- The TGA rejects Hydrix’s (HYD) application for the approval of the Angel Medical Systems’ Guardian product to be distributed in Australia
- The TGA believes that the benefits of the heart monitoring system do not outweigh the risks based on the clinical evidence provided
- The Guardian device previously received approval from the US FDA as it was deemed to fill an unmet medical need and have benefits that outweighed its risks
- Hydrix will seek clarification from the TGA and explore alternative pathways to obtain approval, and it will continue to commercialise the device in other markets
- HYD shares slump 21.37 per cent to trade at 4.7 cents at 1:10 pm AEDT
The Australian Therapeutic Goods Administration (TGA) has rejected Hydrix’ (HYD) application for its implanted heart monitoring system to be distributed in Australia.
The TGA said that in its view, the clinical evidence for the Angel Medical Devices (AngelMed) Guardian system did not demonstrate that patient benefits sufficiently outweighed risks.
The rejection comes despite the device landing US Food and Drug Administration (FDA) approval, which said the benefits of the device outweighed its risks and that it filled an “unmet medical need by providing more effective diagnoses of a life-threatening condition compared to relying on patient symptoms alone”.
Once surgically implanted, the Guardian device uses machine learning algorithms and artificial intelligence to continuously monitor the patient’s heart signal and warn of any coronary syndromes such as silent heart attacks.
Hydric said in its application to the TGA, it provided the same information used to gain regulatory approval in the US, Singapore and Malaysia.
The company is now seeking clarification from the TGA, and during this period, will consider the matters raised and evaluate the alternate pathways and options available to seek approval.
“The TGA’s view came as a surprise and was not the outcome we were expecting, given FDA approval endorsed the safety and efficacy of the Guardian device, concluding the benefits outweighed the risks, based on the same information provided to the TGA,” Hydrix Executive Chair Gavin Coote said.
“It is an unfortunate setback for Australian ACS patients who would benefit from the device, and we will continue to make the case for them as we seek to find an approval pathway with the TGA.
“We will continue commercialisation in Singapore and Malaysia, where we have regulatory
approval, and to progress regulatory approval processes in Japan, Hong Kong, Thailand, and Indonesia.
“While the Australian launch of the Guardian remains a key objective, Australia is only one of the eight countries in which Hydrix has exclusive rights, and these other markets with a combined population greater in size than the USA, represent a significant opportunity to focus on.
“Hydrix has multiple business segments. Pleasingly, Services returned to profitability in the first half on strong growth and the Venture companies are progressing to major inflection points which have the potential to materially increase the value of those investments in the year ahead.”
HYD shares have slumped 21.37 per cent on the back of today’s news to trade at 4.7 cents at 1:10 pm AEDT.