TGA for Uscom SpiroSonic Digital Spirometers

Uscom advanced digital ultrasonic SpiroSonic lung function devices receive regulatory listing for sale in Australia

Uscom announced that the Uscom SpiroSonic product range of lung function monitors have been listed on the Australian Regulator of Therapeutic Goods (ARTG) by the Therapeutic Goods Administration (TGA). This listing allows sale of the Uscom high fidelity, digital ultrasonic SpiroSonic pulmonary function monitors as a class IIA device.

Key Points

  • TGA is Australian regulatory authority for therapeutic goods including medical device and listing is required before sale in Australia
  • Chronic respiratory diseases (asthma, COPD and sleep apnoea) are common and increasing worldwide
  • Uscom 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
  • SpiroSonic devices have recently received CE (European) approval and are currently in process for CFDA (China) and FDA (US) approvals
  • Uscom BP+ and BP+ Reporter are also in process for global regulatory approvals

Regulatory approvals are essential for permission to sell in almost all global jurisdictions and are evaluated in terms of safety and efficacy. The SpiroSonic devices are listed by the ARTG with the identifier 291176. The SpiroSonic devices already have CE (Europe) and now TGA approval, and are in process for CFDA (China) and FDA (USA). The Uscom BP+ and BP+ Reporter are also undergoing the same processes, but because of precedent approvals the timeline may be shorter. However the duration of the regulatory processes vary with jurisdiction and product, and are therefore uncertain. Uscom has already appointed an Australian distributor to begin sales, and multiple new European distributors, and is looking to appoint new US and SE Asian distributors.

Executive Chairman of Uscom, Associate Professor Rob Phillips said, “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.