Ann: FDA Supports Accelerated Approval Pathway for Heart Failure, page-461

Another thought about ischaemic vs non-ischaemic end-stage HF patients to add to my replies to Daniel over the weekend. Every year 100,000 patients progress to end-stage HFrEF in the US. Over 2,500 receive an LVAD and 80% of those are permanent (some are followed by a heart transplant), and most of those 80% are ischaemic. Ischaemic patients' prognosis is poor - they have a 76% lower likelihood of LV functional recovery following LVAD and increased mortality over the first 1-2 years. This resistance to functional recovery is thought to be due to excessive inflammation and microvascular insufficiency in the ischaemic myocardium.Ischaemic patients are generally older and with co-morbidities such as diabetes, thereby closely resembling those in the 566 patient DREAM-HF trial.If we had something to reduce the excessive inflammation and improve the microvascular insufficiency, the ischaemic majority of those receiving LVADs should have much better chance of LV functional recovery and decreased mortality. Enter Mesoblast.The LVAD trial had a much lower than normal proportion of ischaemic patients who had received LVADs - only 70 of 159 were ischaemic, whereas normally most of the 80% permanent LVAD recipients would be ischaemic. So, the subgroups were 44% ischaemic, 56% non-ischaemic.I don't have the full numbers, but I suspect that of the 70 ischaemics there would've been 42 receiving MPCs and 28 Controls (41 and 26 of these were then reported after 2 months).

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Aloha.