- Uscom (UCM) says the China National Medical Administration has certified extended sales of the USCOM 1A device China
- This certification is valid for five years and is the third consecutive approval for the device
- This approval allows current distributors to resume sales while new retailers can begin selling immediately
- USCOM 1A monitors cardiac blood flow and accurately measures cardiac output and stroke volume
- Uscom's share price is up a steady 17.4 per cent with shares currently trading for 13.5 cents apiece
Uscom (UCM) announced the receipt of the China National Medical Administration (NMPA) extension for sale of the USCOM 1A device into China.
The NMPA extension certification for USCOM 1A was issued on December 23 2019 and is valid for five years until December 22 2024.
This certification is the third consecutive approval for the USCOM 1A.
USCOM 1A uses advanced doppler hemodynamics to monitor cardiac blood flow.
Stoke volume monitoring changes the way fluids are managed and how sepsis, hypertension and heart failure are diagnosed.
Fluid remains one of the most challenging clinical interventions and inappropriate administration has dreadful outcomes.
USCOM 1A accurately measures blood flow, stroke volume and cardiac output across the aortic or pulmonary valve.
This device is improving management and saving lives in the neonatal, paediatric, critical care, emergency and maternal populations.
The new agreement allows current distributors to resume USCOM 1A sales, while new distributors, with contracts conditional on receipt of NMPA certification are now free to begin selling USCOM 1A with revenue expected to begin immediately.
Uscom's China HQ, set up in Beijing in November 2018, will provide clinical and technical support for all devices approved in China.
Under the leadership of Teresa Guo, Uscom China has transformed the China distribution model to a new network.
This includes previous Uscom distributors, plus an expanded network of new distributors, meaning the company now has more distributors expanding into more territories.
This expansion is planned to continue as Uscom China inducts additional distribution streams for uncovered territories over the coming year.
As a result of this, China will replace Japan as the second-largest global medical device market after the U.S.
Uscom China's new distribution strategy provides an accessible sales network for these new products as the NMPA approvals are received over the next 12 months.
"This five -ear NMPA approval underwrites the expansion of our new Uscom China HQ, and feeds directly into our new revenue model," Uscom Executive Chairman Professor Rob Phillips stated.
"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," he added.
Uscom's other products, the BP+ and SpiroSonic product series, are currently in NMPA approval process.
Uscom's share price is up a steady 17.4 per cent with shares trading for 13.5 cents apiece at 2:15 pm AEDT.