Press communication
Lund, Sweden, October 10, 2023
This is a translation of the Swedish press release published 2023-10-09
At the jENS conference in Italy on September 23, 2023, the clinical researcher and neonatologist Jurate Panaviene presented new results and conclusions from the NIOMI (Non-Invasive Lung Oxygen Monitoring in Term Infants) study conducted at the University Hospital in Cork, Ireland. Neola Medical’s medical device intended for clinical studies, Neola®, was used to evaluate oxygen measurements on 100 newborn babies. The results from the Irish research group show that Neola® measures oxygen in the lungs of 100% of the participating 100 newborn babies. Furthermore, the company’s GASMAS technology is confirmed to be a safe and well-tolerated technology for lung monitoring of preterm born babies.
In 2021, University Cork College in Ireland began a clinical trial at the Infant Center to investigate the possibility of providing real-time information on the lung function of newborn babies. In the study, oxygen in the lungs was successfully measured in 100% of the 100 newborn babies who participated in the study with Neola®, the company’s medical device for continuous lung monitoring. The influence of the placement of the probes on the signals was investigated, providing information on how to optimally place the probes on the infant’s chest for the best monitoring performance.
The study included 100 newborns 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 positions that give good measurement signals. In practice, this means that healthcare professionals have a wide space to place the probes on the child’s chest and together with Neola®’s built-in feedback of the signals when placing the probes, good measurement signals and stable monitoring are ensured. This gives the advanced medical device, Neola®, the advantages of being easily integrated into an existing workflow in the time-critical neonatal intensive care unit.
The conclusions of the new clinical results presented at the jENS conference, show that Neola Medical’s GASMAS technology is safe and well tolerated to be used for monitoring the lungs of premature babies. The technology enables non-invasive oxygen detection that is unique and provides a new opportunity for doctors and healthcare professionals to monitor lung function in real time.
“The new results from the clinical study on 100 newborn babies confirm that the technology is safe to use for measurements on the lungs of premature babies, and the study also confirms that oxygen was able to be measured in all 100 babies who participated in the study. These are amazing clinical results which further strengthens our view regarding Neola®’s future in neonatal intensive care,” says Hanna Sjöström, CEO of Neola Medical.
About the NIOMI study
Every day, one in ten babies are born prematurely, many of them with underdeveloped lungs that can develop into life-threatening conditions during their stay in the neonatal unit. They are likely to need breathing support due to respiratory distress syndrome (RDS), a serious lung condition whose complications can affect up to 80 percent of babies born extremely premature. Rapid detection and diagnosis are critical in the neonatal intensive care unit to be able to administer treatment and prevent potential impairments later in life in premature infants.
A non-invasive lung monitoring of newborn babies with Neola Medical’s Neola®, Neonatal Lung Analyzer, was used to perform measurements in the NIOMI (Non-Invasive Oxygen Measurement in Infants) study at the University Hospital in Cork, Ireland during 2021-2022. The purpose of this observational study, independent of the company, is to answer several technical questions regarding lung monitoring and future clinical use in neonatal intensive care. The results of the NIOMI study provide information to guide the development of the GASMAS-based systems for future clinical adaptation in preterm infants. The study was led by Professor Eugene Dempsey, Horgan Chair in Neonatology, INFANT Centre, University College Cork (UCC).
“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,” said Professor Eugene Dempsey, the Horgan Professor of Neonatology at University College Cork, clinical leader of neonatal research and principal investigator at the INFANT Research Centre. “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,” says Dempsey.
About the jENS conference
The Congress of joint European Neonatal Societies (jENS) is an important meeting place for the latest research in, among other things, lung-related complications and creates contact between thousands of international pediatricians, clinicians and researchers. The jENS conference is organized by three leading organizations in pediatrics and pediatric research; The European Society for Pediatric Research (ESPR), The European Foundation for the Care of Newborn Infants (EFCNI) and The mission of the Union of European Neonatal & Perinatal Societies (UENPS).
For further information, contact:
Hanna Sjöström, CEO Neola Medical, e-mail: hanna.sjostrom@neolamedical.com
Christian Gyllenberg, CFO Neola Medical, e-mail: christian.gyllenberg@neolamedical.com
Read the entire press release (in Swedish) here: Press release