Uscom has initiated China Food and Drug Administration (CFDA) submissions for approval to sell Uscom BP+ and Uscom SpiroSonic devices in China. CFDA approval is required before medical devices can be sold in China, and is valid for 5 years. The Uscom CFDA approval process is being managed by a specialist Beijing based regulatory consultant and overseen by Uscom Australia and our China Importation and wholesale partner, CIIC.
While the CFDA regulatory process is complex and of uncertain outcome and duration, both the BP+ and SpiroSonic product suites have current CE (European) regulatory approval and CFDA approved precedent devices, which may accelerate the approval timeline. The USCOM 1A has current CFDA approval, while this is the initial submission of the new Uscom BP+ and SpiroSonic devices.
China is an important market for Uscom, with much of it's rapid revenue growth attributable to China sales of the USCOM 1A. The majority of current China sales have been derived from 5 distributors managed by Uscom's Hong Kong based Asia Pacific distribution partners, Pacific Medical Systems. Uscom has recently increased it's China activities and expanded its operations to include an additional partnership with a Shanghai based, Chinese state owned entity, CIIC Shanghai Science and Technology, and its distribution arm, Sense Medical. CIIC Shanghai Science and Technology will be responsible for the importation and wholesale of Uscom devices into China, while Sense Medical have been established to manage distribution of the Uscom devices into multiple Chinese provinces.Uscom CEO Rob Phillips, Global Distribution Manager Denise Pater and Customer Relations Manager Bev Jacobson have just returned from initial training of 8 newly appointed distributors being managed by CIIC and Sense Medical. The training was accompanied by an order for 7 USCOM 1A devices.
Executive Chairman of Uscom, Associate Professor Rob Phillips said, "Success in China is very much a numbers and partners project. We have a state owned, Shanghai based importation and wholesale partner with growth aspirations beginning to feed our USCOM 1A into the 1.37B population Chinese market. The BP+ and SpiroSonic devices can then also be fed into these channels once we receive CFDA approvals. China has 32 provinces while we have previously only had 5 effective distributors. On this trip we trained 8 new CIIC appointed distributors covering previously un-served provinces, and further appointments are in process as we focus on onshore training and technical support. The new China importation and distribution model is planned to provide a platform for significantly increased distribution and revenue for the USCOM 1A, and then the new BP+ and SpiroSonic devices once they are approved for sale in China; this process is now underway."
Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital medical devices are changing the way we diagnose and treat cardiovascular and pulmonary diseases, including hypertension, heart failure, asthma, COPD and sleep disorders. The products are integral for optimising management of sepsis and guidance of fluid, inotropes and vasoactive therapies in critical care monitoring, and in clinical and home care delivered asthma and COPD medications.