Posted: 17 February 2025
Breakthrough Victoria portfolio company, Navi Medical Technologies (Navi), has taken a major step in their mission to making hospital care safer for newborn babies and children, receiving FDA clearance for their Neonav® ECG Tip Location System.
Breakthrough Victoria Investment.
In August 2023 Breakthrough Victoria invested $700,000 in Navi Medical Technologies.
Who Is Navi Medical Technologies?
Navi Medical Technologies is a pioneering Melbourne-based startup dedicated to improving the safety and efficacy of hospital care for critically ill newborn babies and children. Founded with the mission to address the significant challenges in paediatric medical care, Navi is at the forefront of developing innovative medical devices that guide clinicians during life-saving procedures.
The Problem
In neonatal and paediatric intensive care units, the insertion of central venous access devices (CVADs) is a common yet critical procedure. These catheters are essential for administering life-saving therapies, including medications, nutrients, and fluids, directly into the veins of critically ill newborns and children. Despite the importance of these procedures, almost half of all insertions result in misplaced catheters, and even after a successful placement, catheters can unknowingly move or ‘migrate’ to potentially dangerous locations within the body. Misplaced and migrated catheters result in the need for further corrective procedures, can cost the healthcare system billions annually and lead to severe, life-threatening complications if undetected.
The current method for confirming catheter placement relies on x-rays taken after the procedure, which not only delays confirmation but also exposes young patients to additional radiation. This delay can be dangerous, as many of these procedures are performed in urgent or emergency situations, and correct catheter placement is crucial for effective treatment and patient safety.
The Solution
Navi Medical Technologies has developed the Neonav® ECG Tip Location System, a breakthrough device specifically designed for newborn babies and young children. This innovative system assists clinicians in real-time during the catheter insertion process, akin to how a parking sensor aids a driver in parking a car.
The Neonav® device is non-invasive and attaches to the end of an existing catheter. It functions by measuring electrocardiogram (ECG) signals from the heart, which are then displayed on a tablet-like screen. This real-time feedback enables doctors and nurses to accurately guide the catheter to its proper location near the heart, ensuring safe and effective delivery of essential therapies.
Furthermore, the Neonav® system can provide surveillance of the catheter’s position over time, alerting clinicians if it migrates to an unsafe location, thus preventing potential life-threatening risks. The device finished a first clinical trial with 50 newborn participants and is now undergoing a second trial involving 25 critically ill newborns at the Royal Women’s Hospital in Melbourne. The Navi team are also completing preparations for a regulatory submission to expand beyond the U.S. and clear the way for clinical use in Australia and Europe.
The Update
Navi’s world leading technology, the Neonav® ECG Tip Location System, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This achievement not only validates the company’s groundbreaking technology but also positions Navi for significant growth in the U.S. healthcare market.
Following this regulatory success, Navi plans to raise capital later this year to support commercial rollout in the U.S. healthcare system, with plans to secure Australian and European regulatory clearance and replicate the rollout locally and across the rest of the globe.
What they said.
Quotes attributable to Breakthrough Victoria CEO Rod Bristow
“As an investor, we are excited about Navi’s trajectory and its potential to become a leader in the paediatric medical device market. With strong fundamentals, regulatory validation, and a clear pathway to commercialisation, Navi represents a compelling investment opportunity with both financial and wider societal impact.”
Quotes attributable to Navi Technologies CEO and co-founder Alex Newton
“With FDA clearance in hand, we have a unique opportunity to drive substantial impact in one of the world’s largest healthcare markets. For our investors, this represents not just a financial opportunity but a chance to be part of a company dedicated to saving lives and improving paediatric healthcare on a global scale.”
Quotes attributable to Minister for Economic Growth and Jobs Danny Pearson
“This local Victorian company will be taking its home-grown technology to the United States – helping make hospital care safer for critically ill newborn babies on the other side of the world.”
“Victoria is the medical research capital of Australia – this is a booming industry that is backing economic growth and quality advanced manufacturing jobs across our state.”
Quotes attributable to Dr Janene Fuerch, Neonatologist at Stanford Children’s Health
“Central lines are lifesaving but can be challenging to position. We need a guidance system to tell us when we are in the correct location. The Neonav system fulfills that need and gives a characteristically blind procedure a way to move forward, telling you exactly where you are and how to move into the correct position”
