CARDIEX Limited (ASX:CDX) (CARDIEX, the Company) is pleased to announce the successful completion of two significant milestones in the commercialization of its wearable biomarker technology.
Successful Completion of HEARTsense Wearable Study.
The Company has successfully completed its primary study validating the use of its SphygmoCor® biomarker technology in wearables by way of a PPG (Photoplethysmogram) sensor (the “HEARTsense Study”). The objective of the HEARTsense Study was to successfully demonstrate the ability to extract vascular biomarkers from a wearable PPG sensor that could previously only be achieved with the Company’s “gold standard” XCEL biometric monitor, and the soon to be released Pulse biometric monitor.
The XCEL biometric monitor is the market leader in measuring central non-invasive vascular biomarkers and is used by all top 20 US hospitals, global pharmaceutical companies (47 clinical trials), research (2300+ research papers), and in specialist clinical practices. The HEARTsense Study showed that that same proprietary XCEL technology can now be ported into a wearable device in a format compatible with commonly used wearable sensor devices.
Completion of the HEARTsense study is also a key step for the Company as it prepares to lodge its FDA submission for clearance of its CONNEQT Band wearable technology in Q1 FY2025, as well as being a key step towards commercialization.
Commenting on the results of the HEARTsense Study, Cardiex CEO Craig Cooper stated:
“This is a significant achievement for the Company as well as being a game changer for the medical technology industry. This is the first time that medical-grade measurements of arterial health, arterial stiffness, and vascular age have been made by way of a finger-based PPG sensor in a wearable; opening the path to commercialization in a number of device formats.
Our technology strategy has always been to produce products that can be deployed in medical and consumer settings for clinics, in the home, and when on-the-go. Importantly, it’s our focus on medical-grade wearable solutions which distinguishes us from other companies. The HEARTsense Study is a strong validation of that strategy as well as being a key step towards FDA clearance of our CONNEQT Band wearable technology.”
Results of the HEARTsense Study are in the process of being submitted for publication in leading peer-reviewed medical and scientific journals.
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