Profound Medical (PROF) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key product, technology, and clinical updates

• Over 3,000 patients treated with MRI-guided, AI-enhanced TULSA for prostate cancer and BPH at 50+ U.S. sites, supported by 67+ publications and 200+ conference presentations.

• AI assistant and Thermal Boost module FDA cleared in May 2024, enabling precise, autonomous ablation with real-time imaging and temperature control; Thermal Boost used in 50% of recent cases.

• Clinical data show minimal side effects, no blood loss, rapid recovery, and near elimination of incontinence and low rates of treatable erectile dysfunction.

• TULSA-PRO covers whole gland, partial, and focal ablation for a wide range of prostate sizes and disease grades.

• CAPTAIN randomized trial comparing TULSA to prostatectomy completed recruitment, with first data expected April 2025.

Market access, reimbursement, and growth

• CMS reimbursement established January 2024, with new permanent AMA CPT codes effective January 2025 at Urology Level 7, the highest for prostate disease treatments.

• Hospital outpatient payment set at $12,992 and ASC payment at $10,728, both exceeding rates for prostatectomy.

• U.S. annual addressable market estimated at 200,000 prostate cancer and 400,000 BPH/hybrid cases, with a combined TAM of $4.8 billion; BPH module to further expand TAM.

• Margins already over 60%, expected to exceed 70% as business scales; 2023–2024 revenue growth rate of 57–60% with expectations for continued high double-digit growth.

• Transition from cash-pay to reimbursement model, supported by growing sales team and top-tier hospital adoption, is expected to drive mainstream adoption.

Industry partnerships and pipeline

• Siemens partnership enables bundled TULSA+MR solution, reducing infrastructure costs and expanding market reach in 2025.

• Pipeline includes FDA HDE-approved pediatric product, phase 1 pancreatic cancer trial, combination immunotherapy trials, and SONALLEVE for solid organ ablation.

• AI module for BPH treatment to be commercialized by summer 2024, with further design completion and broader launch planned for H2 2025.

• Regulatory-cleared products for adenomyosis and uterine fibroids in use in Asia and Europe, with U.S. expansion planned in 12–18 months.

• Ongoing expansion into urology practices, imaging centers, and ASCs, leveraging MRI diagnostics and follow-up integration.