Neola Medical reached several critical milestones aligned with its business strategy, aimed at market approval by the FDA. The Human Factors Validation Study with Neola®, was successfully concluded with neonatal nurses in the USA, and will lay a foundation for the upcoming market grant application to FDA. Additionally, Neola® obtained a CB certificate according to high international standards, meeting partial regulatory requirements for market approval in the USA.
Summary of the period April–June 2024
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -3 011k (-2 586)
- Cash flow for the period: SEK -6 034k (-4 508)
- Result per share: -0,04 SEK (-0,05)
Summary of the period January–June 2024
- Net operating revenue: SEK 0k (0)
- Operating result: SEK -5 579k (-4 941)
- Cash flow for the period: SEK 7 533k (-9 911)
- Result per share: -0,08 SEK (-0,09)
CEO Comments
During the second quarter of 2024, we’ve achieved several critical milestones in line with our business strategy, that lay a strong foundation for our upcoming FDA application for market approval in the USA.
The successful Human Factors Validation Study of Neola® in Boston, USA, concluded with successful results confirming that Neola® is safe for its intended use by healthcare professionals in neonatal intensive care. In addition to the formal results, we also received positive feedback from participating neonatal nurses highlighting its clinical benefits of lung monitoring in neonatal intensive care. This provides Neola® with excellent prospects for seamless integration into neonatal intensive care.
Additionally, Neola® has obtained a CB certificate, according to high international standards, affirming its safety and essential performance in neonatal intensive care units. The CB certificate signifies that the product has undergone a rigorous and comprehensive testing and evaluation process with particularly high demands on safety, essential performance, and electromagnetic compatibility by the accredited and independent IECEE testing house, FORCE Technology. This is a strong testament to the effectiveness of our structured product development process.
Our market preparation in the USA has also gained momentum. Recognized by Stanford’s international industry experts as one of the world’s top medical technology innovation companies that can improve pediatric care. We were honored by winning the silver medal at the prestigious international competition, Stanford PDC Accelerator Pitch Competition 2024, partially funded by the FDA, to promote innovation in pediatric medical technology. Awarded with $25.000 and mentorship from Stanford’s world-leading medical technology experts we receive tailored advice and full support to accelerate the development and increase the availability of advanced medical technology innovation to reach the vulnerable pediatric patient group as quickly as possible.
Ahead of our market launch in the USA, we are especially glad to have our first American board member as a strategic advisor.
In summary, the first half of 2024 has been focused on fulfilling key achievements for our upcoming FDA application for market approval in the USA. Concluding our technical verification phase and a successful Human Factors Validation Study, we now advance to the clinical validation phase and intensify planning for the clinical study in the USA on preterm born infants.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical's website, www.neolamedical.com
Lund, August 15, 2024
The Board