Hydrix Limited has been advised by the TGA that its current application for regulatory approval to market and distribute the Angel Medical Systems Guardian in Australia is not going to be accepted. Hydrix has not yet received formal notice of its decision from the TGA. Hydrix and AngelMed's position on the Guardian: Australia is one of eight countries where Hydrix has exclusive rights to distribute the Guardian covering a total population of more than 500 million people.

Hydrix has commenced commercialisation of the Guardian in approved markets, including in Singapore and Malaysia, where eight successful implants have been completed. The TGA granted Hydrix until close of business the 27th of February 2023 to consider its response. Hydrix is seeking clarification from the TGA, and during this period, will consider the matters raised and evaluate the alternate pathways and options available to seek a TGA approval.

The TGA has advised that in their view, AngelMed's clinical evidence did not demonstrate that the patient benefits sufficiently outweighed the risks of an implanted device using a pacemaker lead to monitor the heart signal to detect and alarm a patient of a life threatening situation. Hydrix and AngelMed are confident in the safety and efficacy of the Guardian device, and that the benefits outweigh the risks to improve the current standard of care based on more than 3,450 patient years of safety data and 1,550 patient years of efficacy /performance data. When the US FDA approved the device, it stated in its decision that the benefits outweigh the risks, and that the device "fills an unmet medical need by providing more effective diagnosis of a life-threatening condition compared to relying on patient symptoms alone." Hydrix confirms the TGA application and information variously provided included all of the information used to gain regulatory approval in the USA (June 2021), Singapore (August 2022) and Malaysia (June 2022) where it is now being prescribed to suitable ACS patients.