• CONNEQT Pulse arterial health monitor approved by TGA for use in Australia
• Follows prior FDA clearance, enabling commercial activities in Australian market
• Pulse is a clinical-grade vascular biometric monitoring device for cardiovascular health

Cardiex Limited (ASX: CDX) has announced that its CONNEQT Pulse arterial health monitor has been approved by the Therapeutic Goods Administration (TGA) for use in Australia. The Pulse device is now included in the Australian Register of Therapeutic Goods (ARTG), clearing the way for Cardiex to commence commercial activities in the Australian market. This TGA approval follows the Company's prior clearance from the U.S. Food and Drug Administration (FDA). The CONNEQT Pulse is a world-first clinical-grade vascular biometric monitoring device designed for use in both clinical and remote patient monitoring or at-home care settings. It enables the capture of a broad range of arterial health biomarkers, including central blood pressure and arterial stiffness, which are key indicators for cardiovascular risk and vascular health. With TGA approval now in place, Cardiex will begin exploring commercialisation opportunities in Australia, with an initial focus on pharmaceutical, research and clinician markets. These sectors represent early entry points for integration of the Pulse into specialist use cases across clinical trials and cardiovascular disease management care. Cardiex CEO Craig Cooper commented that the TGA approval is another milestone for the company as it expands its regulatory and commercial opportunities, reflecting its commitment to delivering advanced cardiovascular solutions to global healthcare markets.

While the U.S. remains Cardiex's primary focus at this stage, the company is excited to begin laying the foundation for growth in the Australian market following the TGA approval of its CONNEQT Pulse device.