Neola Medical (NEOLA) investor relations material

Unmet clinical need and innovation

• Preterm infants face severe respiratory complications, with current monitoring tools being outdated and invasive.

• There is a significant lack of innovation in pediatric lung monitoring, creating a large opportunity for impactful solutions.

• The new device uses Gas in Scattering Media Absorption Spectroscopy, a novel technology from Lund University.

• The device enables non-invasive, continuous lung monitoring with disposable probes, supporting earlier intervention.

Recent progress and regulatory milestones

• Completed the first clinical study on preterm infants, confirming excellent safety and supporting a sharper clinical strategy.

• Achieved FDA Breakthrough Device Designation, validating the technology's importance and accelerating the regulatory path.

• The designation allows for ongoing FDA dialogue, risk reduction, and priority review, expediting U.S. market entry.

• The product is ready for a pivotal U.S. clinical study ahead of FDA approval.

Commercial strategy and market opportunity

• The U.S. market is prioritized due to its large neonatal intensive care system and high preterm birth rate.

• The business model includes device sales, daily disposable probes, and service agreements, supporting recurring revenue.

• Hospitals benefit from improved clinical outcomes, reduced costly procedures, and higher reimbursement rates.

• High willingness to pay has been observed among U.S. neonatologists and hospitals.