Blood Pressure Breakthrough: CardieX gets FDA green light for world-first vascular biometric monitor

The world’s first, customisable vascular biometric monitor has received regulatory clearance to provide medical grade arterial heart health metrics to patients and clinicians.

The CONNEQT Pulse arterial health monitor, has received 510(K) clearance from the US Food and Drug Administration (FDA), in a solid boost to get CardieX Limited (ASX:CDX) moving on the massive US health care market.

Pulse is the only vital signs monitor targeted at home, clinician, and clinical trial use that provides measurements of both brachial blood pressure (the pressure at your arm) and central blood pressure (the pressure at your aorta/heart) in addition to multiple other vascular health biomarkers.

The CardieX CONNEQT Pulse arterial health monitor has been granted 501k approval by the US FDA. Pic: Supplied (CDX).

The device incorporates CardieX’s patented SphygmoCor® technology, the market leader in central blood pressure and non-invasive arterial waveform analysis for over 20 years.

Pulse provides heart health insights previously only available in hospitals, research institutions and clinical trials reporting on a panel of heart and vascular biomarkers not available in traditional blood pressure monitors. It uses the same pulse wave analysis technology used by cardiologists to predict arterial pressure where it matters most: at the aorta.

US FDA clearance a game changer

FDA clearance means the company’s SphygmoCor technology can now be expanded to be used in decentralised clinical trials, remote patient monitoring, and for self-monitoring at home.

The Pulse’s vascular biomarker reporting enables clinicians and patients to have a more precise and personalised view of vascular health to better inform treatment options and superior outcomes.

The patented, non-invasive central aortic waveform technology measures key indicators of vascular health including central blood pressure, arterial stiffness, and additional vascular biomarkers, such as subendocardial viability ratio, medical grade heart rate (similar to readings obtained in an ICU/hospital setting), central pulse pressure, augmentation pressure and augmentation index.

It enables providers to monitor a patient’s vascular biomarkers without requiring patients to leave the comfort of their homes, as well as enabling clinical trial managers to remotely manage trial participants without having them travel to a clinical trial site.

Affordable price point

The FDA’s clearance of the Pulse democratises CardieX’s market leading SphygmoCor technology by bringing deep vascular insights and clinically relevant heart health metrics to market at a price point that is now affordable to all.

CardieX Group CEO Craig Cooper said the FDA approval marks a major milestone in the field of cardiovascular health management.

“We are thrilled to offer individuals with hypertension and other vascular diseases an innovative new way to monitor their arterial health at home with the same tools the country’s top cardiologists use in their research facilities and clinics,”he said.

“At launch, there won’t be any other vital signs monitor that provides the level of features, personalization, or vascular health insights that will be available on the Pulse. This technology has the potential to truly revolutionise the way hypertension and vascular disease is diagnosed and managed in the future.”

Doctors can prescribe Pulse to patients who need to monitor their heart health. Patient data automatically syncs to the CONNEQT Patient Management Portal (CPMP), a cloud-based HIPAA-compliant patient management tool.

This allows health care professionals to remotely monitor a patients’ arterial health. In addition, consumers and patients can access deep arterial health insights, as well as coaching, lifestyle programs, and other health tools, through the CONNEQT app.

The FDA approval continues a pivotal year for the company which recently completed a $4.5 million placement earlier in the year, strongly backed by several institutional investors, and is preparing for a potential dual listing on a US exchange.

This article was developed in collaboration with CardieX Limited, 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.