Cardiex: Biomarker Applied sciences, Digital Options to Tackle the World’s Largest Well being Problems

Overview

Cardiex Restricted (ASX:CDX) is an ASX-listed medical know-how firm leveraging its proprietary SphygmoCor® know-how to develop and market vascular biomarker applied sciences and digital options targeted on the world’s largest well being issues. The corporate’s groundbreaking know-how – SphygmoCor® – set the benchmark for noninvasive measurement of central aortic pressures and associated arterial well being traits, collectively known as vascular biomarkers.

Whereas measuring arterial well being parameters had all the time been thought of clinically helpful, it was not thought of for routine out-patient medical use because it beforehand required an invasive catheterization process with a strain sensor inserted into the aorta. Based on 40 years of hemodynamics research and backed by 20+ years of analysis, Cardiex’s SphygmoCor know-how employs non-invasive methods to evaluate “central aortic waveforms,” providing precious insights into varied clinically vital arterial well being parameters together with arterial stiffness, central blood strain (the strain on the coronary heart), pulse strain, and essential indicators of vascular well being for main organs corresponding to the center, mind and kidneys.

Assessing central blood strain immediately on the coronary heart is deemed superior to standard blood strain measurements taken on the arm, primarily owing to the center’s proximity to very important organs. Cardiex’s FDA-cleared units exchange conventional blood strain know-how for first-line screening and monitoring of arterial well being standing. The distinctive physiologic insights from the corporate’s units present clinically related data that helps information therapy choices and supply profound advantages for all members of the healthcare group:

For Healthcare Suppliers: Allow physicians to make extra knowledgeable therapy choices based mostly on clinically related vascular well being knowledge.

For Sufferers: Give sufferers the instruments to make higher choices about their very own well being.

For Pharmaceutical Firms: Generate dependable, real-world, clinically related knowledge to speed up drug growth and commercialization.

For greater than 20 years, the corporate’s SphygmoCor know-how has set the benchmark for vascular biomarker assessments, adopted by premier hospitals and pharmaceutical giants worldwide. SphygmoCor is the chosen know-how for measuring central blood strain in all the “prime 20 hospitals” within the US and has performed an important function within the medical trials of main companies together with Bayer, AstraZeneca, Roche, Novartis and GlaxoSmithKline.

Between 2002 and 2023, CDX acquired 5 FDA clearances, the most recent for the CONNEQT Pulse, a first-of-its-kind related vascular biometrics monitor.

Cardiex units have beforehand been offered and used completely in medical settings – principally by specialist clinicians, for analysis, and by pharmaceutical firms for drug evaluation. The introduction of CONNEQT Pulse represents a major shift for Cardiex, permitting the corporate to enter the related care market and transition from area of interest segments to the mass healthcare market. Priced comparably to a house well being monitor, the CONNEQT Pulse is positioned for widespread adoption and could be deployed at scale usually healthcare practices, houses, or any location the place sufferers are current.

The CONNEQT Pulse may also bolster Cardiex’s portfolio in medical trial options with the introduction of a decentralized medical trial (DCT) platform. The Cardiex DCT platform empowers medical trial managers to remotely monitor 1000’s of sufferers of their houses, enabling pharmaceutical firms to extra successfully consider potential vascular outcomes throughout varied trial phases. This results in elevated effectivity and cost-effectiveness in trial outcomes.

Moreover, in response to the rising demand for proactive well being monitoring, Cardiex will probably be launching an progressive wrist-worn system that leverages the SphygmoCor know-how to ship a medical grade wearable with capabilities far past standard well being trackers. The CONNEQT Band will probably be a wearable “cuffless” system designed to watch vascular well being in sufferers in addition to to offer basic well being insights to customers.

Cardiex’s purpose is to determine a holistic ecosystem that promotes cardiovascular well-being and empowers customers to proactively handle their well being as an integral a part of people’ well being routines, contributing to a paradigm shift in preventive cardiovascular care.

The corporate’s first-mover benefit and unique know-how FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers throughout all grownup demographics grant it a particular market place. CDX not too long ago secured AU$14 million in funding, which is sufficient to steer the corporate in the direction of profitability.

With the entry into the related care dwelling market with the CONNEQT Pulse, CDX is transitioning in the direction of a recurring income mannequin based mostly on month-to-month subscription charges. This could excite traders, provided that the recurring income mannequin will obtain the next a number of by the market, thereby boosting the corporate’s valuation.

Firm Highlights

• Cardiex Restricted is an ASX-listed medical know-how firm that develops and markets vascular biomarker applied sciences and digital options for the world’s largest well being issues.
• The corporate’s choices embody FDA-cleared medical and residential well being units alongside digital options tailor-made for managing well being and wellness, delivering distinctive physiologic insights that inform medical therapy choices.
• The corporate’s groundbreaking know-how – named SphygmoCor® – set the benchmark for measuring central aortic pressures and associated arterial well being traits, collectively known as vascular biomarkers.
• These biomarkers, extensively researched and detailed in quite a few peer-reviewed journals, assess cardiovascular danger and information illness administration by predicting organ harm (corresponding to the center, mind, and kidneys) and outcomes (together with coronary heart failure, ischemic coronary heart illness, and stroke), considerably influencing illness prognosis and medical therapy.
• CDX acquired 5 FDA clearances from 2002 to 2023, the newest for the CONNEQT Pulse, a world-first related vascular biometric monitor. The CONNEQT Pulse targets new and vital healthcare channels and transitions the corporate in the direction of a recurring income mannequin based mostly on month-to-month subscription charges.
• CDX’s know-how is uniquely FDA-cleared for noninvasive measurement of central pulse pressures and vascular biomarkers throughout all grownup demographics – thereby granting it a particular aggressive market place. With a major funding spherical not too long ago secured, CDX is poised for profitability forward.

Merchandise and Manufacturers

The corporate’s answer is organised below two manufacturers: ATCOR and CONNEQT.

ATCOR

ATCOR provides options for hospitals, analysis and pharma, and specialist clinician markets. ATCOR’s options have been utilized in 46 pharmaceutical medical trials so far, throughout greater than 1,700 research websites worldwide, and have been highlighted in over 2,400 peer-reviewed research showcased in top-tier medical journals. It provides two units – the corporate’s flagship system, the SphygmoCor XCEL, and the SunTech Oscar 2 with “SphygmoCor Inside”.

SphygmoCor XCEL: The SphygmoCor XCEL measures central and brachial blood pressures, offering insights into cardiovascular perform. Moreover, it assesses quite a few different clinically related vascular biomarkers, providing a complete understanding of arterial stiffness and well being. These superior physiological measurements allow early detection of potential cardiovascular points, guiding focused interventions for sustaining or bettering total cardiovascular well being.

SunTech Oscar 2 with “SphygmoCor Inside”: Collectively developed and marketed by SunTech Medical and Cardiex, the Oscar 2™ ABPM with “SphygmoCor Inside” produces a set of distinctive vascular well being options and well being insights captured by the SphygmoCor know-how over a steady interval. It offers precious diagnostic data that conventional ambulatory blood strain displays are incapable of measuring.

CONNEQT

CONNEQT is concentrated on units and options for dwelling well being, distant affected person monitoring, and decentralized medical trials. Cardiex provides two units below the CONNEQT model – the not too long ago FDA-cleared CONNEQT Pulse and the upcoming CONNEQT Band wearable. The corporate estimates CONNEQT’s complete addressable market alternative to be almost $283 billion throughout three markets – distant affected person monitoring ($175 billion), well being wearables ($104 billion), and decentralized medical trials ($14 billion).

CONNEQT Pulse: The CONNEQT Pulse offers measurements of each central and brachial blood pressures, alongside vascular biomarkers reflecting arterial stiffness and total vascular well being—metrics as soon as completely solely accessible to specialist clinics, analysis, and pharmaceutical firms. As a Bluetooth-enabled system, it empowers sufferers and well being lovers to trace their arterial well being from dwelling, using the identical superior instruments utilized by prime cardiologists in analysis facilities and clinics.

Physicians can prescribe the CONNEQT Pulse to sufferers requiring coronary heart well being monitoring. Affected person knowledge seamlessly integrates with the CONNEQT Affected person Administration Portal (CPMP), a HIPAA-compliant cloud-based instrument that permits healthcare suppliers to remotely monitor sufferers’ arterial well being by the use of a pill. Moreover, customers and sufferers can entry complete arterial well being insights, teaching, life-style applications, and extra well being sources by way of the CONNEQT app.

CONNEQT Band: CONNEQT Band is a world’s-first twin sensor arterial well being wearable system that includes an progressive design with twin (wrist-and finger-based) photoplethysmography (PPG) optical sensors. The wrist-based sensor constantly captures physiological knowledge corresponding to coronary heart charge, respiration, stress, exercise, sleep, and pulse oximetry, whereas our patented on-demand finger-based aspect sensor uniquely derives clinically significant vascular biomarkers representing arterial stiffness and cardiovascular well being.

By combining knowledge from each sensors, the CONNEQT Band provides customers a complete view of their total cardiovascular well being which has by no means been accessible outdoors of a doctor’s workplace. The CONNEQT Band can also be supported by the CONNEQT app, accessible for each iOS and Android units, which serves as a hub the place customers can simply entry detailed studies, monitor their progress over time, discover content material, and obtain customized well being insights and suggestions.

The CONNEQT Band is at the moment within the strategy of FDA submission preparation. This progressive system is poised to increase the corporate’s portfolio in related well being know-how, providing customers a brand new, user-friendly instrument for monitoring their well being metrics. With its cutting-edge options, the CONNEQT Band is predicted to make a major affect in the way in which people handle their wellness, bridging the hole between superior well being monitoring and on a regular basis comfort.

A major world market alternative in wearable well being units is pushed by almost 1.3 billion hypertensive and different vascular illness sufferers. A number of the different wearable system companies have attracted vital funding at excessive valuations in current instances. For example, Oura Well being, a Finnish firm that makes sensible rings for monitoring sleep and bodily exercise, was valued at $2.55 billion in April 2022.

Board of Administrators & Administration

Craig Cooper – Chief Government Officer and Government Director

Craig Cooper has established quite a few affluent well being, digital media, know-how and wellness ventures. Notably, he co-founded Enhance Cell, a distinguished telecommunications firm acknowledged as one of many main cell phone companies within the USA. He’s acknowledged as a distinguished authority and influential determine on a worldwide scale in cellular and wi-fi know-how, in addition to companies associated to digital well being and medical know-how. His enterprise capital endeavors have secured over AU$3 billion, financing a number of the most impactful world digital media know-how firms. Cooper can also be a principal of C2 Ventures, Cardiex’s largest shareholder.

Niall Cairns – Government Chairman

Niall Cairns boasts a profitable 25-year file of investing in each non-public and public firms. He has performed a pivotal function in advancing the worldwide growth of greater than 50 enterprises spanning varied sectors, together with digital media, agtech, medtech, shopper web, and SaaS-based companies. Cairns can also be a principal of C2 Ventures, Cardiex’s largest shareholder.

King Nelson – Non-executive Director

King Nelson brings over 30 years of in depth expertise in medical units. He was beforehand the president and CEO at Uptake Medical Company, concentrating on remedies for emphysema and lung most cancers. Earlier than Uptake, he served as president and CEO of Kerberos Proximal Options, an organization later acquired by FoxHollow Applied sciences. He was additionally president and CEO of VenPro, a coronary heart valve enterprise acquired by Medtronic. King additionally collected 19 years of expertise with Baxter Worldwide and American Hospital Provide Company, progressing via varied roles with growing tasks. These roles included serving as division president for Dade Diagnostics, Bentley Labs, and Baxter’s Perfusion Companies. Nelson is at the moment the CEO at Q’Apel Medical, a medical system firm specializing in neurovascular illness.

Charlie Taylor – Non-executive Director

Charlie Taylor has over three a long time of worldwide advisory expertise and not too long ago concluded his tenure as senior accomplice at McKinsey, the place he oversaw the well being and public sector apply. Taylor has recommended quite a few non-public and public sector healthcare organizations in Australia and globally, masking areas corresponding to technique, digitalization, operational enhancements, progress transformations, worldwide growth, provide chain administration, mergers and acquisitions, and board governance. He’s a non-executive director of Healius, a number one Australian well being diagnostics firm, and a part-time senior board advisor at McKinsey for the well being and public sector apply.

Sanjeev Bhavnani, M.D. – Chief Medical Officer

Dr. Sanjeev Bhavnani has served as a senior medical officer on the Digital Well being Middle of Excellence throughout the FDA’s Middle for Units and Radiological Well being (CDRH), overseeing medical and scientific initiatives regarding digital well being and medical units incorporating synthetic intelligence.

Bhavnani can also be at the moment a senior heart specialist and principal investigator of digital well being and machine studying at Scripps Clinic in San Diego, California, the place he leads applications to develop and validate new applied sciences and to judge the protection and effectiveness of DHTs, nanosensors, cloud-based analytical platforms, handheld imaging applied sciences, AI/ML algorithms and software program as a medical system. For over a decade, Bhavnani was the principal investigator of 90 medical trials and affected person care applications. These applications have enrolled over 30,000 sufferers within the US and in resource-limited areas. His group developed the SMART-FHIR integration interface for DHT knowledge into EMRs for distant affected person monitoring, distant therapeutic monitoring, and continual care administration, making a real-world knowledge platform to watch the healthcare high quality of DHT and ML units in conventional and new shopper fashions of care supply.

Catherine Liao – Chief Technique Officer

Catherine Liao has served as our chief technique officer since September 2022. Beforehand, Liao served as chief govt officer of Blumio, a pioneering medical system startup, from February 2016 to September 2022, the place she led efforts in elevating capital, shaped a management and advisory board wealthy in data spanning healthcare improvements, enterprise know-how, and sensor know-how. Her notable achievements embrace main the commercialization of a groundbreaking medical radar sensor growth platform, which garnered vital trade consideration and was ultimately acquired by Cardiex. Liao holds an MBA from Imperial Faculty London and a Grasp of Science in Well being Economics from the London Faculty of Economics. These credentials underscore her deep and complete perception into the intricacies of each the enterprise world and the healthcare sector, demonstrating a balanced experience essential for navigating and innovating inside at present’s complicated healthcare economies.

Mark Gorelick, Ph.D. – Chief Product Officer

Dr. Mark Gorelick has served as Cardiex’s chief product officer since December 2020, bringing a wealth of expertise from varied management roles within the well being and wellness know-how sector. With a powerful tenure starting in 2007, he has been on the helm as managing director of XPhys Applied sciences, an organization on the forefront of creating progressive health, well being, and wellness merchandise. His strategic imaginative and prescient was additional demonstrated via his function as vice-president of Digital Well being, from 2018 to 2019, at Efficiency Lab Applied sciences, acclaimed for its software program growth prowess within the well being sector. Additional cementing his popularity in well being know-how, Gorelick served because the chief science officer at PAI Well being (initially Mio International) from 2015 to 2018, the place he was instrumental in advancing well being know-how software program options. Holding a BSc and MSc in kinesiology from Dalhousie College and a Ph.D. in biomedical science from College of Wollongong, Gorelick’s instructional background underscores his deep-rooted understanding and progressive method to biomedical science and kinesiology, reinforcing his invaluable contribution to our firm and the broader well being know-how panorama.

This profile was written in collaboration with Couloir Capital.