Neola Medical AB is advancing to the clinical validation phase with its medical device for continuous lung monitoring, Neola®. In preparation for a pivotal clinical study on preterm born babies in the USA, scheduled for 2025, Neola Medical will launch a clinical pilot study at a Swedish hospital. The pivotal clinical study, along with the successful Human Factors study results and the recently obtained CB certificate, will be instrumental in supporting Neola Medical's forthcoming FDA application for market approval in the USA.
“Exciting months lay ahead, as we advance into the clinical validation phase and gear up for the pivotal clinical study on preterm born babies in the USA. This study will be a cornerstone in our journey toward securing FDA market approval.”, says CEO Hanna Sjöström.
Neola Medical takes significant steps toward market approval in the USA. The company's lung monitoring device has achieved critical milestones that meet key regulatory requirements for FDA approval. The successful Human Factors Validation study conducted in the USA, along with the recently acquired CB certification, underscores the product’s safe design and essential performance. As a result, Neola Medical is transitioning from the technical verification phase to the clinical validation phase, initiating clinical studies.
The company is now in detailed planning for a pivotal clinical study on preterm born babies in the USA, scheduled to begin in 2025. In preparation for this, Neola Medical will conduct a clinical pilot study on preterm born babies at a neonatal intensive care unit in Sweden. The clinical protocol for the Swedish study has been finalized, and the company is currently in contract negotiations with a Swedish hospital.