ResusRight – Novel Monitor Advancing The Standard of Care For Neonatal Resuscitation
Pictured: ResusRight's novel NEMO Clinical Monitor advancing the standard of care for neonatal resuscitation.
Each year, three to six per cent of babies require positive pressure ventilation (PPV) at birth to begin breathing1. With 134 million births in 20212, there were up to eight million babies requiring PPV including around 17,000 babies in Australia3.
If a baby requires ventilation at birth, this is provided manually by the clinician with a mask that covers the babies’ mouth and nose. The major cause of variation is leakage from around the edge of the mask, or variations in volume and rate from the healthcare provider providing the care.
Alarmingly, excessive gas volumes delivered during resuscitation can lead to acute lung injury and life-threatening lung collapse (pneumothorax in one per cent of newborns), or lifelong lung damage in preterm babies (60 per cent of very preterm newborns). Meanwhile, insufficient volumes can result in asphyxia. These babies carry a lifelong disease burden that impacts their health, family and the healthcare system. Despite these outcomes, gas volumes and mask leak are not routinely measured during resuscitation.
Hoping to ease this burden and advance the standard of care for neonatal resuscitation, Sydney-based ResusRight has developed the NEMO Clinical Monitor. The NEMO attaches to neonatal resuscitation equipment and guides clinical care through objective feedback on the quality of resuscitation. This feedback enables clinicians to optimise support for each infant to reduce the risk of mortality or morbidities associated with manual ventilation.
The company’s BioMedTech Horizons (BMTH) funded project set out to progress the NEMO Clinical Monitor along the medical technology commercialisation pathway. It funded a first-in-human clinical trial to evaluate the safety and feasibility of using the NEMO Clinical Monitor during manual resuscitation, as well as production and verification of advanced prototypes. Channel development and market exploration activities were also funded to build out the commercial strategy in the local Australian market, as well as in the US and Europe. Several key Australian manufacturing partners were identified to develop all pre-commercial prototypes.
Comprehensive design review and identifying a range of improvements
During the project, ResusRight implemented a fit-for-purpose quality management system (QMS), alongside the clinical trial planning and approvals, to ensure all future development will take place under relevant standard operating procedures. Following manufacture of prototype devices for use in the trial and for technical validation, the team performed a comprehensive design review and identified a range of improvements that will assist in future manufacturing, and ensure it is optimised to improve care during the resuscitation process.
ResusRight’s Chief Clinical Advisor Dr Mark Tracy said the BMTH program’s support has enabled the team to accelerate progress of the NEMO Clinical Monitor through the development and clinical validation phase.
The project achieved all its objectives. The ‘Neonatal Monitoring Trial’ (NeMo Trial), ResusRight’s first-in-human trial run at Westmead Hospital in Sydney, successfully recruited 12 infants. Data analysis demonstrated that the monitor safely and effectively assisted with all resuscitations, with no safety issues related to the investigational device reported. Qualitative and quantitative data collected supported the conclusion that the monitor was used – and functioned – as intended in 100 per cent of resuscitations. Beyond the technical achievement, the team now has invaluable firsthand experience in sponsoring a trial that will be beneficial as NEMO moves toward its pre-market pivotal trial.
Progress made during the BMTH project has positioned the NEMO Clinical Monitor for US Food and Drug Administration (FDA) clearance through the 510(k) pathway within the next 18 months, and Therapeutic Goods Administration (TGA) and Conformité Européenne (CE) clearance after a pre-market pivotal trial, which will evaluate efficacy outcomes, explained CEO of ResusRight, Matt Boustred.
“Seeing the Clinical Monitor being used to help babies during actual resuscitations is a massive step for the company and exciting validation of the work the team has done to date,” he said. “Completing the feasibility study puts us in a great position to conduct a pivotal trial, gain regulatory clearance, and get this technology into the real world, where it can begin to help clinicians care for babies in their first few moments of life.”
ResusRight established key partnerships on the commercialisation pathway including with clinical teams at leading national and international tertiary hospital centres with interest to partake in the pre-market pivotal trial. The company also signed a distribution agreement with Laerdal Global Health, a major multinational corporation and one of the largest medical device manufacturers in the neonatal space. ResusRight’s intangible intellectual property (IP) protection strategy has been established, with one provisional patent application filed.
Off the back of milestones achieved during the BMTH project, ResusRight is raising a $3 million Series A round to fund further commercialisation activities and FDA clearance. Meanwhile, the team is planning to publish the results of the NeMo Trial in a peer-reviewed journal and is currently drafting a manuscript.
BMTH project played a critical role to de-risk technology & bring closer to market
Given the start-up nature of ResusRight and the novel nature of the product it is developing, the BMTH project has played a critical role in progressing the NEMO Clinical Monitor closer to market and de-risking the technology.
According to ResusRight’s Chief Clinical Advisor Dr Mark Tracy, the BMTH program’s support has enabled the team to accelerate progress of the NEMO Clinical Monitor through the development and clinical validation phase – enabling the company to get this technology onto the market sooner.
This was critical to securing partnerships with world-leading hospitals, paving the way for the upcoming multi-centre trials both in Australia and globally.
“For millions of babies born across the world each year, resuscitation is performed with little or no feedback on the quality of the ventilation process,” Dr Tracy said.
“We recognise that the first few minutes of life are essential to both save lives and prevent lifelong brain damage for millions of babies. It was very exciting through this project to provide practitioners in the birthing suite with feedback through the ResusRight monitor for the first time. These first-in-human studies are incredibly difficult to run, and it was remarkable that the team was able to meet the recruitment numbers to demonstrate the feasibility of this technology during resuscitation and gratifying to see the positive clinical feedback collected.”
Pictured, from left: Director BioMedTech Horizons (BMTH) program Elizabeth Stares on a BMTH team visit to ResusRight in Sydney, New South Wales in 2022.
Once the NEMO Clinical Monitor is commercialised, ResusRight hopes resuscitation monitoring will become the new standard of care for every baby that needs help to start breathing – just as pulse oximetry has become standard of care at every resuscitation over the past decade. This type of volume monitoring is standard if a baby is moved to the neonatal intensive care unit; however, a lack of technology developed for the birthing suite has prevented its adoption in this environment. There is already evidence demonstrating the potential effectiveness of respiratory monitors for guiding clinical care, by helping clinicians improve the effectiveness of mask ventilation and, consequently, reducing the burden of inaccurate PPV on so many lives.
1. Neonatal resuscitation in low-resource settings, 2010.
3. Australian Institute of Health and Welfare: Mothers and Babies.