Endra Life Sciences Inc (NDRA)

[THEMASTERS_SON]

TWO MAJOR PIECES OF NEWS…DUE NOW:#2


Adding limited confirmatory clinical data from a subset of ENDRA’s existing clinical evaluation sites, which is expected to be available in 2022.
"We are very encouraged with FDA’s feedback on our TAEUS System’s safety and performance data as well as their support of a De Novo pathway, which is well-suited to TAEUS’ low-to-moderate risk profile and ENDRA’s desired market claims for our novel technology. ENDRA believes it is now aligned with the FDA on the scope of the limited confirmatory clinical data, which is the primary remaining element needed for a De Novo submission. We are confident that a De Novo request is the strongest path to bring our TAEUS technology to the U.S. market. We believe this process should yield sustainable commercial advantages for our TAEUS platform