Neola Medical Q4 Report 2024 – Received approval for initiation of first clinical pilot study on preterm born babies

Summary of the period October–December 2024

• Net operating revenue: SEK 0k (0)
• Operating result: SEK -2 742k (-2 139)
• Cash flow for the period: SEK -4 606k (-5 036)
• Result per share: -0,04 SEK (-0,04)

Summary of the period January–December 2024

• Net operating revenue: SEK 0k (0)
• Operating result: SEK -10 797k (-9 621)
• Cash flow for the period: SEK -2 022k (-18 511)
• Result per share: -0,14 SEK (-0,17)

CEO Comments
We are pleased to share the progress we have made during 2024 on our mission to improve neonatal care. This year has been marked by significant milestones in our journey toward FDA approval and commercialization, while also preparing for the critical next steps in our clinical validation.

A key focus has been laying the groundwork for our pivotal clinical study in the U.S. We successfully obtained the CB certificate for Neola® and completed the Human Factors Validation study in the U.S., meeting partial regulatory requirements for market approval. These achievements mark our transition from the technical verification phase to clinical validation.

Following approval from Swedish authorities, we will initiate our first clinical pilot study on preterm born babies at a neonatal intensive care unit in Sweden, marking the very first clinical study with Neola® on its target patient population. As preterm born babies differ significantly from full-term newborns, insights from this study can guide us in optimizing and refining Neola® to meet the specific needs of this vulnerable patient group. The results will furthermore guide preparations for the pivotal U.S. clinical study that will be instrumental in supporting our planned FDA application for market approval in the U.S. As we move forward, we remain committed to navigating the complexities of clinical studies with diligence.

U.S. market preparations continue to be a key focus area, with recognition from Stanford’s international industry experts as one of the world’s leading innovators in pediatric medical technology, we were honored to win the silver medal at the prestigious Stanford PDC Accelerator Pitch Competition 2024, partially funded by the FDA to promote pediatric innovation. The award provides mentorship from Stanford’s top medical technology experts, offering tailored guidance and support to fast-track our development and market entry.

In October we sponsored a keynote lecture by Professor Vineet Bhandari at Europe’s leading neonatology conference. His presentation, “GASMAS Transit to the NICU – Are We There Yet?”, highlighted GASMAS technology’s potential to improve neonatal care. Engaging with international key opinion leaders is a strategic priority as we strengthen Neola®’s clinical and commercial positioning. By actively participating in high-profile scientific forums, we enhance awareness, credibility, and long-term adoption of our technology in neonatal intensive care, a key to driving market acceptance and future business growth.

During the year, we strengthened our competitive position with both U.S. and European patent grants, securing our innovation pipeline. The year ended on a high note with the U.S. trademark registration of the Neola® logotype, reinforcing our IP protection and elevating Neola® as a trusted symbol of innovation in neonatal intensive care.

Thank you for your continued trust and confidence in our mission. Your support is invaluable as we work toward providing preterm born babies worldwide with a safer 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, February 12, 2025
The Board