Neola Medical’s CEO shares clinical progress and recent milestones in summer 2025 investor letter

As summer unfolds, Neola Medical highlights important progress in its clinical development program. The company has successfully enrolled the first baby in the ongoing clinical pilot study on preterm born babies in Sweden, marking the first real-world use of Neola® to monitor the lungs of a baby in neonatal intensive care. In parallel, preparations advance for the pivotal clinical study in the U.S., following IRB approval and a signed agreement with a prominent neonatal intensive care unit (NICU) at Children’s Regional Hospital at Cooper, Camden, New Jersey, USA. This agreement with one of Neola Medical’s strategically important study sites enables the initiation of the pivotal clinical study on preterm born babies with its medical device for continuous lung monitoring, Neola®, which will play a central role in building the clinical evidence base required to support the planned FDA application for market authorization.