New foetus monitoring device has the potential to reduce birth injuries

By Nykole King

An early-stage Irish medical device plans to “revolutionise labour and delivery” by using light-emitting technology to detect if the foetus is in distress.

The device, called pHetalSafe, will monitor the foetus’ oxygen levels and heartrate. It will also measure other crucial physical health functions without the mother’s heartrate interfering with the sensor.

“There is a lot of sub-optimal care and misdiagnosis around what’s happening with the baby in utero. So, our device will be able to give obstetricians a clearer signal of the actual heartrate,” said Sarusha Pillay, the commercial lead of pHetalSafe.

Obstetricians currently use cardiotocographs during labour and delivery. This involves two belts placed over the abdomen to record labour contractions and the foetus’ heartbeat. However, pHetalSafe would be an improved monitoring technology, reducing birth injuries from lack of oxygen. 

Birth injuries

Earlier this year the High Court settled a landmark case where a woman was left with a birth injury resulting in cerebral palsy, a brain injury and cognitive impairment. She was awarded €31 million from her birth at a Limerick Hospital almost 20 years ago. 

If obstetricians believe the foetus is in distress, they may rush the patient into an emergency caesarean section. However, Pillay said the device will provide more accurate health information to clinical staff and may reduce unnecessary caesarean sections.

A study from the School of Nursing and Midwifery at Trinity College Dublin found that more than one-third of first-time mothers in the country give birth by caesarean section. 

The number of caesarean deliveries have increased steadily over the decade. The January report cited clinician’s “fear of adverse outcomes and subsequent litigation” as one of the reasons for this method of delivery.

“Obstetricians need to feel confident when they’re delivering a baby. That they’re doing the best job they possibly can because there’s litigation elements to this,” said Pillay, who has a background in pharmacy and business administration.

“Our hope is to put this in every hospital in Ireland to give obstetricians the opportunity to be more confident in labour and deliveries.” 

Early phase

The team behind pHetalSafe are in the pre-spin out phase. They are still developing and commercialising the device. They are based out of the INFANT Research Centre at University College Cork in collaboration with the Tyndall National Institute, a research centre with specialisation in biophotonics — the use of light to examine the body’s tissue and cellular processes.

The project team includes co-founders Ray Burke as the technology lead and Dr. Fergus McCarthy, who has a background as an obstetrician to take on the role of clinical lead.

Galway’s medtech hub

Pillay is originally from South Africa. But she moved to Galway in 2020 as part of the BioInnovate Fellowship, a specialist medical device innovation programme situated at the University of Galway. 

Pillay selected Ireland specifically because of its reputation for medtech companies and its innovation ecosystem. She credits the BioInnovate programme for giving her the initial training in medtech entrepreneurship. Starting from finding a need in the market all the way to submitting business grants. 

“What I learned from BioInnovate I’m implementing now,” said Pillay. “Everything I learned there I am now implementing in my commercialisation strategy and plan.”

Development

Recently pHetalSafe received a grant of €1.35 million‎ from Enterprise Ireland. This funding will cover the next two years while they focus on developing the technology and business plan.

“We’ve got two full years of runway ahead of us. So, for two years we’ll knuckle down and try to get our tech ahead,” said Pillay.

While the project is early on, Pillay said the team plans to launch their pivotal trial for the device in Ireland. Clinical trials with start at the Cork University Maternity Hospital, near where they are based. They will also target markets in the United States and United Kingdom.

“Women’s health is very underserved in terms of new innovations in medtech,” said Pillay. “We’re developing something that we feel can make a huge difference in society.”