Cardiex lodges TGA application for arterial health monitor

To advance its global expansion strategy, Cardiex has lodged a TGA application for its CONNEQT Pulse device.

Pic via Getty Images

• Cardiex has formally lodged a TGA application to register its CONNEQT Pulse device in Australia, following FDA clearance in the US

• The move adds to a strong year that includes US shipments, a $3.25m capital raise, and inclusion on the US Blood Pressure Validated Device Listing

• The CONNEQT platform offers clinical-grade heart health insights at home, supporting earlier detection and proactive care

Special Report: Medtech innovator Cardiex has lodged an application with the Therapeutic Goods Administration (TGA) to register its flagship CONNEQT Pulse device for sale in Australia, marking another step in its global expansion strategy.

The company confirmed on Tuesday it had submitted its application for inclusion in the Australian Register of Therapeutic Goods (ARTG), a critical regulatory requirement for its APAC expansion.

CEO Craig Cooper said the submission signalled Cardiex's (ASX:CDX) intent to continue to scale the presence of its CONNEQT brand beyond the United States.

“With FDA clearance in the US and now a formal TGA lodgement in Australia, we are establishing a strong global footprint for the CONNEQT brand,” he said

“We’re excited to bring our transformative cardiovascular technology to new markets and help drive better health outcomes worldwide.”

The move follows the finalisation of a manufacturing and regulatory support agreement with Andon, Cardiex’s global production partner, aimed at supporting the device’s rollout in the Australian market. The TGA’s review process is expected to take between three and six months.

Crucial cardiology insights for users and doctors

The CONNEQT Pulse monitor, which measures advanced vascular biomarkers such as central blood pressure and arterial stiffness, has been designed to provide clinical-grade diagnostics in a home setting.

The device is supported by the CONNEQT app, which recently added a world-first Cardiology Report feature that transforms raw health data into personalised insights for users and their doctors.

Surging demand for at-home health tools

The TGA submission is the latest in a string of milestones for Cardiex this year. In January, the company began shipping the first batch of CONNEQT Pulse units to the US, following a $3.25 million capital raise to fund production. The Pulse device was also recently added to the US Blood Pressure Validated Device Listing.

Mr Cooper said the company’s growth strategy was centred on meeting surging global demand for at-home health tools, especially those targeting cardiovascular conditions – the world’s leading cause of death.

“Our mission is to empower consumers with the tools they need to take charge of their heart health. Lodging the TGA application is a great milestone on that journey,” he said.

Cardiex’s patented SphygmoCor® technology, the foundation of its device suite, is already used in clinical research settings and specialist clinician practices and is gaining traction in consumer health as the push toward personal diagnostics accelerates.

This article was developed in collaboration with Cardiex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Cardiex lodges TGA application for arterial health monitor