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Monday, March 28, 2016 1:03:37 PM
1)application of CE mark, FDA submission, and clinical trial delayed by a quarter. Commercialization outside US Q1 2017 and in US Q3 2017.
2) the five in-human units are now referred to as extended verification units (EEVs)which have been completed and will be used for optimization trials and cadaver studies in Q2 2016. Quote: The cadaver studies are expected to provide more comprehensive and higher quality information in a shorter time period and to have the potential to enable earlier regulatory submission to the FDA.
3) Money for 3-4 months if the offering is fully filled. Another 11 million still needed to operate till the end of 2016.
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