Shots:

• Toni spoke about the CONNEQT Pulse the first dual blood pressure monitor with ATCOR’s SphygmoCor technology. The device is used for remote patient monitoring, home health, and clinical trials 

• She also elaborated about the data used for the pre-marketing submission with FDA. She explained the seven key vascular biomarkers that the device measures and data validating its accuracy 

• The interview gives an understanding of how CardieX along with its subsidiaries ATCOR and CONNEQT are working to advance innovative medical devices, digital solutions, and wearables to raise the standard of care 

Smriti: Can you tell us more about Pulse, how it works, its functioning, and its applications? 

Toni R. Hofhine: The Pulse is a world’s first connected vascular biometric monitor for at-home and in-clinic monitoring. It implements the FDA-cleared SphygmoCor® technology from our sister company ATCOR to measure seven key vascular biomarkers, including central blood pressure – the pressure at the aorta, which experts believe provides a more complex and nuanced picture of vascular health than standard brachial blood pressure monitors. A unique feature to the Pulse is the device display, as it can be customized to show information personalized to each user based on health parameters and disease conditions. We are not aware of any home health monitor that is capable of doing that today.  

We’ve designed the Pulse to target three applications: remote patient monitoring, home health, and clinical trials. For home health, the Pulse connects to a companion app, which leverages AI to analyze the vascular biomarkers that have been measured and offers personalized tips designed to improve a person’s vascular health. The app syncs to a HIPAA-compliant, cloud-based patient management portal to facilitate remote patient monitoring and enables physicians to incorporate the Pulse into their clinical workflow. For clinical trials, the Pulse offers researchers and pharmaceutical companies the ability to capture a full suite of vascular biomarkers necessary to characterize the hemodynamic status of clinical trial participants at their homes and transmit the data directly to the study personnel analyzing the impact of intervention being studied.  

Smriti: What is SphymoCor technology by CardieX and its unique bits? 

Toni R. Hofhine: The SphygmoCor® technology is the gold standard of cardiovascular health technology. It was pioneered by our sister company ATCOR over 20 years ago to non-invasively assess central aortic pressure and indices of arterial stiffness. Since its inception in 1996, our SphygmoCor technology has been independently validated with over 1,400 peer-reviewed clinical publications. 

The technology has traditionally been leveraged by specialist health care providers, on-site clinical trials, research programs, and hospital networks in the form of a variety of patient monitoring solutions such as the SphygmoCor XCEL system and the Oscar 2™ Ambulatory Blood Pressure Monitor. The Pulse will be the first at-home device to feature the technology, allowing health-conscious individuals to access these cutting-edge heart health metrics from the comfort of their own homes.  

Smriti: Can we discuss the data being used for the premarket submission with FDA?  

Toni R. Hofhine: In the FDA submission, we explain how our device works, along with an explanation of the seven key vascular biomarkers it measures and data validating the device’s accuracy. The seven vascular biomarkers are: 

1. Brachial Blood Pressure  

Brachial blood pressure measures the pressure of blood  

at the brachial artery using a blood pressure cuff. High blood pressure is a major risk factor for heart disease and stroke, both of which are leading causes of death in the US. 

2. Central Blood Pressure  

Calculated using pulse wave analysis and a traditional brachial cuff, central blood pressure measures pressure at the root of the aorta. Central blood pressure reflects key vascular issues such as arterial stiffness, which makes it a more accurate predictor of subclinical cardiovascular disease than traditional brachial blood pressure alone.   

3. SEVR  

Subendocardial viability ratio measures the supply of blood that flows to your inner heart muscle in relation to demand. SEVR offers insight into how well a person’s heart is beating, which can give insight into how they can handle the stress of exercise. 

4. Augmentation Pressure  

Augmentation pressure refers to the increase in central aortic pressure caused pressure wave reflection.  A marker of arterial stiffness, elevated augmentation pressure is associated with cardiovascular risk factors as well as increased cardiovascular morbidity and mortality. 

5. Augmentation Index  

An indirect measure of arterial stiffness that increases with age, augmentation index reflects the burden stiff arteries place on the heart. Chronic stress on the heart and the cardiovascular system can lead to heart failure and hypertrophy (enlarged heart).  

6. Central Pulse Pressure  

The height of pressure at the heart, central pulse pressure shows the pressure to which key organs like the heart, brain, and kidneys are exposed.  Central pulse pressure helps identify the risk of end organ damage to key organs like the brain, kidney and heart.   

7. Medical Grade Heart Measurement  

A beat-to-beat heart rate measurement on par with standard ECG-based methods. A consistently high resting heart rate may be a sign of coronary heart disease and is associated with a greater risk of stroke.  

Smriti: Is CONNEQT/ CardieX in discussion with any Pharma/ Biotech companies for Pulse to be used as companion diagnostics? 

Toni R. Hofhine: CardieX has had several interventional trial conversations centered around improving patient outcomes with digital vascular biomarkers and the Pulse.  The trend in trials is leaning towards using a comprehensive protocol design with novel secondary and safety endpoints to focus on a patient-centric approach (versus a population approach), allowing monitoring at therapeutic dosing levels to reduce risk and prevent adverse for determining efficacy and safety.  A positive result of incorporating digital vascular biomarkers into a trial’s protocol design is a lower patient drop-out rate and improved patient retention from routine monitoring.   

Smriti: What role do you think Pulse can play in the Decentralized clinical trials? 

Toni R. Hofhine: Decentralized clinical trials has refocused patient recruiting on the disease or condition vs. the proximity of a patient to a clinical research facility.  Often the benefits are an increase in the enrollment of diverse patients.  The Pulse enables the routine monitoring of a patient’s baseline digital vascular biomarkers for possible risks associated with patient-specific drug interactions during the trial.  With the CONNEQT Pulse, patients will engage remote Bluetooth monitoring in combination with virtual visits, resulting in ‘anywhere patient monitoring’.  Performed within the comfort of a patient’s home and without the need for an RN or NP to visit, patient retention increases with more frequent virtual visits at the same time the overall cost of the trial decreases.   

Smriti: How is the patient data stored and can you tell us how this data is being secured? 

Toni R. Hofhine: Patient data can be tokenized to remove the need to collect personally identifiable information (PII).  All data is encrypted and transferred via Bluetooth using our CONNEQT Mobile App or CONNEQT Tablet app (iOS and Android) and is stored as the patient assessment is completed within a restricted and permissions-based cloud database.  Authentication enables authorized users to access regional trial data based on the principle of least permissions and regional compliance.   

Smriti: Can we talk about other pipeline products of CONNEQT? What next after Pulse launch in 2022? 

Toni R. Hofhine: The Pulse has been our primary focus for a while now and will be our primary focus even after the launch. That said, we do have a wearable in development. The CONNEQT Band will be the first consumer wearable to offer a suite of digital vascular biomarkers using the same gold standard SphygmoCor technology used in the Pulse. Stayed tuned for more. 

Source: CardieX 

About CardieX 

CardieX is a health technology company focused on devices & solutions for the world’s largest population health disorders. Its ATCOR subsidiary is a world leader in the monitoring of vascular biomarkers for clinical trials and health care research 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, remote patient monitoring, and decentralized / "anywhere" monitoring for clinical trials. 

About the Author: 

Toni R. Hofhine is President of ATCOR Medical. She is an experienced global executive commercial and operations leader with more than 30 years of experience in the drug development process from drug discovery through patient delivery. She is a scientist at heart and has brought automated solutions using technology and devices to INDs, NDAs, clinical trials, and health care research. Her passion is to continue improving human health through new technologies/devices, collaboration, strategy, and process efficiencies that are at the intersection of clinical trials, health care research and patient care. 

Source: John Gabrielson SVP, Biosimilars & Head of Business of Similis Bio (JSR Life Sciences) Shares Insights on the Partnership with Blau Farmaceutica to Co-Develop Four Biosimilar Programs