Uscom (ASX:UCM) has announced its SpiroSonic product range of lung function monitors have been approved by the TGA.
This approval allows sale of the Uscom high fidelity, digital ultrasonic SpiroSonic pulmonary function monitors as a class IIA device.
The SpiroSonic devices are high fidelity pulmonary function testing devices used in home care, clinics and advanced pulmonary testing laboratories to diagnose and manage asthma, COPD and sleep apnoea.
The company said it has already appointed an Australian distributor to begin sales, multiple new European distributors, and is looking to appoint new US and south eas Asian distributors.
According to Associate Professor Rob Phillips, executive chairman of Uscom, “Regulatory approval is the path to sales and revenue for our new products, and each new approval represents another regional revenue stream. Our strategic objective is to bring the SpiroSonic devices and the BP+ central blood pressure devices to global markets and anticipate receiving regulatory approvals for all products in all jurisdictions intermittently over the next 12mths. Our current growth has been predominantly attributable to USCOM 1A sales, and so the approval for sale of additional devices in additional jurisdictions represents incremental future revenue opportunities and growth drivers. We are building a real company aiming to combine blue sky, practice changing science with hard measures of sales, revenue, profitability and shareholder distributions. Regulatory approvals are vital steps in this process and a key focus of our operations.”