30 January 2020
Navi Medical Technologies, a Melbourne based start-up company with ambitions to help critically ill newborns, has recently been awarded $396,452 in funding according to a recent media announcement from The Hon Karen Andrews MP, the Minister for Industry, Science & Technology (link).
Navi is working to develop a medical device that uses ECG technology to assist healthcare professionals caring for critical ill newborns. The device, called the Neonav, records and analyses electrical signals from the heart through a central catheter, and provides feedback on the position of the catheter to clinical staff in real-time. The device has the potential to improve the clinical workflow, as well as minimise risks throughout the stay of the patient.
“There’s been a lot of research that’s come out recently that shows around 50% of central lines placed in the veins of newborns actually move to potentially dangerous positions shortly after the initial placement procedure.” says Co-Founder & Chief Executive Officer Alex Newton. “If this migration is not picked up quickly, it can lead to some potentially devastating complications for the patient”.
Navi participated in the BioMelbourne Network ‘Getting Paid in the USA’ program in 2019, including a trip to Minneapolis, which Alex says helped refine the reimbursement strategy and build a stronger commercial case for the Neonav medical device.
“The ability to talk face-to-face with professionals from the US market really helped fill in the gaps in our understanding.” he says. And there were some unintended benefits as well, “I really enjoyed the ability to network with other early stage medtech companies, it was helpful to bounce around some ideas and see what other people are considering too”.
The most recent grant funding from the Department of Industry, Science and Technology will help Navi complete a clinical prototype device, and commence a clinical study to gather ECG data from newborns at the Royal Women’s Hospital in Melbourne. To date,the company has raised around $1.8 million to help commercialise the Neonav.
But their ambitions extend beyond just the Neonav device, according to Alex and the Navi team. “Only around 5% of medical innovations that make it to market have a neonatal indication for use, so we think there’s a huge opportunity for a focussed company such as Navi to assist these specialist doctors and nurses, and give them the products they really need.” says Co-Founder & Chief Operating Officer Shing Yue Sheung.
In fact, this is a deeply personal challenge for many of the Navi team. “I spent some time in the NICU when I was born, so it’s a personal goal of mine to help other premies” says Shing. Navi Co-Founder & Chief Medical Officer, Dr Christiane Theda has spent over 30 years working in Neonatal Intensive Care Units, including a very personal experience of having had preterm twin sons who required NICU care for weeks. “It’s very important for me to leave a mark on my speciality, and one way I can do this is to use my experience to develop the kinds of products I wished I had throughout my career” she says “It’s a dream come true really”. For Co-Founder & Chief Technology Officer Mubin Yousuf, the challenge of helping NICUs in developing regions is important, “I’m from Pakistan originally, and we have some of the highest rates of premature births in the world, so developing products like the Neonav and knowing this will help people around the world is a huge motivation to me”.
Developing products for pediatric market is a challenge, says Alex, since the addressable markets are often smaller but the risks, costs and timelines are similar to other medical devices intended for adult medicine. But Navi has received some assistance from some important, if somewhat unlikely, sources such as the FDA itself. “The FDA recognises this challenge and they’re very supportive of pediatric innovation” says Shing, who won a USD$50,000 grant through the FDA sponsored Pediatric Device Consortia program. The program also provided Navi partnerships and access to world leading hospitals including Texas Children’s Hospital, Children’s Hospital of Philadelphia and Children’s National Hospital in Washington, DC.
“Our goal is build a globally competitive Australian based company” Alex says “so it’s critical to understand the US market, and whether that’s through programs like the FDA Pediatric Device Consortia, or the ‘Getting Paid in the USA’, it’s just so important to the successful commercialisation of a medical device”