CardieX Ltd has submitted a US Food and Drug Administration (FDA) 510(k) clearance application for its Pulse dual blood pressure monitor with shares as much as 26% higher to A$0.365.
Subject to final FDA clearance, Pulse will be CardieX’s first device targeted at both clinicians and consumers, designed to monitor and incorporate a suite of unique arterial health parameters beyond traditional blood pressure.
Pulse’s health parameters have been fully patented and trademarked, and their output enables clinicians and consumers to gain advanced insights into cardiovascular health.
Following FDA clearance, Pulse will be marketed under the company’s CONNEQT brand, targeting new global markets in-home health monitoring, remote patient management and decentralised clinical trials.
SphygmoCor technology
CardieX says Pulse is an integral part of a new digital and device ecosystem for both consumers and clinicians.
The device is built upon 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, specialist clinicians and pharmaceutical companies, all looking to obtain advanced arterial health insights beyond traditional blood pressure.
In a nutshell, the technology non-invasively measures what’s known as ‘central aortic waveforms’ and provides insight into a range of clinically relevant arterial health indicators, including a patient's arterial stiffness, central blood pressure, arterial pulse pressures and key indicators of the vascular health of major organs, such as the heart, brain and kidneys.
Through the company’s ATCOR devices, which are embedded with SphygmoCor, the blood central pressure technology is used in more than 4,000 clinical sites globally, upwards of 250 research projects and 49 clinical trials with the likes of Bayer, AstraZeneca, Andwin, GlaxoSmithKline (GSK) and Novartis.
The same SphygmoCor technology is also deployed in a major global research setting, which to the company’s knowledge is the world’s largest study on 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, targeted at the home health, remote patient monitoring and decentralised clinical trial markets.
The Pulse will be marketed under the company’s CONNEQT brand and FDA lodgement is a crucial step forward in the company’s journey to commercial launch.
Commenting on the significance of the Pulse device for 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 over a decade for researchers, specialist clinicians and pharmaceutical companies in their clinical trials.
“Following receipt of FDA approval … the Pulse will launch that same technology into significant new healthcare markets, giving physicians and patients alike deeper insights into cardiovascular health."
All about CONNEQTion
Once it secures FDA clearance, Pulse will integrate with CardieX’s CONNEQT app to provide medical-grade insights into a suite of arterial diagnostics – enabling consumers and patients to make better-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 remotely manage and monitor patients via a cloud-based portal.
To the company’s knowledge, Pulse will also be the first blood pressure monitor to incorporate ‘over the air’ customisable display screens, based on specific health parameters and disease conditions.