Core Viewpoint - InspireMD, Inc. has established its global headquarters in Miami, Florida, in preparation for the anticipated U.S. launch of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval [1][2]. Company Developments - The new headquarters is a strategic move to support the potential FDA approval of CGuard Prime and to build a world-class commercial and operational team [2]. - The South Florida location is chosen for its rich history in medical device innovation, providing access to talent and resources necessary for the company's growth [2]. Product and Market Strategy - InspireMD is focused on building its marketing, training, and sales operations teams in South Florida to create a robust U.S. commercial organization [3]. - The company has submitted the final module of its Premarket Authorization (PMA) application to the FDA for the CGuard Prime carotid stent system [3]. Technology and Vision - InspireMD aims to utilize its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing outstanding acute results and durable, stroke-free long-term outcomes [4].
InspireMD Announces Establishment of Global Headquarters in Miami, Florida to Support Anticipated U.S. Launch and Commercialization of the CGuard Prime Carotid Stent System