Titan Medical Inc (TMDIF)

[itsallgood11]

company decided to strategically conduct its glp studies first necessitating moving its human factor studies to july/august. the move is not expected to shift its regulatory submission timelines. which remains as follows. : ide approval expected by end of Q3-19. #2 irb approval of 4 sites ( with 1 backup) #3 each site expected to conduct 10 benign hysterectomies .#4 the turnaround time is expected to be a few weeks. #5 510k submission by year end 2019. which will include glp data on acute & chronic pigs. human cadavers studies and human factor studies.
The human factor studies requires a minimum of 34 patients ( company is planning on 40 patients) a composite of 10 endpoints is required for 510k submission, with most endpoints being inta-operative or post -op 30 days. the longest follow up is for "vaginal cuff dehiscence " at 6 weeks.