On February17, 2017, the Registrant received FDA's IDE approval letter which authorized the Registrant to begin a new 10-patient feasibility study to be conducted at up to 5 sites rather than the October 14, 2016 FDA approval for only one site. The FDA approval for expanding the study should expedite the Registrant's ability to enlist patients for the study. The Registrant plans to submit a safety report with the FDA following which we intend to proceed with a trial, which contemplates testing the BST Device with 90 patients
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