G Medical continues expansion, receiving TGA approval for GMP

By Trevor Hoey. Published at May 5, 2020, in ASX Biotechs

Shares in medical device and telehealth company G Medical Innovations Holdings Ltd (ASX:GMV) surged more than 20% on Tuesday morning after the company announced that it had been granted Therapeutics Goods Administration (TGA) approval for its G Medical Extended Holter Patch (GMP).

This marks a significant milestone for the company as the GMP now officially complies with all relevant Australian medical and safety requirements as a Class IIa medical device.

TGA certification adds to the previously granted European ‘CE’ Class II approval received for the GMP.

The G Medical Patch (GMP) is part of the modular Vital Signs Monitoring System (VSMS), an easy-to-use clinical-grade solution for monitoring patients throughout the healthcare lifecycle.

Ideal for use in clinics, assisted living residences, hospitals and with healthcare providers, the GMP streamlines and simplifies healthcare and patient monitoring by delivering continuous, 14 day recording of six-channel ECG.

Importantly, G Medical is also pursuing required regulatory approvals for its GMP in other target markets, including the US.

The GMP seeks to streamline patient monitoring across all stages of the healthcare lifecycle, including pre-hospitalisation, hospitalisation and post-discharge.

The product allows for a higher level of patient care and takes the burden off medical personnel, leading to increased efficiency, decreased liability and a reduced number of re-admissions.

Discussing the significance of this development, as well as pointing to the prospects of other devices developed and being distributed by the group, chief executive Dr Yacov Geva said, “TGA certification is a significant milestone for G Medical and demonstrates how the company’s suite of medical devices and telehealth technologies are relevant to the current environment.

“The company continues to pursue regulatory approvals for both the GMP and the Prizma device in its target markets and looks forward to updating shareholders as they are granted.”

As indicated below, the company has already had significant global success with its Prizma device, including over-the-counter approval by the FDA the US.

Generating diversified recurring revenues

G Medical specialises in innovative next-generation mobile and e-health solutions using its suite of proprietary devices and software solutions, as well as patient service operations, with a view to driving multiple and recurring revenue streams, across numerous verticals and territories.

The group’s medical devices and telehealth platforms are becoming recognised as cost effective and scalable solutions to ease the burden on healthcare systems, which can be adopted and utilised by both the patient and their physicians with relative ease.

The products are not only effective and relevant in the current COVID-19 pandemic, but are also important for the monitoring and remote management of patients with chronic diseases as well as other specific medical indications, in parallel and beyond COVID-19.

The company has had rapid success across a broad range of markets with its Prizma device which 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 also offers a professional real-time patient continuous monitoring solution, G Medical’s Vital Signs Monitoring System (VSMS) and G Medical Patch (GMP).

This modular solution measures a wide range of vital signs that are automatically presented in a call centre (IDTF) or a hospital setting.

The GMP assists in diagnosing patient complaints and conditions remotely, from pre-hospitalisation, hospitalisation, and through to post-discharge home-based settings.

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