Unmet clinical need
Addressing a critical medical need
1 in 10
Every year, around 15 million babies worldwide — about one in ten — are born preterm (before 37 weeks of pregnancy) and often depend on intensive care for survival and long-term outcomes. In neonatal care, every minute counts.
1.1 million
Approximately 1.1 million preterm born babies still die every year due to serious lung conditions. Preterm birth is the leading cause of death for infants under five (after pneumonia), with respiratory failure being the primary driver.
50 %
Many face underdeveloped lungs that can quickly advance into life-threatening complications and lasting disabilities. About fifty percent of the very and extremely preterm born babies show signs of severe disability at the age of 11.
Current monitoring methods
Today neonatal care teams rely on intermittent imaging and monitoring methods such as chest X-rays, manual observation, and invasive blood sampling. These methods come with significant limitations, providing only snapshots of the baby’s condition and can cause discomfort, pain, and stress for the baby. Physicians often experience delays in receiving chest X-ray results, which today are essential for identifying serious conditions such as pneumothorax and atelectasis in preterm born babies and the repeated exposure to radiation can increase the risk of long-term harm.
Rapid access to diagnostic information in neonatal intensive care is critical to enable timely clinical decisions that drive better patient outcomes.
Gestational development by weeks, source.
Lung Monitoring with Neola®
Neola® is designed for use with all preterm born babies in need of lung monitoring, regardless of respiratory support method or care setting. The goal is to provide a safe and non-invasive method to monitor the lungs of these vulnerable patients in real time, with the potential to support instant detection of complications, enable earlier treatment, and ultimately improve care and long-term outcomes.
“I truly appreciate this as a neonatologist, as I frequently encounter cases of pneumothorax where a lung can collapse, and we do not detect it until vital signs begin to change. X-rays are not always particularly helpful. Gaining a real understanding of oxygenation and how well the lungs are expanded could therefore be extremely valuable for our patients.”
– Dr. Janene H. Fuerch, MD, Co-Director of Impact1, Clinical Associate Professor of Pediatrics, Division of Neonatal and Developmental Medicine at Stanford University School of Medicine, Medical Director, Neonatal ECMO at Stanford Children’s Hospital, Palo Alto, USA
Mortality from collapsed lung (pneumothorax) in newborns, source.
Urgent need for more pediatric medical devices
The development of medical technology has focused almost entirely on devices for adults, leaving children, and especially newborns, with far fewer dedicated solutions. This gap has been recognized by the U.S. Food and Drug Administration (FDA), which has highlighted the urgent need for more pediatric medical devices. Stanford University launched the Stanford Impact1 program in 2023 with the vision of improving the health, safety and quality of life of pediatric and maternal patients globally. The same year, Neola Medical was selected as a Stanford Impact1 company, receiving support through the Stanford Impact1 program.
With increased regulatory focus on pediatric medical devices and the United Nations’ goal of reducing preventable neonatal mortality (SDG 3.2), Neola® is positioned to help advance neonatal care worldwide.
Supporting proactive care
Neola® aim to allow healthcare teams to respond instantly to changes in lung function, helping prevent complications from escalating and reducing the need for invasive procedures.
Making care safer
Continuous monitoring with Neola® aim to reduce reliance on painful or risky procedures like repeated x-rays and blood tests, making care safer and more comfortable for the most vulnerable patients.
Upgrading neonatal care
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2. Patented Technology
Neola® is based on the patented GASMAS (Gas in Scattering Media Absorption Spectroscopy) method, developed at the Division of Atomic Physics at Lund University. This innovation enables non-invasive lung monitoring and represents a first-of-its-kind approach to improving neonatal care. The company holds all patent rights for the medical application of the technology.