China NMPA Approves Uscom BP+
Uscom patent-protected high fidelity central blood pressure monitor, BP+, has received Chinese National Medical Products Administration (NMPA) approval for sale into China. The approval follows a rigorous 26 months’ process of testing and validation of the technology and now allows the Uscom BP+ to be sold in China, contributing a new sales revenue stream to Uscom.
The Uscom BP+ is a patent protected digital supra systolic oscillometric device that measures 34 parameters of blood pressure (BP) from each of 3 different sites in the arteries, providing unique information only previously available from invasive cardiac catheters. Coupled with the Uscom BP+ Reporter, the BP+ provides the most advanced technology for BP monitoring of hypertension and vascular health. The BP+ is applicable to home care and across multiple hospital departments including ICU, Emergency, Cardiology, CCU, Obstetrics and ED’s, etc.
Hypertension occurs in approximately 1/3 of all adults (>1.13B adults worldwide), and is the leading modifiable risk factor for cardiovascular disease and death. In China more than 85% of patients with hypertension, ~230m adults, have ineffective diagnosis and control. The new BP+ technology allows for more precise monitoring and improved therapy and outcomes. The NMPA approval of the BP+ is an important advancement for both Uscom and hypertensive and vascular care in China. The Uscom BP+ is installed on the International Space Station for advanced cardiovascular research, and is currently in eHealth studies with some of the world’s leading medical technology companies in the US and Europe.
The digital BP+ and BP+ Reporter is leading the central BP revolution, changing the standards from clinical measurements of BP in the arm to suprasystolic monitoring of BP at the heart.
To date, Uscom China’s business has been based on a single NMPA approved device, the USCOM 1A cardiovascular monitor, which has generated ~$3.75m AUD in annual revenue in 2020, and continues to grow quickly. Uscom China is a wholly-owned subsidiary in Beijing and is also progressing approval of the SpiroSonic series of digital ultrasonic spirometers for diagnosis and treatment of asthma, COPD and post COVID syndrome. 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 “We are deeply committed to China and the NMPA approval of the BP+ is a significant endorsement for our technology and an incremental financial opportunity for Uscom China’s business as we move from one product to two. While the 1A is a hospital sale, the BP+ is an advanced consumer product with a far larger market, and, combined with the BP+ Reporter, sets new standards for monitoring hypertension and vascular health worldwide. The BP+ solution is anticipated to generate significant new revenue as the devices are fed into our growing network of Chinese distributors.”
The NMPA is the regulatory body that regulates medical device approval in China and is focused on assuring the safety and efficacy of new medical technologies.
References: Accessed 15th April
https://www.who.int/news-room/fact-sheets/detail/hypertension
https://www.who.int/china/health-topics/hypertension