Uscom Limited (ASX: UCM) has been granted the prestigious CE mark for the Uscom digital ultrasonic SpiroSonic AIR spirometer, wireless testing system.
The CE mark is recognition of legal compliance with health, safety and environmental standards set by the European community, and is essential for sale of new medical technologies into the European Economic Area and many SE Asian jurisdictions, a market with a combined population of ~1.4 billion people.
The SpiroSonic AIR is the leading technology in spirometry utilising Uscom’s patented multi-path digital ultrasonic technology, wireless induction charging and BT4 wireless communications.
The SpiroSonic AIR connects wirelessly to the mobile phone loaded MyAIR, and SpiroReporter software allowing for remote telemetric and cloud-based diagnosis and monitoring and home care. The BT4 capability will allow simple connection to Uscom’s cloud based Blue Sky eHealth Ecosystem, providing a new pay per use digital revenue source.
Applications – Post COVID Syndrome:
The SpiroSonic AIR is used for the assessment of asthma, COPD, occupational lung disease and post COVID syndrome. COVID is a respiratory infection often complicated by inflammation and fibrosis which results in impaired lung function.
Recent data has demonstrated that 12-17% of severe COVID patients had restrictive lung function on spirometry after three months, suggesting serious residual and potentially progressive pulmonary fibrosis with impaired lung function. The evolution of lung dysfunction in survivors of this complex disease is unknown and many previously infected patients may require on going advanced pulmonary monitoring for optimisation of therapy.
Executive Chairman, Professor Rob Phillips said Asthma has a worldwide prevalence of ~400m, COPD has a worldwide prevalence of ~300M, and post COVID-19 recovery has a worldwide market of ~300m.
Following the COVID pandemic global Spirometry demand is predicted to increase ~160% over the next six years from $2.6 billion to $6.5 billion.
“The spirometry market is predicted to increase ~160% over the next six years to $6.5 billion, making this a very exciting time for Uscom to bring the world leading SpiroSonic AIR to market,” Professor Phillips said.
“The CE mark delivers our SpiroSonic technology to Europe and most SE Asian markets and is part of Uscom’s diversification and globalisation initiatives as we continue to progress US FDA and China NMPA.
“The SpiroSonic AIR is accurate, easy to use, and provides research quality non-invasive lung function testing for patients with asthma, COPD, occupational lung disease and post COVID syndrome, and can be used in the lab, clinic or home.
“The SpiroSonic AIR has advanced digital capabilities, making it an ideal foundation sensor for Uscom’s new Blue Sky eHealth Ecosystem, CRO’s and other international groups developing novel pulmonary care telemetric home use management models.
“The SpiroSonic AIR will be rolled out for sale into the growing Uscom distribution networks in Europe and SE Asian jurisdictions.”