SYDNEY, April 19, 2023 /PRNewswire/ -- Medical device company Baymatob has successfully completed one of Australia's largest maternity health studies for a medical device, enrolling 500 mothers in a pilot study to evaluate its AI-guided labor monitoring device, Oli. The device is the only product of its kind intending to identify individuals at higher risk of developing postpartum hemorrhage (PPH) well before they give birth.
The study was led by Principal Investigators Professor Michael Nicholls, Professor Andrew Bisits and Michelle de Vroom at two Australian sites, Royal North Shore Hospital and The Royal Hospital for Women in Sydney. It used Baymatob's wearable Oli, to monitor the vital signs of both mother and child, including an outcome in identifying mothers at high risk of postpartum hemorrhage (PPH).
Postpartum hemorrhage, or heavy bleeding after childbirth, is the world's leading cause of preventable maternal death. Globally, one mother dies every seven minutes due to postpartum hemorrhage.
Baymatob's Oli device is an Australian-developed wearable device that combines innovative sensor technology and artificial intelligence (AI) interpretation to detect a pending PPH during labor before birth and before postpartum bleeding starts. Oli is worn on the upper abdomen of the mother both before and during labor, and monitors physiological signals of mother and child, including biopotentials, movement, temperature, and deformation.
While complete pilot study results are expected for publication in 2023, current clinical evidence suggests that more than 80 percent of mothers with PPH could have clinical attention before bleeding starts using Oli, improving health outcomes, and decreasing risk.
Lead investigator, midwife Michelle de Vroom said a new detection method for postpartum hemorrhage would dramatically improve patient outcomes for both mothers and children.
"PPH is responsible for nearly one quarter of maternal deaths, and today's approved monitoring technology - which focuses on contractions and heart rates - simply does not detect PPH and associated complications early enough. A large opportunity exists for modern technology, including artificial intelligence, wearable sensors and real-time analytics, to transform maternal and fetal monitoring and deliver better outcomes.
"While it is still early days in evaluating results, the data we have is very promising and indicates Oli's effectiveness in identifying mothers at-risk of PPH before bleeding starts."
Baymatob CEO Tara Croft said the completion of its 500-patient pilot study places the Company on track to a larger pivotal study at Australian and US sites, a definitive step toward regulatory approval.
"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 final results of the pilot study."
The Oli device was originally developed by engineer and mother Dr Sarah McDonald, who established Baymatob after her own traumatic birth experience in 2013.
In August 2021, Oli received Breakthrough Device designation by the US Food and Drug Administration (FDA), recognizing the device's potential to transform US clinical practice and granting the company an expedited regulatory review path.
Baymatob was founded after a traumatic birth experience and aims to transform outcomes for mothers and their babies. The company's flagship product Oli is a platform technology that will provide world-first, definitive clinical diagnoses, that have never-before been seen within pregnancy and labor monitoring. The first of these being a post-partum hemorrhage advance diagnostic capability. Baymatob, with its Oli technology, holds a rare opportunity to truly and completely transform clinical practice, disrupting decades-old technologies, with completely novel and impactful predictive diagnoses.