Bifogade filer
Neola Medical Quarterly Report Q3 2025
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
During the quarter Neola Medical strengthened the leadership team with appointment of a Clinical Director. In addition, the company’s IP portfolio was reinforced in Europe with a newly granted patent extending protection for lung monitoring beyond preterm born babies in this key target market. After the quarter Neola Medical announced a revised timeline before proceeding to next clinical phase as the ongoing clinical pilot study on preterm born babies in Sweden indicates a robust safety profile and need for optimization of Neola®.
Summary of the period July–September 2025
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -2 833k (-2 476)
- Cash flow for the period: SEK -4 390k (-4 950)
- Result per share: -0,04 SEK (-0,04)
Summary of the period January–September 2025
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -8 573k (-8 055)
- Cash flow for the period: SEK 2 568k (2 583)
- Result per share: -0,11 SEK (-0,11)
- Cash at end of the period: SEK 22 123k (24 161)
CEO comments
Revised timeline
This year Neola Medical reached a major milestone with the ongoing clinical pilot study at Södra Älvsborg Hospital in Borås, Sweden, evaluating Neola® for the first time on preterm born babies in neonatal intensive care. This marks a turning point in our mission to bring continuous, non-invasive lung monitoring to the most fragile patients.
Preliminary results from our ongoing clinical pilot study indicate a robust safety profile of Neola® in its first use on preterm born babies under intensive care, encouraging early findings for this highly vulnerable patient group.
At the same time, preliminary findings indicate variations in the data, providing valuable insight for further optimization of the medical device. This knowledge gives us an opportunity to further optimize Neola® before advancing to the next phase of clinical development. As a consequence, the pivotal clinical study in the U.S. will most likely not be initiated in 2026 as previously targeted.
While the results remain preliminary, we view this as important progress in the optimization of Neola®. Once the clinical pilot study is finalized and the full results are available, we will communicate a revised timeline and the next steps.
Welcoming Clinical Director
During the quarter we have strengthened our leadership team with the appointment of PhD Eva Bondesson as Clinical Director. Eva brings deep expertise in clinical research, lung physiology, and regulatory processes, ensuring strong clinical and scientific leadership.
Full IP coverage in target markets
This year has also been one of the strongest yet for our intellectual property strategy. Neola Medical has been granted five new patents across our key target markets — Europe, the U.S., and China — protecting core innovations in continuous lung monitoring. These include patents extending protection beyond preterm born babies to older children and adults, as well as new methods enhancing measurement accuracy. Together, they secure our long-term competitive position and technological leadership.
Finally, I wish to extend my warm thanks to the clinicians who continue to work closely with us, to our investors for their continued confidence in our long-term vision, and to our employees whose dedication defines Neola Medical. The need for better, non-invasive monitoring in neonatal intensive care remains significant, and we remain firmly committed to contributing to its solution.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical's website, www.neolamedical.com
Lund, November 4, 2025
The Board