Keeping mothers and babies safe during childbirth with better fetal monitoring.
The only patient in the hospital that is cuurently not monitored by pulse oximetry technology is the fetus in-uetero. Raydiant Oximetry will change fetal monitoring paradigm by introducing this novel vital sign into obstetrics.
Current fetal monitoring technology (CTG) has the accuracy of a coin toss in predicting fetal distress. CTG technology has a ~90% sensitivity and a ~29% specificity for detecting the distressed fetus at risk for developing metabolic acidosis. Low sensitivity leads to the failed recognition of fetal distress while low specificity leads to the overuse of emergecy C-sections as a means to rescue the distressed fetus. Raydiant Oximetry, Inc. has demonstrated, in the preclinical model, the potential to improve sensitivity to 99% and specificity to 95%, which has the clinical benifit of reducing emergency C-section rates for suspected fetal distress and more accurately identifying the distressed fetus as risk for developing metabolic acidosis and hypoxic ischemic enchephalopathy.
Preclinical sheep studies (11 sheep) First-in-women feasibility studies (25 pregnant women): https://clinicaltrials.gov/ct2/show/NCT03013842 https://clinicaltrials.gov/ct2/show/NCT04081623 https://clinicaltrials.gov/ct2/show/NCT04876846 Currently completing a 60 patient pilot study at UTMB in Galvenston, TX: https://clinicaltrials.gov/ct2/show/NCT05147584
