A Look Back At 2023

From finalising product development, to raising capital, to growing our team, this year has delivered key milestones in preparation for the Neonav ECG Tip Location Systems regulatory clearance and market entry.

Below are some of the important highlights of what has been an amazing 2023:

Completed The Neonav Product Development:

A significant objective for 2023 was to complete the product development work for the Neonav System in preparation for clinical trials in 2024.

After several prototype iterations, the Neonav Device design has been completed. The development of the device is a significant milestone for the company, and has been a huge, combined effort that included our internal engineering and regulatory teams, external product development partners, and the help of dozens of clinicians across the globe providing valuable user insight and feedback.

Pictured: 3D Render Of the Neonav ECG Tip Location System

Achieved Significant Clinical Milestones

This year kicked off the Neonav “ECHO” study, where the Neonav device’s accuracy was compared to Ultrasound to determine how the device performs against the industry gold-standard in determining the location of Umbilical Venous Catheters (UVC’s) and Peripheraly Inserted Central Catheters (PICCs)

The results were extremely promising, with early indications showing a strong concordance between to both modalities.

Additionally, the clinical team conducted a number of studies to test various Neonav device hardware and software iterations, playing a crucial role in accelerating the Neonav development.

Investment & Grants:

During 2023, the our team was awarded a number of grants, with the highlight being the $2.3 million CRC-P grant funding. This funding was part of a $6.28 million project in collaboration with the University Of Melbourne, the Royal Women’s Hospital, and Design + Industry, and will support an upcoming pivotal clinical trial to generate data for FDA clearance.

In addition to the grant funding, Navi received an additional $1.34m from investors, which included a $700,000 lead investment from $2 billion investment fund Breakthrough Victoria

Patents Granted:

We now have 2 granted patents that cover the Neonav system in the USA and Japan, with several more regions soon to be granted. In addition, further work has progressed with other patent families to broaden the scope of our IP coverage.

Strategic partnerships

Navi formed a new strategic investment partnership with Breakthrough Victoria, which is a $2 billion investment fund. The announcement of the partnership took place at a media event at the Royal Women’s Hospital, which was attended by the Deputy Premier Ben Carroll (formally Minister of Innovation), and was featured on several TV and radio national news networks.

You can read more about Breakthrough Victoria’s investment in Navi here

Pictured: Navi team members with the Breakthrough Victoria team

Continued to grow our team:

During 2023, we were lucky enough to welcome some incredible people to our team, whos expertise in clinical, regulatory and quality affairs have provided invaluable contributions and insight.

Zorana Mayooran

An RA/QA Specialist who is instrumental in ensuring Navi meets all the necessary regulatory and quality requirements for FDA Clearance and beyond.

Rosina Velona

Clinical Research Coordinator who is managing a number of clinical activities both domestically and abroad as we seek FDA clearance and expand our commercialisation, research and development activities.

The Navi US Roadshow

Throughout the year, Navi team members spent several weeks in the United States visiting key hospital sites and talking with key opinion leaders in the vascular access industry to expand our network, gain critical insight into the US Children’s Hospital market, and receive important user feedback to help with the Neonav development.

The data collected from these trips have already been incorporated into the Neonav’s product design.

Navi CTO Recognised

Navi CTO and Co-Founder Mubin Yousuf was listed in the SAARI Collective's top 101 Startup Founders List!

This was in recognition for the incredible talent and innovation behind his work in developing the Neonav device. It's great to see his talent and expertise being recognised alongside an incredibly talented list of founders from the South Asian Australian community!

It has been a huge year for the Navi, and we would like to thank all our partners who have contributed their time, knowledge, capital and other resources in helping us achieve so many critical milestones in 2023, and to continue our mission to provide brighter, healthier futures for children everywhere in 2024.

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 secures $2.3 million CRC-P grant funding

We are delighted to announce Navi has been awarded a Round 14 Cooperative Research Centres Projects (CRC-P) grant to further the development of of the Neonav ECG Tip Location System.

Navi has secured $2.3 million in grant funding as part of a $6.28 million project in collaboration with the University Of Melbourne, the Royal Women’s Hospital, and Design + Industry. The project will support an upcoming pivotal clinical trial to generate data for FDA clearance, and is a major step forward in our journey to bring the Neonav device to market.

The Neonav, which is currently in development, addresses the unmet need for accurate and non-invasive tip location of catheters in critically-ill newborns and children, ultimately enabling clinicians to deliver faster and safer therapies.

Shing Yue Sheung, Navi's Chief Operating Officer, expressed his enthusiasm regarding the CRC-P grant and its potential impact.

“The CRC-P grant funding will play a critical role in advancing our device's path to market, and highlights the hard work and dedication of our entire team. We are immensely grateful to our Project Partners for their support and belief in our vision of helping children live brighter, healthier futures."

The CRC-P grant program supports collaborative research projects that foster innovation and strong partnerships between industry and research organisations, and are awarded through a competitive, merit-based selection process and are assessed by an independent committee of industry experts.

Being awarded this grant not only recognises Navi's potential to improve the standard of care in critically-ill newborn and children, but also acknowledges the collaborative efforts of multiple stakeholders dedicated to advancing medical technologies and improving the lives of our most vulnerable cohort of patients.

On the collaborative nature of the grant, Mr. Sheung continued,

“We would like to acknowledge and thank the Australian Government and it’s CRC-P program for their ongoing commitment and investment in developing the local medtech industry, as well as our Project Partners; The Royal Women's Hospital, the University of Melbourne, and Design + Industry for their continued support.”

A Year In Review - Innovating For Brighter Futures

As we march into 2023, we wanted to take a moment to reflect on what has been a tremendously exciting past year for the Navi team.

Pictured: Navi founders (left to right) - Christiane Theda, Brad Bergmann, Shing Sheung, Mubin Yousuf, Wei Sue, Alex Newton

Whilst the current global environment has been filled with uncertainty, our team have been laser focused on developing the Neonav® ECG Tip Location System in order to deliver real impact in the treatment of critically-ill newborn and predicatric patients. This focus has delivered a year filled with significant progress and momentum, and has put our team in a strong position as we begin 2023 and beyond.

Below are some highlights of what has been an incredibly successful year for our team:

Built Up A Team Of Strategic Partners & Investors

This year has seen Navi receive a string of successful grant applications totalling over $4 million, which provides not only critical funding for upcoming product and clinical development work, but just as importantly provides strong validation from a wide-range of experts on the strength of our technology, team and vision. Below is a list of successful grant outcomes for 2022:

Clinical Translation and Commercialisation Medtech (CTCM) program

This $1.2m funding was granted to support the expansion of pilot study clinical activities, and the finalisation of device design and manufacturing, as well as execution of core commercialisation activities.

You can 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

Accelerating COmmercialisation Grant (Tranche 2)

The Accelerating Commercialisation Grant is administered by the Australian Federal Government’s Department of Industry, Innovation and Science

The $600k in matched funding will support the completion of the next critical phase of product development work, as well as complete an upcoming interventional pilot study.

Medtech manufacturing capability program (mmcp)

Funded by the Victorian Government Department of Jobs, Precincts and Regions, the $178k MMCP funding aims to support local manufacturing of Victorian-based medtech companies in turning innovative ideas into real-life healthcare solutions.

Victorian Medical Research Acceleration Fund (vmraf)

The research project being funded will 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.

The MMCP and VMRAF programs are administered by the Victorian Government’s department of Jobs, Precincts and Regions.

external capital investMENT

We have also had the support of some existing investors who have provided follow-on investment in 2022, as well as welcomed new investors to the Navi family, more exciting news on this coming soon!

Advancing our clinical research

The first phase of clinical studies came to a close in 2022, which provided our development team with valuable data that has helped advance the Neonav’s proprietary technology into the next generation prototype device.

The data collected involved recruiting over 130 newborn subjects across several clinical studies and procedures at the Royal Women’s Hospital NICU in Melbourne, Australia.

This work has laid the foundation for the next phase on clinical work, which includes the upcoming Ultrasound confirmation study, where we will be determining the accuracy of the Neonav® using Ultrasound technology, as well as an upcoming pilot study, which will be an interventional study using the final Neonav® product design.

Breakthrough Device Designation

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for our medical device, the Neonav® ECG Tip Location System, as a method for navigating and positioning umbilical venous catheters in newborn patients.

The Breakthrough Device Designation is only given to devices that represent a significant breakthrough in effective treatment or diagnosis of life-threatening or debilitating conditions, and to technology where there is no approved or cleared alternative currently marketed in the US.

This Designation gives our team the opportunity to work closely with the FDA to develop the Neonav®, and will ultimately help expedite access for one of the most vulnerable and overlooked patient groups.

Watch the below video to learn more about the FDA Breakthrough Device Designation:

First Patent allowed in the USA

A significant milestone was achieved in 2022, with our first patent being allowed by the US Patent Office, which we expect to be granted in early 2023.

The patent (US 20210259778A1) titled “Catheter Location Determination In Pediatric Patients” covers a series of claims surrounding the placement of catheters utilising our proprietary ECG-based technology.

There is a significant amount of work underway in broadening the IP position of the Neonav®, as well as future technologies with broader clinical applications that will drive further value for the company and its shareholders.

Further expanded our US-based network

The Navi team attended the Association for Vascular Access annual conference in Minneapolis, MN, USA, where Navi's Chief Medical Officer A/Prof. Christiane Theda was selected to present and share Navi’s research findings on central line placement in critically-ill newborns.
The four day event is the premier meeting for vascular access healthcare professionals, providing the team an opportunity to explore industry insights, new product demonstrations, clinical advancements, and networking opportunities.

The team also spent time in San Francisco developing networks form the UCSF Benioff Children's Hospitals, where Navi Co-founder and COO Shing Yue Sheung won the Gold prize of USD$50,000 at the UCSF-Stanford Pediatric Device Consortium’s Michael R. Harrison Innovation Symposium pitch competition.

Pictured: Shing Yue Sheung being awarded the gold prize at the UCSF-Stanford PDC pitch competition

Advanced Product Development

The Neonav® product development showed significant progressed during the past year, which included:

• Working with front line health care workers across Australia and the USA to gather valuable device feedback.

• Worked with engineering partners to refine the concept direction for the Neonav® including industrial design, improved user interface, optimised hospital workflow integration, and finalise design decisions on the device ecosystem.

• Upgraded our R&D workspace to help test and develop current and future innovations.

The above work will be implemented into the next generation prototypes that will be used in our upcoming pilot study in late 2023.

We Supported the Next Generation Of Innovators

Navi was proud to be the official major sponsor of the Melbourne University Biomedical Engineering Society (MUBES) 2022 Medithon, which was a multi-day event was designed to help graduate students apply their learnings towards solving real-world healthcare problems in the pediatric space, and pitch their very own prototype idea to a panel of clinicians, academics and industry professionals.

Navi CTO Mubin Yousuf delivered the keynote presentation, as alumni of the University of Melbourne, the founders of Navi are thrilled to be able to give back and support the next generation of medtech innovators.

Media Highlights

Navi co-founder and Chief Medical Officer A/Professor Christiane Theda was a guest on Seven Network's “House of Wellness”, where she spoke about our medical device, the Neonav® ECG Tip Location System.

The powerful segment captured the challenges that critically-ill newborns and their families face with a touching story from the Constable family, whose child Nash had spent several weeks in the Neonatal Intensive Care Unit and took part in our clinical research at The Royal Women's Hospital.

As always, it is a huge motivation to see the positive impact our technology can have on both newborn patients and their families, and it's these stories that drive the Navi team to innovate and grow.

Navi CEO Alexander Newton and Chief Medical Officer Christiane Theda were also guests on the "Beyond The Medicine Cabinet" podcast series with Zoë Callister-Hakewill.

The episode covered the story of Sarah and James, whose son Archie spent 210 days in the NICU, and discussions about how Navi's medical innovation, the Neonav® ECG Tip Location System, can improve the standard of care in newborn and pediatric patients

You can listen to the full episode below:

Continued Team Growth

The Navi team welcomed Katerina Barons as a full time Data Analyst, and Shehan Wisidagama as our new R&D engineer. Both Katerina and Shehan assist in critical value-add activities in the development of the Neonav® and other technologies.

Pictured: Katerina Barons - Data Analyst

Pictured: Shehan Wisidagama - R&D Engineer

Neonav® granted FDA Breakthrough Device Designation

Navi Medical Technologies is pleased to announce that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for the Neonav® ECG Tip Location System as a method for navigating and positioning umbilical venous catheters in newborn patients.

The Breakthrough Device Designation is only given to devices that represent a breakthrough in effective treatment or diagnosis of life-threatening or debilitating conditions, and to technology where there is no approved or cleared alternative currently marketed in the US.

Navi COO Shing Yue Sheung is excited about how the designation will support the Neonav® regulatory submission process, “we are thrilled to be given the opportunity to work closely with the FDA to develop the Neonav® device in order to help raise the level of care for newborns, who are one of the most vulnerable patient groups that are often overlooked in new device developments.”

One of the primary benefits availability to Navi through the Breakthrough Device Designation is a priority review pathway with the FDA, which includes the opportunity to receive additional review resources to expedite patient access to the Neonav device.

“While the Neonav® System is not yet available in the US market, we are hopeful that Breakthrough Device Designation will help expedite patient access to the Neonav® System and provide clinicians with a real-time catheter placement and surveillance solution, as well as further highlight the significant unmet needs facing newborn patients,” says Shing.

The Breakthrough Device Designation was supported by early stage Neonav® clinical studies conducted at the Royal Women’s Hospital in Melbourne, Australia, as well as other well documented published studies that highlight the adverse events associated with malpositioned umbilical venous catheters, and other central lines, used in the care of newborns.

“Unfortunately, progress in catheter placement technology for critically-ill newborns has been limited over the years, with the current standard of care for tip placement in newborns still relying on X ray confirmation that takes place after the procedure has been completed. X rays’ lack of real-time feedback often results in delays to treatment, repeated dosage of ionising radiation, and offers very little in terms of surveillance. While other ECG-based technologies do exist, they are primarily for older children and adults, do not have surveillance capabilities built in, and cannot easily or effectively be used to treat the unique requirements of critically-ill newborns.”

The Neonav® ECG Tip Location system offers a number of important improvements over the current standard of care for placing and monitoring central catheter placements in critically-ill newborn patients. The Neonav®’s new ECG-based algorithm technology will provide real-time feedback to clinicians on central catheter tip location inside newborn patients, as well as provide fast and effective surveillance capabilities to help detect instances of catheter migration or dislocation.

ABOUT CENTRAL LINE CATHETERS

Over 1 million central lines are placed in newborn and pediatric patients globally, allowing for fast and effective delivery of mediations, nutrients and fluids. Limited real-time visibility of the catheter during insertion, as well as throughout the dwell time, can lead to instances of movement and misplacement that can result in adverse events, complications, increased costs and in some cases even death. 

ABOUT THE NEONAV® ECG TIP LOCATION SYSTEM

The Neonav ECG Tip Location System is currently being developed to address the unique needs to safely place central lines in critically-ill newborn and pediatric patients. The Neonav® system utilises a novel proprietary algorithm that will enable fast and accurate location detection of central lines during the initial insertion procedure, and will enable ongoing surveillance to alert clinical users when a catheter moves to an unsafe location.

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.

Podcast: The Tailored Solution Giving Neonates A Fighting Chance

Navi CEO Alex Newton and Chief Medical Officer A/prof Christiane Theda sat down with the team from the LiSTNR podcast “Beyond The Medicine Cabinet”, where they covered the story of Sarah and James, whose son Archie spent 210 days in the NICU. They also discussed Navi’s current innovation, the Neonav ECG Tip Location System, and the importance of giving every child the best start from day one.

You can listen to the entire podcast below, or scroll down to read highlights from the discussion:

Some highlights from the podcast include:

• Due to complications during pregnancy, Sarah and James’s son Archie was born premature at 26 week gestation, weighing just over 500 grams.

• Just after birth, little Archie was rushed away to the Neonatal Intensive Care Unit (NICU), where he would receive numerous procedures and surgeries, including Central Vascular Catheters, or CVC’s and ultimately stay for 210 days.

• CVC’s deliver life saving medications, nutrition and fluids to premature newborns like Archie.

• The position and location of CVC’s inside the patient is important. If the catheter ends up in an area that is deemed unsafe, such as deep inside the heart or liver, this can cause significant complications and harm if left undetected.

• Stephanie Pitts, who is a Vascular Access Nurse based in Florida, USA, explained CVC’s and the challenges using them in premature newborns in more detail

  “Infants and neonates are not small adults. They have distinct key physiological differences between babies and adults … They are much more difficult when it comes to vascular access procedures because of their [smaller] size vessel size and complexity.”

Pictured: Premature newborn in the Neonatal Intensive Care Unit (NICU)

• Navi co-founder and CEO Alex Newton explained the solution he and the Navi team are working on,

  “What we are building is a medical device called an ECG Tip Location System that essentially listens to the electrical activity of the heart through the catheter, and by analysing the signal we are actually able to provide real time positioning data back to the doctors and nurses … we can tell them if [the catheter] is in a safe location, or if it is still in a safe location”.

• The Neonav device will not only help make the insertion procedures quick and easy for the doctors and nurses, but more importantly improve patient safety and reduce complications associated with incorrectly positioned catheters.

• A/Professor Christiane Theda, who is a senior neonatologist and Navi Chief Medical Officer, understands all too well the challenges doctors face regarding central line positioning, explaining the issue relating to catheter migration:

  “Sometimes the catheters once they are in the right spot still actually move a little bit, and we call that a migration event. With the Neonav [ECG Tip Location System] we offer a method to check on that migration fairly quickly and easily without disturbing the baby much … so this way we can contribute to the patients safety to make sure the catheters stay in a safe location,”

• Gillian Foo, a Neonatal fellow in Melbourne uses this technology currently in a clinical study, and thinks it is an easy and practical technology to use bedside:

  “Essentially, it’s a very easy technology to use. [The Neonav algorithm] tells you if there is a red bit that’s too high, means you’re in too far too close to the heart. If there is no red bit and no wave, then you’re not deep enough and you need tp push that catheter in deeper.”

• Navi CEO Alex Newton highlights the current gap regarding available medical devices available specifically for newborns

  “The data from the FDA shows that only 5% of medical devices that are approved in the US market actually have an indication for use in newborn patients. So when you talk to specialists in the neonatal or pediatric domain, it’s a common frustration to say that they just cant find the right size products some time.”

Animation example of a central line migration event occurring in the liver (left) and the heart (right)

Memorable quotes:

• “It was horrific … we had to make the decision whether they would revive him or not, which was traumatic … I remember he was so tiny, the size of James’s hand … [he had] all these tubes and wires everywhere.” - Sarah (Archie’s mother)

• “Just having a small improvement in that [of a persons life] could grow into a huge amount of impact into that persons life…. so for us, one of the areas we wanted to look at was to try and have a positive influence on somebodies life as early as possible” - Alex Newton, CEO of Navi Medical Technologies

• “When he was first born he had the [umbilical] line through his umbilical chord access point. And then when he was about 2 weeks old he got his first PICC line, which he was only about 500 grams then … we just know how precious [the central lines] are as they are the only access point for his food and medication … essentially keeping him alive …” - Sarah (Archie’s mother)

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.