VSMS ECG Patch receives US FDA 'Emergency Use Authorisation' for patients being treated for COVID-19

VSMS ECG Patch receives US FDA 'Emergency Use Authorisation' for patients being treated for COVID-19

Press releases may be edited for formatting or style | May 20, 2020 Cardiology

Background on VSMS Patch and its applicability to COVID-19 patients

The Patch is part of the modular VSMS and is an easy-to-use, clinical grade solution used for monitoring patients through the healthcare lifecycle. The Patch streamlines and simplifies healthcare and patient monitoring by delivering continuous, 14 day recording of 6 channel ECG.

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US healthcare professionals can now use the Patch in a hospital setting to monitor the QT syndrome prolongation of a patient's electrocardiogram. The patch will be used to monitor patients who are 18 years of age or older and receiving treatment for COVID-19 with drugs that can prolong QT syndrome and may cause life-threatening arrhythmias.

QT syndrome prolongations are usually measured on a 12-lead ECG at various time points during drug exposures. However, the use of a 12-lead ECG for patients being treated for COVID-19 is burdensome and presents additional risk to patients and healthcare professionals due to the need for in-person consultations.

The FDA has now concluded that the Patch may be effective for remotely monitoring QT syndrome prolongations in COVID-19 patients and may reduce the risk of a healthcare professional's exposure to the disease.

Patients will be monitored for up to 14 days wearing the patch. During the monitoring period, the Patch will record and transmit ECG data, which will be saved and wirelessly transmitted to G Medical Diagnostic call centres for analysis. A call centre certified cardiographic technician will then compile the clinical findings and send an extensive report to the prescribing physician at the hospital.

Market opportunity and supply chain

There are currently over 1.46m confirmed cases of COVID-19 in the USA, with numbers expected to rise in the coming months. G Medical is confident that the Patch can help ease the burden healthcare professionals face due to COVID-19 and reduce workers' exposure to the disease.

G Medical has a robust and well-established supply chain including quality manufacturing facilities in Israel. The Company is now aggressively scaling production of the Patch at these facilities in anticipation of immediate demand that is likely to come from US hospitals and healthcare facilities imminently.

Authorised for release by Yacov Geva, Managing Director.

Released through: Henry Jordan, Six Degrees Investor Relations: +61 (0) 431 271 538

About G Medical Innovations

G Medical (ASX: GMV) was founded in August 2014, aiming to be at the forefront of the digital health revolution, developing the next generation of mobile health (mHealth) technologies. The Company leverages the experience and expertise of its Board to deliver best-in-class solutions to address this global opportunity.

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