Uscom Limited has filed 510K application for clearance of SpiroSonic spirosonometric devices and accompanying SpiroReporter apps and software to the Centre for Devices and Radiologic Health of the US Food and Drug Administration (FDA). The submission has been received by the FDA and allocated a processing number (K220982) with a series of responses due over the next 60 days. FDA clearance, if received, will allow for sale of the SpiroSonic technologies in the US.

The SpiroSonic devices contain patent protected spirosonometry technology which includes digital vocal user guidance, phonic outputs and auto- diagnostic interpretation. Background: Asthma, Chronic Obstructive Pulmonary Disease (COPD), and more recently COVID, short and long, are pulmonary diseases that can cause substantial morbidity and mortality. Spirometry is an established method of measuring lung function and selecting optimal treatment, but current technology is limited by poor patient compliance, inaccurate measurements and complexity of use and difficulty of device maintenance.

SpiroSonic digital spirosonometry is Uscom's new approach to ultrasonic spirometry specialised for simplified, more hygienic and more accurate measurement and ideal for widespread adoption. Operations: The FDA review process follows a strict path including acceptance, review, substantive review, and decision, over a period of 90 days, excluding any request for additional information. The submission included more than 2,000 pages of supporting documentation and test results.

The SpiroSonic devices have CE clearance in Europe, and are mid NMPA review in China with clearance expected in approximately 6 to 12 months. The global Spirometry market is predicted to grow at 11.1% CAGR to reach $1.28b USD by 2025 driven by increasing incidence of respiratory disease, increasing age of population and the shift of spirometry devices toward smart phone-based data acquisition. The incidence of pulmonary fibrosis as a complication of acute and long COVID will also drive future demand for home use spirometry with an estimated population of 500m to 1b patients infected worldwide.

The current market is predominantly clinics and hospitals, but shifting to the more cost- effective delivery of lung performance management in home care with eHealth. There are also a number of emerging and specialised lung function organisations, with many linked to pharma testing for effectiveness of new pulmonary drugs, all of which are based on back-end software and analytics but which require premium front end sensors. It is in this space that Uscom has collaborated with Koneksa Health to create innovative solutions for monitoring pulmonary physiology.

Uscom's digital Spirosonometric technology provides the stand-alone ultrasonic lung function testing with innovative on-board analytics and guidance. Uscom has also appointed Sovereign Medical to distribute its devices on the US East Coast from New York to Florida further enhancing its nascent US distribution. Sovereign Medical specialise in distribution into critical care, respiratory care, emergency medicine, sleep medicine, maternal health, and infusion therapy fields, all aspects of care Uscom devices address.

Uscom's US team has begun training 12 of Sovereign's specialty team on Uscom products, and expect to launch sales in the next two months. The agreement is for the sale of 40 USCOM 1A units over a 3-year term and if forecasts are met is anticipated to generate profitability for the US subsidiary, creating a material change for Uscom Limited.