A stirring conversation between Catherine Liao and PharmaShots on SphygmoCor Technology

Shots:

Catherine Liao, Chief Strategy Officer of CardieX, discusses the recent partnership between CardieX’s subsidiary ATCOR and Datacubed Health
Catherine delves deep into the growing dependence on decentralized clinical trials in the healthcare community and cites a few challenges in the study that come with it

Catherine stresses the potential of SphygmoCor technology while discussing the "Pulse", a vascular biomarker device apt for remote monitoring, and DCTs

Saurabh: Please tell us about ATCOR’s partnership with Datacubed Health.

Catherine: Datacubed Health facilitates virtual patient engagement during a clinical trial, accelerating patient enrollment, increasing patient adherence, and decreasing patient discontinuation rates to increase the likelihood of a clinical trial completing within schedule and budget. ATCOR is a provider of technology enabling non-invasive arterial health monitoring, providing an additional clinically relevant layer of health insights. The partnership between ATCOR and Datacubed Health will enable both companies to jointly carry out trial monitoring across therapeutic programs using ATCOR’s CONNEQT Pulse vascular biomarker device (the “Pulse”).

Saurabh: Our readers would like to know how ATCOR and Datacubed Health’s patient-centric trial model will personalize the patient journey and advance patient access across therapeutic areas.

Catherine: By integrating the Pulse into a trial, trial managers can easily add arterial health monitoring into their clinical studies. Should a vascular biomarker’s value increase or decrease beyond the expected threshold or range, the Datacubed Health Platform can prompt the clinical trial site to investigate the change and potentially avert an impending adverse event. As well, these biomarkers can be used by the trial sponsor to assess the efficacy and safety of the intervention being studied.

The vascular biomarkers produced by ATCOR’s suite of products have been studied and reported in numerous peer-reviewed publications with the clinical focus being on cardiovascular risk and the status (health) of the vascular system. The biomarkers we measure have been shown to be predictive of end-organ damage (e.g., heart, brain, kidney), disease outcomes (e.g., ischemic heart disease, stroke) and for guidance in monitoring therapeutic interventions.

Saurabh: The company mentioned the utilization of the CONNEQT Pulse vascular biomarker device developed by CardieX’s subsidiary CONNEQT Health. Would you please tell us about the device?

Catherine: The Pulse is the first connected vascular biometric monitor to incorporate our SphygmoCor technology for home use, decentralized clinical trials, and remote patient monitoring. The Pulse will offer dual blood pressure (central and brachial) and other advanced measures of vascular health. In addition, it will be the first smart connected vascular biometric monitor to enable a discrete physiological profile which personalizes each vascular health parameter reference to the patient, a feature not available with traditional blood pressure monitors.

Our CONNEQT Pulse incorporates our SphygmoCor parameters and can be customized based on an individual’s specific health condition enabling patients to specifically focus on the unique vascular health insights that directly impact them. Using the Pulse, consumers will be able to view a real-time customizable display of their data, have access to science-based educational content and health programming, and enable a share function that enables data to be disseminated to friends, family, health care providers and clinical research managers.

We received FDA clearance for the Pulse in April 2023, and it will be available to healthcare providers and their patients later in the year. The device will allow us to expand our existing “on-site” product offering to pharmaceutical and biotechnology companies already using our SphygmoCor XCEL technology to also include decentralized clinical trials where patient vascular health data is uploaded to the cloud from home or wherever the patient is located.

Saurabh: PharmaShots readers are curious to know more about SphygmoCor technology.

Catherine: While measuring central aortic blood pressure has always been regarded as clinically beneficial, it was not considered for routine out-patient clinical use as it previously required an invasive catheterization procedure with a pressure sensor inserted into the aorta. Our patented SphygmoCor vascular biosensing technology non-invasively extracts high fidelity arterial signals at the heart and other major organs from multiple sensor formats including cuff- based pressure sensors, finger-based PPG sensors for advanced vascular health insights, and wrist-based PPG sensors for additional health and fitness parameters.

Based on data obtained from invasive evaluations, SphygmoCor technology uses non-invasive peripheral pulse recordings to reconstruct central aortic pressure pulse along with cardiovascular related physiologic variables with the objective of providing clinically relevant information about the status (or health) of the arterial system. The features are detected by the pulse wave analysis proprietary algorithm implemented in our SphygmoCor devices. This method, which has been validated through invasive studies and FDA cleared and has been implemented in non-invasive blood pressure devices and used in clinical research studies since 1996.

The vascular biomarkers produced by SphygmoCor have been studied and reported in numerous peer-reviewed publications with the clinical focus being on cardiovascular risk and the status (health) of the vascular system. The assessment is predictive of end-organ damage (e.g., heart, brain, kidney), disease outcomes (e.g., ischemic heart disease, stroke, death from cardiovascular disease) and for guidance in monitoring therapeutic interventions. It is our belief that incorporation of these variables into primary and specialty care can profoundly impact patient management and outcomes.

Saurabh: The focus area of ATCOR has always been clinical trials. Please tell us how decentralized trials are better than traditional clinical trials.

Catherine: The COVID-19 pandemic has significantly accelerated the adoption of decentralized clinical trials (“DCTs”). Wearable devices and remote patient monitoring have enabled more procedures to occur away from research sites. Respondents of an EY-Parthenon survey estimates that 50% of clinical trials will be hybrid or decentralized by 2024. MarketResearch estimates the global market for decentralized clinical trials to reach US$14.2 billion by 2026.

With just 5% of eligible patients participating in clinical research according to a study lead by researchers at THREAD Research, trial decentralization broadens trial sponsors’ access to a larger and a more diverse pool of patients. A 2021 McKinsey & Company survey reported that 100% of pharma and CROs expected to include virtual trial methodologies within their drug trials, and of those surveyed, 89% reported they would run trials from patient’s homes. Decentralization can also reduce the workload for trial investigators, since traditional site activities (such as vital signs measurements) can be performed remotely by trial participants themselves.

We believe that DCTs offer a significant opportunity for our technology in wearables and remote patient monitoring. The Pulse is a smart connected vascular biometric monitor designed with decentralized clinical trials in mind that will offer a suite of relevant vascular health insights not otherwise readily available.

Saurabh: Decentralization of clinical trials is being considered as the future of clinical trials. What are the challenges faced in decentralized trials?

Catherine: DCTs represent the future of clinical research, promising improved accessibility and reduced costs. Safeguarding data security and privacy in the context of digital technologies and data sharing is paramount to protect participants' personal health information. Digital literacy among participants and investigators needs to be considered to maximize engagement and data quality. Less tech-savvy study participants or those lacking access to necessary technology may result in them being excluded, potentially reducing the diversity of study participants. Adherence to trial protocols and participant retention become more challenging when participants are responsible for remote adherence, requiring innovative strategies to maintain commitment throughout the trial. Lastly, adapting traditional regulatory frameworks to accommodate DCTs poses complexity, especially with studies that span across multiple countries with varying guidelines. We are confident that incorporation of novel technologies, education and thoughtful deployment strategies can overcome such challenges.

Image Source: Canva

About the Author

Catherine Liao

A passionate technologist and entrepreneur known for her intuition, hustle and know how, Catherine Liao has an uncanny ability to recognize the white space where technology can be used to solve unmet needs. At age 19, Catherine got her start in tech working as a systems engineer for one of the first Internet conferencing services in the 90s. That eventually led her to the World Health Organization, where she successfully scaled WHO’s web infrastructure during the peak of the SARS epidemic, when demand for content exploded 20x overnight, topping over 14 million hits a day. As the Chief Strategy of CardieX, Catherine now leads the go-to-market strategy for an innovative global medical devices company specializing in heart health.

Prior to CardieX, Catherine served as the co-founder and CEO of Blumio, a venture-backed startup that developed a wearable sensor for blood pressure monitoring. The company was acquired by CardieX in 2022. Before embarking on her entrepreneurial journey, Catherine worked with some of the world’s largest enterprises, leveraging technology to drive business outcomes for over a decade. At Cisco, she helped commercialize technologies that enhanced the efficiency of business-critical applications, including the timely transmission of medical images, a breakthrough that allowed physicians to make medical decisions without delays. Leading a solutions marketing team at Riverbed, she spearheaded the go-to-market strategy of the company’s application performance platform.

An active leader in the startup community with an MBA from Imperial College London and MSc in Health Economics from London School of Economics, Catherine provides guidance and mentorship to other entrepreneurs as an Executive Mentor for Santa Cruz Accelerates and a Program Lead for the Startup Leadership Program. In her downtime, you’ll likely find Catherine at her favorite wine bar where she is serves as an investor—and chief glass washer.