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Last Update: 27-Mar-13 07:48 ET
Venaxis shares ticking higher pre-market following US study update
Venaxis (APPY $2.37 +0.09) continues to enroll patients into its ongoing pivotal U.S. clinical study of APPY1, as well as make strong progress on its European market development initiatives. CEO Steve Lundy commented, "We identified a number of significant milestones for 2013 and during the recent months have begun achieving them, including initiation of our pivotal study for APPY1, which we anticipate, upon completion, will support filing for regulatory clearance with the FDA. We also obtained CE Marking for APPY1, and we commenced an initial launch of the product for market development purposes in Europe. As we expected, 2013 has been characterized so far by continued progress on these critical initiatives. We are encouraged by our successful execution to date and we plan to remain focused and diligent so that we can reach the important milestones to come." Enrollment into the APPY1 pivotal U.S. clinical study is expected to continue across the 28 participating hospital sites throughout much of 2013. Based on current projections, the Company anticipates completing the study and potentially filing with the FDA for regulatory clearance of APPY1 by year end 2013.
