Two New Uscom Devices for China
Uscom has completed the development of two new specialised cardiovascular monitors, the “USCOM O2” and the “USCOM Basic”. The development of these two new monitors creates for Uscom a three-tier range of Uscom haemodynamic monitors for sale into China.
Uscom is required to obtain regulatory approval of the China National Medical Products Administration (NMPA) for the two new specialised cardiovascular monitors prior to the commencement of sales. The NMPA process involves 9 steps including document writing, collection, translation, review and product testing, and is estimated to take 12 months for approval, if milestones are achieved according to guidelines.
The USCOM 1A is an advanced haemodynamic monitor which can be used to diagnose and manage sepsis, heart failure, hypertension, and fluid, inotrope and vasoactive administration in adults, children and neonates. The new “USCOM O2” is the high end of the Uscom technology range and includes direct measurement of blood oxygen saturation generating beat to beat measures of oxygen delivery, a complex and critical measure of cardiovascular performance. The new “USCOM Basic” is a defeatured device which will be marketed competitively against lower functioning technologies in price-sensitive tenders. These new monitors will be marketed through Uscom China’s current Chinese distribution
network.
Uscom has sold >500 USCOM 1A units into China, and its Beijing subsidiary, Uscom China, generates ~70% of Uscom’s global sales. The USCOM 1A is recommended as a preferred method for the management of serious COVID 19 cases by the National Health and Medical Commission of the People’s Republic of China. In 2020 Uscom China installed 56 USCOM 1A units in specialised hospitals designated for treatment of severe COVID 19 cases. Uscom China has been listed as a National High Tech Medical Enterprise by China’s Ministry of Science.
Executive Chairman of Uscom, Associate Professor Rob Phillips said “More devices equals more revenue, and additional devices for sale in China, our major market, is the logical strategic next step to promote strong on going revenue growth. These new devices will expand the market reach of our successful USCOM 1A by creating a three-tiered range of haemodynamic monitoring technologies, each with specialised features for different levels of clinical complexity and price. These new devices will also be prepared for regulatory submission in our other global markets.”
Uscom recently received NMPA approval for sale into China of its advanced hypertension monitoring technology, the BP+ susprasystolic oscillometric BP monitor. The BP+ is currently being prepared for market in China as Uscom’s second product and should be generating revenue within the next 3 months. The NMPA is the body that regulates medical device sales in China and is focused on determining the safety and efficacy of new technologies.