G Medical Innovations (ASX: GMV) is getting closer to being able to commercialise its Prizma medical smartphone case across China, with CE, CFDA and FDA regulatory audits scheduled at the company’s Guangzhou production facility later this month.
The medical device company said the audits are due to commence on 22 September. Following the receipt of successful results around three weeks later, G Medical expects to receive its certification and can start the manufacture and distribution of its units into territories that require either of the three approvals in place.
G Medical was the first company this year to be admitted into the “Green Channel” of the Guangdong Provincial CFDA regulatory approval process, back in February.
US and UK distribution
Meanwhile, the company has started distribution of its Prizma device in the US, where it already has FDA approval.
G Medical’s plan is to sell the Prizma directly to existing primary and specialty care service providers, who will then issue/on-sell the device to their patients. Alternatively, patients can purchase directly from the company via a physician prescription.
The company has also recently expanded into the UK, appointing a sales manager in the region on a commission basis.
According to G Medical, initial units will continue to be produced at the company’s facility in Israel, with a view to transfer and expand production to the China production facility once regulatory approval has been received.
Hong Kong IPO update
The company announced its intentions a month ago to list its Chinese subsidiary, Guangzhou Yimei Innovative Medical Science and Technology Co Ltd (GYIMSTC), on the Hong Kong Stock Exchange.
G Medical has engaged global investment bank UOB Kay Hian (Hong Kong) Ltd as advisors for the listing with the initial market capitalisation of at least HK$1.5 billion ($260 million).
Under the proposed listing, the subsidiary would spin off from G Medical, with G Medical retaining a minimum of 50% interest in GYIMSTC.
Further to the August announcement, G Medical has been approached by several institutions expressing interest in participating in the initial public offering being led by UOB.
The company said it was conducting early stage discussions with these institutions and planned to update the market on its progress.
In addition, G Medical has begun preliminary talks with institutions participating in other international stock exchanges about the possibility of additional listings for the company.
Shares in G Medical climbed more than 15% to $0.38 by early afternoon trade.