Raydiant Oximetry

Raydiant Oximetry is a clinical-stage medical device company developing innovative technologies to improve outcomes for mothers and babies during childbirth. Their flagship product, LUMERAH, is a low-cost, non-invasive sensor that continuously monitors fetal oxygenation during labor. It measures fetal blood oxygen saturation levels by performing a color analysis using a safe, light-based technology placed on the mother's abdomen.

LUMERAH aims to address the limitations of the current standard of care, electronic fetal heart rate (FHR) monitoring, which has low sensitivity and specificity for detecting fetal distress. While FHR monitoring has been associated with a nearly 6-fold increase in the Cesarean delivery rate in the US from 1970 to 2022, it has a 99% false-positive rate for conditions like hypoxia and impending fetal death during labor.

Initial preclinical and clinical studies indicate that LUMERAH could significantly improve the sensitivity and specificity for detecting fetal distress, potentially reducing newborn neurological injuries and medically unnecessary Cesarean deliveries. In a 2023 clinical study, LUMERAH demonstrated a 95% sensitivity and 84% specificity for detecting fetal distress, compared to 85-90% sensitivity and 29-40% specificity for FHR monitoring.

LUMERAH received FDA Breakthrough Device status in September 2018, expediting its path to market approval. In April 2024, the FDA granted an Investigational Device Exemption (IDE) for an Early Feasibility Study of LUMERAH at Eastern Virginia Medical School under Dr. George Saade.

Raydiant Oximetry has raised over USD 7.5 million in funding, including a Series A3 extension in June 2024 led by Cross-Border Impact Ventures. The company aims to raise USD 25 million in its Series B round to complete commercial product development and launch a pivotal FDA trial.