Neola Medical advanced its U.S. regulatory pathway in the second quarter of 2025, signing an agreement with Children's Regional Hospital at Cooper and securing IRB approval to enable the initiation of the pivotal clinical study on preterm born babies in the U.S. under the leadership of Dr. Vineet Bhandari. The quarter also marked the enrollment of the first patient in the company's Swedish clinical pilot study on preterm born babies and the granting of a European patent for continuous lung monitoring, the second validation in a new patent family.
Summary of the period April-June 2025
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -3 028k (-3 011)
- Cash flow for the period: SEK -6 152k (-6 034)
- Result per share: -0,04 SEK (-0,04)
Summary of the period January-June 2025
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -5 740k (-5 579)
- Cash flow for the period: SEK 6 958k (7 533)
- Result per share: -0,07 SEK (-0,08)
- Cash at end of the period: SEK 26 513k (29 111)
CEO Comments
During the first half of 2025, Neola Medical reached a significant clinical milestone with the initiation of our first clinical pilot study on preterm born babies in Sweden. In May, the first baby was successfully enrolled, marking the first real-world use of Neola® to continuously monitor the lungs of a preterm born baby in neonatal intensive care. This milestone represented the culmination of years of dedicated development and marked the beginning of an important phase in validating the safety and performance of Neola® in its target patient group. This is particularly important as preterm born babies' lung physiology and medical needs differ substantially from those of full-term newborns.
The insights gained from the clinical pilot study in Sweden, estimated to conclude during fall, may offer valuable input as we continue to refine Neola®. In parallel, we are preparing for the next step in our clinical development, the pivotal clinical study in the U.S., which will form part of the clinical evidence base for our planned FDA application for market authorization.
As part of these preparations, we have signed an agreement with the neonatal intensive care unit (NICU) at Children's Regional Hospital at Cooper in Camden, New Jersey. Institutional Review Board (IRB) approval was received, a key regulatory milestone, enabling the initiation of the pivotal clinical study on preterm born babies. We are honored to collaborate with Dr. Vineet Bhandari, serving as principal investigator of the study and recognized globally as one of the world's most respected key opinion leaders in neonatology. His clinical leadership at Cooper's NICU brings significant credibility and momentum to this strategically important study site, which will play a central role in our U.S. regulatory pathway.
This quarter also brought important recognition of our innovation, with a new European patent strengthening our IP position in a key market and our nomination for Sweden's global Pioneer Prize bringing international visibility and new opportunities for collaboration and growth.
As we move forward with the clinical pilot study in Sweden and continued progress in preparing for the pivotal clinical study in the U.S., we stay committed to our mission of giving preterm born babies a safer, stronger start in life.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical's website, www.neolamedical.com
Lund, August 25, 2025
The Board
For further information, contact:
Hanna Sjöström, CEO
e-mail: hanna.sjostrom@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 complications 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 a spectroscopic method that measures changes in lung volume and oxygen gas concentration. 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 2025-08-25 07:55 CEST.
