China 5 Year NMPA Certification for Uscom
SYDNEY, Australia, Monday 6th January 2020: Uscom Limited (ASX code: UCM) (the Company or Uscom) today announced receipt of the China National Medical Products Administration (NMPA) extension regulatory certification for sale of the USCOM 1A device into China. The new NMPA extension certification for USCOM 1A was issued on the 23rd December 2019 and is valid for 5 years until 22nd December 2024. The certification is the third consecutive extension approval for the USCOM 1A.
This approval allows current distributors to resume USCOM 1A sales, while new distributors, with contracts conditional on receipt of the NMPA certification, are now free to begin selling USCOM 1A, and this new revenue is expected to begin immediately.
Uscom’s China HQ, set up in Beijing in Nov 2018, will provide clinical and technical support for all Uscom devices approved in China. Under the leadership of Ms Teresa Guo, Uscom China has transformed the China distribution model to a new network which includes previous Uscom distributors plus an expanded network of new distributors, meaning Uscom now has more distributors penetrating into more territories. This expansion is planned to continue as Uscom China inducts additional distribution streams for uncovered territories over the coming year.
China, with an expected 2020 medical device market of $600 billion RMB (>$100B AUD), will replace Japan as the second-largest global medical device market after the United States. The BP+ and SpiroSonic product series, including the innovative SpiroSonic AIR, a revolutionary digital, induction charging, home care ultrasonic technology based on wireless telemetry coupled with the SpiroSonic AIR App, are currently in NMPA approval process. Uscom China’s new distribution strategy provides an accessible sales network for these new Uscom products as the new NMPA approvals are received over the next 12 months.
Executive Chairman of Uscom, Professor Rob Phillips said “This 5 year NMPA approval underwrites the expansion of our new Uscom China HQ, and feeds directly into our new revenue model. Our Director of China operations, Ms Teresa Guo, has established a new direct distribution network in China, based on growing our current long term partners while adding new partners. Over the coming 12 months we expect approvals for a number of new products in China, and these will be fed into our expanded direct distribution channels. China is one of the fastest growing medical device markets in the world, and Uscom is committed to this market with its rapidly expanding China team. The NMPA USCOM 1A extension approval and the new Uscom China operations is the beginning of new era for Uscom.”
Uscom manufactures and markets the USCOM 1A, the Uscom BP+, and the Uscom SpiroSonic digital ultrasonic spirometry technologies. These premium digital devices are changing the way we diagnose and treat cardiovascular and pulmonary diseases. The USCOM 1A provides vital guidance for optimising management of sepsis and the administration of fluid, inotropes and vasoactive therapies in critical care monitoring. The BP+ SpiroSonic devices improve diagnosis and management of hypertension, heart failure, asthma, COPD and sleep disorders in the clinical and home care environments.