FocalTherics is on a powerful growth trajectory after rebranding and refocusing on its core focal therapy business, with major wins in revenue, sales, and global expansion. HIFU revenue surged 39% YoY to $13.2M, while Focal One system sales hit an all-time high with 13 units sold globally — up 44%. Their installed base now stands at 184 systems, including 96 in the U.S. and 88 internationally. Major health systems like Cleveland Clinic and Kaiser Permanente are scaling adoption, while international deals include Imperial College London and a new French sale following reimbursement approval. Clinically, they’re advancing with FDA 510(k) submission for remote tech FocalConnect, enabling transcontinental collaboration, and CMS is proposing a 12% HIFU payment bump for 2027. Beyond prostate cancer, they’re expanding into BPH treatments in Latin America and launching their first commercial endometriosis program in Europe — tapping into markets worth over $10 billion.
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