VitalTrace

What VitalTrace does

VitalTrace is a clinical-stage Australian medical device company developing DelivAssure, the world's first continuous lactate biosensor for fetal monitoring during childbirth. Founded in 2017 by Dr Arjun Kaushik and headquartered in Malaga, Western Australia, the company targets obstetricians and hospital systems with a Class III medical device designed to provide real-time, objective lactate measurements (0-8 mmol/L range) as a direct indicator of fetal hypoxia and acidosis — addressing a problem where current cardiotocography (CTG) is an indirect and often inaccurate proxy contributing to $7.4B in annual health economic burden in the US and 25% of US medical malpractice claims.

The proprietary technology uses enzymatic electrochemical sensors — analogous to continuous glucose monitors — layered onto a minimally invasive 3D macroneedle with ECG capability for compatibility with existing fetal monitoring workflows. The chemistry is specifically optimised for the low-oxygen fetal environment and integrated with a class III clean room manufacturing facility established with $4M in WA government support. DelivAssure received FDA Breakthrough Device Designation in 2024, with first peer-reviewed clinical data published in The SMFM Pregnancy Journal in June 2025 and clinical trials conducted at Royal North Shore Hospital, Monash Health, King Edward Memorial Hospital, and Box Hill Hospital.

The business model is single-use medical device sales through enterprise hospital procurement and multi-year contracts. VitalTrace is currently pre-revenue and preparing for US market entry via the Texas Medical Center Innovation (TMCi) 2025 HealthTech Accelerator, with platform extensions planned into neonatal intensive care (supported by a $500K FHRI Fund grant in November 2025), cardiac rehabilitation, athletic performance, and consumer wearables. The company has raised over $14M across three fundraising rounds including multiple Australian federal and state government grants, and is led by a CEO/CMO/CSO/COO team augmented by a world-class advisory bench including Mark Vreeke (TheraSense/Abbott CGM architect), Prof. George Saade (former SMFM President), and Partha Ray (ex-Medtronic/J&J, launched world's first real-time CGM).

Name

VitalTrace

Legal name

VitalTrace Pty Ltd

Website

https://vitaltrace.com.au

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

VitalTrace is a clinical-stage Australian medical device company developing DelivAssure, the world's first continuous lactate biosensor for real-time fetal monitoring during childbirth, targeting obstetricians and hospital systems to address the limitations of current cardiotocography-based monitoring.

Ownership category

akta.pro rank

Product category

Fetal Monitoring Medical Devices

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)

akta.pro primary industry

Maternal, Fetal & Neonatal Monitoring (CTG, Infant Wearables) (HLAHACAF)

akta.pro secondary industries

Maternal, Neonatal & Pediatric Remote Monitoring (HLACAPAG), Maternal & Neonatal Remote Monitoring Platforms (HLACAFAC)

Keywords

• Continuous lactate monitoring
• Fetal monitoring biosensor
• Obstetric medical device
• Intrapartum monitoring
• Electrochemical biosensor

Headquarters

HQ city

Wembley

HQ country

Australia

HQ region

Oceania

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Operations, Infrastructure, Marketing or Sales

Revenue model

1. Medical Device Sales (DelivAssure): VitalTrace generates revenue through the sale of DelivAssure, their continuous lactate biosensor device for childbirth monitoring. As a clinical-stage company with FDA Breakthrough Device Designation, they are preparing for commercialisation targeting hospital systems globally. The device is designed for single-use clinical application during labour and delivery.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

VitalTrace develops and manufactures DelivAssure, a clinical-stage continuous lactate biosensor for real-time fetal monitoring during childbirth. The device uses proprietary enzymatic electrochemical sensor chemistry layered onto a minimally invasive 3D macroneedle with ECG capability, interfacing with interstitial fluid to provide obstetricians continuous lactate data (0–8 mmol/L) optimized for low-oxygen fetal conditions. The platform has FDA Breakthrough Device Designation and is sold as a single-use clinical device to hospitals and healthcare systems.

Product overview

VitalTrace is a clinical-stage medical technology company pioneering continuous lactate monitoring technology. Their core product is DelivAssure, the world's first continuous lactate biosensor for obstetrics, with Breakthrough Device Designation from the FDA. The company is also developing platform extensions for neonatal intensive care (NICU), adult medical applications (cardiac rehabilitation), and consumer wearables. Their unified platform integrates biosensor chemistry, electronics, data software, and advanced manufacturing to deliver real-time biochemical monitoring across maternal health, newborn care, and broader medical applications.

Differentiator

Problem solved

Functional benefit

Brands

• DelivAssure: World's first continuous lactate biosensor for childbirth monitoring. FDA Breakthrough Device designated product enabling obstetricians to make evidence-based decisions during childbirth by providing continuous real-time lactate monitoring.

Products and services

• DelivAssure The world's first continuous lactate biosensor for childbirth monitoring. DelivAssure provides obstetricians with continuous, real-time lactate data (0–8 mmol/L) for evidence-based decisions during labour, using a proprietary enzymatic electrochemical sensor layered onto a minimally invasive 3D macroneedle with simultaneous ECG capture. The device interfaces with interstitial fluid, is optimised for low-oxygen fetal conditions, and features a familiar form factor for high clinical adoption. Sold as a single-use clinical device to hospitals and obstetric departments.

Quantifiable outcome

• Reduced neonatal death and lifelong brain injury through direct measure of fetal wellbeing
• +4 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature5 records

Partnerships

Twelve partnerships are on record, tiered core and minor.

• University of Western AustraliacoreStrategic or Co-development PartnerResearch collaborator and key partner in developing the continuous lactate biosensor technology. VitalTrace was founded based on research from UWA. The university has featured the co-founders and continues collaboration on clinical trials and technology development.
• University of SydneycoreStrategic or Co-development PartnerResearch collaborator in the development of fetal monitoring technology and clinical trial activities.
• University of Technology SydneycoreStrategic or Co-development PartnerResearch collaborator contributing to the development of the continuous lactate monitoring technology.
• University of California San DiegocoreStrategic or Co-development PartnerDr. Lee Hubble holds a Faculty Affiliate position at UC San Diego Department of Nanoengineering, the epicentre of electrochemistry and Dr. Joseph Wang's laboratory, contributing technical expertise to biosensor development.
• Royal North Shore HospitalcoreStrategic or Co-development PartnerClinical trial partner and site for testing DelivAssure technology. Prof. Jonathan Morris previously Director of The Kolling Institute of Medical Research based at Royal North Shore Hospital.
• Monash HealthcoreStrategic or Co-development PartnerClinical trial partner and site for DelivAssure testing. Dr. Vinayak Smith serves as clinical and commercial advisor from Monash University.
• King Edward Memorial HospitalcoreStrategic or Co-development PartnerClinical trial partner and site for testing the continuous lactate biosensor technology.
• Box Hill Hospital - Eastern HealthcoreStrategic or Co-development PartnerClinical trial partner and site for DelivAssure testing during childbirth monitoring studies.
• Texas Medical Center InnovationcoreStrategic or Co-development PartnerVitalTrace selected for TMCi 2025 HealthTech Accelerator - the largest healthcare provider in the United States. Partnership provides deep understanding of US hospital landscape and introductions to leading institutions in Boston, Washington, Texas, East Virginia, New York and Philadelphia.
• Imperial College LondonminorStrategic or Co-development PartnerCommercialisation consultant partner contributing expertise in fetal medicine through Prof. Christoph Lees, Professor of Obstetrics at Imperial College.
• Perron InstituteminorStrategic or Co-development PartnerResearch collaborator contributing to the biosensor technology development ecosystem.
• iPREP WAminorStrategic or Co-development PartnerIndustry and PhD Research and Engagement Program where VitalTrace worked with 'Dream Team' of Alvin Lee (signal processing), Saman Akbar Zadeh (data science), and Georgios Mavropalias (biomedical science).

Scale indicators14 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Dexcom: Dexcom pioneered continuous glucose monitoring (CGM) using similar electrochemical enzymatic biosensor technology. They serve as both a technical reference point and a comparable commercialization trajectory for continuous biosensor adoption in clinical practice.
• Masimo: Masimo developed rainbow SET pulse oximetry for non-invasive patient monitoring, including fetal applications. Comparable as a non-invasive continuous monitoring technology company targeting the same hospital end-users.
• Bloomlife: Bloomlife is a women's health technology company focused on remote maternal and fetal monitoring using wearable sensors. Directly competes for the same obstetrician customer segment with a wearable electrophysiology approach.
• Biorithm: Biorithm is a Singapore-based startup developing remote fetal monitoring using abdominal ECG. Targets similar maternal-fetal monitoring use cases with a non-invasive patch approach, providing another emerging competitive threat in continuous fetal monitoring.
• Nuvo Group (INVU): Nuvo Group developed INVU, a remote fetal monitoring platform for pregnancy and labor. Targets the same obstetrician and maternal-fetal medicine customer segment as VitalTrace with a different technology approach (remote patch-based vs. continuous lactate biosensor).

Broad incumbents

• Medtronic Diabetes: Medtronic's Diabetes division was an early CGM player and a major MedTech incumbent where VitalTrace advisor Partha Ray launched the world's first real-time CGM products. Represents both a comparable continuous biosensor commercialization reference and a potential strategic acquirer.
• Mindray: Mindray is a leading global patient monitoring manufacturer with a fetal monitoring product line. Their cost-competitive offerings compete for hospital procurement budgets in both developed and emerging markets.
• Philips (Avalon fetal monitors): Royal Philips is the dominant incumbent in electronic fetal monitoring (Avalon FM30/FM50 series). Currently VitalTrace's chief competitor; their CTG-based fetal heart rate monitoring is the standard of care that DelivAssure aims to supplement or replace.
• GE Healthcare: GE Healthcare's maternal-fetal monitoring portfolio (including the Corometrics series) is widely deployed in US labor and delivery units. Represents another entrenched incumbent against which VitalTrace must position DelivAssure for hospital formulary inclusion.
• Abbott (FreeStyle Libre): Abbott's FreeStyle Libre CGM uses comparable enzymatic electrochemical sensor technology and acquired the TheraSense/Abbott CGM portfolio where Mark Vreeke (VitalTrace advisor) previously worked. Direct technological analog demonstrating commercial viability at scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/VitalTrace
• LinkedInlinkedin.com/company/vitaltrace

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds3 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about VitalTrace