Two small human Proof of Concept studies have been conducted, one NIH fundet study at Brigham and Women‘s Hospital and the other at Tallahassee Memorial Hospital. The published data validate that using light to suppress melatonin has demonstrated a strong suppression of labor. These findings reflected a success rate in excess of 70%.
The Company is currently readying itself to conduct multi-center pivotal clinical trials in the UK and US. These separate trials will being designed to gain marketing approvals for:
Stopping contractions in healthy preterm pregnant women who are experiencing spontaneous contractions, and
As a preventative home healthcare therapy to prevent the onset of preterm contractions in healthy, at-risk women.
It is anticipated that the trials will commence in 2021.