Hydrix Limited advised engagement with, the Australian Therapeutic Goods administration (TGA), in the Company's view, the best path forward to reach an approval with the TGA, is to withdraw the current application with a view to resubmitting at a later date. Whilst the TGA acknowledged Guardian device benefits, the company's understanding in principle is, they are not yet convinced that the patient benefits sufficiently outweigh potential risks from using an endocardial lead (used in pacemaker implants), in the Australian context. The Guardian uses the pacemaker lead to continuously monitor the heart to detect and alarm a patient of a life-threatening cardiac event. Angel Medical Systems
will continue to gather patient data to assist Hydrix with a view to resubmitting to the TGA in due course.