Cardiex’s CONNEQT Pulse included on the US Blood Pressure Validated Device List

CONNEQT Pulse vascular biometric monitor now officially included on the US Blood Pressure Validated Device List (VDL).
CONNEQT Pulse is the only connected vascular biomarker monitor with central blood pressure, heart stress, arterial stiffness, and other novel cardiovascular parameters on the VDL.
CONNEQT Pulse monitors heart health with the same accuracy as a hospital monitor.
Groundbreaking biometric monitor for both clinicians and consumers based on 20+ years of innovation and market leadership.
FDA-cleared device will launch in the US next quarter.

Cardiex (ASX: CDX) has achieved a significant milestone with its CONNEQT Pulse vascular biometric monitor now officially included on the US Blood Pressure Validated Device List (VDL). The endorsement underscores the clinical precision and reliability of the CONNEQT Pulse device, bolstering its credibility among healthcare professionals and consumers ahead of its US market launch next quarter.

The FDA-cleared CONNEQT Pulse transcends conventional blood pressure monitors by measuring central blood pressure (the pressure in the arteries near the heart), arterial stiffness (how flexible your arteries are), heart stress, and pressures felt at the major organs (e.g. heart, brain, kidneys) – all together providing a more comprehensive assessment of cardiovascular health.

Unlike traditional invasive methods that required a catheter in the heart, the CONNEQT Pulse offers a non-invasive solution for clinicians and patients to access and obtain insights from novel vascular biomarkers and is currently the only connected biomarker monitor with central blood pressure, heart stress, vascular organ pressures, and arterial stiffness parameters on the US VDL. The underlying SphygmoCor technology in the CONNEQT Pulse has been utilised in 47 clinical trials with global pharmaceutical giants like GlaxoSmithKline, AstraZeneca, Bayer, and Novartis – adding to its robust clinical foundation and market opportunity.

In addition, the CONNEQT Pulse is also the first fully programmable and personalised biometric monitor that can be customised by patients or physicians depending on specific therapeutic use cases. When combined with the CONNEQT app and CONNEQT’s patient management tools the CONNEQT Pulse provides a more comprehensive suite of solutions for patient care, remote patient monitoring, and the management of participants in decentralised clinical trials.

For healthcare professionals, the CONNEQT Pulse is also a crucial tool for improving patient outcomes by detecting potential health issues early, enabling timely interventions to prevent serious conditions and reducing the need for emergency care or invasive procedures.

Cardiex CEO Craig Cooper emphasised the significance of the VDL inclusion:

“Joining the VDL highlights our commitment to providing healthcare professionals and patients with cutting-edge technology that offers precise, reliable, and novel cardiovascular health monitoring,” he said.

“As we prepare for the US market launch, we’re confident that the CONNEQT Pulse will play a pivotal role in enhancing patient care and outcomes.”

Tackling hypertension

Cardiovascular diseases are the leading cause of death globally, according to the World Health Organization (WHO), with complications arising from hypertension playing a significant role.

In the US, cardiovascular disease remains the leading cause of mortality, presenting a substantial opportunity for Cardiex.

“About half the adult population in the US is now considered hypertensive. Other major markets for us include Alzheimer’s and dementia, kidney disease, and heart failure, because arterial stiffness and inflammation are significant indicators for those health conditions,” Cooper said.

“Importantly, our devices can determine if you need to be in a treatment program for hypertension and multiple other health conditions, even when traditional blood pressure monitors suggest otherwise,” Cooper added.

Countdown to Launch

Cardiex is well-funded to support the launch of the Pulse device in Q1 FY 2025. The company recently completed an institutional placement and entitlement offer, raising $8 million, along with a funding commitment agreement from the investment vehicle of CEO (Cooper) and chairman (Niall Cairns) providing an additional $6 million during 2024, pending shareholder approval.

This article was developed in collaboration with Cardiex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.