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BioTime (NYSEMKT: BTX) Submits CE Mark Application for EU Approval of Renevia®

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 …

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