Followers | 45 |
Posts | 7008 |
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Alias Born | 02/24/2004 |
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Thursday, November 30, 2017 11:48:28 AM
http://secfilings.nasdaq.com/filingFrameset.asp?FilingID=11926477&RcvdDate=3/13/2017&CoName=VERICEL%20CORP&FormType=10-K&View=html
We completed enrolling and treating patients in our completed Phase 2b ixCELL-DCM study in February, 2015. Patients were followed for 12 months for the primary efficacy endpoint of MACE. On March 10, 2016, we announced the trial had met its primary endpoint of reduction in clinical cardiac events and that the incidence of adverse events, including serious adverse events, in patients treated with ixmyelocel-T was comparable to patients in the placebo group. Patients are now being followed for an additional 12 months for safety. Because the trial met the primary endpoint, patients who received placebo or were randomized to ixmyelocel-T in the double-blind portion of the trial but did not receive ixmyelocel-T have been offered the option to receive ixmyelocel-T. We successfully treated the last patients in February 2017 and the last follow-up visit will occur approximately one year later.
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