Summary

All current Neonatal Resuscitators, whether Flow-Inflating Bag (FIB), Self -Inflating Bag (SIB) or T-Piece type, are Pressure-Driven.

As Newborns transition to Extrauterine life their Lung Compliance rapidly increases. Using current pressure-driven devices, Physics dictates that as Lung Compliance Increases Volume must also increase.

The compliance of a system is defined as the change in volume that occurs per unit change in the pressure of the system” https://www.ncbi.nlm.nih.gov/books/NBK538324/

Multiple studies have shown excessive volume delivery can lead to over-inflation of the Newborn’s Lungs, resulting in Lung Injury, Brain Injury, lifelong Respiratory and Neurological impairment, Bronchopulmonary Dysplasia (BPD), long-term Healthcare System dependency and/or death.

How does the NextStep™ differ from current Neonatal Resuscitators?

Unlike all current Neonatal Resuscitators, the NextStep™ is NOT Pressure-Driven and manually operated but Volume-Controlled and Automated.

Being Volume-Controlled the NextStep™ Works with Physics and maintains safe, operator pre-set Volume throughout changes in lung compliance, whilst controlling Respiratory rate, I:E ratio, PEEP and Max. Airway Pressure, thereby mitigating the risk of Volutrauma, Lung Injury, Brain Injury (BPD) and death.

Healthcare cost for BPD survivors is estimated at CAD$700,000/patient. With 2M+ new survivors annually, mitigation of BPD has the potential benefit to save up to CAD$1.4T/year in Healthcare costs. https://bmcpediatr.biomedcentral.com/articles/10.1186/s12887-020-02037-5. The Social benefit to millions of Families every year – immeasurable. 

‘The NextStep Neonatal Resuscitator and Transport Ventilator provides the Delivery Room Clinician an easy-to use, safe, 21st Century alternative to aged SIB and T-Piece resuscitators, with the accuracy of a NICU ventilator at a fraction of the size, weight, power-consumption, capital and servicing costs’.

KM Medical NZ will partner with a global respiratory device Manufacturer to commercialize the NextStep™ platform.