CardieX Ltd has applied for US Food and Drug Administration (FDA) 510(k) approval for its dual blood pressure monitor Pulse, with shares up a whopping 26% to A$0.365.
Subject to final FDA approval, Pulse will be CardieX’s first device aimed at both clinicians and consumers, designed to monitor and record a range of unique arterial health parameters beyond traditional blood pressure.
Pulse’s health parameters are fully patented and proprietary, and their output enables clinicians and consumers to gain advanced insights into cardiovascular health.
Upon FDA approval, Pulse will be marketed under the company’s CONNEQT brand, targeting new global markets for in-home health monitoring, remote patient management and decentralized clinical trials.
SphygmoCor technology
CardieX says Pulse is an integral part of a new digital and device ecosystem for consumers and clinicians alike.
The device is based on CardieX’s existing FDA-cleared SphygmoCor® central blood pressure technology, developed by CardieX’s subsidiary ATCOR and considered the “gold standard” of central blood pressure measurement.
SphygmoCor technology has been used for more than 20 years by researchers, specialty clinicians and pharmaceutical companies, all seeking advanced insights into arterial health beyond traditional blood pressure.
In a nutshell, the technology non-invasively measures what are known as ‘central aortic waveforms’ and provides insights into a range of clinically relevant arterial health indicators, including a patient’s arterial stiffness, central blood pressure, arterial pulse pressure and key indicators of the arterial heart rate. vascular health of important organs, such as the heart, brain and kidneys.
Through the company’s ATCOR devices, which are embedded with SphygmoCor, the blood pressure technology is used in more than 4,000 clinical sites worldwide, more than 250 research projects and 49 clinical trials with companies such as Bayer, AstraZeneca, Andwin, GlaxoSmithKline (GSK) and Novartis .
The same SphygmoCor technology is also being deployed in a large global research environment, which to the company’s knowledge is the largest study in the world examining the impact of COVID-19 on cardiovascular health.
SphygmoCor is also being deployed in other clinical trials with Yale University, Andwin Scientific and Philip Morris.
Finger on the pulse
Pulse represents CardieX’s first integration of ATCOR’s SphygmoCor technology into a blood pressure monitor, targeting home health, remote patient monitoring and decentralized clinical research markets.
The Pulse will be marketed under the company’s CONNEQT brand and FDA registration is a critical step forward in the company’s journey to commercial launch.
Commenting on the importance of the Pulse device to global health outcomes, Macquarie Medical School Professor Emeritus Alberto Avolio said: “ATCOR’s market-leading central aortic pressure technology (SphygmoCor®) has been the ‘gold standard’ for researchers, specialists clinicians and pharmaceutical companies in their clinical trials.
“After receiving FDA approval… the Pulse will launch that same technology in key new healthcare markets, providing both physicians and patients with deeper insights into cardiovascular health.”
All about CONNEQTion
Once FDA approval is obtained, Pulse will integrate with CardieX’ CONNEQT app to provide medical insights into a range of arterial diagnostics, enabling consumers and patients to make more informed decisions about their health.
The FDA classified the CONNEQT app as a Medical Device Data System in May.
When connected to the CONNEQT Portal, a tablet-based patient management platform, Pulse will also help physicians manage and monitor patients remotely through a cloud-based portal.
To the company’s knowledge, Pulse will also be the first blood pressure monitor with over-the-air customizable displays, based on specific health parameters and disease states.