Navitechnologies

Market position

Navi positions the Neonav as a next-generation, fit-for-purpose device for a pediatric and neonatal population it describes as underserved by existing vascular access products. The device holds US FDA Breakthrough Device designation, and the company has attracted competitive Australian government commercialisation grants and investment from Breakthrough Victoria.

The Neonav is designed specifically for newborn and pediatric patients rather than adapted from adult devices, and extends beyond insertion guidance to enable non-invasive bedside spot checks of catheter tip position throughout dwell time. It relies on proprietary algorithms interpreting cardiac electrical activity recorded through the catheter, avoiding reliance on post-procedure x-ray for tip confirmation.

Technology

The Neonav is a non-invasive ECG-based tip location system designed specifically for newborns and children. It connects to a standard catheter, captures electrical signals from the patient's heartbeat recorded through the catheter, and applies proprietary algorithms to interpret cardiac electrical activity and display real-time catheter tip location. This supports both guidance during insertion and non-invasive bedside spot checks for ongoing surveillance of catheter position during dwell time, as an alternative to confirming placement with post-procedure x-ray.

Go-to-market

The company develops its products in collaboration with clinicians internationally and runs clinical studies with hospital partners, including the Royal Women's Hospital in Melbourne. Its stated commercialisation path is to complete product development and a major clinical trial to obtain FDA approval, then establish manufacturing and logistics for entry into the US market, with the Australian market also targeted.

Doctors and nurses in neonatal and pediatric intensive care units who insert and manage central vascular access devices in critically ill newborns, infants and children.

Geography

Headquartered in Melbourne, Victoria, Australia, with a later company release describing the company as Melbourne- and Boston-based. Clinical work has been conducted at the Royal Women's Hospital in Melbourne, and the company works with clinicians internationally while targeting the US and Australian markets.

History

Founded in 2017, Navi developed clinical prototypes and ran clinical studies at the Royal Women's Hospital in Melbourne. In May 2022 it announced a $1.26 million first tranche of a Series A round, supported by the Australian Government's Accelerating Commercialisation Program, to fund product development and an interventional pilot study, reporting more than $3 million raised to date. In October 2022 it was awarded $1.2 million from the Australian Government's Clinical Translation and Commercialisation Medtech Program delivered by MTPConnect, by which point it reported more than AUD$6 million raised. In August 2023 it announced the close of a $2.4 million round including a $700,000 lead investment from Breakthrough Victoria plus federal grants. A subsequent company release reported an A$6.8 million capital raise to commercialise the technology in the US, with the company then described as Melbourne- and Boston-based.

Risks & controversies

The company is pre-market: the Neonav remains in development and requires completion of product development work and a major clinical trial to obtain FDA approval before US commercialisation, and manufacturing and logistics capabilities are still to be established. A significant share of funding to date has come from competitive government grant programs.