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.

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.

The Rise Of Catheter Tip Surveillance

Central catheter placements in critically-ill children is a relatively common surgical procedure. However, once the catheter enters the patients blood vessel, it is an unknown where the catheter tip ends up during the procedure. For clinicians, this lack of easily accessible, real-time feedback is one the challenging aspects of performing these procedures. Currently, the most common method of confirming the catheter tip location is the use of x-ray, but only after the procedure has taken place. The result - around 40% of catheters are misplaced during the insertion procedure, often requiring clinicians to repeat the procedure that ultimately delays treatment to critically-ill newborn and pediatric patients.

Pictured: Premature newborn in a NICU with an Umbilical Venous Catheter inserted

The problem doesn’t stop there. After the initial placement location has been confirmed, the dwell time (the time the catheter remains inside the patient) can be up to 30 days in some central catheters such as Peripherally Inserted Central Catheters (PICC’s). During this time, the catheter can move or “migrate” from a safe location to other areas in the body, which can have a significant on impact treatment, or cause serious harm to the patient. What’s most concerning is the frequency these migration events can occur, with recent studies showing up to 50% of correctly placed catheters migrate within 7 days.

For example, a correctly placed catheter in the Inferior Vena Cava (a high blood flow vessel area located just below the heart) could migrate away from the safe position over several days and end up in the heart. This can cause a number of complications such as cardiac tamponade, where fluid builds up in the space around the heart that can ultimately extend patient hospital stay, or worse, could be fatal.

Animation example of catheter migrations and related complications

While ECG Tip Location Technologies have been developed in recent years to help with the catheter placement problem, current technologies primarily focus on the adult population, and only focus on the initial placement of the catheter while mostly ignoring the migration issue.

“90% of catheters had migrated from their position on the preceding scan”

— Hoellering A et. al.

Shing Yue Sheung, Navi COO and Biomedical Engineer, knows all too well the current limitations of existing ECG Tip Location Systems,

“Most ECG Tip Location Systems on the market today have limited capabilities when dealing with the pediatric cohort, especially premature newborns. Speaking with neonatologists and clinical staff from around the world, it had become clear to the Navi team that catheter migration was a big problem, possibly bigger than misplacement on insertion, and that it needed a solution.”

There is growing evidence that supports the need for a technology that can provide clinicians with surveillance capabilities of the catheter during its dwell time. Migration, and the subsequent complications that follow, lead to poor patient outcomes as well as increased costs to hospitals.

A 2018 study by Hoellering A et. al.¹ identified that migration prevalence in a neonatal cohort of patients was staggaringly high, showing “90% of catheters had migrated from their position on the preceding scan” after correct initial insertion.

Another recent paper in 2021 by Acun, C et al.² highlighted that “catheter migration is the most common complication in neonates”, recommending periodic imaging during the first 3 days after PICC insertion (as most migration occurred within this period).

Explainer Video On How The Neonav ECG Tip Location System will help with catheter misplacement and surveillance

Navi’s Neonav® ECG Tip Location System, which is currently in development, will address this gap in catheter surveillance, by developing a device that not only is specifically designed for critically-ill newborn and pediatric patients, but also will provide clinical staff with a comprehensive means of catheter tip surveillance - from initial insertion right through its dwell time. This will enable faster treatment, reduced complications, improved hospital efficiencies and reduced costs, ultimately leading to better patient outcomes, and enabling children everywhere to live brighter, healthier futures.

1. Hoellering, Adam et al. “Study of movement of umbilical venous catheters over time.” Journal of paediatrics and child health vol. 54,12 (2018): 1329-1335. doi:10.1111/jpc.14073

2. Acun, C., Baker, A., Brown, L. S., Iglesia, K. A., & Sisman, J. (2021). Peripherally inserted central catheter migration in neonates: Incidence, timing and risk factors. Journal of Neonatal-Perinatal Medicine, (Preprint), 1-7.

2021 - A Year In Review

From restrictions, to lockdowns, to the general fog of uncertainty, this past year has presented a number of challenges that required all businesses to embrace change.

Despite these pandemic challenges, the team at Navi made significant progress towards our vision of giving children brighter, healthier futures through medical innovations. Below are some of the 2021 highlights:  

Expanded Our Clinical Activities

Lockdowns and restrictions brought on by the COVID-19 pandemic had a significant impact on clinical activities, with hospitals taking precautionary measures that included halting clinical research for a period of time.

Pictured: The Neonav® clinical prototype used during the Navi feasibility study and the Royal Women’s Hospital in Melbourne, Australia.

Pictured: Mubin Yousuf and A/Prof Christiane Theda at the Royal Women’s Hospital in Melbourne, Australia.

Despite this setback, our research team, headed by Navi Chief Medical Officer A/Prof Christiane Theda and CTO Mubin Yousuf, made some significant progress on our clinical research activities.

The Neonav® feasibility study, which involves the use of the Neonav® clinical prototype device to record real-world patient data, is in its final stages. To date, over 120 patients have been recruited across multiple studies that cover both Umbilical Venous Catheterisation (UVC) and Peripherally Inserted Central Catheter (PICC) procedures, with hundreds of data points being logged and incorporated into our proprietary location detection algorithm technology.

Local & Global Recognition

Navi’s work on the Neonav® Tip Location System had received attention both domestically and abroad this year, which included significant media exposure, as well as participation in a number of high profile events:

Parliamentary Recognition

A highlight was the Navi team receiving recognition from Federal Minister Karen Andrews, who made a notable mention of Navi as a leading example of next generation of innovative healthcare businesses as part of her address to parliament.

National News Coverage

The work Navi has been doing was also featured on Channel 7 News, where Navi CEO Alex Newton was interviewed as part of a prime time news segment that shared some patient stories and successes from our clinical research at The Royal Women's Hospital.

Additionally, the Herald Sun included a feature article that focused on the real-life impact the Neonav® has had during its clinical study at the Royal Women’s Hospital.

Presented At The Association For Vascular Accesses (AVA) In The USA

Across the pacific in the United States, Navi Chief Medical Officer A/Prof Christiane Theda and CEO Alex Newton presented (virtually) at this year’s Association For Vascular Access (AVA) conference.

AVA is a leading multidisciplinary community that seeks to advance research to bring about evidence-based innovations in vascular access. At the conference, both Alex and Christiane shared the results of the recent Neonav® clinical studies surrounding the Electrocardiogram (ECG) Waveforms Associated with Central Venous and Arterial Catheterisations in Neonates.

Participated on a global stage

Navi also participated in some of the worlds largest pitch competitions and accelerators in 2021:

• Awarded finalists in the Extreme Tech Challenge (XTC), which is the worlds largest start up competition for purpose-driven companies.

• Navi took part in the MedTech Innovators APAC Accelerator Program, which only accepted the top 20 medtech startups in the Asia/Pacific region to take part.

Both the XTC and the MedTech Innovator programs provided a global platform to introduce our technology to a broader audience, and receive valuable feedback and validation to help drive further progress. 

Grants and funding

Navi was successful in a number of grants during 2021, with notable wins including the Victorian Government’s Victorian Technology Adoption & Innovation Program (TAIP) grant. This grant provided important financial support towards core product development activities, but also provided significant media exposure that launched Navi into the national spotlight.

Additionally, Navi was also awarded the Federal Government’s Entrepreneurs program – growth grant, which helped support key business development activities.

Navi also finished up the Accelerating Commercialisation Grant project, which was awarded by the Federal Government, and provided matched funding to support important product development and clinical milestones during the 2021 period.

Significant Product Development Milestones

This year brought further advancement in the Neonav® development, with significant progress made on both the Neonav® capital hardware, as well as the consumable componentry that form a core part of the Neonav’s ecosystem. Both aspects of product development have been progressed to advanced stages of the design process.

This video explains how the Neonav® ECG Tip Location System works, as well as its benefits compared to the current standard of care:.

Increased Accuracy

Preliminary testing of the Neonav® algorithm with real-world procedural data collected from our ongoing clinical studies achieved an accuracy of over 93% for catheter tip location detection for UVC procedures. This result is extremely encouraging, and is a strong indictor that greater accuracy is to be expected as more data is collected and the technology matures over the coming 12 months.

“[The Neonav®] achieved an accuracy of over 93% for catheter tip location detection for UVC procedures.”

Moved into our new home

This year also saw the Navi team move to our new home at Melbourne Connect, which is a purpose-built innovation precinct right in the heart of the city’s Biomedical precinct, and is a powerhouse innovation and collaboration in Melbourne.

We are grateful to be a part of such an amazing, inspiring community of emerging thinkers and leaders in Melbourne.

Growing the Navi family

The latest member of the Navi family was welcomed in October 2021, with the birth of Oliver “Ollie” Newton, Navi CEO Alex Newton’s second child.

Doctor's Day 2021

The 30th of March is National Doctors’ Day; a day that celebrates the impact physicians around the world have on people lives. 

As a medical device company that is driven by a vision of giving children brighter, healthier futures, we have a deep awareness and appreciation for the incredible work doctors do. We are also privileged to work alongside some passionate physicians who have helped us on our journey, and who we would like to show some appreciation and recognition on this day.

We have chosen three doctors that we’d like to highlight for this special day.

One such doctor is our very own Chief Medical Officer, A/Prof Christiane Theda, who has dedicated over 30 years of her life caring for critically-ill newborns.

Christiane is currently a senior Neonatal Consultant at the Royal Women’s Hospital, as well as co-founder of Navi. She leads our clinical studies which support the development of the Neonav ECG Tip Location System, a device that will provide clinicians with real-time feedback on the location of the catheter tip across a number of procedures.

A/Professor Christiane Theda pictured beside a clinical prototype of the Neonav

Whilst dedicating a huge part of her life to Neonatal medicine, she did not really know what area of medicine she wanted to focus on when she commenced her medical studies;

“I had not “planned” to become a neonatologist. During my studies, my thoughts were to become a specialist in sport medicine, radiology or neurology.” 

However, a chance encounter with a young 8-year-old patient during her rotations in paediatrics as a student caused her to consider helping children as an area of focus.

“When I had my first workday in the NICU (neonatal intensive care unit), I went home thinking: Neonatology is it, the NICU is the place I am going to spend the rest of my professional life”.

Having worked as a clinician around the world in Germany, the USA as well as Australia, Christiane is focused and driven by one simple yet powerful guiding principle,

“[It’s] very simple – and maybe it sounds a bit cliché: help the babies and their families!”

And it is this guiding principle that drives Dr. Theda not only as a doctor, but also as an entrepreneur and inventor.

“New technologies offer so many opportunities to innovate; if it is software and data processing or other amazing new engineering developments, I feel that there is “a lot out there” in regard to advances and technology that will contribute to improved care for critically ill newborns and children”.

Another doctor that Navi has worked with closely in development of the Neonav is A/Professor Andreas Pflaumer.

Originally from Munich, Germany, Dr. Pflaumer is a Paediatric Cardiologist with a sub-specialty interest in electrophysiology. He holds an honorary appointment at the MCRI Murdoch Children’s Research Institute), and sits on Navi’s Advisory Panel as a key clinical advisor. 

A/Prof Andreas Pflaumer.

Source: rch.org.au

His journey to becoming a doctor was one driven by impact;

“I did my internship 30 years ago in Germany. At that time Electrophysiology was not an established field of practice. During my internship, I was impressed how children deal with disease and how much potential for change there was with the right treatment.”

This observation led him to focus on helping children as a paediatrician, which ultimately led him towards his speciality in cardiology;

“During my time as paediatrician, I learned that cardiac disease and neural disease have the most severe impact on a child’s early life”.

Whilst there are significant challenges and stresses that Dr. Pflaumer faces as a paediatric cardiologist, it is the outcomes that really drive him,

“Working in a very technical field, it is important to keep the balance between the technical possibilities, the potential risks of a treatment and the benefits for the child while still providing the best care. While this can be very difficult, the reward of a seeing a previously sick child thriving is always worth it.”

Looking forward, Dr. Pflaumer is most excited for the digital transformation of the health industry and the introduction of new technologies to help ease administrative burden that comes with it;

“The digital transformation of the health industry is the most exciting, though also the most challenging development. In the past 20 years, technology dramatically changed the way we understand and treat heart disease.”

“This first step of digitalisation though burdens all health care workers with administrative tasks and reduces the time we spend with the patients and their families. I hope that the further development of machine-learning and artificial intelligence will reverse this development and allow not only a more effective, but also a more personal and patient centred medicine.”

Another inspiring doctor and good friend of the Navi team is Dr Mardi Steere, who is currently Executive General Manager for Medical & Retrieval Services at the Royal Flying Doctors Service (Central Operations). Dr. Steere also has a strong driving passion for the development of universal health coverage for the underserved, especially for countries and communities with limited access to health care, and has provided some valuable insight to the Navi team on the challenges of delivering effective care to sick children in regional and Low-Middle Income Countries.

Pictured: Dr. Mardi Steere . Source: Royal Flying Doctors Service

“After completing my postgrad Paeds Emergency training in the US, I and my husband (a civil engineering projects manager) really felt convicted that we have been given so much that we needed to give back. We moved to Kenya with our kids in 2011 to serve in a Christian mission hospital - we planned to go for 2 years initially and ended up staying for 8.”

Living and working with her dedicated and professional Kenyan colleagues gave Dr. Steere life changing perspective of healthcare.

“We are incredibly fortunate to live in a wealthy country in Australia that views healthcare as a right & prioritises funding it.”

In her current role at the Royal Flying Doctors Service, Dr. Steere is facilitating equitable healthcare access for rural, regional and remote Australians.

“It is simply unacceptable that urban Australians have some of the best health outcomes in the world; while our most remote communities have outcomes on par with LMIC’s (Low-and-Middle Income Countries).”

“Comprehensive healthcare access should be available in this day and age to all Australians, no matter where you live.”

What most excites Dr. Steere about the future of medicine are the possibilities brought on by innovation, 

“There has never been a greater time to innovate - in telehealth; in new approaches to chronic disease management; in nanotechnology to miniaturise diagnostic equipment & therapeutics; in creative approaches to healthcare delivery. If we can improve how to better care for isolated communities in Australia, the broader applications for other countries could also be astronomical”

“Wouldn’t it be amazing to make a real difference for our own population that also happens to have a global impact?”

There’s an inspirational thread that links Dr. Theda, Dr. Pflaumer, and Dr. Steere; despite the challenges they face in their respective fields, they are all focused on their patients first and foremost, and optimistic about the role technology can play in improving standards of care.

The team at Navi would like to thank Dr. Theda, Dr. Pflaumer and Sr. Steere, as well as doctors globally who dedicate their lives to helping others.