Founder's own experience leads to invention and breakthrough

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A Sydney-based company founded by a Sydney mother after her own traumatic birth experience has developed a world-first labour monitoring device that has achieved US FDA breakthrough designation. 

Mechatronic engineer and mother, Dr Sarah McDonald, completed a PhD in medicine and founded Baymatob after the traumatic birth of her son in 2013.

The company has since grown to a team of 13. Baymatob has also gained seed and follow-on investment funding from the NSW Health Medical Devices Fund totalling more than $4.4 million.

“Since the birth of my son Ollie, my life focus has centred around improving outcomes and experience for mothers and their babies during pregnancy and labour. Gaining FDA Breakthrough Device Designation is a huge accomplishment, and step closer in achieving this vision” said Dr McDonald.

The designation for Baymatob's maternal diagnostic tool called 'Oli' puts it on a streamlined and supported path toward regulatory approval in the US.

Oli is being developed to identify a woman, during labour, who is at a higher risk of developing abnormal postpartum uterine bleeding or postpartum haemorrhage.

Globally, postpartum haemorrhage is the leading cause of preventable maternal death, with a mother dying every seven minutes. Between five and 15 per cent of all mothers in Australia and New Zealand experience some level of postpartum haemorrhage.

The breakthrough designation reflects the FDA's view that Oli can provide more effective treatment or diagnosis for a life-threatening or irreversibly debilitating disease or condition.

The designation program aims to provide patients and health care providers with timely access to selected medical devices by speeding up development, assessment, and review.

“Oli’s ability to predict postpartum haemorrhage in advance is a game-changer that will save lives and reduce lifelong health impacts for mothers, such as emergency hysterectomies,” said Professor Michael Nicholl, clinical director for the maternal, neonatal and women's health network for Northern Sydney Local Health District.

Professor Nichol has been involved in a study using Oli at Royal North Shore Hospital.

At present, postpartum haemorrhage can only be identified after an individual loses a significant volume of blood.

The advance notification that Oli provides has the aim of enabling better outcomes for mothers and babies. It gives clinicians access to important information in order to better prepare, proactively manage and respond to postpartum haemorrhage. With the use of Oli, it is hoped that fewer women will die and the severity of maternal morbidities will be reduced.

Oli detected postpartum haemorrhage more than an hour before any postpartum blood loss occurred, the study using Oli at Royal North Shore Hospital has found.

“Oli has been embraced by both women and clinicians during the study. We cannot wait until this is available for clinical use,” said Michelle de Vroome, principal investigator of the Oli study and midwifery manager for the Northern Sydney Local Health District.