Authorization

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

Patch now authorised in the USA for emergency use for patients undergoing treatment for COVID-19



Patch entitled for reimbursement under US CPT code scheme a?? adds to GMV's growing revenue profile



Large addressable market for G Medical - ~1.5m confirmed cases of COVID-19 recorded in the US[i] so far



Fast route to market - manufacturing ramp-up of patch now underway at established facility in Israel



Patch will remotely monitor the QT syndrome prolongation on a patient's electrocardiogram a?? all data will be compiled with extensive reports sent to healthcare professionals and GMV call centres for analysis

REHOVOT, Israel, May 19, 2020 /PRNewswire/ -- Medical device and telehealth company G Medical Innovations Holdings Ltd (ASX: GMV) ("G Medical" or "Company") is pleased to report a significant development for the Company with receipt of Emergency Use Authorisation ("EUA") status from the US Food and Drug Administration ("FDA") for the Company's Vital Signs Monitoring System ("VSMS") ECG Patch ("Patch") for the remote monitoring of the QT interval of an ECG in patients who are undergoing treatment in a hospital setting for COVID-19 with drugs that can prolong QT intervals and may cause fatal arrhythmias. Prolonged QT intervals outline a rhythm disorder in the heart (medically known as an arrhythmia) whereby an individual's heart muscle takes longer to recharge between beats. This can potentially lead to fainting, seizures or sudden death. Under the EUA 'Issuance of Authorisation', the FDA concluded that "there is no adequate, approved, and available alternative to the emergency use of the VSMS Patch for remote monitoring of the QT interval of an ECG in patients who are undergoing treatment in a hospital setting for COVID-19 with drugs that can prolong QT intervals and may cause life-threatening arrhythmias. In addition, remote monitoring may reduce the [Health Care Professionals] HCP risk of exposure to SARS-CoV-2 during the COVID-19 pandemic."[ii]The Company will continue its manufacturing of the Patch at its wholly owned R&D facilities in Israel and also via an FDA and ISO certified medical device contract manufacturer in Israel, ahead of future production at G Medical's Guangzhou China production facility. The Authorisation will be effective until the declaration that circumstances exist justifying the authorisation is terminated under section 564(b)(2) of the relevant Act or the EUA is revoked under section 564(g) of the Act.
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