Ventripoint’s VMS System Approved for Sale and Clinical Use in China
Toronto, Ontario, March 4, 2019 – Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”, TSXV:VPT, OTCQB:VPTDF) is pleased to announce that its Partner, Ma’anshan YuTian Medical Technology Co. Ltd (“YuTian Technology”), has received CFDA approval and a Certificate of Production (CoP) from the FDA in the People’s Republic of China for the VMS (QAS-R in China) system to be clinically used to analyze the right ventricle (RV) of the heart.
“We commend our Chinese partners for their diligence in achieving approval for the VMS,” lauded Dr. George Adams, CEO. “Now all 32,000 hospitals in China and its territories have access to a 2D ultrasound analytical system to accurately assess right-heart function.”
“We are looking forward to the rapid rollout of the VMS as we have a number of key leading hospitals which have been preparing to acquire the system,” stated Kevin Li, CEO of Yutian Technology.
The company had previously received GMP certification for the manufacturing facility in Ma’anshan. The factory is fully functioning and scaled to produce the VMS at a significant rate to address the Chinese market. Yutian Technology has also received the Chinese equivalent of ISO60601 for the VMS, which allows it to be used in hospitals in China.
Marketing efforts are well underway in the Chinese market with the creation of a multi-channel distribution network. The medical-device market in China was estimated at over US$58 billion in 2017 and experienced 20% growth from 2015 to 2016. There are over 2,500 Tier 1 hospitals and a total of 32,000 hospitals, with over 1,000 new hospitals currently under construction.
Heart disease is the number one healthcare issue in China with 23% of hospital admission for cardiovascular conditions. This is almost twice the 13% rate in North America. In addition, it is common to have an echocardiogram prior to any surgery and so the rate of exams is much higher than the rate in the USA. China represents a large and rapidly growing market for the VMS.
As reported previously (NR November 3, 2015), the Company entered into an agreement to allow Shanghai YuTian Medical Investment Management Co. Ltd (“Shanghai YuTian”), an investment company in China, to establish a joint venture (“JV”) in China. As previously reported (NR, Sept 22, 2016), the JV, Ma’anshan YuTian Medical Technology Co. Ltd (“YuTian Technology”) was established in the city of Ma’anshan in Anhui Province. Shanghai YuTian is the largest shareholder in YuTian Technology. The joint venture partners include Shanghai YuTian, Anhui Province Hi-tech Venture Capital Investment Co. Ltd., and Ma’anshan Economic and Development Zone Venture Capital Investment Co. Ltd.
As previously reported (NR May 7, 2017), YuTian Technology made a submission to the Chinese FDA for approval to sell the VMS in China and to certify the factory to build VMS product. As stated above this has now been achieved.
About Ventripoint Diagnostics Ltd.
Ventripoint’s technology is a leading Artificial Intelligence (AI) approach known as Knowledge-Based Reconstruction (KBR), used to create applications to monitor heart disease, a leading cause of death worldwide. The VMS+ is the first cost-effective and accurate AI tool for measuring whole heart function using conventional ultrasound. The Company has developed a suite of applications for all major heart diseases and is actively commercializing the approach to improve cardiac care.
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