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Proceeds from the financing will enable JenaValve to complete the Company’s investigational device exemption (IDE) premarket approval (PMA) study to obtain FDA approval for its Trilogy Heart Valve System, a treatment for high surgical risk patients with symptomatic, severe aortic regurgitation (AR). In addition, JenaValve will use the proceeds to bolster its real-world data development initiatives in Europe, as well as to expand its worldwide manufacturing capabilities. JenaValve received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its premarket approval (“PMA”) application for the Trilogy Heart Valve System for the treatment of symptomatic, severe aortic regurgitation (AR) in high surgical risk patients. “JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe aortic regurgitation, addressing an estimated multi-billion-dollar U.S. market opportunity.
CaliforniaHealthcare