Cardiex wins TGA greenlight; shares jump +11%

Cardiex Ltd (ASX:CDX) has popped +11% intraday to 4.7cps as the smallcap healthcare stock wins a key approval from the TGA.

That relates to its flagship ‘Conneqt Pulse’ device, which is ultimately a smartphone-compatible cardiovascular health biometrics tracking product.

“The Pulse is a world-first clinical-grade vascular biometric monitoring device designed for use in both clinical and remote patient monitoring or at-home … it enables the capture of a broad range of arterial health biomarkers, including central blood pressure and arterial stiffness,” Cardiex wrote on Monday.

Last month, Cardiex got a key app onto the Apple app store, which was met with little fanfare from investors. But two major approvals later – one from the TGA, and more importantly, an earlier approval from the USA’s FDA – and the company’s share price is looking somewhat healthier.

(Worth noting is that there’s far less hurdles to tackle getting the TGA to approve a health device as opposed to a new drug.)

Still, that Australian landscape isn’t necessarily Cardiex’s foremost market of interest.

“While the U.S. remains our primary focus at this stage, we’re excited to begin laying the foundation for growth in Australia,” CDX chief Craig Cooper said.

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

The question, of course, is whether Conneqt Pulse can stand out in a well-established market of biometrics devices.

CDX last traded at 4.7cps.

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