Medical device company Baymatob has completed a pilot study to assess its artificial intelligence (AI)-guided labour-monitoring device, Oli.
The Oli wearable device is an Australian-developed innovation intended for the identification of individuals with a greater likelihood of developing postpartum haemorrhage (PPH) before they give birth.
Claimed to be one of the largest maternity health studies for a medical device in Australia, the pilot study involved 500 women as participants.
Principal investigators Michael Nicholls, Andrew Bisits and Michelle de Vroom led the study conducted at Royal North Shore Hospital and The Royal Hospital for Women in Sydney, Australia.
The results from the pilot study are expected to be revealed this year.
According to the company, the current clinical evidence indicated that more than 80% of mothers with PPH could have clinical attention before bleeding starts using Oli.
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Baymatob CEO Tara Croft said: “We’re so grateful to the 500 mothers, obstetricians and midwifery staff who participated in this landmark study. The early results we have seen are already a strong indication of Oli’s potential impact and its potential for saving the lives of both mothers and children.
“Completing this study paves the way for a larger pivotal trial in 2023, which will be critical in a successful FDA submission. Entering 2023, we are now readying to undertake this pivotal trial as we await the final results of the pilot study.”
The Oli device helps monitor the vital signs of both mother and child and detects mothers at high risk of PPH, thereby improving patient outcomes.
It aggregates sensor technology and AI interpretation for the identification of a pending PPH during labour before birth and prior to the start of postpartum bleeding.
In August 2021, the company secured breakthrough device designation from the US Food and Drug Administration (FDA) for the Oli device.
Postpartum haemorrhage is considered to be one of the main causes of preventable maternal death.