Fresenius Medical Care AG "Weekend data keeps Theranova commercially relevant"

Research evidence excerpt

Fresenius Medical Care AG "Weekend data keeps Theranova commercially relevant"

redible alternative, potentially limiting

expected gains in FME market share and equipment sales.

What is the MOTheR HDx trial?

Theranova is a novel dialyser (consumable filter within a dialysis machine) that allows a

traditional dialysis machine to better remove middle sized molecules. The MOTheR HDx

study trials Theranova against online-HDF (OL-HDF) which, based on our analysis, is very

similar to HV-HDF which is being rolled out by FME.

Why did we think this could impact the HV-HDF prospects?

We believe HV-HDF is a clear positive for FME and should help US volumes. However,

Theranova could be a viable alternative for other providers and has benefits including:

less training, no additional capex, a more flexible cost approach, and no need for

infrastructure change. This could mean that FME is less likely to gain volume share from

competitors, and it may reduce external demand for the 5008X vs. initial expectations.

What were the results from the weekend?

Based on the abstract published by Ortiz et al, we believe the key results were as follows:

The study met its primary endpoint: HDx (Theranova) was shown to be non-

inferior to OL-HDF in reducing combined outcome of all-cause death and stroke

(ischemic or hemorrhagic), acute coronary syndrome (angina and myocardial

infarction), peripheral arterial disease (amputation or revascularization) and

ischemic colitis (mesenteric thrombosis). The study delivered a hazard ratio of 0.87

and was statistically significant with a p value of 0.011. The hazard ratio

confidence interval of 0.63 to 1.19 was wide but this is a non-inferiority study.

The study did not show statistically significant non inferiority on all cause