March 13, 2018 11:56am
Shares jump +$0.22 or +8.24% to $2.89
BTX “submitted” a design dossier application for CE Mark approval to market Renevia® in Europe. BioTime anticipates CE Mark approval in the second half of 2018.
It’s definitely a milestone for BTX made available by the clinical performance of Renevia, as demonstrated in the pivotal trial. There is still the issue of U.S approval?
- The CE Mark application was based on Renevia® successfully meeting its primary endpoint with treated patients retaining approximately 100% of transplanted volume at six months.
- In addition to strong product performance at 6 months, treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months.
- All Renevia® transplants were shown to be generally well tolerated and there were no device-related serious adverse events noted during this trial.
Enjoy the upside while it lasts, wait for Q4 and FY17 numbers and cash position to displace the news on 3/15 …