SIME Diagnostics today announced the publication of a new clinical study in
Frontiers in Paediatrics. Conducted by neonatologists at Mayo Clinic in Rochester, the research evaluated a first-in-market diagnostic platform that analyses gastric aspirates obtained shortly after birth to predict the need for prolonged respiratory support, enabling early screening for lung maturity and risk of Respiratory Distress Syndrome at birth.
The study confirms the strength of SIME Diagnostics’ AI-enabled, point-of-care platform and completes this phase of clinical evaluation ahead of the final studies required to support FDA submission for market clearance. It builds on years of scientific development and focuses on outcomes directly relevant to everyday clinical decision-making in newborn respiratory care.
First-in-class screening platform addressing a large, underserved market with a significant unmet need
Early identification of respiratory distress risk addresses a major unmet clinical need in neonatal care; in the United States alone, roughly 550,000 premature babies are born each year, driving an annual healthcare burden estimated at $26 billion or more, with costs rising steeply for those needing prolonged NICU care due to respiratory complications — underlining the significant market potential for timely screening tools where no equivalent solution currently exists.¹²³
Clinically meaningful endpoint, study design, and key findings
The primary endpoint of the study was respiratory status at six hours of life, defined by whether infants required ongoing respiratory support or were breathing room air. Newborns still needing oxygen therapy or assisted ventilation beyond the normal post-birth transition at this timepoint are widely recognised as being at high risk of Respiratory Distress Syndrome, a surfactant-deficiency condition that is a leading cause of morbidity and mortality in premature infants and is associated with longer intensive care stays and greater use of hospital resources.
A total of 179 infants born between 31 and 41 weeks’ gestation were enrolled. Gastric aspirates were collected within 30 minutes of delivery and analysed using a point-of-care device that measures surfactant levels from very small sample volumes using spectroscopy, with the spectral output processed by AI-based algorithms to provide a rapid result.
The study demonstrated strong specificity and meaningful sensitivity, showing that biochemical signatures obtained shortly after birth correlate closely with subsequent need for ongoing respiratory support. These findings suggest that early biochemical assessment of lung maturity could support more accurate triage and treatment decisions in the first hours of life, improving quality of care while also helping to significantly reduce unnecessary intensive care admissions, inter-hospital transfers, and associated healthcare costs.
Advancing on the FDA pathway toward market readiness
Led by a major United States neonatal centre and published in a peer-reviewed paediatric journal, this study confirms the clinical relevance of this AI-enabled neonatal respiratory screening test and strengthens confidence as SIME Diagnostics moves toward its next key milestones.
This work completes the current phase of clinical evaluation. The product now enters formal analytical validation ahead of a pivotal, multi-site study planned to start at the end of 2026, which will be a central component of the upcoming FDA submission for market clearance. With the product developed and late-stage studies advancing, SIME Diagnostics is now fully focused on regulatory approval, market access, and commercial adoption.
About SIME Diagnostics
SIME Diagnostics develops AI-powered diagnostic platforms for acute and intensive care settings. Its lead product is a point-of-care lung maturity test designed to help clinicians assess the risk of respiratory distress in newborns shortly after birth. In parallel, the company is in the final stages of development of an adult ICU product targeting acute respiratory distress syndrome (ARDS), demonstrating the scalability of its core technology across neonatal and adult critical care.
¹ https://www.ncbi.nlm.nih.gov/books/NBK11358/
² https://pmc.ncbi.nlm.nih.gov/articles/PMC10549985
³ https://www.marchofdimes.org/peristats/reports/united-states/prematurity-profile
