During the quarter, Neola Medical 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 potentially life-threatening lung collapse. The Company also completed a rights issue providing approximately SEK 32.5 million before issue costs, and was granted a U.S. patent for reducing optical noise in lung monitoring measurements.
Summary of the period April-June 2026
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -3 716k (-3 028)
- Cash flow for the period: SEK -5 924k (-6 152)
- Result per share: -0,05 SEK (-0,04)
CEO comments
Advancing the next phase with strengthened focus and financing
During the second quarter of 2026, Neola Medical continued to advance an important next phase in the development of Neola®. Following the final results from our first clinical pilot study in preterm born babies, we have strengthened our clinical and regulatory understanding, sharpened our strategic focus, and secured financing to support the continued path toward future market introduction in the U.S. and Europe.
In April, we reported final results from our clinical pilot study in Sweden, confirming a favorable safety profile of Neola® across the studied patient population, including very low birth weight preterm born babies. This was an important milestone for Neola Medical, as the study represented the first real-world use of Neola® in its intended patient population within neonatal intensive care.
Based on the study results and preclinical findings, we have sharpened our product offering by introducing lung collapse detection as a key capability. We believe this is where Neola® can provide significant clinical value by enabling continuous monitoring and decision support for timely intervention in potentially life-threatening lung complications in preterm born babies.
During the quarter, we also continued our preparations for the U.S. regulatory pathway. Our next steps include 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. targeted for mid-2027, subject to regulatory feedback and final study design.
Rights issue supports continued development
To support this next phase, Neola Medical completed a rights issue in June. The rights issue was subscribed to approximately 70 percent and provided the Company with approximately SEK 32.5 million before issue costs. I would like to thank our shareholders and new investors for their continued support. The proceeds are intended to finance the continued development of Neola®, including preclinical and clinical validation studies, regulatory activities, and commercial preparations ahead of future market introduction.
Focused on long-term value creation
We also continued to strengthen our intellectual property portfolio during the quarter. In June, Neola Medical was granted a U.S. patent for reducing optical noise in lung monitoring measurements. With this patent approved in the U.S. and China, and with an application pending in Europe, we continue to build protection around important parts of our technology platform.
The first half of 2026 has been an important period for Neola Medical. We have moved from our first clinical use in preterm born babies into a more focused development phase, supported by clinical insights, strengthened financing, and continued IP progress. We remain committed to disciplined execution and to 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, August 20, 2026
The Board
For further information, contact:
Hanna Sjöström, CEO
e-mail: hanna.sjostrom@neolamedical.com
David Folkesson, CFO
email: david.folkesson@neolamedical.com
About Neola Medical
Neola Medical AB (publ) develops an innovative medical technology device for non-invasive, continuous lung monitoring and real-time alerts of potentially life-threatening lung collapse in preterm born babies. By enabling instant detection, the technology aims to support earlier intervention, improve clinical decision-making, enhance long-term outcomes, and ultimately contribute to saving lives. The patented, cutting-edge technology was developed at Lund University in Sweden and is based on near-infrared light measurements in the lungs. Neola Medical builds on Sweden's longstanding legacy of medical technology innovation and contributions to global health care. Neola Medical was founded in 2016 and is listed on NASDAQ First North Growth Market (ticker: NEOLA). Read more at www.neolamedical.com. The company's Certified Adviser is FNCA Sweden AB.
This information is information that Neola Medical is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-20 07:00 CEST.
