Biotech: GMV finishes trials needed to enter Chinese market; shares rally
Health & Biotech
Health & Biotech
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G Medical Innovations (ASX:GMV) has added up to 35 per cent to its share price in morning trade after completing the clinical studies it needs to enter the Chinese market with its Prizma medical monitoring case for smartphones.
G Medical had a delay to its Prizma approval process for the large Chinese market after the death of its chief principal investigator.
The completed trials of 208 patients at three facilities tracked people’s electrocardiography (ECG) results using the Prizma case, blood-oxygen saturation (SPO2) and body temperature and compared the result to data delivered by hospital equipment.
G Medical plans to throw data into a dossier for regulators and lodge it by the end of the March quarter.
The company will then have its fingers crossed for an approval from China’s National Medical Products Administration (NMPA) this year.
NMPA was previously known as the China Food and Drug Administration (CFDA).
Israel-based G Medical CEO and executive director Dr Yacov Geva said the completion of the clinical trials was a milestone for the company and its Chinese market entry.
“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,” he told the market this morning.
“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.”
Morgans analyst Iain Wilkie described the latest development as “a bit spivvy”.
He told Stockhead the Chinese market was a big deal and Morgans was taking a watching brief of the company and its efforts, although there were other medical technology companies the stockbroker preferred.
These included ResApp Health (ASX:RAP) with its “potentially massive” upside and US Food and Drug Administration and Australian Therapeutic Goods Administration plans as part of its commercialisation strategy.
ResApp has a Smartphone app people can use to diagnose and manage respiratory diseases like croup, asthma and pneumonia.
G Medical was up over 22 per cent at 11c around midday.
Invex Therapeutics (ASX:INV) chief scientific officer and executive director Professor Alexandra Sinclair director has joined the board of the International Headache Society (IHS). The neurology company is developing the purposed drug Exenatide for intracranial pressure and posted its quarterly results to market today after ending the December quarter with $10.8m cash.