SpiroSonic AIR Approved for European CE Mark
- Patent protected wireless lung function testing technology
- Asthma, COPD, and post-COVID syndrome
- Spirometry market is predicted to double in 12 months
- Globalisation initiative – Europe, SE Asia and the US
Uscom notifies the market of notice to approve CE mark for the Uscom digital ultrasonic SpiroSonic AIR spirometer. The CE mark is recognition of legal compliance with health, safety and environmental standards set by the European Community, and is essential for the sale of new medical technologies into the European Economic Area and many SE Asian jurisdictions, a market with a combined population of ~1.4B people.
The Technology:
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 3 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 ongoing advanced pulmonary monitoring for optimization of therapy.
The Market:
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. Deteriorating environmental air quality and harmful levels of air pollution affect approximately 2B people worldwide. Increasing elderly populations, constrained health budgets, and technological advances in respiratory care devices will drive the spirometry market, and encourage home spirometer monitoring and an increased clinical focus on monitoring respiratory diseases further stimulating demand. Following the COVID pandemic global Spirometry demand is predicted to increase ~160% over the next 6 years from $2.6B to $6.5B.
Regulatory Approval:
The regulatory approval of medical devices is becoming increasingly complex and time-consuming and this notice of CE Mark comes at the end of an 18-month process that has been complicated by the COVID-19 pandemic and repeated changes in CE regulations. This complexity, a liability to incumbents, acts as an extra barrier to entry for competitors.
Commentary:
Executive Chairman of Uscom, Professor Rob Phillips said “The spirometry market is predicted to increase ~160% over the next 6 years to $6.5B, making this a very exciting time for Uscom to bring the world leading SpiroSonic AIR to market. 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.”
Uscom Devices:
Uscom manufactures and markets the USCOM 1A haemodynamic monitor, the Uscom BP+, central blood pressure monitor, and the Uscom SpiroSonic digital ultrasonic spirometers, and the VENTITEST and VENTITEST-S ultrasonic ventilator calibrators for optimising respiratory device performance.
References:
https://spirosonic.com Arnold DT, Hamilton FW, Milne A, et al. Patient outcomes after hospitalisation with COVID-19 and implications for follow-up; results from a prospective UK cohort. medRxiv preprint doi:
https://doi.org/10.1101/2020.08.12.20173526
https://www.marketresearchfuture.com/reports/spirometry-market-6539