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Friday, December 08, 2017 2:55:44 PM
Lexington’s President Eric Willis comments, “As recently announced, we are moving ahead quickly towards the commencement of our HeartSentry pilot clinical research study designed to build the foundational dataset ultimately aimed at supporting FDA clearance. As we plan for market entry, we know that a key element to commercial success will come from fielding a product that meets the threshold for medical insurance coverage. Regulatory approval rarely guarantees payment coverage for new devices, so we are undertaking what we believe is the prudent strategy of beginning that process today. We are delighted to have the opportunity to work with the Navigant team and feel certain the advice and direction we receive will prove invaluable towards providing HeartSentry the best strategy for market introduction.”
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