During the quarter, Neola Medical completed enrollment and reported positive safety results from its first clinical pilot study in preterm born babies in Sweden. The study confirmed a favorable safety profile of Neola® and provided clinical insights supporting the company’s sharpening of strategic focus toward high-value clinical applications, particularly the detection of life-threatening lung collapse. In addition, the Board of Directors resolved on a rights issue of approximately SEK 46.8 million, intended to support continued clinical, preclinical and regulatory activities ahead of future market introduction in the U.S. and Europe.
Summary of the period January–March 2026
CEO comments
Positive clinical study results -advancing toward next phase
The first quarter of 2026 marked an important milestone for Neola Medical with the completion of enrollment and final results from our first clinical study on preterm born babies. The study represented the first real-world use of Neola® in its intended patient population within neonatal intensive care and confirmed a favorable safety profile across the studied patient population, including very low birth weight preterm born babies.
The study also provided valuable clinical insights that are guiding the optimization of the device and sharpening our strategic focus toward high-value clinical applications, particularly the detection of life-threatening lung collapse.
Based on these results, we are advancing the next phase of development, including continued preclinical validation, regulatory interactions with the U.S. Food and Drug Administration (FDA), and preparations for a clinical study in preterm born babies in the U.S. by mid 2027.
Rights issue to support continued growth
To support these activities, the Board of Directors resolved to carry out a rights issue of approximately SEK 46.8 million, subject to approval at the Annual General Meeting. The rights issue is intended to finance the continued development of Neola®, including preclinical and clinical validation studies, regulatory activities, and commercial preparations ahead of future market introduction in the U.S. and Europe. The rights issue is supported by subscription commitments from existing shareholders, members of the Board and Management.
Welcome to the Annual General Meeting
I would also like to warmly welcome our shareholders to the Annual General Meeting on May 28, 2026, in Lund. The meeting will provide an opportunity to reflect on the progress achieved during 2025 and the first months of 2026.
Focused on long-term value creation
The quarter has demonstrated the strength of our team, technology and long-term vision. We remain focused on disciplined execution and on advancing Neola® toward becoming an important tool in neonatal intensive care, supporting earlier intervention and improved outcomes for some of the most vulnerable patients.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical's website, www.neolamedical.com
Lund, May 19, 2026
The Board