CardieX expands chronic kidney disease
clinical trial agreement with Bayer

The expanded contract, which is now valued at more than US$2 million, will see CardieX’s subsidiary lease two of its devices and provide expanded data management services for a chronic kidney disease trial that’s taking place across the globe.

CardieX Ltd (ASX:CDX) has secured a second material expansion to its clinical trial with global pharmaceutical company Bayer AG (ETR:BAYN, OTC:BAYZF).

Via subsidiary ATCOR, the ASX-listed health technology company inked amendments with Bayer to add 15 sites and two countries to the CONCORD clinical trial, a study into patients with chronic kidney disease who also have diabetes and/or hypertension.

It means the clinical trial, which harnesses ATCOR’s blood pressure management technology, is now taking place across 84 sites and 13 countries under the existing contract.

The trial expansion adds US$495,000 in revenue to CardieX’s bottom line, while total contracted revenues have surpassed the US$2 million mark.

“Forms basis of competitive differentiation”

Speaking to the trial’s expansion, CardieX managing director and CEO Craig Cooper said: “This further contract amendment and expansion with Bayer continues to validate the unique capabilities of our FDA-cleared SphygmoCor® technology.

“Importantly, it is this technology — that is trusted by the leading global pharmaceutical companies — that forms the basis of our competitive differentiation as we expand into wearables, smart home health devices and other new markets.”

CONCORD clinical trial

CardieX and Bayer first struck up the CONCORD agreement in 2017, establishing a contract under which ATCOR would provide clinical trial lab and data management services, along with devices for the chronic kidney disease trial.

At the time, the contract was worth US$756,000, but when the agreement was amended and expanded in March 2020, its value jumped to US$1.53 million.

Now, that deal has been expanded yet again, with ATCOR set to lease its ATCOR XCEL and Oscar 2 devices to Bayer and provide expanded data management services for the CONCORD trial.

The US$495,000 increase in contract value is tied to a jump in incremental patient visits — up to a combined 2,700 visits from the previously forecast 2,400 — over 15 more sites in two extra countries.

The CONCORD clinical trial is on schedule to conclude by January 2022.

Deepening partnership with Bayer

In today’s ASX announcement, CardieX reported the contract expansion aligns with its expectations around further positive amendments.

This is in respect of the ASX-lister’s other contracted trials with Bayer — in addition to new contracts in the immediate future – which together pose the opportunity to secure new incremental revenue over FY21 and FY22.

The CONCORD trial is one of two major ongoing trials that ATCOR currently has under contract with Bayer, the other of which is the NEON trial.

A third Bayer clinical study, the AVANTI heart failure trial, recently concluded on schedule.

Spotlight on ATCOR technology

ATCOR’s XCEL device is the only Food and Drug Administration-cleared device for measuring the central aortic waveform and reporting on associated clinical data in all adult subjects.

XCEL is used by clinicians, research institutions and pharmaceutical companies to monitor critical hemodynamic data during patient treatment and drug trials in multiple clinical settings and for multiple disease states.