Neola Medical Q3 Report 2024 – Intensifying preparations for the first pivotal clinical study on preterm born babies in the U.S. to secure market approval by the FDA
Neola Medical is entering the clinical validation phase and is making significant strides toward securing market approval in the U.S., for continuous lung monitoring device, Neola®. The company’s competitive position is strengthened, highlighted by the recent patent grants in both the U.S. and Europe. The preparations for the pivotal clinical study on preterm born babies in the U.S. is progressing and the clinical protocol has been aligned during a pre-submission meeting with the FDA. In parallel, a pilot clinical study on preterm born babies is being prepared in Sweden, to further streamline preparations for the U.S. study.
Summary of the period July–September 2024
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -2 476k (-2 540)
- Cash flow for the period: SEK -4 950k (-3 565)
- Result per share: -0,04 SEK (-0,05)
Summary of the period January–September 2024
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -8 055k (-7 482)
- Cash flow for the period: SEK 2 583k (-13 476)
- Result per share: -0,11 SEK (-0,13)
CEO Comments
During the third quarter of 2024, we have entered the clinical validation phase and are progressing our preparations for clinical studies, making advancements toward securing market approval in the U.S., for our continuous lung monitoring device, Neola®. With CB certificate and Human Factors Validation study completed during the first half year of 2024, we now advance to the next key milestone for the company, conducting our first pivotal clinical study on preterm born babies in the U.S.
The U.S. study, which will lay the foundation to our upcoming FDA application, is planned to start in 2025. During a pre-submission meeting with the FDA, we aligned on the clinical protocol for the pivotal clinical study and the clinical need of our medical device for continuous lung monitoring of preterm born babies was noted. To streamline preparations for the U.S. pivotal clinical study, we are also preparing a clinical pilot study on preterm born babies at a neonatal intensive care unit in Sweden.
Building on our progress to clinical studies we are continuing to strengthen our competitive position, highlighted by the recent patent grants in both the U.S. and Europe. These expansions in intellectual property protection reinforce the protection of the company’s innovation pipeline for continuous lung monitoring and ensure that Neola® remains at the forefront of modern neonatal care, safeguarding our innovations and market leadership.
In summary, we have taken significant steps toward securing market approval in the U.S., as we advance to clinical validation phase, and intensify our preparations for the pivotal clinical study on preterm born babies in the U.S.
We look forward to the dynamic and productive months ahead, remaining steadfast in our commitment to improving care for preterm born infants. Our mission is clear: to not only save more babies but also to give them the best chance to thrive, living healthy lives with fewer severe disabilities.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical's website, www.neolamedical.com
Lund, November 6, 2024
The Board