T2 Biosystems’ recent Breakthrough Device designation by the FDA isn’t an acknowledgement of the device’s effectiveness or clinical value proposition, only that it diagnoses life-threatening conditions.
The T2Dx Instrument adds additional hospital expense but provides little clinical value, hence the miniscule sales numbers.
The value of the T2Bacteria test is low because it does not measure bacterial susceptibility to antibiotics and, therefore, does not change clinical practice. Other similar technologies have been flops.
In every 2018 quarter, TTOO’s unsustainable research revenue was higher than its much more important product revenue.
TTOO has $44M in debt, paying interest at an usurious 12.5% rate.
Read the entire article on Seeking Alpha here.