Project title: Clinical translation of a novel continuous lactate biosensor for fetal monitoring
VitalTrace was founded to improve the safety for mothers and babies during childbirth - babies being some of our youngest and most vulnerable patients. We are passionate about eliminating the unnecessary health, psychological and economic burdens from inaccurate childbirth monitoring.
This project will progress development and clinical testing of a continuous lactate sensor, with the potential to revolutionise fetal monitoring during labour globally.
Current fetal monitoring technology is inaccurate, subjective and creates difficulties for clinicians leading to complications for mothers and babies. VitalTrace is developing DelivAssureTM, a breakthrough technology designed to continuously monitor clinically validated biomarkers to reduce fetal morbidities and wirelessly transmit readings to an associated display monitor.
VitalTrace will design and implement the First-in-Fetus trial of our novel continuous lactate biosensor, which has already received Breakthrough Device designation from the US FDA. This fetal trial data will be used alongside complementary laboratory results and further clinical trial data to secure regulatory approval in Australia and the US. It will also underpin and accelerate the scale-up of VitalTrace’s unique manufacturing operations in Australia.
CTCM Project Round: Two
State: Western Australia
- CTCM Grant: $656,666
- Industry Contribution: $385,000
- In-kind: $150,000
Duration: 1 August 2023 - 30 June 2025