The Vancouver-based company said it closed out the Phase I requirements for the 115-patient Tiara-II trial in the U.K. and Germany, after several reviews. The Clinical Events Committee looked at adverse events, the Data & Safety Monitoring Board reviewed the data and government regulatory and ethics committees reviewed the interim clinical report on 20 patients.
Neovasc said the approval means Tiara-II can proceed in those countries with no restrictions.
“The Neovasc team is excited about the positive news from the governmental healthcare authorities in Germany and the U.K., as well as from the independent ethics committees in both countries. After their review of the submitted, detailed results of the first 20 Tiara implants, we received all required approvals to continue this Tiara-II clinical study into the second and final phase of full enrollment, without further restrictions,” president & CEO Fred Colen said in prepared remarks.
NVCN shares were up 7.5% to 72.92¢ today in mid-afternoon trading.
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