NAVI CLOSES $2.4 MILLION ROUND FOR ITS BREAKTHROUGH MEDICAL DEVICE

Navi 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

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.”

Pictured (left to right): Navi CMO and co-founder Associate Professor Christiane Theda, Navi CEO and co-founder Alex Newton, Minister of Industry and Innovation Ben Carroll.

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.

Pictured: Navi CMO Associated Professor Christiane Theda demonstrating the Neonav prototype to Minister of Industry and Innovation Ben Carroll

The Minister for Industry and Innovation Ben Carroll, who was present at today’s announcment at the Royal Women’s Hospital, reiterated the governments support for Navi and its technologies postiential impact, “We invest in innovation to maximise the economic benefits for Victoria and to ensure better care for our youngest patients.” 

Alex Newton said funding will be channelled 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."

About Navi Medical Technologies:

Navi Medical Technologies is a medical device startup headquartered in Melbourne, Australia. Focused on delivering clinical innovations, Navi's passion lies in creating cutting-edge solutions that enable children worldwide to live brighter and healthier futures through its medical innovations. Navi is currently developing the Neonav ECG Tip Location System, designated as a Breakthrough device by the US FDA, and will enable doctors and nurses to provide better, safer care for critically ill newborn and pediatric patients.

For media inquiries, please contact:

Brad Bergmann

Director of Communications, Navi Medical Technologies

Phone: +61 (3) 9059 4919

Email: brad@navitechnologies.com

Navi Awarded $1.2 million CTCM Funding

Melbourne-based Medtech startup awarded $1.2M government funding to develop device that helps safely deliver life-saving medications to preterm babies.

The Navi team is pleased to announce that it has successfully secured $1.2 million in funding from the Australian Government’s Clinical Translation and Commercialisation Medtech (CTCM) Program.

Delivered by MTPConnect, the funding is part of the Medical Research Future Fund initiative that identifies and nurtures high quality medical device projects that have commercial potential and support their translation through early clinical trials.

This funding demonstrates a strong level of confidence in the potential of Navi’s technology, which will enable clinicians to safely deliver life-saving medication to premature babies through its novel catheter tip location system, the Neonav®.

Navi co-founder and CEO Alex Newton said his team is focused on addressing a really important but often overlooked challenge in the care of sick kids.

“Misplacement and movement of central catheters can have devastating impacts on critically-ill patients. The Neonav® ECG Tip Location System solves this problem by giving doctors and nurses the real-time data they need to place and monitor the position of central catheters, making it safer and easier to deliver life-saving treatments to their patients”.

Pictured: Navi co-founder and Chief Medical Officer A/Prof. Christiane Theda with Neonav clinical prototype

Navi was founded in 2017 and has raised over AUD$6 million to date to develop its ground-breaking Neonav® catheter surveillance technology. This funding will support the expansion of pilot study clinical activities, and the finalisation of device design and manufacturing, as well as execution of core commercialisation activities.

Navi co-founder and CTO Mubin Yousuf, who has spearheaded the development of the Neonav’s proprietary tip location algorithm, said the successful CTCM grant application provided further validation of Navi’s product development and commercialisation strategy,

“Funding through the CTCM Program is highly competitive, with only a handful of the most promising applications being successful. The whole team is delighted with the outcome, and we’re looking forward to completing our project milestones and bringing this important device to market as soon as possible”. 

Pictured: Navi co-founder and COO Mubin Yousuf demonstrating the Neonav clinical prototype

The company’s recent string of successful grant applications and funding over the past year, along with a successful capital raise, brings Navi closer to achieving its vision of helping children everywhere live brighter, healthier futures.

Read the Australian Governments official announcement at https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/169-million-for-cutting-edge-medical-innovations

About Navi:

Founded in 2017, Navi’s vision is to give children everywhere brighter, healthier futures through medical innovations.

Navi is developing a catheter tip location technology called the Neonav®, which will allow clinical staff to quickly and safely place catheters inside critically-ill preterm and pediatric patients so they can deliver life-saving medications, nutrients and fluids.

Navi has already commenced in-human clinical studies of its catheter surveillance technology and is working towards finalising the device.

Navi Awarded Recent Victoria Medical Research Acceleration Fund Grant

The team at Navi is pleased to announce that, in partnership with the Royal Women’s Hospital, we have been successful in receiving grant funding through the recent round from the Victorian Medical Research Accelerating Fund (VMRAF).

Video: Introduction to the Neonav® ECG Tip Location device concept

The research project being funded, will be conducted at the Royal Women’s Hospital in Melbourne, and use Ultrasound technology to help further validate the accuracy of the Neonav® algorithm, as well as the use of ECG technology to accurately detect central venous catheter migration in critically-ill newborns.

Associate Professor Christiane Theda, Navi’s Chief Medical Officer, co-founder, and lead investigator for the research project, is excited about commencing this next round of research;

“The clinical and product teams at Navi have worked hard over the past few years to develop a first clinical prototype of our Neonav® device which has performed brilliantly in our studies so far. This next phase of work will allow us to collect important data that will give us new insights into how we can better refine and improve our technology so it can help us in our goal of providing safer care for critically-ill newborns.”

Pictured left to right: Shing Yue Sheung, Mubin Yousuf, A/Prof. Christiane Theda, Wei Sue, Alex Newton

Launched by the Victorian Government in 2017, the VMRAF provides grant support to accelerate health and medical research and fast-track innovative projects from research to real-world impact. This is the second VMRAF grant that Navi has been successful with, after also receiving support in 2020 for a Round 4 project.

Navi CEO and co-founder Alex Newton says these sort of grant programs are an important part of developing local medtech industries in Melbourne;

“We’re so grateful for the support from the Victorian government. Grants such as the VMRAF are critical sources of funding for early-stage medical device companies looking to develop products for a global market.”

In 2022, Navi has received support from various grant programs including the VMRAF, MMCP and TAIP funds form the Victorian Government, as well as the Federal Governments Accelerating Commercialisation Grant.

To date, Navi has secured over $2 million in State and Federal government funding, which has played a key role in furthering the development of Neonav® device.

These programs provide important validation on both the commercial and clinical strategy, and enables Navi to establish research, development and manufacturing capabilities locally in Victoria.

Pictured: Early-stage Neonav clinical prototype used in part of a study at the Royal Women’s Hospital in Melbourne, Victoria

The Navi team would like to extend a special thank you to the Victorian Government Department of Jobs, Precincts and Regions (DJPR) and the Royal Women’s Hospital in Melbourne, for their ongoing support in helping Navi develop medical innovations that will help children everywhere live brighter, healthier futures.

Navi Awarded Victorian Government Manufacturing Grant

The team at Navi are pleased to announce that we have been successful in receiving a $178k grant from the Medtech Manufacturing Capability Program (MMCP).

Funded by the Victorian Governments Department of Jobs, Precincts and Regions, the MMCP grant aims to support local manufacturing of Victorian-based medtech companies.

“Navi was founded in Melbourne, our office is located in Melbourne, and our amazing clinical and commercial partners are also based in Melbourne. We are thrilled and appreciative of the support the Victorian Government has provided us, and the broader Victorian medtech industry,” says Mubin Yousuf, Navi co-founder and CTO.

“The grant will go towards critical product development milestones as we transition from prototype to a market-ready device in the coming years,” says Mubin.

Pictured from left: Mubin Yousuf (CTO), Alex Newton (CEO), Shehan Wisidagama (R&D), Wei Sue (CFO)

The device being developed, called the Neonav® ECG Tip Location System, provides clinical staff with real-time location information on where central catheters are positioned inside patients, taking out a lot of the guess work in these common procedures and allowing for fast and effective treatment of critically-ill newborn and pediatric patients.

To date, a number of Neonav® clinical prototypes have been manufactured locally in Melbourne, Australia, and have been used in clinical studies held at the Royal Women’s Hospital, also located in Melbourne.

Navi Secures $1.26 Million Funding

Navi Medical Technologies is pleased to announce that it has successfully raised $1.26 million as part of the first tranche of funding of our current fundraising round.

This latest round of funding, supported by the Australian Government Department of Industry, Science, Energy and Resources through the Accelerating Commercialisation Program, represents the first tranche of a larger Series A round which will help complete the next critical phase of product development work, as well as complete an upcoming interventional pilot study.

“The pilot study will be the first time our Neonav® ECG Tip Location System is used in an interventional setting, which will be a significant milestone for the development of our device,“ says Navi CEO Alex Newton, who is grateful to Navi’s investment and clinical partners for their ongoing support and is looking forward to the progress that will be made off the back of this recent capital raise,

Pictured: Navi CTO Mubin Yousuf and COO Shing Yue Sheung demonstrating the Neonav clinical prototype

“We’ve received an overwhelming amount of support from clinicians all over the world. The issue surrounding misplacement and migration of central catheters in newborn and pediatric patients is one experienced globally. With this new round of funding, we will be taking a big leap forward in bringing our technology to the USA and Australian markets, and start setting a new standard of care,” Newton said.

To date, Navi has raised over $3 million which has funded a number of clinical prototypes and clinical studies at the Royal Women’s Hospital in Melbourne, Australia.

Research and development of the Neonav® has been supported by like-minded investors such as Stephen Ho, who understands the positive impact technologies like the Neonav® will have on sick children globally,

Pictured left to right: Stephen Ho with Navi CEO Alex Newton

“I am a strong believer in supporting individuals and companies that want to make the world a better place. The team at Navi is something we should all get behind as they work to bring their innovation to life. This will help change the lives of the most vulnerable for the better, and ultimately for humanity.”

Navi will look to raise additional funding later this year in a second tranche to complete further product development work, and has started early discussions with interested investment partners.