ASX Health Stocks: CardieX jumps 16pc after FDA clearance; 3 other ASX biotechs to commence trials

CardieX jumps 16pc after getting FDA clearance for CONNEQT Pulse
CONNEQT Pulse is a world first multi-use vascular biometric monitor
Three ASX biotechs received clearance to commence studies

Health devices and wearables tech company CardieX (ASX:CDX) surged by more than 16% this morning after saying that the US FDA has granted 510(k) clearance for its CONNEQT Pulse vascular biometric monitor.

The CONNEQT Pulse is a world-first multi-use vascular biometric monitor that provides measurements of both brachial blood pressure (the pressure at your arm), and central blood pressure (the pressure at your heart/aorta), along with arterial waveform analysis and other unique vascular biomarkers.

It incorporates CardieX subsidiary ATCOR’s market-leading SphygmoCor central blood pressure technology.

Unlike CardieX’s existing suite of products, the Pulse is a “stand-alone” medical device in a form factor that is easy to use and operate without requiring specialist training.

Research shows that central aortic pressures (the pressure in the aorta/heart) can be considered as having independent and higher predictive value for the consequences of hypertension such as heart disease, stroke, vascular disease and kidney failure relative to traditional brachial blood pressure.

Heart disease is indeed the number one killer in the US, with one person dying every 34 seconds according to the CDC.

And under the newest guidelines, which were revised in 2018, nearly half of all American adults now meet the criteria for high blood pressure (defined as a reading over 130/80 mmHG).

CardieX says the FDA’s 510(k) clearance of the CONNEQT Pulse has the potential to dramatically help stem this epidemic by improving access to remote patient monitoring with advanced biometric insights.

“CONNEQT Pulse’s 510(k) clearance by the FDA marks a major milestone in the field of cardiovascular health management,” said CEO Craig Cooper.

“This technology has the potential to truly revolutionise the way hypertension and vascular disease is diagnosed and managed in the future,” he added.

CardieX share price today:

Trial commencement approvals for these 3 ASX biotechs

Meanwhile, three biotech companies have received approvals to commence their clinical trials.

PYC Therapeutics (ASX:PYC) rose 8% after receiveing Institutional Review Board approval to commence the first ever clinical study for the treatment of Retinitis Pigmentosa type 11 (RP11).

PYC will now commence the process to enrol patients in the study, and anticipates first patient dosing before the end of May.

RP11 is a progressive and irreversible blinding eye disease affecting ~1 in every 100,000 children. There are no treatment options currently available for patients with RP11, which represents an estimated >$1 billion annual addressable market.

Chimeric Therapeutics (ASX:CHM) is also set to commence its Phase 1B clinical trial of CHM 1101 after receiving approval from the ethics review board.

This approval will see Chimeric leading a two-part Phase 1B clinical study, enrolling patients with recurrent and/or progressive GBM (glioblastoma multiforme) at multiple clinical trial sites.

Part A of the trial will treat 3-6 patients, completing the Phase 1 CHM 1101 dose escalation/confirmation study that was initiated at City of Hope Cancer Centre in LA.

Part B of the trial will be a dose expansion cohort designed to enrol 12-26 patients with recurrent and/or progressive GBM using the recommended Phase 2 dosing plan, and assessing for efficacy and safety.

Upon successful completion of the Part B dose expansion cohort, a registration trial will be initiated in alignment with regulatory feedback.

Meanwhile, Antisense Therapeutics (ASX:ANP) has also received both regulatory authority and ethics committee approval to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD) in Bulgaria.

The Bulgarian approval follows similar approval received in Turkey in February this year.

Antisense also expects to conduct the trial at sites in Australia. After undergoing the ethics assessment, the company has received requests for clarification and is now preparing a response.