Australian Mobile and e-Health company G Medical Innovations Holdings Limited (ASX:GMV) has successfully completed the necessary clinical trials required to obtain National Medical Products Administration (NMPA) approval for the use of its Prizma device in the People’s Republic of China.
Prizma allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs, with the added advantage that users are able to store their medical data in the cloud and share it with third parties such as healthcare professionals and family members.
G Medical has completed the additional trials with 208 patients with three of its partner hospitals, the Guangzhou Women and Children’s Medical Centre, the Zhujiang Hospital of Southern Medical University and the Sixth Affiliated Hospital of Sun Yat-sen University.
The trials included measurements for electrocardiography (ECG), blood-oxygen saturation (SPO2) and body temperature using the Prizma device benchmarked against the relevant ‘gold standard’ hospital diagnostic equipment.
The company is currently interpreting the large amount of statistical data generated and a dossier of results will be finalised for lodgement with the NMPA. G Medical expects to lodge the required information with the NMPA by the end of April 2020, and is confident that it will receive NMPA clearance for its Prizma medical device.
CEO and Executive Director Dr Yacov Geva said NMPA approval for the Prizma device will allow for the commencement of G Medical’s commercial sales and services activities within the Chinese market.
NMPA approval for the manufacture of the company’s medical devices has already been granted for its Guangzhou production facility, leaving it well positioned to capitalise once NMPA approval for the Prizma device is granted.
Receipt of NMPA approval for the Prizma device will also allow G Medical to accelerate existing distribution and services arrangements with its China partners being; Beijing SilverLake Investment Co., Ltd and Shandong Boletong Information S&T Co. Ltd, underpinning multiple potential revenue streams (in accordance with requirements to the respective agreements as previously announced).
The company is continuing the NMPA regulatory approval process for its GMP ‘Patch’ (VSMS) and will provide further updates as developments are progressed.
“The completion of these clinical trials is a major milestone for G Medical and an important step in securing our entry into the large Chinese market,” Dr Geva said.
“The company will shortly lodge the required documentation to the regulator and we are confident that NMPA approval will be received towards the middle of the year.
“Following this, the provisions for our device sales and services are expected to be able to materialise quickly via our existing established in-country partners, as well as to allow for additional partnerships to be explored.
“G Medical looks forward to updating shareholders as relevant information is lodged with the NMPA and further developments are made.”