NAVI Raises $2.4 Million for Breakthrough Medical Device Aiding Critically Ill Newborns

03 August 2023 | Thursday | News

Navi Medical Technology Pty Ltd, a medical device startup focusing on pediatric innovations, is pleased to announce the successful completion of its latest funding round, securing a total of $2.4 million. Investors who took part in this round of funding included a $700,000 lead investment from $2 billion investment fund Breakthrough Victoria, as well as federal grants from the Australian Government
Image Source : Public Domain

Image Source : Public Domain

  • After a successful raise Navi Medical Technologies has closed a $2.4 million round of funding, which included a $700,000 lead investment from Breakthrough Victoria.
  • The company's innovative Neonav® ECG Tip Location System is designated as a Breakthrough medical device by the US-FDA, enabling faster and safer delivery of life-saving therapies to critically ill newborn and pediatric patients.
  • The current standard of care for inserting central catheters in critically ill newborns and young children often leads to high instances of misplacements, posing life-threatening risks if undetected; the Neonav® device solves this problem by displaying real-time catheter location information using a proprietary algorithm.
  • The funding will help with completing a major clinical trial to obtain FDA approval for the Neonav® ECG Tip Location System

Navi is currently developing the Neonav® ECG Tip Location System, which is a novel medical device designated as a Breakthrough innovation by the US Food and Drug Administration (FDA).

Navi Medical Technologies CEO Alex Newton said the Neonav is set to raise the standard of care by enabling doctors and nurses to administer therapies more safely to critically ill newborns and pediatric patients.

"At present, central catheters are inserted into the veins of critically ill newborns and young children in a blind procedure. Doctors are only able to confirm the location of the catheter with an x-ray after the procedure has already taken place. Unfortunately, this approach leads to a large number of instances where the catheters are misplaced, exposing patients to potentially life-threatening complications if left undetected."

The Neonav system, which is currently in advanced stages of development, represents a transformative solution by seamlessly connecting to a standard catheter and capturing electrical signals from the patient's heartbeat. Using a proprietary algorithm, the Neonav system provides real-time catheter location of the catheter tip. Real-time tip location allows clinicians to position the catheter quickly and safely during procedures, as well as enable ongoing surveillance of the catheter position to ensure safe continued use.

Alex Newton said funding will be channeled towards the next critical phase of work. "Primarily we're focused on completing product development activities and a major clinical trial to obtain FDA approval, which will allow us to set up our manufacturing and logistics capabilities in preparation for our entry into the U.S market."

Associate Professor Christiane Theda, Chief Medical Officer at Navi Medical Technologies, expressed her gratitude for the recent investment and emphasized the significance of this milestone, "For more than 30 years I've been dreaming of a device to assist with placement of catheters to help my patients. With the support of Breakthrough Victoria and our other partners, we're now one big step closer to bringing the Neonav ECG Tip Location System to the bedside."

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