CardieX ratchets up commercialisation strategy with FDA lodgement for CONNEQT Pulse
Health & Biotech
Health & Biotech
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CardieX is a step closer to launching its world first CONNEQT Pulse dual blood pressure monitor, after filing a clearance submission with the US FDA
Australian medical technology companyn CardieX Limited (ASX:CDX), has, together with its manufacturing partner, submitted a clearance application to the US Food and Drug Administration (FDA) for a world first dual blood pressure and arterial health monitor, the CONNEQT Pulse (the “Pulse”).
With FDA clearance, Pulse will be the world’s first cloud-connected, customisable, multi-use arterial health monitor to include CardieX subsidiary ATCOR’s SphygmoCor® central aortic blood pressure technology.
The device is targeted at the home health, remote patient monitoring, and decentralized clinical trial markets.
The Pulse will allow clinicians, patients and consumers alike to gain advanced insights into cardiovascular health beyond traditional blood pressure measurements, thanks to a series of patented and trademarked heart and vascular health biometrics which are incorporated into the monitor.
The Pulse is part of a new digital and device ecosystem for both consumers and clinicians built upon CardieX’s FDA-cleared “gold standard” SphygmoCor® central blood pressure technology, developed by CardieX’s subsidiary, ATCOR.
SphygmoCor® non-invasively measures what is known as “central aortic waveforms” and enables insight into multiple clinically relevant arterial health indicators – such as a patient’s arterial stiffness, central blood pressure (the blood pressure at your heart), pulse pressures, and key indicators of the vascular health of major organs (heart, brain, kidneys etc.).
SphygmoCor® technology has been in use for more than 20 years by researchers and specialist clinicians with over 4000 clinical installations globally and over 250 current research projects.
Currently, SphygmoCor® is in use in the world’s largest study by Artery on the impact of COVID-19 on cardiovascular health as well as multiple other clinical trials.
The Pulse will allow the Company to expand its market leading solutions beyond its traditional specialist clinician and pharmaceutical markets into remote patient monitoring, home health, and decentralized clinical trials. Using the CONNEQT Physician Portal, a cloud-based patient management tool, physicians will also be able to remotely manage and monitor patients – significantly enhancing the level of care provided to patients.
According to CardieX Group CEO Craig Cooper, the Pulse introduces a game-changing opportunity to make a significant global health impact on the world’s largest killer – cardiovascular disease.
“By combining a full suite of arterial health parameters into a simple to use, affordable device, patients and clinicians alike will now be able to better identify arterial disease at an earlier stage – setting the foundation for maximum impact on global health outcomes.” he says.
Commenting on the potential impact of the Pulse for healthcare markets, Alberto Avolio, Professor Emeritus at Macquarie Medical School, Macquarie University called ATCOR’s market leading technology the “gold standard” for over a decade with researchers, specialist clinicians, and pharmaceutical companies in their clinical trials.
“The Pulse now launches that same technology into significant new healthcare markets giving physicians and patients alike deeper insights into cardiovascular health,” Avolio says.
John R. Cockcroft, Visiting Professor, Dept Advanced Cardiology, Columbia University Medical Centre, New York agrees, adding: “The Pulse will enable healthcare practitioners to obtain unique cardiovascular health insights in order to inform better decision making around treatment.
“Importantly, the Pulse will also be the first device to target widespread adoption of arterial stiffness and central blood pressure as key indicators of cardiovascular health.”
CardieX has been the subject of a flurry of analyst interest this year with MST Access placing a $1.50 valuation on CardieX – five times the current share price.
MST was the second leading analyst in six months to put a buy on CardieX, after Blue Ocean initiated coverage in December with a “spec buy” recommendation and target price of $1.60.
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.