of the presenters was Jurate Panaviene, who announced the results of the NIOMI study, in which Neola Medical’s medical device Neola was evaluated on 100 newborn babies. BioStock reached out to the company’s CEO Hanna Sjöström to find out more.
Lund-based Neola Medical has developed the medical device Neola, which aims to continuously monitor lung function in premature babies. Approximately one in ten babies is born prematurely, before their lungs are ready for life outside the womb. An important part of the care of these children is to monitor the lungs in order to detect problems that can be life-threatening.
Neola offers a non-invasive solution that differs from today’s often painful and risky monitoring methods, such as X-rays and blood sampling. Through probes that are attached directly to the skin, the system can continuously monitor lung volume changes and oxygen concentration, enabling early detection and treatment of complications.
Positive results from investigator-initiated study
In 2021, the University of Cork, Ireland, initiated the NIOMI clinical trial with a research version of the Neola systemto investigate the possibility of providing real-time information about lung function in newborn babies. The study included 100 newborn babies in different weight classes between 2.4 and 4.9 kg, where the probes were placed in different positions on the chest to evaluate the impact of different placements on the measurement signals.
The study successfully measured the oxygen in the lungs of all 100 participating children. In addition to the encouraging results, the study also provided valuable insight into how the probes are best placed on the baby’s chest for optimal monitoring performance.
Professor Eugene Dempsey, who led the study, says the following about the Neola system:
“This system has the potential to significantly change the way we monitor babies in the neonatal intensive care unit, particularly premature babies and full-term babies receiving mechanical ventilation. Not only can we monitor them more closely in real time, but we can reduce exposure to x-rays and limit the number of blood tests performed.”
The results presented at the jENS congress
The results of the NIOMI study were recently presented at the Congress of Joint European Neonatal Societies (jENS), where prominent neonatal engineers from all over Europe gathered to discuss the latest research in the field. With the presentation, Neola is taking an important step towards establishing its technology as a trusted solution for continuous lung monitoring.
Comments from the CEO
BioStock spoke to Neola Medical’s CEO Hanna Sjöström, to find out more about the results and what they mean for the company.
To begin with, the research team managed to measure the oxygen in all participating children in the study. How does this fit in with your expectations of the study?
– These are fantastic clinical results from a large study by an independent research group. What is particularly good is that the measurements were stable and worked on all 100 participating newborn babies. The results further strengthen our view that Neola has a promising future in neonatal intensive care.
What conclusions can be drawn from this?
– The research group’s conclusions from the new clinical results show that the company’s GARMAS technology is a safe and well-tolerated technique for lung monitoring of premature infants. This is a fundamental conclusion that is of great importance for more doctors to become interested in using Neola on their patients.
What were the results regarding the measurement of the lung volume changes?
– The study included 100 newborn babies in different weight classes between 2.4 – 4.9 kg. The probes were placed in different positions on the chest and the results show that for each child there are many different placements that provide good measurement signals. In practice, this means that healthcare professionals have ample leeway to place the probes on the baby’s chest.
– This flexibility is important for Neola to be easily integrated into an existing workflow in the time-critical neonatal intensive care unit.
What do the results of the study mean for the continued work with the Neola system?
– We are in a phase where Neola is now largely fully developed, and the results give us confidence that the technology works well and is safe to use on newborn babies. The results also confirm that Neola can measure oxygen in the lungs of all babies, which means that those results boosting us as we enter our upcoming clinical study on premature infants in the US, which is planned for 2024.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.