Neola Medical AB takes significant steps toward securing market approval in the USA for continuous lung monitoring device, Neola®. These accomplishments include the company’s transition from technical verification phase to clinical validation phase, preparing for clinical studies on preterm born babies. Building on the progress to clinical validation, recent patent grants in both the USA and Europe, are strengthening the company’s competitive position and reinforces the protection of its innovation pipeline of medical device for continuous lung monitoring.
“We are making significant strategic advancements toward securing market approval in the USA for our continuous lung monitoring device, Neola®. We are not only advancing our commercialization strategy in the USA but also progressing to clinical validation, preparing a pivotal clinical study in the USA, which will be instrumental in supporting Neola Medical's forthcoming FDA application and bringing our medical device for continuous lung monitoring, Neola® to market.”, says CEO Hanna Sjöström.
Read more about the latest news in the investor letter autumn 2024, attached to this press release and available on the company’s website www.neolamedical.com