Wednesday, September 15, 2021 10:48:20 PM
The market for dedicated cardiac PET systems for small and medium cardiology offices won't really open up until F-18 Flurpiridaz gets FDA approval. Flurpiridaz will be able to be bought in individual doses, as opposed to needing to make the significant investment in a Rb-82 generator, where schedules need to be stacked to optimize the per unit dose economics.
There's also the fact that Fluorpiridaz has a long enough half life to have patients perform exercise stress, which most cardiologists prefer over pharmaceutical stress for patients capable of running on the treadmill.
"Treadmill exercise is the preferred mode of stress in patients undergoing radionuclide MPI studies, given the increased clinical information provided by exercise testing variables. An important attribute of flurpiridaz is that it can easily be used in conjunction with exercise treadmill testing, owing to its longer (110 min) half-life of 18F. Although treadmill exercise PET-MPI is feasible using N-13 ammonia, it is not practical and commonly used (26). Exercise rubidium-82 (Rb-82) studies are not performed because of its very short half-life (75 ms). Being able to perform exercise stress has been a distinct advantage of SPECT-MPI over Rb-82 PET. Importantly, in the subset of 228 patients undergoing exercise treadmill testing in this trial, flurpiridaz PET-MPI was statistically superior to SPECT-MPI with respect to sensitivity and overall diagnostic performance as measured by area under the ROC curve."
https://www.sciencedirect.com/science/article/pii/S0735109720355315
The last timeline I heard Lantheus discus the timeline for Flurpiridaz approval was in their second quarter 2020 CC, saying GE expected to complete enrollment in mid-2021, with commercialisation in early 2023.
https://www.fool.com/earnings/call-transcripts/2020/07/30/lantheus-holdings-inc-lnth-q2-2020-earnings-call-t.aspx
But don't take my word for it, look at what the largest dedicated SPECT maker has to say about it:
https://www.digirad.com/flurpiridaz-change-cardiac-pet-imaging/
Hopefully Positron can pick up some key talent from Digirad's cardiology sales and marketing team as they build theirs.
"Our houses are such unwieldy property that we are often imprisoned rather than housed in them." - Henry David Thoreau, Walden: Economy, 1854
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