CardieX Limited announced (together with its manufacturing partner, Andon) the filing of a 510(k) submission with the US Food and Drug Administration (FDA) for the CONNEQT Pulse (Pulse) ­ a dual blood pressure and arterial health monitor targeted at the home health, remote patient monitoring (RPM), and decentralized clinical trial (DCT) markets. Subject to final FDA clearance, Pulse will also be the CardieX's first arterial health monitor, to incorporate a full suite of patented and trademarked heart and vascular health parameters beyond traditional blood pressure, that is marketed to both clinicians and consumers. The Pulse will enable clinicians, patients, and consumers alike to gain more advanced insights into cardiovascular health. To the Company's knowledge, 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. Pulse is an integral part of a new digital and device ecosystem for both consumers and clinicians built upon CardieX's existing FDA-cleared SphygmoCor® central blood pressure technology, developed by CardieX's subsidiary ATCOR, that is considered to be the "gold standard " of central blood pressure measurement. Through the Company's ATCOR devices embedded with SphygmoCor® technology, 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. The same SphygmoCor® technology (as embedded in the Company's ATCOR XCEL device) is also currently 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, as well as being deployed in other existing clinical trials with Yale University, Andwin Scientific, and Philip Morris. "Pulse" is CardieX's first integration of ATCOR's SphygmoCor® central aortic waveform technology into a blood pressure monitor targeted at the home health, remote patient monitoring, and decentralized clinical trial markets. The Pulse will be marketed under the Company's CONNEQT brand and FDA lodgement is a significant step forward in the Company's product development journey to commercial launch. On receipt of FDA clearance, Pulse will integrate with the 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 Company reported the FDA classification of the "CONNEQT App" as a `Medical Device Data System' ("MDDS") on 18 May 2022. When connected to the CONNEQT Portal (the "Portal"), a tablet-based patient management platform, the Pulse will enable physicians 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. These features will make Pulse unique in the remote patient monitoring ("RPM") market in
multiple ways, including: 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; 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; 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; 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 Being fully customizable ­ allowing physicians to 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"), which the Company sees as a significant opportunity with the global DCT market forecast to reach $16B by 2027. Following receipt of FDA clearance, the Pulse device will enable patients, clinicians and consumers to be empowered with advanced, medical grade insights into vascular health.