Profound(US:PROF)2025-06-25 16:19TULSA-PRO Overview - FDA cleared TULSA-PRO in August 2019, with the first commercial site in January 2020, and AI assistant cleared in May 2024[1] - Over 50 sites have installed TULSA-PRO, treating over 3,000 patients using a patient cash pay business model[1] - New reimbursement codes established by AMA, placed by CMS in urology Level 7, effective January 2025[1] - TULSA-AI Volume Reduction announced at AUA 2025, expanding the applicability of TULSA-PRO[1] Clinical Evidence and Utilization - 99% of patients treated with TULSA-PRO have prostate cancer (PCa), with 28% of those also having low-grade BPH[33] - 53% of ablations performed are whole gland ablations, offering flexibility in treatment[33] - TACT pivotal trial showed a median perfused prostate volume decrease of 91%, from 37 cc to 3 cc, on MRI at 1 year[60] Market and Reimbursement - The total addressable market (TAM) for TULSA is approximately $5 billion, with about 70% in recurring revenue[36] - Medicare reimbursement for TULSA treatment became effective January 1, 2025, classified at Urology Level 7[107] TULSA-AI Volume Reduction - TULSA-AI Volume Reduction uses Volume Customizer and Treatment Arc for BPH symptom relief[54] - TULSA for BPH resulted in a 73% improvement in IPSS symptoms in a Phase I-II study[69]