Announcement of 510(k) premarket submission with the FDA for CONNEQT Pulse
IRVINE, Calif., June 28, 2022 /PRNewswire/ -- CardieX Limited (ASX: CDX), a global health technology company focused on cardiovascular disease, has together with its manufacturing partner Andon filed a 510(k) premarket submission with the U.S. Food and Drug Administration (FDA) for the CONNEQT Pulse (Pulse) – a world first dual blood pressure and arterial health monitor targeted at the home health, remote patient monitoring, and decentralized clinical trial markets.
Subject to final FDA-clearance, Pulse will also be the world's first arterial health monitor to incorporate a full suite of patented and trademarked heart and vascular health parameters beyond traditional blood pressure, enabling clinicians, patients, and consumers alike to gain more advanced insights into cardiovascular health. Pulse will also be the first blood pressure monitor to incorporate "over the air" (OTA) customizable display screens based on specific health parameters and disease conditions.
CONNEQT Pulse - World's First Dual Blood Pressure Monitor with SphygmoCor® Technology
Pulse is an integral 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® technology has been in use for over 20 years by researchers, specialist clinicians, and pharmaceutical companies looking to obtain advanced arterial health insights beyond traditional blood pressure.
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.). Measuring central blood pressure at the heart is considered to be superior to standard measurements of blood pressure at the arm mainly due to the proximity of the heart to the major organs.
SphygmoCor® is currently used in over 4000 clinical sites globally, over 250 current research projects by major medical research institutions, and 49 clinical trials to-date with the likes of Bayer, AstraZeneca, Andwin, GlaxoSmithKline (GSK), Novartis, and others. 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 existing clinical trials with Yale University, Andwin Scientific and Philip Morris.
The Pulse is a world first incorporation of SphygmoCor® central aortic waveform technology into a blood pressure monitor targeted at the home health, remote patient monitoring, and decentralized clinical trial markets.
Pulse Digital Ecosystem to Provide Advanced Insights to Clinicians and Consumers
Pulse will integrate with the CONNEQT Consumer App to provide medical-grade insights into a complete suite of FDA-cleared arterial diagnostics – enabling consumers and patients to make better informed decisions about their health.
In addition, when connected to the CONNEQT Physician Portal (the "portal"), physicians will be able to remotely manage and monitor patients via a cloud-based, HIPAA-compliant, patient management portal – providing physicians with the ability to significantly enhance practice revenues and patient health outcomes. Pulse will be unique in the remote patient monitoring (RPM) market in multiple ways including:
- By providing a full suite of unique and proprietary arterial health parameters in an easy-to-use device for more advanced insights into a patient's vascular health, beyond traditional blood pressure measurements;
- By enabling physicians to monitor multiple risk factors for hypertension and cardiovascular disease and other health disorders such as Alzheimer's, kidney disease, preeclampsia, and stroke risk;
- By empowering physicians with new diagnostic insights into a patient's overall vascular health including arterial stiffness, central blood pressures, and central pulse pressures, to name a few;
- By allowing physicians to bill for remote patient monitoring reimbursement at a level not available with traditional blood pressure monitors due to the unique, additional, CPT reimbursement code payable on the use of Pulse for central arterial waveform analysis; and
- By being fully customizable - allowing physicians to remotely set up specific personalized arterial health parameters to monitor for each patient.
In addition, CardieX's existing clinical trial partners will also be able to use the Pulse and Portal to remotely manage decentralized clinical trials (DCT's), a significant opportunity for the Company with the global DCT market forecast to reach $US16B by 2027.
Pulse to Include World First Arterial Health Parameters
Pulse will enable patients, clinician's and consumers to be empowered with advanced, medical grade insights into vascular health. A sampling of the Pulse parameters, traditionally only available to specialist clinician markets, include:
- Brachial Systolic Blood Pressure.
- Brachial Diastolic Blood Pressure.
- Central Systolic Blood Pressure: Based on central arterial waveform analysis – a measurement of blood pressure at the heart (the ascending aorta).
- Arterial Age (ArtyAge®): A measurement of both Augmentation Pressure (AP) + Heart Rate.
- Exercise Capacity® (eCAP®): based on the SEVR Index (Subendocardial Viability Index) – an index of myocardial oxygen supply and demand, and other proprietary algorithms.
- Heart Stress (HSX™): an index based on proprietary algorithms that measure stress on the heart.
- TruHR®: Clinical grade beat-to-beat heart rate - similar to that obtained in a hospital setting.
- Arterial Stiffness Factor (ASF®): Based on Augmentation Pressure (AP) – a clinical standard for measuring arterial stiffness, and other proprietary algorithms.
- ARTY® Score: A comprehensive heart-health score based on a patient's combined ArtyAge®, eCAP®, HSX™, TruHR®, and ASF®.
- VitalsRisk®: a measurement of central pulse pressure and other proprietary algorithms that measure the vascular health of major organs (the heart, brain, kidneys etc.).
- 7-Day Brachial Blood Pressure Average.
- 30-Day Brachial Blood Pressure Average.
- 7-Day Central Blood Pressure Average.
- 7-Day Arty Score Trend, ArtyAge®, eCAP®, HSX™, TruHR®, ASF®.
- Blood Pressure Variability (BPV+®).
Individually, and together, the Pulse parameters provide unique and valuable insights into a patient's cardiovascular health validated by decades of studies, research, and specialist clinical use. Clinicians and patients will be able to customize and prioritize the parameters they see on the Pulse via the CONNEQT App, thereby enabling personalized insights into specific health conditions. So, for example, a patient at risk for Alzeimers' may wish to prioritize the display of central pulse pressure and arterial stiffness, whereas a patient looking to manage hypertension may wish to prioritize both central and brachial blood pressure readings.
CardieX Group CEO, Craig Cooper, commented: "The submission of our application for FDA clearance on the Pulse represents the most significant event for CardieX in over 20 years when we were initially granted FDA clearance on our SphygmoCor® technology, the current 'gold standard' in central arterial waveform measurement. Pulse extends that legacy into new, significant markets and importantly, is set to redefine the diagnostic paradigm for the identification and treatment of vascular and arterial disease.
Traditionally, the level of technology incorporated in the Pulse was only available to specialist clinicians, research institutions, and pharmaceutical companies for clinical trials. Pulse is the 'tip of our spear' in now driving widespread adoption of arterial stiffness and central blood pressure as key indicators of cardiovascular health - at a price point targeted at consumers, mass-clinician markets, and other significant healthcare channels."
For more information, you can find images and physician and healthcare testimonials in this press kit. To stay up-to-date on the launch and availability of Pulse, sign up for alerts at: conneqthealth.com.
CardieX is a global health technology company. Its ATCOR subsidiary is a world leader in medical devices for hypertension, cardiovascular disease, and other vascular health disorders based on the Company's "gold standard" SphygmoCor® central blood pressure technology. CardieX's CONNEQT subsidiary develops and markets medical devices, digital solutions, and wearables for home health, primary clinician, and other healthcare channels. CardieX is listed on the Australian Stock Exchange (ASX:CDX).
SOURCE CardieX Limited