Cardiex receives TGA approval for CONNEQT Pulse arterial health monitor

• Cardiex’s CONNEQT Pulse device approved by the TGA, enabling Australian market entry
• Approval follows earlier FDA clearance and supports broader CONNEQT Health platform expansion
• $6.5m capital raise underway to fund manufacturing, sales and digital platform growth

Special Report: Health technology company Cardiex has achieved an important milestone, receiving Therapeutic Goods Administration (TGA) approval for its CONNEQT Pulse arterial health monitor.

The device is now listed on the Australian Register of Therapeutic Goods (ARTG), following earlier clearance by the US Food and Drug Administration (FDA).

Designed for both clinical and at-home use, the CONNEQT Pulse uses pulse wave analysis to measure advanced arterial biomarkers such as central blood pressure and arterial stiffness, key indicators for cardiovascular health and risk. The device forms part of the company’s broader CONNEQT Health platform, which includes medical devices, digital health tools and software solutions for cardiovascular monitoring and patient engagement.

With Australian regulatory approval now in place, Cardiex (ASX:CDX)  will begin assessing local commercial opportunities, with an initial focus on the pharmaceutical, research, and clinician sectors.

“TGA approval of the Pulse is another milestone for Cardiex as we expand our regulatory and commercial opportunities,” CEO Craig Cooper said.

“This approval reflects our commitment to delivering advanced cardiovascular solutions to global healthcare markets. While the US remains our primary focus at this stage, we’re excited to begin laying the foundation for growth in Australia.”

The approval comes as Cardiex launches a capital raise of up to $6.5 million, comprising a $2.4 million share placement to institutional and sophisticated investors and a $4.1 million non-renounceable entitlement offer to eligible shareholders.

Funds will support the ongoing commercial expansion of the CONNEQT Health business, including manufacturing, sales, marketing and digital platform development.

The entitlement offer will open on 6 June 2025 and close on 20 June 2025, with allotment and final settlement expected by the end of the month. A shareholder meeting to approve C2 Ventures’ participation in the placement is scheduled for July (C2 Ventures is the investment vehicle of directors Niall Cairns and Craig Cooper).

Blackpeak Capital, Stralis Capital Partners, and Taylor Collison have been appointed as joint lead managers to the raise. Blackpeak is also acting as underwriter to the entitlement offer, while Taylor Collison is managing both the institutional and retail components.

The company is proposing a webinar to update on activities with details to be announced shortly.

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.