VitalTrace – On a Mission to Prevent Childbirth Complications by Developing a Real-time Fetal Biosensor
Pictured, front left - all from VitalTrace, Dr Michael Challenor Co-founder and Chief Technical Officer; middle, Nadia Rahman Scientist; right, Dr Shaghraf Javid Electrochemist; rear, Robert Atkinson Research Chemist and Patent Officer.
Childbirth remains a comparatively high-risk period for both mother and child, and delivery complications, most seriously an interruption of oxygen to the baby and its brain, can result in disability with lifelong consequences.
There were 134 million births1 and 2.3 million neonatal deaths in 20212. While neonatal death rates have fallen approximately 50 per cent in 30 years, they still ranked fifth overall in terms of deaths globally3 with main causes being birth asphyxia (inadequate oxygen) and birth trauma, neonatal sepsis and infections, and preterm birth complications.
Such devastating outcomes from asphyxia drive the obvious interest for monitoring babies’ wellbeing during pregnancy and childbirth. The current gold standard for real-time monitoring during birth is cardiotocography (CTG) developed in Australia in 1981. While transformational, it is now recognised, including by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, that it can be inaccurate and prone to subjective interpretation.
CTG monitors are attached to the mother’s stomach during birth and indirectly measure the fetal heart rate. When signs of distress are observed through an increased heart rate a blood sample from the baby may be taken and analysed for lactate levels to indicate hypoxia. Blood sampling is an invasive and time-intensive lab-based test and having a real-time monitor may have benefits in detecting hypoxia much earlier than currently possible. In addition, each year, emergency C-sections are performed on thousands of healthy mothers and babies because of a 50 per cent false-positive rate associated with CTG monitoring4.
Improving safety for mothers and babies during childbirth
Western Australian medical device company VitalTrace was founded to improve safety for mothers and babies during childbirth and eliminate the unnecessary health, psychological and economic burdens from inaccurate childbirth monitoring.
The aim of VitalTrace’s BioMedTech Horizons (BMTH) program project was to progress the development of a precision real-time fetal biosensor – DelivAssure™ – for the prevention of fetal complications during childbirth.
Specifically supported by BMTH funding, the company set out to develop manufacturing methods and establish facilities and capabilities in Australia to produce precommercial prototypes of the biosensor suitable for use in its intended environment.
With birth asphyxia causing 900,000 deaths annually5 and many more babies suffering lifelong impacts, the combined factors of the risk of these complications and inadequate monitoring have contributed to an increasing rate of caesarean sections in many Western countries including Australia. Of the 310,000 births in Australia in 20216, 37 per cent were by caesarean section7 and 47 per cent of those were unplanned emergency interventions8.
The health economics model developed by VitalTrace indicates unnecessary C-sections and fetal hypoxia triggered by unclear data from current monitoring devices impose a healthcare burden of US$6.4 billion annually in the US and Australia.
Kicking goals, achieving more, establishing manufacturing facilities in Perth
During the BMTH project, VitalTrace achieved far more than its original objectives. The team designed a manufacturable product, developed manufacturing methods with potential for scale-up manufacturing, established two manufacturing facilities in Perth, successfully produced pre-commercial prototypes, and performed animal studies to gain insights on performance, safety and usability.
Pictured, left: The leg plate for the VitalTrace real-time fetal biosensor.
This progress has been critical to support VitalTrace’s engagement with regulators, including the US Food and Drug Administration (FDA) who granted a breakthrough designation in 2021, and with new intellectual property generated supporting one granted patent and two patents filed.
With the initial phase being a tech-transfer process from an outsourced international contract manufacturer, the team established new in-house capabilities in formulation, microfabrication and manufacturing that gave an improved ability to rapidly iterate through design and quality challenges and resulted in a significant increase in production yield.
VitalTrace Head of Manufacturing Ana Fonseca said: “Achieving extremely reproducible sensors through precise manufacturing has been a great outcome of the project, generating scalable capabilities as we enter global markets.”
VitalTrace CEO and Co-Founder Dr Arjun Kaushik explained further: “With input from our Australian research partners and local parts suppliers, the creation of an Australian-first advanced biosensor manufacturing capability is an achievement the team is particularly proud of. This feat has enabled the company to de-risk itself significantly in the eyes of investors.
Unique manufacturing capability through BMTH results in more funds raised
“The BMTH grant was able to bring forward our manufacturing timeline by at least two years, accelerate research and development and increase the reliability of our novel biosensors. The flow-on effect of this has been massive for VitalTrace, allowing us to secure funding from investors, who looked favourably on our progress in a short span of time.
“Our valuation has tripled since the last raise, mainly due to the value of our unique manufacturing capability resulting from the BMTH program. This has resulted in the company's ability to raise funds that will help it progress towards human trials and regulatory approval,” said Dr Kaushik.
Pictured: Some of the VitalTrace team at work in the company's facilities in Perth, Western Australia.
VitalTrace has recently secured further funding for a commercial launch from the Western Australian government and MTPConnect’s Clinical Translation and Commercialisation Medtech (CTCM) program, to support a human clinical trial. A second funding, from the Western Australian government, has also been secured (Investment Attraction Fund) to progress manufacturing facilities towards commercial prototypes.
When DelivAssure™ receives regulatory approval, it has the potential to ensure the dynamic process of labour is safer for mothers and babies. Once obstetricians have access to real-time lactate values, they will be able to assess whether there is fetal distress and quickly determine whether an emergency C-section is required.
The impact of this project is likely to extend beyond VitalTrace and its immediate stakeholders, to future mothers and babies, obstetricians, midwives, clinicians and hospitals around the world, who stand to benefit the most.
2. World Health Organization, The Global Health Observatory.
3. World Health Organization, The Top 10 Causes of Death.
5. World Health Organization, Newborn Health
6. Australian Bureau of Statistics.
7. Australian Institute of Health and Welfare. Health of Mothers and Babies.
8. Australian Institute of Health and Welfare. MyHospitals procedures data