G MEDICAL GRANTED FDA 510(K) CLEARANCE FOR ITS “PRIZMA” MEDICAL...

G MEDICAL GRANTED FDA 510(K) CLEARANCE FOR
ITS “PRIZMA” MEDICAL SMARTPHONE JACKET
• Paves the way for launch and commercialisation into the United States
Mobile and e-Health company G Medical Innovations Holdings Ltd (“G Medical” or the “Company”) is pleased to announce it has been granted U.S Food and Drug Administration (FDA) 510(K), Class II approval to market and sell its Prizma Medical Smartphone Jacket in the United States.
The Prizma is one of two key products developed by G Medical. It is aimed at everyday consumers focused on their health and wellbeing, and allows consumers to turn their smartphone into a mobile medical monitor to measure a wide range of vital signs. In addition, users can store their medical data in the cloud and share it with any 3rd party including professionals and family.
Similar regulatory approvals are in progress in China, Europe, Australia and other markets in line with the Company’s priorities. The Company looks forward to providing further updates to shareholders as these approvals unfold.
Commenting on the FDA Clearance, G Medical CEO Dr. Yacov Geva, said: “Today marks a very significant milestone in the history of G Medical as we receive clearance from the FDA to launch into the United States. Such news is in line with our commitment to shareholders to move quickly from development to commercialisation. It also aligns with our vision as we continue to develop our product pipeline based on our strong IP portfolio. Availability of the Prizma in the near future will immediately benefit consumers and their healthcare providers.”
In line with this approval, the Company also announces that this significant milestone will trigger the conversion of 70,000,000 Class A Performance Rights into fully paid ordinary shares, ranking equally with the existing fully paid ordinary shares on issue. The shares will remain escrowed until 10 May, 2019. The terms and conditions of the Class A Performance Rights are set out in Section 15.6 of the Company’s Replacement Prospectus dated 14 March 2017.